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MINDRAY Clinical Chemistry Solutions

PRODUCT LIST A. Biochemistry Reagents .................................................................................................................................. 4

1. Hepatic .................................................................................................................................................... 4 1.1 ALT (Alanine Aminotransferase) ..................................................................................................... 4 1.2 AST (Aspartate Aminotransferase) ................................................................................................. 5 1.3 GGT (gamma-Glutamyltransferase) ............................................................................................... 7 1.4 ALP (Alkaline Phosphatase) ........................................................................................................... 8 1.5 ALB (Albumin) .............................................................................................................................. 10 1.6 TP (Total Protein) ......................................................................................................................... 11 1.7 Bil-D (Bilirubin Direct, VOX Method) ............................................................................................ 13 1.8 Bil-D (Bilirubin Direct, DSA Method) ............................................................................................. 14 1.9 Bil-T (Bilirubin Total, VOX Method) ............................................................................................... 15 1.10 Bil-T (Bilirubin Total, DSA Method) ............................................................................................. 17 1.11 PA (Prealbumin).......................................................................................................................... 18 1.12 TBA (Total Bile Acids) ................................................................................................................. 19 1.13 CHE (Cholinesterase) ................................................................................................................ 21

2. Renal ..................................................................................................................................................... 22 2.1 Crea (Creatinine, Sarcosine Oxidase Method) ............................................................................. 22 2.2 Crea (Creatinine, Modified Jaffé Method)..................................................................................... 24 2.3 Urea/BUN (Blood Urea Nitrogen) ................................................................................................. 25 2.4 UA (Uric Acid) ............................................................................................................................... 27 2.5 CO2 (Carbon dioxide) ................................................................................................................... 29

3. Cardiac .................................................................................................................................................. 30 3.1 CK (Creatine Kinase) ................................................................................................................... 30 3.2 CK-MB (Creatine Kinase-MB Isoenzyme) .................................................................................... 32 3.3 a-HBDH (α-Hydroxybutyrate dehydrogenase) ............................................................................. 34 3.4 LDH (Lactate Dehydrogenase) ..................................................................................................... 35 3.5 HCY (Homocysteine) ................................................................................................................... 36

4. Lipids ..................................................................................................................................................... 38 4.1 Apo A1 (Apolipoprotein A1) .......................................................................................................... 38 4.2 Apo B (Apolipoprotein B) .............................................................................................................. 39 4.3 Lp(a) (Lipoprotein(a)) ................................................................................................................... 41 4.4 HDL-C (High Density Lipoprotein - Cholesterol) ........................................................................... 42 4.5 LDL-C (Low Density Lipoprotein - Cholesterol) ............................................................................ 44 4.6 TC (Total Cholesterol) .................................................................................................................. 45 4.7 TG (Triglycerides) ......................................................................................................................... 47

5. Diabetes ................................................................................................................................................ 48 5.1 Glu (Glucose, HK method) ........................................................................................................... 48 5.2 Glu (Glucose, GOD-POD Method) ............................................................................................... 50 5.3 HbA1c (Hemoglobin A1c) ............................................................................................................. 51 5.4 FUN (Fructosamine) ..................................................................................................................... 53

6. Pancreatitis ........................................................................................................................................... 55 6.1 α-AMY (alpha-Amylase) ............................................................................................................... 55 6.2 LIP (Lipase) .................................................................................................................................. 57

7. Inorganic ions ........................................................................................................................................ 58 7.1 Ca (Calcium) ................................................................................................................................ 58 7.2 Mg (Magnesium) .......................................................................................................................... 60 7.3 P (Phosphorus) ............................................................................................................................ 61 7.4 Fe (Iron) ....................................................................................................................................... 62

8. Immune ................................................................................................................................................. 64 8.1 Ig A (Immunoglobulin A) ............................................................................................................... 64 8.2 Ig G (Immunoglobulin G) .............................................................................................................. 66 8.3 Ig M (Immunoglobulin M) ............................................................................................................. 67 8.4 C3 (Complement C3) ................................................................................................................... 69 8.5 C4 (Complement C4) ................................................................................................................... 70 8.6 CRP (C-reactive Protein) .............................................................................................................. 72 8.7 RF (Rheumatoid Factor) .............................................................................................................. 73 8.8 ASO (Antibodies Against Streptolysin O) ...................................................................................... 74

B. Calibrator & Quality Control ......................................................................................................................... 76 1. Calibrator ............................................................................................................................................... 76

1.1 Multi Sera Calibrator .................................................................................................................... 76 1.2 Lipids Calibrator ........................................................................................................................... 77 1.3 Specific Proteins Calibrator .......................................................................................................... 78 1.4 CK-MB Calibrator ......................................................................................................................... 79 1.5 Lipoprotein(a) Calibrator .............................................................................................................. 80 1.6 Prealbumin Calibrator .................................................................................................................. 80

2. Quality Control ...................................................................................................................................... 81 2.1 Multi Control Sera N ..................................................................................................................... 81 2.2 Multi Control Sera P ..................................................................................................................... 82 2.3 Lipids Control N ............................................................................................................................ 83 2.4 Lipids Control P ............................................................................................................................ 84 2.5 HDL&LDL Cholesterol Control P .................................................................................................. 84 2.6 Specific Proteins Control N .......................................................................................................... 85 2.7 Specific Proteins Control P ........................................................................................................... 86 2.8 CK-MB Control N ......................................................................................................................... 86 2.9 CK-MB Control P .......................................................................................................................... 87 2.10 Lipoprotein(a) Control N&P ........................................................................................................ 87 2.11 Prealbumin Control N&P ............................................................................................................ 88

ALT

LDH

A. Biochemistry Reagents

1. Hepatic

1.1 ALT (Alanine Aminotransferase)

Order Information

Cat. No. Package size

ALT0102 R1 4×35 mL + R2 2×18 mL

ALT0103 R1 6×40 mL + R2 2×32 mL

ALT0104 R1 6×60 mL + R2 3×32 mL

ALT0105 R1 2×250 mL + R2 1×125 mL

Clinical significance Alanine aminotransferase (EC 2.6.1.2, ALT), formerly called Glutamic Pyruvic Transaminase (GPT), is one of liver-specific

enzymes. It can catalyze the interconversion of amino acids and α-ketoacids by transfer of amino groups. Elevated ALT levels can

indicate myocardial infarction, muscular dystrophy, especially in hepatobiliary diseases. Measurement of ALT is often used in

diagnosis and monitoring treatment of liver diseases and heart diseases. The AST/ALT ratio is often used for differential diagnosis

in liver diseases: if the AST/ALT ratio < 1, it indicates mild liver damage; otherwise it is associated with severe, often chronic liver

diseases.

Method UV-assay according to IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) without pyridoxal

phosphate activation.

Reaction Principle

α-oxoglutarate + L-alanine L-glutamate + pyruvate

pyruvate + NADH + H+ L-lactate + NAD+

Alanine aminotransferase catalyzes the reversible transamination of L-alanine and α-oxoglutarate to pyruvate and L-glutamate.

The pyruvate is then reduced to lactate in the presence of lactate dehydrogenase (LDH) with the concurrent oxidation of reduced

β-nicotinamide adenine dinucleotide (NADH) to β-nicotinamide adenine dinucleotide (NAD). This change in absorbance is directly

proportional to the activity of ALT in the sample.

Reagent Components and Concentrations

R 1 TRIS buffer 150 mmol/L

L-Alanine 750 mmol/L

LDH ≥1200 U/L

R 2 α-oxoglutarate 90 mmol/L

NADH 0.9 mmol/L

Storage and Stability Stable up to expiry date indicated on the label, when stored unopened at 2℃－8℃ and protected from light.

Once opened, the reagent is stable for 28 days when refrigerated on the analyzer or refrigerator.

Contamination of the reagents must be avoided.

Do not freeze the reagents.

Assay procedure

Blank Sample

Reagent 1 1000 μL 1000 μL

Dist water 100 μL －

Sample － 100 μL

Mix, incubate for 5 min, then add:


Mix thoroughly, read the absorbance after 1 min and monitor time. Read the absorbance again for additional 3 min.

ΔA/min = [ΔA/min sample]- [ΔA/min blank]

Reference Intervals

Sample Type Conventional Units S.I.Units

Male ≤45 U/L ≤0.75 μkat/L

Female ≤34 U/L ≤0.57 μkat/L

Reportable Range


Serum / Plasma 4－500 U/L 0.07－8.33 μkat/L

If the value of sample exceeds 500 U/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+ 9) and repeat the assay

using this dilution, the result should be multiplied by 10.

1.2 AST (Aspartate Aminotransferase)

Order Information


AST0102 R1 4×35 mL + R2 2×18 mL

AST0103 R1 6×40 mL + R2 2×32 mL

AST0104 R1 6×60 mL + R2 3×32 mL

AST0105 R1 2×250 mL + R2 1×125 mL

Clinical significance

AST

MDH

Aspartate aminotransferase (EC 2.6.1.1, AST)，formerly called Glutamic Oxalacetic Transaminase (GOT), is present in both

cytoplasm and mitochondria of cells，belonging to the transaminase family, which catalyze the conversion of amino acids and

α-oxoglutarate by transfer of amino groups. AST is commonly found in various human tissues. The heart muscle is found to have

the most activity of the enzyme, secondly in the brain, liver, gastric mucosa, skeletal muscle and kidneys. The serum AST present

low activity in the healthy human body, but when these tissues injury or damage, AST is released into blood and results in high

blood AST activity. Measurement of AST in serum and plasma is mainly used for the diagnosis of heart muscle damages, liver

damages and skeletal muscle diseases as well as for monitoring the treatment. The AST/ALT ratio is often used for differential

diagnosis in liver diseases. While the ratio < 1, it indicates mild liver damage, otherwise it is associated with severe, often chronic

liver diseases.

Method

UV-assay according to IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) without pyridoxal

phosphate activation.

Reaction Principle

L-aspartate + α-oxoglutarate oxaloacetate + L-glutamate

oxaloacetate + NADH + H+ L-malate + NAD+

(MDH－Malate dehydrogenase，EC1.1.1.37)

In the assay reaction, the AST catalyzes the reversible transamination of L-aspartate and α-oxoglutarate to oxaloacetate and

L-glutamate. The oxaloacetate is then reduced to malate in the presence of malate dehydrogenase with NADH being oxidized to

NAD+. The rate of the photometrically determined NADH decrease is directly proportional to the rate of formation of oxaloacetate

and thus the AST activity.

Reagents Components and Concentrations

R 1：

TRIS buffer 100 mmol/L

L-aspartate 300 mmol/L

LDH ≥900 U/L

MDH ≥600 U/L

R 2： α-oxoglutarate 60 mmol/L

NADH 0.9 mmol/L





Assay procedure

Blank Sample


GGT


Sample － 100 μL





Reference Intervals

Sample Type Conventional Units S.I. Units

Male ≤35 U/L ≤0.58 μkat/L

Female ≤31U/L ≤0.52 μkat/L

Reportable Range





1.3 GGT (gamma-Glutamyltransferase)

Order Information


GGT0102 R1 4×35 mL + R2 2×18 mL

GGT0103 R1 6×40 mL + R2 2×32 mL

GGT0104 R1 6×60 mL + R2 3×32 mL

GGT0105 R1 2×250 mL + R2 1×125 mL

Clinical significance Gamma-Glutamyltransferase (EC 2.3.2.2, GGT) is a transferase, widely distributed in tissues, particularly in the liver, pancreas,

kidney and spleen. The measurement of GGT is often used in the diagnosis and monitoring of hepatobiliary diseases. Increased

GGT activity can indicate the damage of hepatobiliary tissue. GGT test is also a sensitive screening test for occult alcoholism.

Method UV-assay for the quantitative determination of gamma-glutamyltransferase (GGT) according to Szasz.

Reaction Principle

L-γ-glutamyl-3-carboxy-4-nitroanilide + glycyl-glycine L-γ-glutamyl- glycyl-glycine + 5-amino-2-nitrobenzoate

Gamma-glutamyltransferase transfers the gamma-glutamyl group of gamma-glutamyl-3-carboxy-4-nitroanilide to glycyl-glycine

with the production of p-nitroaniline. The amount of 5-amino-2-nitrobenzoate results in the elevated absorbance which is directly

proportional to the activity of GGT in the sample.



Glycyl-glycine 150 mmol/L

R 2 L-γ-glutamyl-3-carboxy-4-nitroanilide 20 mmol/L





Assay procedure

Blank Sample



Sample － 100 μL





Reference Intervals


Male <49 U/L <0.82 μkat/L

Female <32 U/L <0.53 μkat/L

Reportable Range





1.4 ALP (Alkaline Phosphatase)

Order Information


ALP0102 R1 4×35 mL + R2 2×18 mL

ALP0103 R1 6×40 mL + R2 2×32 mL

ALP0104 R1 6×60 mL + R2 3×32 mL

ALP0105 R1 2×250 mL + R2 1×125 mL


Alkaline phosphatase, a hydrolytic enzyme acts optimally at alkaline pH, is formed in liver and is existed in almost all tissues of the

body. Under some conditions, such as gestation, budding children, high alkaline phosphatase activities are normal physiological

phenomenons. Pathologic high alkaline phosphatase activities may exist in hepatobiliary diseases, bone diseases, bone

metastases and hyperparathyroidism. Decreased activity occurs uncommonly and is only observed in about 0.2% old people.

Method

International Federation of Clinical Chemistry and Laboratory Medicine（IFCC） modified method

Reaction Principle

p-Nitrophenyl phosphate + H2O p-Nitrophenol + Pi

By the action of ALP and magnesium ions, p-Nitrophenyl phosphate is catalysed to p-Nitrophenol, and the absorbency increase is

directly proportional to the activity of ALP.

Reagents Components and concentrations

R1：

AMP buffer 435 mmol/L

Magnesium acetate 2.5 mmol/L

Zinc sulfate 1.2 mmol/L

R2： p-Nitrophenyl phosphate 60 mmol/L

Storage and stability Up to expiration date, when stored unopened at 2-8℃and protected from light.

Once opened, the reagents are stable for 28 days when refrigerated on the analyzer or refrigerator.



Assay procedure

Blank Sample


Dist. water 20 μL －

Sample － 20 μL

Mix, incubate for 2 min. at 37℃, then add:


Mix thoroughly, incubate at 37℃ for 1 min.,

and then read the absorbance change value within 3 min.


Reference Intervals

Sample Type Conventional Units

Female Male

Serun/ 1-30day 75-316 U/L 48-406 U/L

ALP

Mg2+

Nonionic surfactant

pH=4.2

Plasma 1month-1year 82-383 U/L 124-341 U/L

1-3year 104-345 U/L 108-317 U/L

4-6year 93-309 U/L 96-297 U/L

7-9year 86-315 U/L 69-325 U/L

10-12year 42-362 U/L 51-332 U/L

13-15year 74-390 U/L 50-162 U/L

16-18year 52-171 U/L 47-119 U/L

>18year 30-120 U/L

Reportable Range


Serum / Plasma 5-800 U/L 0.08-13.33 μkat/L

If the value of sample exceeds 800 U/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+5) and rerun; the result

should be multiplied by 6.

1.5 ALB (Albumin)

Order Information


ALB0102 R 4×40 mL

ALB0103 R 6×40 mL

ALB0104 R 6×60 mL

ALB0105 R 4×250 mL


Albumin is an essential binding and transport protein, which is an important carrier for various substances and main contributor for

the plasma colloid osmotic pressure.

Albumin levels in serum or plasma is used for monitoring of liver diseases (e.g. liver cirrhosis) and kidney diseases (e.g. nephrotic

syndrome), judging the degree of hydropsy.

Furthermore, according to detecting the plasma albumin level, the nutritional status of patients and prognosis of elderly inpatients

is attained.

Method

Bromcresol green（BCG）method

Reaction Principle

BCG + Albumin Glaucous complex

At a slightly acid pH (pH=4.2), serum albumin combines with bromcresol green to produce a glaucous complex. The absorbency

increase is directly proportional to the concentration of albumin.


R：

Citrate buffer 30 mmol/L

Bromocresol green 0.26 mmol/L

Surfactant 1.5 g/L

Storage and stability Up to expiration date indicated on the label, when stored unopened at 2-8℃ and protected from light.


Contamination of the reagent must be avoided.

Do not freeze the reagent.

Assay procedure

Blank Sample

R 1000 μL 1000 μL


Sample － 10 μL

Mix thoroughly at 37℃, and read the absorbance 5 min. later.

ΔA = [ΔA sample]- [ΔA blank]

Reference Intervals

Sample Type S.I. Units

Serum / Plasma

Newborn 35-49 g/L

1 to 20 years 36-51 g/L

Adult 35-53 g/L

> 60 years 34-48 g/L

Reportable Range


Serum / Plasma 3-60 g/L

If the value of sample exceeds 60 g/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+1) and rerun; the result should

be multiplied by 2.

1.6 TP (Total Protein)

Order Information


TP0102 R 4×40 mL

TP0103 R 6×40 mL

TP0104 R 6×60 mL

TP0105 R 4×250 mL


Serum total protein, including albumin, is take charge of transporting substances, including macromole- cules, and maintaining

the plasma osmotic pressure. Hypoproteinemia can be caused by anti-body deficiency syndrome, liver cirrhosis, impaired kidney

function, diarrhea and nutritional loss. Hyperproteinemia is seldom discovered. Only serious chronic inflammation or self-immunity

disease may lead to hyperproteinemia.

Method

Biuret method

Reaction Principle

Cu2+ + Protein Copper-protein complex (blue-violet colour)

At an alkaline solution (pH>12) copper ions combine with protein to produce a blue-violet colour complex. The absorbency

increase is directly proportional to the concentration of protein.


R：

Sodium-potassium tartrate 32 mmol/L

Sodium hydroxide 200 mmol/L

Potassium iodide 30 mmol/L

Cupric sulfate 12 mmol/L





Assay procedure

Blank Sample

R 1000 μL 1000 μL


Sample － 20 μL

Mix thoroughly at 37 ℃, and read the absorbance 10 min. later.


Reference Intervals


Serum / Plasma

Adults 66-83 g/L

Prematures 57-80 g/L

Newborns 41-63 g/L

Reportable Range


Serum / Plasma 2 g/L-120 g/L

pH

If the value of sample exceeds 120 g/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+ 1) and rerun; the result


1.7 Bil-D (Bilirubin Direct, VOX Method)

Order Information


DBI0202 R1 4×35 mL + R2 2×18 mL

DBI0203 R1 4×38 mL + R2 2×20 mL

DBI0204 R1 4×60 mL + R2 2×32 mL

DBI0205 R1 2×250 mL + R2 1×125 mL


Direct bilirubin measurements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders,

including hepatitis and gall bladder block. Determination of both total serum bilirubin and direct bilirubin may help in the differential

diagnosis of jaundice.

Method Vanadiate Oxidating Method (VOX method)

Reaction Principle

Bilirubin Dehydrobilirubin

By the action of inhibitor and vanadic acid ion at pH 3.0, direct bilirubin is specially oxidated to dehydrobilirubin, and the

absorbency decrease at 450 nm is directly proportional to the concentration of direct bilirubin.


R 1： Tartrate buffer 100 mmol/L

R 2： Phosphate buffer 10 mmol/L

Vanadiate 4 mmol/L

Storage and stability Stable up to expiry date indicated on the label, when stored unopened at 2-8℃ and protected from light.




Assay procedure

Blank Sample



Sample － 100 μL

Vanadiate

pH 3.0



Mix thoroughly, incubate at 37℃ for 5 min, and then read the absorbance change value.


Reference Intervals


Serum / Plasma 0.1-0.4 mg/dL 1.7-6.8 μmol/L

Reportable Range


Serum / Plasma 0.06-25.3 mg/dL 1-430 μmol/L

If the value of sample exceeds 430 μmol/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+ 9) and rerun; the result


1.8 Bil-D (Bilirubin Direct, DSA Method)

Order Information


DBI0102 R1 4×20 mL + R2 1×20 mL

DBI0103 R1 4×32 mL + R2 4×8 mL

DBI0104 R1 4×48 mL + R2 4×12 mL

DBI0105 R1 2×250 mL + R2 1×125 mL


Bilirubin consists of conjugated and unconjugated forms. Direct bilirubin is mainly the former and exists in the liver. It is conjugated

with glucuronic acid to convert into soluble substance and excreted via the bile ducts. Elevated levels of direct bilirubin are usually

related with hepatitis, occlusion of bile ducts and hepatatrophia caused by acute hepatitis. It is reported that when the total

bilirubin ≤3 mg/dL, the ratio of Bil-D/Bil-T can be used for differentiating the haemolytic jaundice with liver or gall jaundice. The

critical ratio is 3.3. In the haemolytic icterus, the ratio is lower than 3.3.

Method

Diazotized Sulfanilic Acid (DSA) Method

Reaction Principle

Bilirubin + Diazo salt Azobilirubin

Direct bilirubin couples with diazo salt at an acid condition to form a red product of azobilirubin. The absorbency increase is

directly proportional to the concentration of direct bilibrubin in the sample.


R1： Hydrochloric acid 170 mmol/L

H+, Surfactant

Sulfanilic acid 29 mmol/L

R2： Sodium nitrite 72 mmol/L


Once opened, the reagents are stable for 28 days at 18-25℃. And the working solution is stable for 14 days when refrigerated on

the analyzer or refrigerator.



Assay procedure Working solution must be prepared before use.

To prepare the working solution, mix 4 parts R1 with 1 part R2, e.g. 4 mL R1 + 1 mL R2.

Blank Sample

Reagent 1000 μL 1000 μL


Sample － 100 μL

Mix thoroughly at 37 ℃, and read the absorbance 2-5 min. later.


Reference Intervals


Serum / Plasma ≤0.3 mg/dL ≤5.13 umol/L

Reportable Range


Serum / Plasma 1-260 μmol/L



1.9 Bil-T (Bilirubin Total, VOX Method)

Order Information


TBI0202 R1 4×35 mL + R2 2×18 mL

TBI0203 R1 4×38 mL + R2 2×20 mL

TBI0204 R1 4×60 mL + R2 2×32 mL

TBI0205 R1 2×250 mL + R2 1×125 mL


Bilirubin measurements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders,

including hepatitis and gall bladder block. Determination of both total serum bilirubin and direct bilirubin (water-soluble bilirubin

derivates such as mono and diglucuronides) may help in the differential diagnosis of jaundice.

Method Vanadiate Oxidating Method (VOX method)

Reaction Principle

Bilirubin Dehydrobilirubin

By the action of vanadic acid ion at pH 3.0, bilirubin is oxidated to dehydrobilirubin, and the absorbency decrease at 450 nm is

directly proportional to the concentration of total bilirubin.


R 1： Citrate buffer 100 mmol/L

Surfactant ＜1%

R 2： Phosphate buffer 10 mmol/L

Vanadiate 4 mmol/L





Assay procedure

Blank Sample



Sample － 100 μL





Reference Intervals


Serum / Plasma 0.3-1.1 mg/dL 5.1-19 μmol/L

Reportable Range


Serum / Plasma 0.12-40.2 mg/dL 2-684 μmol/L



Vanadiate

pH 3.0

1.10 Bil-T (Bilirubin Total, DSA Method)

Order Information


TBI0102 R1 4×20 mL + R2 1×20 mL

TBI0103 R1 4×32 mL + R2 4×8 mL

TBI0104 R1 4×48 mL + R2 4×12 mL

TBI0105 R1 2×250 mL + R2 1×125 mL


80-85% bilirubin is breakdown product of hemoglobin, and 15-20% bilirubin roots in proteins containing hemoglobin. Measuring

the bilirubin in plasma is used for diagnosing and discriminating the reason of jaundice. Hyperbilirubinemia is due to the excess

increase of bilirubin and may cause by prehepatic jaundice (e.g. hemolysis), intrahepatic jaundice (e.g. virus hepatitis) or

post-hepatic jaundice (e.g. gall-stone). Some chronic and congenital diseases can also result in Hyperbilirubinemia.

Method

Diazotized Sulfanilic Acid (DSA) Method

Reaction Principle

Bilirubin + Diazo salt Azobilirubin

By using a special surfactant to accelerate the solubility of conglutinated bilirubin, total bilirubin with diazo salt at an acid condition

to form a red product of azobilirubin. The absorbency increase is directly proportional to the concentration of bilibrubin.


R1：

Hydrochloric acid 100 mmol/L

Sulfanilic acid 5 mmol/L

Surfactant 1% (m/v)

R2： Sodium nitrite 72 mmol/L


Once opened, the reagents are stable for 28 days at 18-25℃. And the working solution is stable for 14 days when refrigerated on

the analyzer or refrigerator.



Assay procedure Working solution must be prepared before use.

To prepare the working solution, mix 4 parts R1 with 1 part R2, e.g. 4 mL R1 + 1 mL R2.

H+, Surfactant

Blank Sample

Reagent 1000 μL 1000 μL


Sample － 100 μL

Mix thoroughly at 37℃，and read the absorbance 10 min. later.


Reference Intervals


Serum / Plasma Adult 0.1-1.2 mg/dL 2-21 μmol/L

Reportable Range


Serum / Plasma 1.7-600 μmol/L



1.11 PA (Prealbumin)

Order Information


PA0102 R1 1×40 mL + R2 1×15 mL

PA0103 R1 1×40 mL + R2 1×15 mL

PA0104 R1 2×40 mL + R2 2×15 mL

PA0105 R1 1×240 mL + R2 1×90 mL


Measurement of PA in serum aids in the assessment of nutritional status. PA levels decrease in protein-energy malnutrition and

return toward normal values with nutritional repletion. Increased PA concentrations are found in patients with a positive nitrogen

balance. PA has also been used to monitor nutritional therapy during the transition from total PA nutrition to oral or enteral feeding.

Method

Turbidimetry Method

Reaction Principle

Anti-human PA antibody + PA Immunocomplex (agglutination)

Determination of the concentration of PA through photometric measurement of immunocomplex between antibodies of PA and PA

present in the sample, the absorbency increase is directly proportional to the concentration of PA.

Reagents Components and concentration

R1：

Tris-HCL buffer 50 mmol/L

Sodium chloride 100 mmol/L

PEG <2 % (m/v)

R2： Tris-HCL buffer 50 mmol/L

Anti-human PA antibody (goat) dependent on titer





Assay procedure

Blank Sample



Sample － 7 μL

Mix, incubate for 3 min. at 37 ℃, and read the blank absorbance, then add:


Mix thoroughly at 37 ℃, and read the absorbance again 5 min. later.


Reference Intervals


Serum 200～400 mg/L

Reportable Range


Serum 10～800 mg/L

If the value of sample exceeds 800 mg/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+ 1) and rerun; the result


1.12 TBA (Total Bile Acids)

Order Information


TBA0102 R1 2×30 mL + R2 1×20 mL

TBA0103 R1 4×40 mL + R2 2×28 mL

TBA0104 R1 4×45 mL + R2 2×32 mL

TBA0105 R1 1×240 mL + R2 1×80 mL


Bile acids are synthesised in the liver as a breakdown product of cholesterol and secreted into the gall bladder. They are released

into the small intestine where they solubilise dietary lipids such as cholesterol, aiding their absorption into the bloodstream. The

efficiency of bile acids extraction from the blood declines with decreasing liver function, causing the serum bile acids level to rise.

The measurement of bile acids is a sensitive indicator of liver function. Bile acids levels also rise when bile flow is reduced or

blocked (cholestasis) and additional bile acids escape into the bloodstream.

Method Enzymatic cycling assay

Reaction Principle

By the action of 3α-Hydroxysteroid Dehydrogenase and Thio-NAD, bile acids can be specially oxidated. Simultaneity, the reaction

production 3-ketosteroid is deoxidated to bile acids by the action of 3α-Hydroxysteroid Dehydrogenase and NADH. Then, the

quantities of bile acids were greatly magnified by the enzymatic cycling reaction. The rate of absorbency increase at 405nm is

directly proportional to the bile acids concentration.


R 1： Good’s buffer 100 mmol/L

Thio-NAD 952.9 mg/L

R 2：

Good’s buffer 100 mmol/L

NADH 6.1 g/L

3α-Hydroxysteroid Dehydrogenase 12500 U/L





Assay procedure

Blank Sample



Sample － 4 μL



Mix thoroughly, incubate at 37℃ for 1 min., and then read the absorbance change value within 3 min.


Thio-NAD Thio-NADH

Bile acids 3-ketosteroid

NADH NAD

3α-HSD

3α-HSD

CHE

Reference Intervals


Serum / Plasma ≤ 10 µmol/L

Reportable Range


Serum / Plasma 2-180 µmol/L

If the value of sample exceeds 180 µmol/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+ 9) and rerun; the result


1.13 CHE (Cholinesterase)

Order Information


CHE0102 R1 2×40 mL+R2 1×16 mL+Calibrator 1×3 mL+Control 1×5 mL




Two related enzymes have the ability to hydrolyse acetylcholine. One is called true cholinesterase or cholinesterase I, the other is

called pseudocholinesterase or cholinesterase II. Cholinesterase I is responsible for the prompt hydrolysis of a acetylcholine at

nerve endings to mediate transmission of the neural impulse across the synapse. The biological role of Cholinesterase II is

unknown. pseudocholinesterase is found in the liver, pancreas, heart, serum and in the white matter of the brain. Clinically, it

serves as an indicator of possible insecticide poisoning, and is measured as an index of liver function. Pre-operative screening of

cholinesterase is used to detect patients with atypical forms of enzyme and hence avoid prolonged apnea caused by slow

elimination of muscle relaxants.

Method

DGKC Method

Reaction Principle

Butyrylthiocholine + H2O thiocholine + butyrate

Thiocholine + potassium hexacyanoferrate (III) dithiobis(choline) + potassium hexacyanoferrate(II)

In the assay reaction, the CHE catalyzes the reversible hydrolysis of butyrylthiocholine to thiocholine and butyrate. The thiocholine

instantaneously reduces the yellow hexacyanoferrate (III) to the almost colorless hexacyanoferrate (II). The rate of the

photometrically determined hexacyanoferrate (III) decrease is directly proportional to the rate of formation of thiocholine and thus

the CHE activity.


R1：

Pyrophosphate buffer 100 mmol/L

Potassium hexacyanoferrate(III) 2.4 mmol/L

Preservative appropriate

Surfactant appropriate

R2：

Tris buffer 100 mmol/L

Butyrylthiocholine 3.0 mmol/L


Calibrator: lyophilized calibrator based on human serum

Control: Lyophilized control based on human serum

Assay procedure

Blank Sample



Sample － 4 μL



Mix thoroughly, read the absorbance after 1-2 min and monitor time. Read the absorbance again for additional 1-3 min.


Reference Intervals


Male 4620－11500 U/L 77.0－191.7 μkat/L

Female 3930－10800 U/L 65.5－180.0 μkat/L

Reportable Range



If the value of sample exceeds 20000 U/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+9) and repeat the assay


2. Renal

2.1 Crea (Creatinine, Sarcosine Oxidase Method)

Order Information


CRE0202 R1 2×30 mL + R2 1×20 mL

CRE0203 R1 4×40 mL + R2 2×28 mL

CRE0204 R1 4×60 mL + R2 2×42 mL

CRE0205 R1 3×250 mL + R2 1×250 mL


Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a

calculation basis for measuring other urine analytes.

Method Sarcosine Oxidase Method

Reaction Principle

Creatinine + H2O Creatine

Creatine + H2O Sarcosine

Sarcosine + O2 + H2O Glycin + HCHO + H2O2

2H2O2 + 4-aminoantipyrine + ESPMT Quinonimine + 4H2O

The absorbency increase at 546 nm of the product Quinonimine is directly proportional to the concentration of creatinine.


R 1：

CRTase >40KU/L

Sarcosine Oxidase >7KU/L

Ascorbic acid oxidase 2KU/L

Catalase >100KU/L

ESPMT 0.47mM

R 2：

Creatininase >400KU/L

Peroxidase >50KU/L

4-aminoantipyrine 2.95 mmol/L





Assay procedure

Blank Sample



Sample － 60 μL


CRTase

Sarcosine

Catalase

Creatininas




Reference Intervals


Serum/Plasma Male 0.8-1.3 mg/dL 70-115 μmol/L

Female 0.5-0.9 mg/dL 44-80 μmol/L

Reportable Range


Serum / Plasma 0.11-102 mg/dL 10-9000 μmol/L



2.2 Crea (Creatinine, Modified Jaffé Method)

Order Information


CRE0102 R1 3×35 mL + R2 3×35 mL

CRE0103 R1 4×40 mL + R2 4×40 mL

CRE0104 R1 4×45 mL + R2 4×45 mL

CRE0105 R1 2×250 mL + R2 2×250 mL


Creatinine is synthesized at a constant rate form creatine phosphate during muscle contractions. Since the excretion of creatinine

in healthy individuals is independent of diet and it is constantly produced, the clearance ratio of creatinine is one of the most

sensitive indexes for glomerular filtration rate (GFR) detecting. Many renal diseases such as glomerular nephritis, nephropathy

syndrome, and serious renal failure will lead to elevated levels of creatinine in serum. It is a practical method to measure the

creatinine level together with the urea level to distinguish the reason of azotemia.

Method

Modified Jaffé method

Reaction Principle

Creatinine + Picric acid Creatinine-Picric acid complex

At an alkaline solution, creatinine combines with picric acid to form an orange-red colored complex. The absorbency increase is

directly proportional to the concentration of creatinine.


R1： Sodium hydroxide 0.38 mol/L

OH-

R2： Picric acid 15 mmol/L

Storage and stability Up to expiration date indicated on the label, when stored unopened at 2-8℃and protected from light.




Assay procedure

Blank Sample



Sample － 18 μL

Mix, incubate for 1 min. at 37℃ , then add:


Mix thoroughly, incubate at 37℃ for 30 s and then read the absorbance change value over a further 2 min.


Reference Intervals


Serum / Plasma Men

<50 years: 74–110 µmol/L

>50 years: 72–127 µmol/L

Women 58–96 µmol/L

Urine Men 800–2000 mg/24 hours

Women 600–1800 mg/24 hours

Reportable Range


Serum / Plasma / Urine 9–2420 μmol/L



2.3 Urea/BUN (Blood Urea Nitrogen)

Order Information


URE0102 R1 4×35 mL + R2 2×18 mL

URE0103 R1 6×40 mL + R2 2×32 mL

URE0104 R1 6×60 mL + R2 3×32 mL

URE0105 R1 2×250 mL + R2 1×125 mL

GLDH

Urease


Urea is the final products of the protein and aminophenol catabolism. Adult produces 16 g urea everyday. Diseases associated

with elevated levels of urea in blood are referred to as uremia or azotemia. Parallel determination of urea and creatinine is used to

distinguish the reason of azotemia. Prerenal azotemia may cause by starvation, pyrexia, dehydration, increased protein

catabolism, cortisol treatment or decreased renal perfusion (e.g. serious heart failure, lack of water), while creatinine level remains

within the reference ranges. Postrenal azotemia may cause by the obstruction of the urinary tract, in this regard, both urea and

creatinine levels rise, but urea is in a higher extent.

Method

Urease-glutamate Dehydrogenase, UV method

Reaction Principle

Urea + 2H2O 2NH4+ + CO3 2-

α-Oxoglutarate + NH4+ + NADH L-Glutamate + NAD+ + H2O

Urea is hydrolyzed by urease, and one of the products, ammonia, helps to turn NADH to NAD+ with the catalysis of GLDH. The

absorbency decrease is directly proportional to the concentration of urea.


R1:


ADP 750 mmol/L

Urease ≥40 KU/L

GLDH ≥0.4 KU/L

R2: NADH 1.2 mmol/L

α-Oxoglutarate 25 mmol/L





The standard is stable, even after opening, up to the stated expiration date when stored at 2-8℃.

Assay procedure

Blank Sample



Sample － 10 μL

Mix, incubate for 2 min. at 37℃. , then add:


Mix thoroughly, incubate at 37℃ for 30 s and then read the absorbance change value over a further 1-2 min.


Uricase

Ascorbate oxidase

POD

Reference Intervals


Serum / Plasma Adult 2.8-7.2 mmol/L

Urine Morning Urine 141-494 mmol/L

Reportable Range


Serum / Plasma / Urine 1-40 mmol/L

If the value of sample exceeds 40 mmol/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+ 3) and rerun; the result


2.4 UA (Uric Acid)

Order Information


UA0102 R1 4×40 mL + R2 2×20 mL

UA0103 R1 6×40 mL + R2 2×32 mL

UA0104 R1 6×60 mL + R2 3×32 mL

UA0105 R1 2×250 mL + R2 1×125 mL


Uric acid is synthesized in liver and excreted via kidney, and it is the final products of the purine metabolism. The most common

complication of hyperuricemia is the formation of urate crystals, which is called tophus, around the joints. Further causes of

elevated blood concentrations of uric acid are renal function disease, starvation, drug abuse, toxicosis, malignant tumour, and

increased alcohol and incretion disorders. Reasons of Hypouricemia are hereditary metabolic disorders, renal diseases, severe

hepatic diseases and drug effects.

Method

Uricase-Peroxidase (Uricase-POD) method

Reaction Principle

Ascorbic acid + O2 dehydro-ascorbic acid + H2O

Uric acid + H2O + O2 Allantoin + CO2 + H2O2

TOOS + 4-AAP + 2H2O2 + H+ Quinoneimine + 4H2O

By using ascorbic oxidase to eliminate the interference of ascorbic acid, the uric acid is catalyzed to produce H2O2, which oxidize

the 4-AAP to yield a colored dye of quinoneimine. The absorbency decrease is directly proportional to the concentration of uric

acid.


R1:

Phosphate buffer 70 mmol/L

Peroxidase 5000 U/L

Ascorbate oxidase 3000 U/L

TOOS 0.72 mmol/L

R2:


Peroxidase 10000 U/L

4-Aminoantipyrine 1.7 mmol/L

Uricase 750 U/L





Assay procedure

Blank Sample



Sample － 25 μL



Mix thoroughly at 37 ℃, and read the absorbance again 4-5 min. later.


Reference Intervals


Serum / Plasma Men 3.6-8.2 mg/dL 214-488 μmol/L

Women 2.3-6.1 mg/dL 137-363 μmol/L

Urine Normal diet <800 mg/24 h <4.76×105 μmol/ 24 h

Limitative purine <600 mg/24 h <3.57×105 μmol/24 h

Reportable Range


Serum / Plasma / Urine 20.8-1500 μmol/L

If the value of sample exceeds 1500 μmol/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+3) and rerun; the result

should be multiplied by 4. Assay urinary uric acid, the sample should be diluted 1 + 9 with 9 g/L NaCl ，and the result multiplied by

10.

2.5 CO2 (Carbon dioxide)

Order Information


CO20102 R 2×20 mL+Calibrator 1×1.5 mL+Control 1×5 mL




Measurement of CO2 is used in the diagnosis of the acid-base-balance in the blood. Increased and decreased values indicate

disorders associated with disturbances of the metabolic and respiratory systems. Increase of CO2 may indicate respiratory

dysfunction, hyperaldosteronism, or Cushings syndrome. decrease of CO2 may indicate ketoacidosis, lactic acidosis, kidney

disease, diarrhoea, methanol poisoning, salicylate toxicity, ethylene glycol poisoning, or Addisons disease.

Method

Enzymic method

Reaction Principle

HCO3- + PEP Oxaloacetate + H2PO4

-

Oxaloacetate + NADH analog + H+ Malate + NAD+ analog

The resultant consumption of NADH analog causes a decrease in absorbance at 405 nm, which is proportional to the

concentration of CO2 in the sample being assayed.


R:

PEPC ≥1.2 KU/L

MDH ≥30 KU/L

PEP 15.8 mmol/L

NADH analog 3.8 mmol/L

MgSO4 100 mmol/L

Stabilizer appropriate



Calibrator: Sodium hydrogen carbonate




Once opened, the calibrator are stable for 15 days at 2-8℃, do not freeze.

Once dissolved, the control is stable for 15 days at -20℃ (when frozen once)

PE

P

M

D



Assay procedure

Blank Sample

R 300 μL 300 μL


Sample － 3 μL

Mix thoroughly at 37 ℃, and read the initial absorbance after a further 2 minutes then final absorbance after 3 further minute.

ΔA = ([initial abs.]- [final abs.])/3 minutes

Reference Intervals


Serum /

Heparin plasma Adults 22.0-29.0 mmol/L

Reportable Range


Serum / Heparin plasma 1.0 mmol/L-50.0 mmol/L

If the value of sample exceeds 50.0 mmol/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+ 1) and rerun; the result


3. Cardiac

3.1 CK (Creatine Kinase)

Order Information


CK0102 R1 2×40 mL + R2 1×20 mL

CK0103 R1 4×38 mL + R2 2×20 mL

CK0104 R1 3×45 mL + R2 3×12 mL

CK0105 R1 2×250 mL + R2 1×125 mL


Creatine kinase (CK) is an enzyme, which consists of isoenzymes mainly of the muscle (CK-M) and the brain (CK-B). CK exists in

serum in dimeric form as CK-MM, CK-MB, and CK-BB and as macroenzyme. Elevated CK values are observed in cardiac muscle

damages and in skeletal muscle diseases. Measurement of CK is used especially in conjunction with CK-MB for diagnosis and

monitoring of myocardial infarction.

Method International Federation of Clinical Chemistry and Laboratory Medicine（IFCC） method

Reaction Principle

Creatine phosphate + ADP Creatine + ATP

ATP + Glucose ADP + Glucose-6-phosphate

Glucose-6-phosphate + NADP+ Gluconate-6-phosphate + NADPH + H+

Creatine kinase (CK) catalyzes the phosphorylation of ADP, in the presence of creatine phosphate, to form ATP and creatine. The

catalytic concentration is determined from the rate of NADPH formation, measured at 340 nm, by means of the hexokinase (HK)

and glucose-6-phosphate dehydrogenase (G6P-DH) coupled reactions.


R 1：

Imidazole buffer 100 mmol/L

Glucose 20 mmol/L

N-acetylcysteine(NAC) 0.2 mmol/L

Magnesium acetate 10 mmol/L

EDTA 2 mmol/L

NADP 2 mmol/L

AMP 5 mmol/L

HK >4 U/mL

R 2：

Creatine phosphate 30 mmol/L

ADP 2 mmol/L

G6P-DH >2.8 U/mL





Assay procedure

Blank Sample



Sample － 25 μL



Mix thoroughly, incubate at 37℃ for 3 min., and then read the absorbance change value within 1-3 min.


Reference Intervals

CK

HK

G6P-DH


Serum / Plasma Male ≤ 171 U/L ≤ 2.85 μkat/L

Female ≤ 145 U/L ≤ 2.41 μkat/L

Reportable Range



If the value of sample exceeds 1000 U/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+ 9) and rerun; the result


3.2 CK-MB (Creatine Kinase-MB Isoenzyme)

Order Information


CKB0102 R1 2×40 mL + R2 1×20 mL

CKB0103 R1 4×38 mL + R2 2×20 mL

CKB0104 R1 3×45 mL + R2 3×12 mL

CKB0105 R1 2×250 mL + R2 1×125 mL


Creatine kinase (CK) is an enzyme, which consists of isoenzymes mainly of the muscle (CK-M) and the brain (CK-B). CK exists in

serum in dimeric form as CK-MM, CK-MB, and CK-BB and as macroenzyme. Determination of CK-MB values possesses highly

specificity in myocardial damages. So, measurement of CK-MB is used for diagnosis and monitoring of myocardial infarction.

Method International Federation of Clinical Chemistry and Laboratory Medicine（IFCC） method.

Reaction Principle Creatine kinase activity is measured in the presence of an antibody to the creatine kinase-M monomer which completely inhibits

creatine kinase-MM but does not affect the B monomer activity of the creatine kinase-MB or creatine kinase-BB. Since creatine

kinase-MB consists of equal M and B subunits, its measured activity is 50 percent of that found in the absence of the antibody.

Creatine kinase-B monomer activity is then determined in the following reaction sequence.

CK-MM + Anti-CK-MM Antigen-Antibody Complex

ADP + Creatine phosphate Creatine + ATP

ATP + Glucose ADP + Glucose -6-phosphorate

Glucose -6-phosphorate + NADP+ Gluconate-6-phosphate + NADPH + H+

In the reaction, the creatine kinase-B catalyzes the transfer of a phosphate group from the creatine phosphate substrate to ADP.

The subsequent formation of ATP is measured through the use of two coupled reactions catalyzed by hexokinase (HK) and

Creatine Kinase-B

Hexokinase

G6P-DH

glucose-6-phosphate dehydrogenase (G6P-DH) which results in the production of the reduced form of NADPH from NADP. The

rate of absorbency increase at 405nm is directly proportional to the activity of creatine kinase-B.


R 1：

Imidazole buffer 100 mmol/L

Glucose 20 mmol/L

N-acetylcysteine(NAC) 0.2 mmol/L

Magnesium acetate 10 mmol/L

EDTA 2 mmol/L

NADP 2 mmol/L

AMP 5 mmol/L

HK >4 U/mL

Goat Anti-Human polyclonal antibody 2000 U/LCK-MM

R 2：

Creatine phosphate 30 mmol/L

ADP 2 mmol/L

G6P-DH >2.8 U/mL





Assay procedure

Blank Sample



Sample － 50 μL



Mix thoroughly, incubate at 37℃ for 3 min., and then read the absorbance change value within 1-3 min.


Reference Intervals


Serum ≤ 24 U/L ≤ 0.4 μkat/L

Reportable Range


Serum 5-600 U/L 0.08-10.00 μkat/L



3.3 a-HBDH (α-Hydroxybutyrate dehydrogenase)

Order Information


HBD0102 R1 4×35 mL + R2 2×18 mL

HBD0103 R1 6×40 mL + R2 2×32 mL

HBD0104 R1 4×45 mL + R2 4×12 mL

HBD0105 R1 2×250 mL + R2 1×125 mL


α-Hydroxybutyrate dehydrogenase is an isoenzyme of lactate dehydrogenase. The level of α-HBDH is higher than other

isoenzymes of LDH in heart muscle tissue, so it is somewhat more sensitive and more specific in the diagnosis of myocardial

infarction.

The HBDH/LDH ratio can be used for differentiation liver disease from heart disease. A decreased ratio indicates liver diseases,

on the contrary an increased ratio means myocardial infarction.

Method

UV-assay according to German Society of Clinical Chemistry (DGKC).

Reaction Principle

α-Oxobutyrate + NADH + H+ α-Hydroxybutyric acid + NAD+

By the catalysis of α-HBDH, α-Oxobutyrate is deoxidated into α-Hydroxybutyric acid, at the same time NADH is oxidized into

NAD+. The absorbency decrease is directly proportional to the activity of α-HBDH.


R1： Tris buffer 100 mmol/L

α-Oxobutyrate 4.4 mmol/L


NADH 1.27 mmol/L

Storage and stability Up to expiration date, when stored unopened at 2-8℃and protected from light.




Assay procedure

Blank Sample



Sample － 10 μL

α-HBDH

LDH

Mix, incubate at 37℃ for 3 min., then add:


Mix thoroughly, incubate 37℃ for 1-2 min., and then read the absorbance change value within 2-3 min.


Reference Intervals


Serum / Plasma Adult 72-182 U/L. 1.2-3.0 μkat/L

Reportable Range





3.4 LDH (Lactate Dehydrogenase)

Order Information


LDH0102 R1 4×35 mL + R2 2×18 mL

LDH0103 R1 6×40 mL + R2 2×32 mL

LDH0104 R1 4×45 mL + R2 4×12 mL

LDH0105 R1 2×250 mL + R2 1×125 mL

Clinical significance Lactate dehydrogenase (EC 1.1.1.27, LDH) is a tetramer composed of two different subunits. It has five isoenzymes. LDH is

widely distributed in tissues, particularly in the liver, muscles, kidneys and heart. Increased LDH activities can indicate a variety of

pathological conditions, such as myocardial infarction, liver diseases, blood diseases and cancers. Because of the lack of organ

specificity of LDH, parallel measurement of its isoenzymes or other enzymes such as ALP, ALT and AST is necessary for

differential diagnosis.

Method UV-assay according to IFCC (International Federation of Clinical Chemistry and Laboratory Medicine).

Reaction Principle

L-lactate + NAD+ pyruvate + NADH + H+ Lactate Dehydrogenase catalyzes the conversion of L-lactate to pyruvate in the presence of lactate dehydrogenase (LDH). In the

process, β-nicotinamide adenine dinucleotide (NAD) is deoxidized to NADH. This change in absorbance is directly proportional to

the activity of LDH in the sample.



L-Lactate 5 mmol/L

R 2 NAD+ 7.0 mmol/L





Assay procedure

Blank Sample



Sample － 100 μL

Mix, incubate for 2－3 min, then add:




Reference Intervals


Men < 248 U/L < 4.13 μkat/L

Women < 247 U/L < 4.12 μkat/L

Reportable Range





3.5 HCY (Homocysteine)

Order Information


HCY0102 R1a 6×10mL + R1b 6 + R1c 6 + R2 1×11mL + Calibrator 1×1mL + Quality control

2×1mL

HCY0103 R1a 6×10mL + R1b 6 + R1c 6 + R2 1×11mL + Calibrator 1×1mL + Quality control

2×1mL

HCY0104 R1a 12×10mL + R1b 12 + R1c 12 + R2 2×11mL + Calibrator 1×1.5mL + Quality

control 2×1.5mL


Homocysteine (Hcy) is a thiol-containing amino acid produced by the intracellular demethylation of methionine. Total

homocysteine (tHcy) represents the sum of all forms of Hcy including forms of oxidized, protein bound and free. Elevated level of

tHcy has emerged as an important risk factor in the assessment of cardiovascular disease. Excess Hcy in the blood stream may

cause injures to arterial vessels due to its irritant nature, and result in inflammation and plaque formation, which may eventually

cause blockage of blood flow to the heart. Elevated tHcy levels are resulted from four major causes including: a) genetic

deficiencies in enzymes involved in Hcy metabolism such as cystathionine beta-synthase (CBS), methionine synthase (MS), and

methylenetetrahydrofolate reductase (MTHFR); b) nutritional deficiency in B vitamins such as B6, B12 and folate; c) renal failure

for effective amino acid clearance, and d) drug interactions such as nitric oxide, methotrexate and phenytoin that interfere with

Hcy metabolisms. Elevated levels of tHcy are also linked with Alzheimer’s disease and Osteoporosis. Guidelines for tHcy

determination in clinical laboratories have recently been established.

Method

Enzymatic Assay Method

Reaction Principle

Oxidated HCY＋Reducing reagent Deoxidizd HCY

Deoxidizd HCY HCY enzyme Sulfureted hydrogen

Sulfureted hydrogen＋ Chromogen ＋ oxidant Methyl blue complex


R1a： Tris 20 mmol/L

R1b： HCY enzyme /

R1c： Reducer /

R2: Oxidant 2.8g/L

Calibrator Concentration see label

Quality control Concentration see label


Once opened, the R2 reagent is stable for 28 days when refrigerated on the analyzer or refrigerator, Once mixed the R1 working

reagent can stable for 7 days.



Once opened, the calibrator and control are stable for 28 days at 2–8℃, do not freeze.

Assay procedure

Blank Sample



Sample － 20 μL





Reference Intervals


Serum/plasma 5～15 μ mol/L

Reportable Range


Serum/plasma 1.0～40.0 μ mol/L

If the value of sample exceeds 40.0 μ mol/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+ 9) and the result


4. Lipids

4.1 Apo A1 (Apolipoprotein A1)

Order Information


APA0102 R1 1×35 mL + R2 1×12 mL

APA0103 R1 4×40 mL + R2 2×28 mL

APA0104 R1 3×45 mL + R2 3×15 mL

APA0105 R1 1×240 mL + R2 1×80 mL


ApolipoproteinA1 is the major protein component of high-density lipoprotein, which takes charge of transferring excess cholesterol

to the liver, so it is a protective factor of atherosclerosis.

ApoA1 can foreshow the early coronary heart disease; furthermore evaluate the function of lowering fat therapy.

Decrease of ApoA1 level exists in inherited hypolipoproteinemia, cholestasis, sepsis and atherosclerosis. And increase exists in

liver disease, pregnancy and estrogen treatment.

Method

Turbidimetry Method

Reaction Principle

Anti-human ApoA1 antibody + ApoA1 Immunocomplex (agglutination)

Determination of the concentration of ApoA1 through photometric measurement of immunocomplex between antibodies of ApoA1

and ApoA1 present in the sample, the absorbency increase is directly proportional to the concentration of ApoA1.


R1： Phosphate buffer 100 mmol/L

PEG <2% (m/v)


Anti-human apolipoproteinA1 antibody (goat) dependent on titer





Assay procedure

Blank Sample


Dist.water 15 μL －

Sample － 15 μL





Reference Intervals


Serum Men 1.05-1.75 g/L

Women 1.05-2.05 g/L

Reportable Range


Serum 0.2-2.3 g/L

If the value of sample exceeds 2.3 g/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+ 1) and rerun; the result


4.2 Apo B (Apolipoprotein B)

Order Information


APB0102 R1 1×35 mL + R2 1×12 mL

APB0103 R1 4×40 mL + R2 2×28 mL

APB0104 R1 3×45 mL + R2 3×15 mL

APB0105 R1 1×240 mL + R2 1×80 mL


ApolipoproteinB is the major protein component of low-density lipoprotein, which takes charge of transferring cholesterol to the

cells and associate with atherosclerotic plaque formation.

Scientific studies have shown that ApoB can foreshow the risk of coronary heart disease，so the evaluation result about the risk of

coronary heart disease based on ApoB level is equal to which based on the low density lipoproteins concentration.

Method

Turbidimetry Method

Reaction Principle

Anti-human ApoB antibody +ApoB Immunocomplex (agglutination)

Determination of the concentration of ApoB through photometric measurement of immunocomplex between antibodies of ApoB

and ApoB present in the sample, the absorbency increase is directly proportional to the concentration of ApoB.



PEG <2% (m/v)


Anti-human apolipoproteinB antibody(goat) dependent on titer





Assay procedure

Blank Sample



Sample － 15 μL





Reference Intervals


Serum Men 0.60–1.40 g/L

Women 0.55–1.30 g/L

Reportable Range


Serum 0.2–2.2 g/L



4.3 Lp(a) (Lipoprotein(a))

Order Information


LPA0102 R1 2×32 mL + R2 1×8 mL

LPA0103 R1 4×40 mL + R2 2×10 mL

LPA0104 R1 4×45 mL + R2 2×10 mL

LPA0105 R1 3×250 mL + R2 1×75 mL


Lipoprotein (a) is a lipoprotein subclass. Studies have identified Lp(a) as a putative risk factor for atherosclerotic diseases. High

Lp(a) in blood is a risk factor for coronary heart disease (CHD), cerebrovascular disease (CVD), atherosclerosis, thrombosis, and

stroke. Measurement of Lp(a) in serum aids in the assessment of these diseases.

Method

Turbidimetry Method

Reaction Principle

Anti-human Lp(a) antibody + Lp(a) Immunocomplex (agglutination)

Determination of the concentration of Lp(a) through photometric measurement of immunocomplex between antibodies of Lp(a)

and LP(a) present in the sample, the absorbency increase is directly proportional to the concentration of Lp(a).



PEG 3 % (m/v)

R2： Anti-human Lp(a) antibody (goat) dependent on titer





Assay procedure

Blank Sample


POD

CHE + CHO

Catalase


Sample － 15 μL





Reference Intervals


Serum <30 mg/dL

Reportable Range


Serum 4～100 mg/dL

If the value of sample exceeds 100 mg/dL, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+ 1) and rerun; the result


4.4 HDL-C (High Density Lipoprotein - Cholesterol)

Order Information


HDL0102 R1 1×40 mL + R2 1×14 mL

HDL0103 R1 4×40 mL + R2 2×28 mL

HDL0104 R1 4×60 mL + R2 2×42 mL

HDL0105 R1 3×250 mL + R2 1×250 mL


HDL cholesterol is inversely related to the risk of developing coronary artery disease. A low HDL/LDL cholesterol ratio is directly

related to the risk of developing coronary artery disease. A high HDL cholesterol is associated with the "longevity" syndrome.

Method Direct method

Reaction Principle

（1） LDL,VLDL, Chylomicrons Cholestenone + H2O2

2H2O2 2H2O + O2

（2） HDL Cholestenone + H2O2

H2O2 + HDAOS + 4-aminoantipyrin Quinonimine

The System monitors the change in absorbance at 600 nm. This change in absorbance is directly proportional to the

concentration of cholesterol in the sample and is used by the System to calculate and express the HDL-cholesterol concentration.


R 1：


Cholesterol esterase 600 U/L

Cholesterol oxidase 380 U/L

Catalase 600 KU/L

HDAOS 0.42 mmol/L

R 2：


4-aminoantipyrine 1.0 mmol/L

Peroxidase >2.8 U/mL

Surfactant ＜2%





Assay procedure

Blank Sample



Sample － 12 μL



Mix thoroughly, incubate at 37℃ for 5 min., and then read the absorbance change value.


Reference Intervals


Serum Male >0.9 mmol/L

Female >1.15mmol/L

Reportable Range


Serum 0.05-6 mmol/L

If the value of sample exceeds 6 mmol/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+ 9) and rerun; the result


POD

CHE + CHO

Catalase

4.5 LDL-C (Low Density Lipoprotein - Cholesterol)

Order Information


LDL0102 R1 1×40 mL + R2 1×14 mL

LDL0103 R1 4×40 mL + R2 2×28 mL

LDL0104 R1 4×60 mL + R2 2×42 mL

LDL0105 R1 3×250 mL + R2 1×250 mL


LDL-Cholesterol is directly related to the risk of developing coronary heart disease. A low HDL/LDL-Cholesterol ratio is directly

related to the risk of developing coronary artery disease. Elevated LDL-Cholesterol is the primary target of cholesterol-lowering

therapy.

Method Direct method

Reaction Principle

（1） HDL,VLDL, Chylomicrons Cholestenone + H2O2

2H2O2 2H2O + O2

（2） LDL Cholestenone + H2O2

H2O2 + TOOS + 4-aminoantipyrin Quinonimine

The System monitors the change in absorbance at 600 nm. This change in absorbance is directly proportional to the

concentration of cholesterol in the sample and is used by the System to calculate and express the LDL-cholesterol concentration.


R 1：


Cholesterol esterase 600 U/L

Cholesterol oxidase 500 U/L

Catalase 600 KU/L

TOOS 2 mmol/L

R 2：


4-aminoantipyrine 4 mmol/L

Peroxidase 4 U/mL





Assay procedure

Blank Sample



Sample － 12 μL



Mix thoroughly, incubate at 37℃ for 5 min., and then read the absorbance change value.


Reference Intervals


Serum 0-4.11 mmol/L

Reportable Range


Serum 0.05-25.8 mmol/L



4.6 TC (Total Cholesterol)

Order Information


TC0102 R 4×40 mL

TC0103 R 6×40 mL

TC0104 R 6×60 mL

TC0105 R 4×250 mL


Cholesterol is a main component of cell membranes and lipoprotein and it is the precursor for steroid hormones and bile acids

synthesizing. Cholesterol is transported in plasma by low-density lipoprotein.

The level of the individual’s total cholesterol is used in screening early atherosclerosis and monitoring the clinical effect of drugs or

low-fat diet.

Method

Cholesterol oxidase- Peroxidase (CHOD-POD) method

Reaction Principle

CHE

Cholesterol ester + H2O Cholesterol + Fatty acid

Cholesterol + O2 4-Cholestenone + H2O2

2H2O2 + 4-Aminoantipyrine + Phenol Quinoneimine + 4H2O

By the catalysis of CHE and CHO, Cholesterol ester is catalyzed to yield H2O2, which oxidates 4- Aminoantipyrine with phenol to

form a colored dye of quinoneimine. The absorbency increase is directly proportional to the concentration of cholesterol.


R：


Phenol 5 mmol/L


Cholesterol esterase >150 KU/L

Cholesterol oxidase >100 KU/L

Peroxidase 5 KU/L





Assay procedure

Blank Sample

R 1000 μL 1000 μL


Sample － 10 μL



Reference Intervals


Serum / Plasma ≤5.2 mmol/l

Reportable Range


Serum / Plasma 3.85-769.23 mg/dL 0.1-20.0 mmol/L



CHO

POD

4.7 TG (Triglycerides)

Order Information


TG0102 R 4×40 mL

TG0103 R 6×40 mL

TG0104 R 6×60 mL

TG0105 R 4×250 mL


Triglycerides are the most abundant naturally lipids. It consists of three fatty acids and one glycerol, and is transported in plasma

combing with apolipoproteins. Measurement of triglycerides is used for detecting early atherosclerotic risks, classing hyperlipo-

proteinemia and monitoring the clinical effect of drugs or low-fat diet. High triglyceride levels often lead to liver or kidneys disease,

diabetes and pancreas disease.

Method

Glycerokinase Peroxidase- Peroxidase Method

Reaction Principle

Triglycerides + 3H2O Glycerol + fatty acid

Glycerol + ATP Glycerol-3-phosphate + ADP

Glycerol-3-phosphate + O2 Dihydroxyacetone Phosphate + H2O2

H2O2 + 4-Aminoantipyrine + 4-Chlorophenol Quinoneimine + HCl + H2O Through a sequence of enzymatic catalysis steps by lipase, GK and GPD, triglycerides is catalyzed to yield H2O2, which oxidize 4-

Aminoantipyrinel to yield a colored dye of quinoneimine. The absorbency increase is directly proportional to the concentration of

triglycerides.


R：


4-Chlorophenol 5 mmol/L

ATP 2 mmol/L

Mg2+ 4.5 mmol/L

Glycerokinase ≥0.4 U/mL

Peroxidase ≥0.5 U/mL

Lipoprotein lipase ≥1.3 U/mL


Glycerol-3-phosphate-oxidase ≥1.5 U/mL

Storage and Stability Up to expiration date indicated on the label, when stored unopened at 2-8℃ and protected from light.

GK

POD

GPO

Lipase




Assay procedure

Blank Sample

R 1000 μL 1000 μL


Sample － 10 μL



Reference Intervals


Serum / Plasma ≤ 2.3 mmol/L

Reportable Range


Serum / Plasma 0.1-12.5 mmol/L



5. Diabetes

5.1 Glu (Glucose, HK method)

Order Information


GLU0202 R1 4×36 mL + R2 2×34 mL

GLU0203 R1 4×40 mL + R2 2×40 mL

GLU0204 R1 6×45 mL + R2 3×45 mL

GLU0205 R1 2×250 mL + R2 1×250 mL


Carbohydrates supply the body energy with glucose, which is the most important monosaccharide in blood, and it is an

indispensable energy supplier for cellular function.

Measuring blood glucose is used for the diagnosis of carbohydrate metabolism disorders and monitoring of treatment in diabetes

mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, pharmic hypoglycemia and insulinoma.

Method

HK method

Reaction Principle

Glucose + ATP glucose-6-phosphate + ADP

Hexokinase catalyzes the phosphorylation of glucose to glucose-6-phosphate by ATP.

Glucose-6-phosphate + NAD+ 6-phosphogluconate + NADH + H+

Glucose-6-phosphate dehydrogenase oxidizes glucose-6-phosphate in the presence of NADP to gluconate-6-phosphate. No

other carbohydrate is oxidized. The rate of NADPH formation during the reaction is directly proportional to the glucose

concentration and can be measured photometrically.


R1：


G-6-PDH 20 KU/L

ATP 10 mmol/L

R2：


HK 1 KU/L

NAD+ 0.5 mmol/L





The standard is stable, even after opening, up to the stated expiration date when stored at 2-8℃.

Assay procedure

Blank Sample



Sample － 30 μL

Mix, incubate at 37 ℃ for 3 min., and read the blank absorbance, then add:


Mix thoroughly 37 ℃, and read the absorbance again 5 min. later.


Reference Intervals


Capillary vessel whole blood

Adult

70-100 mg/dL 3.9-5.5 mmol/L

Vein whole blood 60-100 mg/dL 3.5-5.5 mmol/L

Vein plasma 70-115 mg/dL 3.9-6.4 mmol/L

HK

G6P-DH

Reportable Range



If the value of sample exceeds 33.0 mmol/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+1) and rerun; the result


5.2 Glu (Glucose, GOD-POD Method)

Order Information


GLU0102 R1 4×40 mL + R2 2×20 mL

GLU0103 R1 4×40 mL + R2 2×20 mL

GLU0104 R1 6×60 mL + R2 3×32 mL

GLU0105 R1 2×250 mL + R2 1×125 mL


Carbohydrates supply the body energy with glucose, which is the most important monosaccharide in blood, and it is an

indispensable energy supplier for cellular function.

Measuring blood glucose is used for the diagnosis of carbohydrate metabolism disorders and monitoring of treatment in diabetes

mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, pharmic hypoglycemia and insulinoma.

Method

Glucose oxidase-Peroxidase (GOD-POD) method

Reaction Principle

D-Glucose + O2 D-Gluconic acid + H2O2

2H2O2 + 4-AAP + p-Hydroxybenzoic acid sodium + H3O+ Quinoneimine + 5H2O

By the catalysis of GOD, Glucose is oxidated to yield H2O2, and then at the present of POD, H2O2 oxidates 4-Aminoantipyrine with

p-Hydroxybenzoic acid sodium to form a colored dye of quinoneimine. The absorbency increase is directly proportional to the

concentration of glucose.


R1：


Ascorbate oxidase 4700 U/L

Glucose oxidase 4000 U/L

R2：


Peroxidase 6700 U/L


p-Hydroxybenzoic acid sodium 1.3 mmol/L

GOD

POD





Assay procedure

Blank Sample



Sample － 3 μL

Mix, incubate at 37 ℃ for 5 min., and read the blank absorbance, then add:


Mix thoroughly 37 ℃, and read the absorbance again 5-10 min. later.


Reference Intervals


Capillary vessel whole blood

Adult

70-100 mg/dL 3.9-5.5 mmol/L

Vein whole blood 60-100 mg/dL 3.5-5.5 mmol/L

Vein plasma 70-115 mg/dL 3.9-6.4 mmol/L

Reportable Range


Serum / Plasma 0.3-35 mmol/L

If the value of sample exceeds 35 mmol/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+1) and rerun; the result


5.3 HbA1c (Hemoglobin A1c)

Order Information


HBA0102 R1 2×30mL+R2 1×12mL+Calibrator 2×1mL + Quality control 2×1mL Pretreatment Solution

1×150ml


1×200ml


2×150ml


Hemoglobin (Hb) consists of four protein chains with four heme portions, and is the red-pigmented protein located in the

erythrocytes. Its main function is the transport of oxygen and carbon dioxide in blood. Each Hb molecule is able to bind four

oxygen molecules. Hb consists of a variety of subfractions and derivatives. Among this heterogeneous group of hemoglobins

HbA1c is one of the glycated hemoglobins, a subfraction formed by the attachment of various sugars to the Hb molecule. HbA1c

is formed in two steps by the non-enzymatic reaction of glucose with the N-terminal amino group of the β-chain of normal adult Hb

(HbA). The first step is reversible and yields labile HbA1c. This slowly rearranges in the second reaction step to yield stable

HbA1c. In the erythrocytes, the relative amount of HbA converted to stable HbA1c increases with the average concentration of

glucose in the blood. The conversion to stable HbA1c is limited by the erythrocyte’s life span of approximately 100 to 120 days. As

a result, HbA1c reflects the average blood glucose level during the preceding 2 to 3 months. HbA1c is thus suitable to monitor

long-term blood glucose control in individuals with diabetes mellitus. More recent glucose levels have a greater influence on the

HbA1c level. The approximate relationship between HbA1c and mean blood glucose value during the preceding 2 to 3 months

has been analyzed by several studies.

Method

Enzymatic Assay Method

Reaction Principle

In the first reaction, the concentration of hemoglobin is measured at absorbance of fixed wavelength, and simultaneously the

fructosyl dipeptides are generated from the N-terminus amino groups of the beta-chain of HbA1c by the reaction of protease. In

the second reaction, the reaction of Fructosyl peptide oxidase(FPOX) with fructosyl dipeptides, generated hydroperoxide allows

10-(carboxymethylaminocarbonyl)-3,7-bis(dimethylamino) phenothiazine sodium salt to develop a color in the presence of

peroxidase. The change in absorbance is measured for HbA1c determination. The combined assay results for hemoglobin and

HbA1c are used by the system to calculate and express HbA1c(%).


R1： Tris buffer 2.7 mmol/L

R2： Peroxidase 1500 U/L

Fructosyl peptide oxidase 1500 U/L

Pretreatment

Solution

Hemolysin 5 g/L







Once dissolved, the calibrator and control are stable for 15 days at 2–8℃,do not freeze.

Assay procedure

Pretreatment Procedure of Whole Blood Prior to testing, whole blood samples should be centrifuged at 2000 rpm for 5 min.

Get 25uL blood corpuscle from the blood corpuscle deposition into a sample cup or an Eppen-dorf microfuge tube.

Add 500 μL of Pretreatment Solution into sample cup or an Eppen-dorf microfuge tube.

Close the test tube and lysis the blood by shaking vigorously. Then mix the solution by either swirling gently or by using a vibration

mixer.

The hemolysate can be used as working samples after 5 minute.

1). Hb

Blank Sample



Sample － 12 μL

Mix, incubate for 5 min. at 37 ℃, and read the blank absorbance A


2). HbA1c

Blank Sample



Sample － 12 μL



Mix thoroughly at 37 ℃, and read the absorbance again 5 min later.


Reference Intervals


Who blood

According to IFCC 2.9-4.2%

According to NGSP/DCCT 4.8-5.9%

According to JCCLS 4.3-5.8%

Reportable Range


Who blood 3-16 %

If the value of sample exceeds 16%, the sample should be diluted with Pretreatment Solution (e.g. 1+ 1) and rerun.

5.4 FUN (Fructosamine)

Order Information


FUN0102 R1 2×30 mL+R2 1×15 mL+Calibrator 1×1.5 mL+Control 1×1 mL




Fructosamine is a time-averaged indicator of blood glucose levels and is used to assess the glycemic status of diabetics. The

concentration of glycated proteins such as glycohemoglobin, glycoalbumin or glycated total protein is generally recognized to be

valuable in evaluating the glycemic status of diabetic patients.

Method

Colorimetric Assay.

Reaction Principle

fructosamine + NBT colored complex

This colorimetric assay is based on the ability of ketoamines to reduce nitrotetrazolium-blue (NBT) to formazan in an alkaline

solution. The rate of formation of formazan is directly proportional to the concentration of fructosamine. Uricase serves to

eliminate uric acid interference and detergent eliminates matrix effects. The rate of reaction is measured photometrically at 546

nm.


R1:

Carbonate buffer 100 mmol/L

Uricase ≥400 U/L

Sodium cholate 3.0 mmol/L


R2: Phosphate buffer 20 mmol/L

NBT 3.0 mmol/L

Calibrator: 1-Deoxy-1-morpholino-D-Fructose








Assay procedure

Blank Sample



Sample － 20 μL



Mix thoroughly at 37 ℃ 4-5 min later, and read the absorbance again 1-2 min. later.


Reference Intervals ≤286 µmol/L

α-amylase

Reportable Range


Serum / Heparin plasma 5-1000 μmol/L



6. Pancreatitis

6.1 α-AMY (alpha-Amylase)

Order Information


AMY0102 R1 1×38 mL + R2 1×10 mL

AMY0103 R1 4×20 mL + R2 2×10 mL

AMY0104 R1 4×45 mL + R2 4×12 mL

AMY0105 R1 2×250 mL + R2 1×125 mL


α-Amylases originate from various organs and are mainly produced by the pancreas (P-type) and the salivary glands (S-type).

α-Amylases catalyze the hydrolytic degradation of polymeric carbohydrates, such as amylose, amylopectin and glycogen by

cleaving 1, 4-α-glucosidic bonds into various fragments. The pancreatic amylase is produced by the pancreas and released into

the intestinal tract; the salivary amylase is synthesized in the salivary glands and secreted into saliva. Because of its small

molecular weight, the blood amylase is eliminated through the kidney and excreted into urine. Elevation of urine amylase activity

reflects the rise of serum amylase activity. Measurement of α-amylase in serum and urine is mainly used for the diagnosis of

pancreatic disorders, as well as for detecting the development of complications. Normally the α-amylases present low activity, in

acute pancreatitis the blood amylase activity increases within 8-12 hours after onset of abdominal pain, peaks after approx. 12-24

hours. The blood amylase activity returns to normal values at the latest after 2-5 days, but the high urine amylase level will still last

for 5-7 days.

However, various nonpancreatic diseases, e.g. parotitis, renal insufficiency or pulmonary inflammation, can also increase amylase

levels. To confirm pancreatic disorders, additional pancreas specific enzyme, lipase or pancreatic-α-amylase, is recommended to

be determined at the same time.

Method This method is in accordance with the continuous monitoring of recommendations on the IFCC (International Federation of

Clinical Chemistry).

Reaction Principle

5Ethylidene-G7-PNP + 5H2O 2Ethylidene-G5 + 2G2-PNP + 2Ethylidene-G4 + 2G3-PNP + Ethylidene-G3 + G4-PNP

α-glucosidase

2G2-PNP + 2G3-PNP + G4-PNP + 14H2O 5PNP + 14Glucose

(PNP－p-nitrophenol; G－α-glucose)

In the assay reaction, the substrate 4, 6- ethylidene-(G7)-1, 4-nitrophenyl-(G1) –α, D-maltoheptaoside (EPS-G7) is cleaved by

α-amylases and subsequent hydrolysis of all the degradation products to p-nitrophenol with the aid of α-glucosidase (100%

chromophore liberation). The increase in absorbance of the p-nitrophenol formed at 405 nm is directly proportional to the activity

of α-amylases.


R 1： TRIS buffer 50 mmol/L

Magnesium sulphate 10 mmol/L

α-Glucosidase 4500 U/L

R 2： TRIS buffer 50 mmol/L

E-pNP-G7 5.5 mmol/L





Assay procedure

Blank Sample



Sample － 5 μL





Reference Intervals


Serum (Male/ Female) ≤100 U/L ≤1.67 μkat/L

Spontaneous urine ≤1000 U/L ≤16.67 μkat/L

Collected urine ≤900 U/24h ≤15.00 μkat/24h

Reportable Range

SAMPLE TYPE CONVENTIONAL UNITS S.I. UNITS

Serum / Plasma /Urine 5－1500 U/L 0.08－25 μkat/L



6.2 LIP (Lipase)

Order Information


LIP0102 R1 : 1×35mL + R2: 1×9mL + Calibrator:1×3mL + Quality control 1×5mL

LIP0103 R1 : 1×40mL + R2: 1×10mL + Calibrator:1×3mL + Quality control: 1×5mL

LIP0104 R1 : 2×40mL + R2: 2×10mL + Calibrator:1×3mL + Quality control: 1×5mL

Clinical significance Lipases are glycoproteins with a molecular weight of 47000 daltons. They are defined as triglyceride hydrolases which catalyse

the cleavage of triglycerides to diglycerides with subsequent formation of monoglycerides and fatty acids. Lipase enzymes are

produced in the pancreas and also secreted in small amounts by the salivary glands as well as by gastric, pulmo-nary and

intestinal mucosa. Determination of lipase is used for di-agnosis and treatment of diseases of the pancreas such as acute and

chronic pancreatitis and obstruction of the pancreatic duct.

Method Enzymatic Colorimetric Assay Method

Reaction Principle The method for the determination of lipase is based on the cleavage of specific chromogenic lipase substrate

1,2-O-dilaurylrac-glycero-3-glutaric acid-(6’methyl-resorufin)-ester emulsified in stabilized micro-particles. In the presence of

specific activators of pancreatic lipase as colipase, calcium ions and bile acids, the substrate is con-verted to

1,2-O-dilauryl-rac-glycerol and glutaric acid-6’-methylresorufinester which decomposes spontaneously to glutaric acid and

methylresorufin. The increase of absorbance at 580 nm, due to methylresorufin formation, is proportional to the activity of lipase in

the sample.


R1

Tris 40 mmol/L

Desoxycholate 1.8 mmol/L

Taurodesoxycholate 7.2 mmol/L

Colipase >1mg/L

R2:

Tartrate buffer, 15 mmol/L

Calcium chloride 0.13 mmol/L

Lipase Substrate ≥ 0.7 mmol/L

Standards Activity see label

Quality control Activity see label

Storage and stability Up to expiration date indicated on the label, when stored unopened at 2-8 ℃ and protected from light.




Once dissolved, the calibrator and control are stable for 30 days at -20℃(only freeze once).

Assay procedure

Blank Sample



Sample － 2 μL



Mix thoroughly, incubate 37℃ for 2 min., and then read the absorbance change value within 2 min.


Reference Intervals


Serum/plasma ≤ 38U/L

Reportable Range


Serum/plasma 5～250U/L

If the value of sample exceeds 250U/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+ 1) and the result should be

multiplied by 2.

7. Inorganic ions

7.1 Ca (Calcium)

Order Information


CA0102 R 4×40 mL

CA0103 R 6×40 mL

CA0104 R 4×45 mL

CA0105 R 4×250 mL


In plasma, calcium consists of three forms: free, conglutinated with proteins or complex with anions such as phosphate,

bicarbonate and citrate. Calcium is an absolutely necessary cation for cell functions. For example: muscle contraction, bone

mineralization, glycogen metabolism, blood concretion and nerve impulses conduction.

Renal diseases, liver diseases, intestinal malabsorption, acute pancreas inflammation, vitamin D deficiency, adrenal cortical

hormone therapy, diuretic treatment and hypoparathyroidism all may result in low levels of total calcium.

Hyperparathyroidism, hyperthyroidism, Addison’s disease, intussuscept vitamin D or vitamin A excessively, malignant diseases

with metastases and sarcoidosis will lead to high levels of total calcium.

Method

Arsenazo Ⅲ method

Reaction Principle

Calcium + Arsenazo Ⅲ a blue colored complex

By using 8-hydroxyquinoline-5-sulfonic acid to eliminate the interference of magnesium, calcium ions combine with Arsenazo Ⅲ

to produce a blue colored complex at a neutral solution. The absorbency increase is directly proportional to the concentration of

calcium.


R：


8-Hydroxyquinoline-5-sulfonic acid 5 mmol/L

Arsenazo Ⅲ 0.12 mmol/L





Assay procedure

Blank Sample

R 1000 μL 1000 μL


Sample － 10 μL



Reference Intervals



Urine Male < 250 mg/24 h (6.2 mmol/24 h)

Female < 300 mg/24 h (7.5 mmol/24 h)

Reportable Range


Serum / Plasma / Urine 0.1-3.75 mmol/L

If the value of sample exceeds 3.75 mmol/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+1) and rerun; the result


pH=7

7.2 Mg (Magnesium)

Order Information


MG0102 R 4×40 mL

MG0103 R 6×40 mL

MG0104 R 4×45 mL

MG0105 R 4×250 mL


Magnesium is one of the most abundant cations in the body, and plays an important role in cell respiration, glucose metabolism

and transmembrane transport.

Magnesium can activate more than 300 kinds of enzymes, the famous of which is Na+-K+-ATP enzyme.

Hypomagnesemia may cause by defective gastrointestinal absorption, body fluid losses, diuretic therapy, aminoglucoside

treatment, endocrinopathy and alcoholism, and the inherited disease is also an infrequent reason.

Hypermagnesemia is found in acute and chronic renal failure, magnesium excess, dehydration and diabetic acidosis.

Method

Xylidyl blue method

Reaction Principle

Xylidyl blue + Magnesium Xylidyl blue-Magnesium complex

By using the EGTA to eliminate the interference of calcium, magnesium ions combine with xylidyl blue to produce a xylidyl blue

-magnesium complex at an alkaline solution. The absorbency increase is directly proportional to the concentration of magnesium.


R：

Ethanolamine 49 mmol/L

EGTA 0.13 mmol/L

Xylidyl blue 0.09 mmol/L

Surfactant ＜2% (m/v)





Assay procedure

Blank Sample

OH-

R 1000 μL 1000 μL


Sample － 10 μL



Reference Intervals


Serum / Plasma

Neonates 0.48–1.05 mmol/l

Children 0.60–0.95 mmol/l

Women 0.77–1.03 mmol/l

Men 0.73–1.06 mmol/l

Urine Male 3–5 mmol/24 h

Reportable Range


Serum / Plasma / Urine 0.04-4.16 mg/dL 0.04–2.05 mmol/L



7.3 P (Phosphorus)

Order Information


P0102 R 4×40 mL

P0103 R 6×40 mL

P0104 R 4×45 mL

P0105 R 4×250 mL


PO43+ is the main anion in the cell, and its metabolism is closely related with Ca2+. In the body, the main form of Phosphorus is

calcium phosphate salt, which is the inorganic substance of the bones. The others take part in the glucose metabolism,

constitution of phospholipids, phosphoproteins, nucleic acids and nucleic protein. Phosphorus plays an important role in energy

transfer, muscle contraction and nerve conduction. Increased values occur in renal failure, hypoparathyroidism, pseudo

hypoparathyroidism, acute metabolically acid toxicosis and calcium phosphate loss of bones and cells. Decreased values occur in

malabsorption, hyperparathyroidism, alcoholism and vitamin D deficiency.

Method

Phosphomolybdate Method

Reaction Principle

Ammonium molybdate + Sulphuric acid + Phosphate phosphomolybdate complex

Ammonium molybdate combines with phosphate in present of sulphuric acid to produce a phosphomolybdate complex. The

absorbency increase is directly proportional to the concentration of phosphate.


R：

Ammonium molybdate 0.3 mmol/L

Sulphuric acid 0.5 mol/L

Surfactant <2% (m/v)





Assay procedure

Blank Sample

R 1000 μL 1000 μL


Sample － 10 μL

Mix thoroughly, at 37℃ and read the absorbance 3 min. later.


Reference Intervals


Serum/Plasma Adults 2.5-4.5 mg/dL 0.81-1.45 mmol/L

Children 4.0-7.0 mg/dL 1.29-2.26 mmol/L

Urine 0.4-1.3 g/24 h 12.9-42 mmol/24h

Concentrations in plasma are about 0.25 mg/dL (0.08mmol/L) lower than in serum.

Reportable Range


Serum / Plasma / Urine 0.3-4.0 mmol/L



7.4 Fe (Iron)

Order Information


Fe0102 R1 2×40 mL+R2 1×16 mL+Calibrator 1×1.5 mL+Control 1×5 mL

Ascorbic acid




Measurements of iron are used in the diagnosis and treatment of a number of conditions such as iron deficiency anemia,

hemochromatosis and chronic liver disease.

Method

Colorimetric assay（Ferrozine）.

Reaction Principle

Transferrin (Fe3+)2 2Fe2++ Transferrin

Fe2++ 3 Ferrozine colored complex

Under acidic conditions, iron is liberated from transferrin. Ascorbate reduces the

released Fe3+ ions to Fe2+ ions which then react with Ferrozine to form a colored complex. The color intensity is directly

proportional to the concentration of iron concentration and can be measured photometrically.


R1:

Citric acid 230 mmol/l

L-Ascorbic Acid 150mmol/L

Thiourea 145 mmol/L


R2: Ferrozine 10 mmol/L


Calibrator: Ammonium iron sulfate








Assay procedure

Blank Sample



Sample － 20 μL

Mix, incubate for 5-10 min. at 37 ℃, and read the blank absorbance, then add:


Mix thoroughly at 37 ℃, and read the absorbance 1-2 min. later.


Reference Intervals


Serum / Plasma Men 45-158 μg/dL 8.1-28.3 μmol/L

Women 37-145 μg/dL 6.6-26.0 μmol/L

Reportable Range


Serum/ heparin plasma 0.9-200 μmol/L



8. Immune

8.1 Ig A (Immunoglobulin A)

Order Information


IGA0102 R1 1×40 mL + R2 1×20 mL

IGA0103 R1 1×40 mL + R2 1×20 mL

IGA0104 R1 2×40 mL + R2 2×20 mL

IGA0105 R1 1×250 mL + R2 1×125 mL


Immunoglobulin A is an antibody playing a critical role in mucosal immunity. More IgA is produced in mucosal linings than all other

types of antibody combined; between 3 and 5g is secreted into the intestinal lumen each day. However, sources are correct when

they indicate immunoglobulin G as the most common form of immunoglobulin in the human body. In its secretory form, IgA is the

main immunoglobulin found in mucous secretions, including tears, saliva, colostrum, intestinal juice, vaginal fluid and secretions

from the prostate and respiratory epithelium. It is also found in small amounts in blood. Because it is resistant to degradation by

enzymes, secretory IgA can survive in harsh environments such as the digestive and respiratory tracts, to provide protection

against microbes that multiply in body secretions.

Measurements of immunoglobulin A are used in the diagnosis and treatment of immune deficiency states, protein-losing

conditions, chronic infections, myeloma, cirrhosis and liver disease.

Method

Turbidimetry Method

Reaction Principle

Anti-human IgA antibody + IgA Immunocomplex (agglutination)

Determination of the concentration of IgA through photometric measurement of immunocomplex between antibodies of IgA and

IgA present in the sample, the absorbency increase is directly proportional to the concentration of IgA.


R1：



PEG <2 % (m/v)

Surfactant <2 % (m/v)

R2： Anti-human IgA antibody (goat) dependent on titer

PEG <2 % (m/v)





Assay procedure

Blank Sample



Sample － 3 μL





Reference Intervals


Serum

0～1 years 0.00～0.83 g/L

1～3 years 0.20～1.00 g/L

4～6 years 0.27～1.95 g/L

7～9 years 0.34～3.05 g/L

10～11 years 0.53～2.04 g/L

12～13 years 0.58～3.58 g/L

14～15 years 0.47～2.49 g/L

16～19 years 0.61～3.48 g/L

＞20 years 0.7～4 g/L

Reportable Range


Serum 0.2～5.6 g/L



8.2 Ig G (Immunoglobulin G)

Order Information


IGG0102 R1 1×40 mL + R2 1×20 mL

IGG0103 R1 1×40 mL + R2 1×20 mL

IGG0104 R1 2×40 mL + R2 2×20 mL

IGG0105 R1 1×250 mL + R2 1×125 mL


Immunoglobulin G is a monomeric immunoglobulin, built of two heavy chains γ and two light chains. Each IgG has two antigen

binding sites. It is the most abundant immunoglobulin and is approximately equally distributed in blood and in tissue liquids,

constituting 75% of serum immunoglobulins in humans. IgG molecules are synthesised and secreted by plasma B cells.

Measurements of IgG are used in the diagnosis and treatment of immune deficiency states, protein-losing

conditions, chronic infections, liver disease, as well as specific diseases such as multiple sclerosis, mumps, meningitis,and

immunoglobulin G myeloma.

Method

Turbidimetry Method

Reaction Principle

Anti-human IgG antibody + IgG Immunocomplex (agglutination)

Determination of the concentration of IgG through photometric measurement of immunocomplex between antibodies of IgG and

IgG present in the sample, the absorbency increase is directly proportional to the concentration of IgG.


R1：



PEG <2 % (m/v)


R2： Anti-human IgG antibody (goat) dependent on titer

PEG <2 % (m/v)





Assay procedure

Blank Sample



Sample － 3 μL



Mix thoroughly at 37 ℃, and read the absorbance again 3-5 min. later.


Reference Intervals


Serum

0～1 years 2.32～14.11 g/L

1～3 years 4.53～9.16 g/L

4～6 years 5.04～14.64 g/L

7～9 years 5.72～14.74 g/L

10～11 years 6.98～15.60 g/L

12～13 years 7.59～15.49 g/L

14～15 years 7.16～17.11 g/L

16～19 years 5.49～15.84 g/L

＞20 years 7～16 g/L

Reportable Range


Serum 0.3～35 g/L

If the value of sample exceeds 35 g/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+ 1) and rerun; the result


8.3 Ig M (Immunoglobulin M)

Order Information


IGM0102 R1 1×40 mL + R2 1×10 mL

IGM0103 R1 1×40 mL + R2 1×10 mL

IGM0104 R1 2×40 mL + R2 2×10 mL

IGM0105 R1 1×240 mL + R2 1×60 mL


Immunoglobulin M is a basic antibody that is present on B cells. It is the primary antibody against A and B antigens on red blood

cells. IgM antibodies appear early in the course of an infection and usually reappear, to a less extent, after further exposure. IgM

antibodies do not pass across the human placenta. These two biological properties of IgM make it useful in the diagnosis of

infectious diseases.

Measurements of IgM are used in the diagnosis and treatment of immune deficiency states, protein-losing conditions,

Waldenstrom’s macroglobinemia, chronic infections, and liver disease.

Method

Turbidimetry Method

Reaction Principle

Anti-human IgM antibody + IgM Immunocomplex (agglutination)

Determination of the concentration of IgM through photometric measurement of immunocomplex between antibodies of IgM and

IgM present in the sample, the absorbency increase is directly proportional to the concentration of IgM.


R1：



PEG <2 % (m/v)


R2： Anti-human IgM antibody (goat) dependent on titer

PEG <2 % (m/v)





Assay procedure

Blank Sample



Sample － 3 μL





Reference Intervals


Serum 0～1 years 0.00～1.45 g/L

1～3 years 0.19～1.46 g/L

4～6 years 0.24～2.10 g/L

7～9 years 0.31～2.08 g/L

10～11 years 0.31～1.79 g/L

12～13 years 0.35～2.39 g/L

14～15 years 0.15～1.88 g/L

16～19 years 0.23～2.59 g/L

＞20 years 0.4～2.3 g/L

Reportable Range


Serum 0.05～4.8 g/L

If the value of sample exceeds 4.8 g/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+1) and rerun; the result


8.4 C3 (Complement C3)

Order Information


C30102 R1 1×40 mL + R2 1×20 mL

C30103 R1 1×40 mL + R2 1×20 mL

C30104 R1 2×40 mL + R2 2×20 mL

C30105 R1 1×250 mL + R2 1×125 mL


Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aid in the diagnosis of

immunologic disorders, especially those associated with deficiencies of complement components.

Complement C3 is a protein of the immune system. It plays a central role in the complement system and contributes to innate

immunity. In humans it is encoded on chromosome 19 by a gene called C3.

Method

Turbidimetry Method

Reaction Principle

Anti-human C3 antibody +C3 Immunocomplex (agglutination)

Determination of the concentration of C3 through photometric measurement of immunocomplex between antibodies of C3 and C3

present in the sample, the absorbency increase is directly proportional to the concentration of C3.


R1：



PEG 0.26 mmol/L

R2：



Anti-human C3 antibody (goat) dependent on titer





Assay procedure

Blank Sample



Sample － 3 μL





Reference Intervals


Serum 0.9～1.8 g/L

Reportable Range


Serum 0.04～3.3 g/L



8.5 C4 (Complement C4)

Order Information


C40102 R1 1×40 mL + R2 1×15 mL

C40103 R1 1×40 mL + R2 1×15 mL

C40104 R1 2×40 mL + R2 2×15 mL

C40105 R1 1×240 mL + R2 1×90 mL


Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aid in the diagnosis of

immunologic disorders, especially those associated with deficiencies of complement components.

Complement C4 is a protein involved in the complement system.It is responsible for the Chido Rodgers blood group system. The

degradation product of C4 has been identified as a biomarker for systemic lupus erythematosus.

Method

Turbidimetry Method

Reaction Principle

Anti-human C4 antibody +C4 Immunocomplex (agglutination)

Determination of the concentration of C4 through photometric measurement of immunocomplex between antibodies of C4 and C4

present in the sample, the absorbency increase is directly proportional to the concentration of C4.


R1：



PEG 0.26 mmol/L

R2：



Anti-human C4 antibody (goat) dependent on titer





Assay procedure

Blank Sample



Sample － 3 μL





Reference Intervals


Serum 0.1～0.4 g/L

Reportable Range


Serum 0.015～0.8 g/L



8.6 CRP (C-reactive Protein)

Order Information


CRP0102 R1 1×40 mL + R2 1×10 mL

CRP0103 R1 1×40 mL + R2 1×10 mL

CRP0104 R1 2×40 mL + R2 2×10 mL

CRP0105 R1 1×240 mL + R2 1×60 mL


C-Reactive Protein is a protein found in the blood in response to inflammation. CRP is produced by the liver and by fat cells. It is a

member of the pentraxin family of proteins.

C-reactive protein measurements are useful in the clinical evaluation of stress, trauma, infection, inflammation, and surgery.

Measuring and charting CRP values can prove useful in determining disease progress or the effectiveness of treatments.

Method

Turbidimetry Method

Reaction Principle

Anti-human CRP antibody + CRP Immunocomplex (agglutination)

Determination of the concentration of CRP through photometric measurement of immunocomplex between antibodies of CRP and

CRP present in the sample, the absorbency increase is directly proportional to the concentration of CRP.


R1：


PEG 0.26 mmol/L



Anti-human CRP antibody (goat) dependent on titer





Assay procedure

Blank Sample



Sample － 17 μL





Reference Intervals


Serum <5.0mg/L

Reportable Range


Serum 2～150 mg/L

If the value of sample exceeds 150 mg/L, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+ 1) and rerun; the result


8.7 RF (Rheumatoid Factor)

Order Information


RF0102 R1 1×40mL + R2 1×15mL + Calibrator 5×0.5mL + Quality control 1×3mL




Rheumatoid factors are a heterogeneous group of autoantibodies directed against the antigenic determinants on the Fc-region of

IgG molecules. They are important in the diagnosis of rheumatoid arthritis, but can also be found in other inflammatory-rheumatic

diseases and in various non-rheumatic diseases. They are also found in clinically healthy persons over 60 years of age. Despite

these restrictions, the detection of rheumatoid factors is a diagnostic criterion of the American College of Rheumatology for

classifying rheumatoid arthritis.

Method

Particle-enhanced Immunoturbidimetric Assay Method

Reaction Principle

When an antigen-antibody reaction occurs between RF in a sample and denatured human IgG which has been sensitized to latex

particles, agglutination results. This agglutination is detected as an absorbance change (550 to 660 nm), with the magnitude of the

change being proportional to the quantity of RF in the sample. The actual concentration is then determined by interpolation from a

calibration curve prepared from calibrators of known concentration.


R1 Tris 20 mmol/L

Aseptic 0.95 g/L

R2:

Suspension of latex particles coated with human

gamma-globulin

15 mmol/L

Aseptic 0.95 g/L




Once opened, the reagents and calibrator are stable for 28 days when refrigerated on the analyzer or refrigerator.

Contamination must be avoided.

Once dissolved, the control is stable for 15 days at 2-8 ℃

Do not freeze the reagents, calibrator and control.

Assay procedure

Blank Sample



Sample － 8 μL



Mix thoroughly, incubate 37℃ for 1.5 min., and then read the absorbance change value 1.5 min. later.


Reference Intervals


Serum ≤ 18 IU/mL

Reportable Range


Serum 4～120 IU/mL

If the value of sample exceeds 120 IU/mL, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+ 1) and the result should

be multiplied by 2.

8.8 ASO (Antibodies Against Streptolysin O)

Order Information


ASO0102 R1 : 1×40mL + R2: 1×40mL + Calibrator 1×0.5mL + Quality control 1×3mL




Immunological testing for specific antibodies to streptococcal metabolic products yields important information about previous

streptococcus infections. Antibodies are produced against the pathogen and its metabolic products. One example is the antibody

to streptolysin O, an enzyme produced by Lancefield group A β-hemolytic streptococci. Determination of antistreptolysin O is

performed when toxic and sensitizing associated illnesses occur, such as rheumatic fever (major symptoms: carditis, polyarthritis,

chorea minor, subcutaneous nodules, erythema annulare) and poststreptococcal acute glomerulonephritis.

Method

Particle-enhanced Immunoturbidimetric Assay Method

Reaction Principle

When an antigen-antibody reaction occurs between ASO in a sample and denatured human IgG which has been sensitized to

latex particles, agglutination results. This agglutination is detected as an absorbance change (572 nm), with the magnitude of the

change being proportional to the quantity of ASO in the sample. The actual concentration is then determined by interpolation from

a calibration curve prepared from calibrators of known concentration.


R1

Tris 20 mmol/L

NaCl 150 mmol/L

Aseptic 0.95 g/L

R2:

Suspension of latex particles coated with streptolysin

O

15 mmol/L

Aseptic 0.95 g/L




Once opened, the reagents and calibrator are stable for 28 days when refrigerated on the analyzer or refrigerator.

Contamination must be avoided.

Once dissolved, the control is stable for 15 days at 2-8 ℃

Do not freeze the reagents, calibrator and control.

Assay procedure

Blank Sample



Sample － 3 μL


Reagent 2 150μL 150μL

Mix thoroughly, incubate 37℃ for 1 min., and then read the absorbance change value 3-4 min. later.


Reference Intervals


Serum Adults <200 IU/mL

Children <150 IU/mL

Reportable Range


Serum 20～1000IU/mL

If the value of sample exceeds 1000IU/mL, the sample should be diluted with 9 g/L NaCl solution (e.g. 1+ 1) and the result should

be multiplied by 2.

B. Calibrator & Quality Control

1. Calibrator

1.1 Multi Sera Calibrator

Package size

20×3 mL, 10×3 mL

Intended use Multi Sera Calibrator is used for calibration of quantitative determination of routine chemistry analytes on Mindray BS

measurement system。

Summary Multi Sera Calibrator contains the following analytes:

Albumin（ALB） Alkaline Phosphatase（ALP） Alanine Aminotransferase（ALT）

α-Amylase（α-AMY） Aspartate Aminotransferase（AST） Direct Bilirubin（DB）

Total Bilirubin（TB） Calcium（Ca） Total Cholesterol（TC）

Creatine Kinase（CK） Creatinine（Crea） Glucose（GLU）

Gamma–Glutamyltransferase（γ-GT） α-Hydroxybutyrate Dehydrogenase

（α-HBDH） Lactate Dehydrogenase（LDH）

Magnesium（Mg） Phosphorus（P） Total Protein（TP）

Triglycerides（TG） Urea（Urea） Uric Acid（UA）

By calibrating the selected analytes, Mindray BS-series chemistry analyzers can generate valid calibration factors, and then

calculate the concentrations or activities of each sample automatically after analysis. Mindray BS measurement system is

composed of Mindray BS-series chemistry analyzers, Mindray reagent kits, calibrators and control materials.

Components Multi Sera Calibrator is a lyophilized calibrator based on human serum. The concentrations or activities of the calibrator

components are lot-specific.

Storage and Stability The calibrator is stable up to expiration date indicated on the label when stored in unopened vial at 2~8℃ and protected from light.

Once reconstituted, please store calibrator tightly capped when not in use. The stability information is as below.

Temperatures of storage Stability

Universal components Total Bilirubin Direct Bilirubin

15~25℃ 8 hours 6 hours 3 hours

2~8℃ 2 days 1 day 8 hours

-25~-15℃ (when frozen once) 4 weeks 2 weeks 2 weeks

Traceability of Calibrator The calibrator values assigned by Mindray standard transfer procedure and routine method are listed in the value sheet. The

traceability process is based on prEN ISO 175112 and ISO181533, each analyte (measurand) in this calibrator is traceable to the

available reference method and (or) reference material, or manufacturer’s reference standard. Traceability information is given

below. Details of traceability are available on request.

1.2 Lipids Calibrator

Package size

5×1 mL

Intended use Lipids Calibrator is used for calibration of quantitative determination of lipids analytes on Mindray BS measurement system.

Summary Lipids Calibrator contains Apolipoprotein A1（ApoA1）, Apolipoprotein B（ApoB）, HDL- Cholesterol (HDL-C）, LDL- Cholesterol

（LDL-C）. By calibrating the selected analytes, Mindray BS-series chemistry analyzers can generate valid calibration factors,

then calculate the concentrations of each sample automatically after analysis. Mindray BS measurement system is composed of

Mindray BS-series chemistry analyzers, Mindray reagent kits, calibrators and control materials.

Components

Analytes Reference methods/materials

Urea, TB, GLU, TP, TG, TC,

UA, Crea, Ca, Mg

International Reference Measurement Method or/and

Standard Reference Material from NIST

LDH, γ-GT , CK, α-AMY IFCC Primary Reference Procedures

ALB ERM-DA470K

ALT, AST, α-HBDH, ALP, DB, P Manufacturer’s Selected Measurement Procedure

Lipids Calibrator is a lyophilized calibrator based on human serum. The concentrations of the calibrator components are

lot-specific.




15~25℃ 8 hours

2~8℃ 5 days

-25~-15℃ (when frozen once) 4 weeks


traceability process is based on prEN ISO 175112, each analyte (measurand) in this calibrator is traceable to the available

reference method and (or) reference material. Traceability information is given below. Details of traceability are available on

request.

1.3 Specific Proteins Calibrator

Package size

5×1 mL

Intended use Specific Proteins Calibrator is used for the calibration of quantitative determination of specific proteins on Mindray BS

measurement system.

Summary Specific Proteins Calibrator contains the following analytes:

Complement C3（C3） Complement C4（C4） C- Reactive protein（CRP）

Immunoglobulin A（IgA） Immunoglobulin G（IgG） Immunoglobulin M（IgM）

By calibrating the selected analytes, Mindray BS-series chemistry analyzers can generate valid calibration factors, and then

calculate the concentrations of each sample automatically after analysis. Mindray BS measurement system is composed of

Mindray BS-series chemistry analyzers, Mindray reagent kits, calibrators and control materials.

Components Specific Proteins Calibrator is a liquid calibrator based on human serum. The concentrations of the calibrator components are

lot-specific.


ApoA1, APBOB WHO Standard Reference Material

HDL-C, LDL-C CDC Reference Measurement Method and NIST Standard Reference

Material


Once opened, it is stable for 28 days when capped tightly and avoiding microbial contamination at 2~8℃.


traceability process is based on prEN ISO 175112, each analyte (measurand) in this calibrator is traceable to the available

reference material. Traceability information is given below. Details of traceability are available on request.

1.4 CK-MB Calibrator

Package size

3×1 mL

Intended use CK-MB Calibrator is used for calibration of quantitative determination of cardiac enzyme analyte on Mindray BS measurement

system。

Summary CK-MB Calibrator contains Creatine Kinase-MB (CK-MB) analyte. By calibrating the selected analytes, Mindray BS-series

chemistry analyzers can generate valid calibration factors, and then calculate the activities of each sample automatically after

analysis. Mindray BS measurement system is composed of Mindray BS-series chemistry analyzers, Mindray reagent kits,

calibrators and control materials.

Components CK-MB Calibrator is a lyophilized calibrator based on serum. The activities of the calibrator components are lot-specific.




15~25℃ 1 day

2~8℃ 2 days

-25~-15℃ (when frozen once) 28 days


traceability process is based on prEN ISO 175112 and ISO181533, the analyte (measurand) in this calibrator is traceable to


C3, C4, IgA, IgG, IgM ERM-DA470K

CRP ERM-DA472

manufacturer’s selected measurement.

1.5 Lipoprotein(a) Calibrator

Package size

3×1 mL

Intended use Lipoprotein(a) Calibrator is used for calibration of quantitative determination of lipid analyte on Mindray BS measurement system.

Summary Lipoprotein(a) Calibrator contains Lipoprotein(a) （LP(a)） analyte. By calibrating the selected analytes, Mindray BS-series

chemistry analyzers can generate valid calibration factors, and then calculate the concentrations or activities of each sample

automatically after analysis. Mindray BS measurement system is composed of Mindray BS-series chemistry analyzers, Mindray

reagent kits, calibrator and control materials.

Components Lipoprotein(a) Calibrator is a lyophilized calibrator based on human serum. The concentrations of the calibrator components are

lot-specific.




15~25℃ 1 day

2~8℃ 30 days


traceability process is based on prEN ISO 175112, each analyte (measurand) in this calibrator is traceable to manufacturer’s

Selected Measurement Procedure.

1.6 Prealbumin Calibrator

Package size

3×1 mL

Intended use Prealbumin Calibrator is used for calibration of quantitative determination of prealbumin on Mindray BS measurement system.

Summary Prealbumin Calibrator contains Prealbumin (PA) analyte. By calibrating the selected analytes, Mindray BS-series chemistry

analyzers can generate valid calibration factors, then calculate the concentrations or activities of each sample automatically after

analysis. Mindray BS measurement system is composed of Mindray BS-series chemistry analyzers, Mindray reagent kits,

calibrators and control materials.

Components Prealbumin Calibrator is a lyophilized calibrator based on human serum. The concentrations of the calibrator components are

lot-specific.




15~25℃ 8 hours

2~8℃ 2 days

-25~-15℃ (when frozen once) 2 weeks


traceability process is based on prEN ISO 175112, the analyte (measurand) in this calibrator is traceable to the ERM-DA470K.

2. Quality Control

2.1 Multi Control Sera N

Package size

20×5 mL, 10×5 mL

Intended use Multi Control Sera N is used in routine chemistry analytes quality control by monitoring accuracy and precision of Mindray BS

measurement system and test ability of clinical laboratory.

Summary Multi Control Sera N contains the following analytes:





Gamma–Glutamyltransferase（γ-GT） α-Hydroxybutyrate Dehydrogenase Lactate Dehydrogenase（LDH）

（α-HBDH）

Immunoglobulin A (IgA) Immunoglobulin G (IgG) Immunoglobulin M (IgM)



Mindray BS measurement system is composed of Mindray BS-series chemistry analyzers, Mindray reagent kits, calibrators and

control materials.

Components Multi Control Sera N is a lyophilized control based on human serum. The concentrations or activities of the control components

are lot-specific and almost at normal levels for the methods used.

Storage and Stability The control is stable up to expiration date indicated on the label when stored in unopened vial at 2~8℃ and protected from light.

Once reconstituted, please store control tightly capped when not in use. The stability information is as below.






2.2 Multi Control Sera P

Package size

20×5 mL, 10×5 mL

Intended use Multi Control Sera P is used in routine chemistry analytes quality control by monitoring accuracy and precision of Mindray BS


Summary Multi Control Sera P contains the following analytes:





Gamma–Glutamyltransferase（γ-GT） α-Hydroxybutyrate Dehydrogenase

（α-HBDH） Lactate Dehydrogenase（LDH）




control materials.

Components Multi Control Sera P is a lyophilized control based on human serum. The concentrations or activities of the control components

are lot-specific and almost at abnormal or pathological levels for the methods used.








2.3 Lipids Control N

Package size

6×3 mL

Intended use Lipids Control N is used in Lipids quality control by monitoring accuracy and precision of Mindray BS measurement system and

test ability of laboratory.

Summary The control contains the following analytes:

Triglycerides（TG） Total Cholesterol（TC） HDL- Cholesterol (HDL-C）

LDL- Cholesterol（LDL-C） Apolipoprotein A1（APOA1） Apolipoprotein B（APOB）


control materials.

Components Lipids Control N is a lyophilized control based on human serum. The concentrations of the control components are lot-specific and

almost at normal levels for the methods used.


Once reconstituted, please store tightly capped when not in use. The stability information is as below.


15~25℃ 2 day

2~8℃ 5 days


2.4 Lipids Control P

Package size

6×3 mL

Intended use Lipids Control P is used in Lipids quality control by monitoring accuracy and precision of Mindray BS measurement system and

test ability of laboratory.

Summary The control contains Triglycerides (TG), Total Cholesterol (TC), Apolipoprotein A1 (APOA1), and Apolipoprotein B (APOB).


control materials.

Components Lipids Control P is a lyophilized control based on human serum. The concentrations of the control components are lot-specific and

almost at abnormal or pathological levels for the methods used.




15~25℃ 2 day

2~8℃ 5 days


2.5 HDL&LDL Cholesterol Control P

Package size

4×3 mL

Intended use HDL&LDL Cholesterol Control P is used in lipids analytes quality control by monitoring accuracy and precision of Mindray BS


Summary HDL&LDL Cholesterol Control P contains HDL- Cholesterol (HDL-C）and LDL- Cholesterol（LDL-C）analytes. Mindray BS

measurement system is composed of Mindray BS-series chemistry analyzers, Mindray reagent kits, calibrators and control

materials.

Components HDL&LDL Cholesterol Control P is a lyophilized control based on human serum. The concentrations of the control components

are lot-specific and almost at abnormal or pathological levels for the methods used.




15~25℃ 1 day

2~8℃ 5 days


2.6 Specific Proteins Control N

Package size

5×1 mL, 10×1 mL

Intended use Specific Proteins Control N is used in specific proteins quality control by monitoring accuracy and precision of Mindray BS

measurement system and test ability of laboratory.

Summary Specific Proteins Control N contains the following analytes:

Complement factor C3（C3） Complement factor C4（C4） C- Reactive protein（CRP） Immunoglobulin A（IgA）

Immunoglobulin G（IgG） Immunoglobulin M（IgM） Albumin（ALB） Total Protein（TP）


control materials.

Components Specific Proteins Control N is a liquid control based on human serum. The concentrations of the control components are

lot-specific and almost at normal levels for the methods used.



2.7 Specific Proteins Control P

Package size

5×1 mL, 10×1 mL

Intended use Specific Proteins Control P is used in specific proteins quality control by monitoring accuracy and precision of Mindray BS


Summary Specific Proteins Control P control contains the following analytes:

Complement C3（C3） Complement C4（C4） C- Reactive protein（CRP） Immunoglobulin A（IgA）

Immunoglobulin G（IgG） Immunoglobulin M（IgM） Albumin（ALB） Total Protein（TP）


control materials.

Components Specific Proteins Control P is a liquid control based on human serum. The concentrations of the control components are

lot-specific and almost at abnormal or pathological levels for the methods used.



2.8 CK-MB Control N

Package size

4×3 mL

Intended use CK-MB Control N is used in cardiac enzyme analyte quality control by monitoring accuracy and precision of Mindray BS


Summary CK-MB Control N contains Creatine Kinase-MB (CK-MB) analyte. Mindray BS measurement system is composed of Mindray

BS-series chemistry analyzers, Mindray reagent kits, calibrators and control materials.

Components CK-MB Control N is a lyophilized control based on serum. The activities of the control components are lot-specific and almost at

normal levels for the methods used.




15~25℃ 1 day

2~8℃ 3 days


2.9 CK-MB Control P

Package size

4×3 mL

Intended use CK-MB Control P is used in cardiac enzyme analyte quality control by monitoring accuracy and precision of Mindray BS


Summary CK-MB Control P contains Creatine Kinase-MB (CK-MB) analyte. Mindray BS measurement system is composed of Mindray

BS-series chemistry analyzers, Mindray reagent kits, calibrators and control materials.

Components CK-MB Control P is a lyophilized control based on serum. The activities of the control components are lot-specific and almost at

abnormal or pathological levels for the methods used.




15~25℃ 1 day

2~8℃ 3 days


2.10 Lipoprotein(a) Control N&P

Package size

Control N: 2×1 mL

Control P: 2×1 mL

Intended use Lipoprotein(a) Control N&P is used in lipids analyte quality control by monitoring accuracy and precision of Mindray BS


Summary The control analyte is Lipoprotein(a)(LP(a)). Mindray BS measurement system is composed of Mindray BS-series chemistry

analyzers, Mindray reagent kits, calibrators and control materials.

Components Lipoprotein(a) Control N&P contains two levels: Lipoprotein(a) Control N and Lipoprotein(a) Control P. The concentrations of the

Lipoprotein(a) Control N and Lipoprotein(a) Control P are respectively at normal and pathological levels for the methods used.

Both of the controls are lyophilized controls based on human serum and the concentrations of control components are lot-specific.




15~25℃ 1 day

2~8℃ 30 days

-25~-15℃ (when frozen once) 3 months

2.11 Prealbumin Control N&P

Package size

Control N: 3×1 mL

Control P: 3×1 mL

Intended use Prealbumin Control N&P is used in prealbumin quality control by monitoring accuracy and precision of Mindray BS measurement

system and test ability of laboratory.

Summary The control analyte is Prealbumin (PA). Mindray BS measurement system is composed of Mindray BS-series chemistry analyzers,

Mindray reagent kits, calibrators and control materials.

Components Prealbumin Control N&P contains two levels: Prealbumin Control N and Prealbumin Control P. The concentrations of the

Prealbumin Control N and Prealbumin Control P are respectively at normal and pathological level for the methods used. Both of

the controls are lyophilized controls based on human serum and the concentrations of control component are lot-specific.




15~25℃ 8 hours

2~8℃ 2 days

-25~-15℃ 2 weeks (when frozen once)

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