stardust mc15 chemistry parameters alat(gpt) fs (ifcc mod.)

1 845 2701 10 02 71

September 2007/3

StarDust MC15 Chemistry parameters

GPT

Kinetic

Monoreagent application

WL1 340

Units U/l

Temperature 37

Factor 1745

N of Read 5

Interval 30

Delay 120

Lim Abs 0.7 min

Lin. Limit 250

Norm High 41

Norm Low 0

Decimals 0

Sample Vol 50

Reagent Vol 500

MC15

Procedure:

For Monoreagent mix 4 parts R1 + 1 part R2

STABILITY: 4 WEEKS AT 2 - 8° C 5 DAYS AT 15 - 25° C The Monoreagent must be protected from light!

Pipette into the cuvette strips in the appropriate way. A free initial cuvette position must be left to perform the optical zero (blank)

Reagent (Reading zone)

Sample (Sample zone)

Samples 500 µl 50 µl

Place the cuvette strip in the incubating position and leave it for 5 minutes at 37°C

Go into programme no. 1 . Input the number of samples and the initial position for them.

Place the cuvette strip in the mixing position and press MIX

Place the cuvette strip in the reading position and press READ

ALAT(GPT) FS (IFCC mod.) Order information

Cat. No. 1 2701 .. .. …

Notes

1. Please refer to the package insert for ALAT(GPT) FS (IFCC

mod.) for detailed information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. Manufactured by

DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.

**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.

2 845 0220 10 02 71

September 2007/3


ALBU

EP

WL1 630

WL2 546

Units g/dl

Temperature 37

Std 5.0

Factor

Lin. Limit 6.0

Norm High 5.2

Norm Low 3.5

Decimals 1

Sample Vol 5

Reagent Vol 500

Reac. Time 180

MC15

Procedure:

Reagent ready to use

See package insert for reagent stability

Pipette into the cuvette strips in the appropriate way.



Blank 500 µl

Std (Optional) 500 µl 5 µl



Place the cuvette strip in the incubating position for 5 minutes.

Go into programme no. 3 . Input the number of samples and the initial position for them and whether a recalibration is needed.


ALBUMIN FS Order information

Cat. No. 1 0220 .. .. …

Notes

1. Please refer to the package insert for Albumin FS for

detailed information about the test on the following:




2. Manufactured by

DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany


3 845 0242 10 02 71

May 2008/4


MALB

Multi Std - Differential

WL1 405

WL2

Units mg/l

Number of standards 6

Point 1/ Conc NaCl - 0

Point 2 / Conc *Level 1 TruCal Alb U/CSF





Readings per standard 1

Readings per sample 1

Temperature 37

Lin. Limit 333

Norm High 20

Norm Low 0

Decimals 1

Sample Vol 20

Reagent Vol 400 + 80

Delay 0

Reac. Time 180

*Input by user

MC15

Procedure:

Reagents are ready to use

Pipette into the cuvette strips in the appropriate way. Samples are dispensed directly into the reading zone

Reagent 1 (Reading zone)

Sample (Reading zone)

Blank 400 µl

Stds (Optional) 400 µl 20 µl


Place the cuvette strip in the incubating position for 10 minutes

Go into the programme no. 31. Input the number of samples and the initial position for them and whether a recalibration is needed.


When the reading is completed take out the cuvette strip and add 80 µl R2 into the sample position in all the cuvettes



ALBUMIN IN URINE/CSF FS (Microalbumin)

Urine/CSF application

Order information

Cat. No. 1 0242 .. .. …

Notes

1. Please refer to the package insert for Albumin in Urine/CSF

FS *Microalbumin for detailed information about the test on the following:




2. Manufactured by



4 845 0401 10 02 71

September 2007/3


ALP

Kinetic

Monoreagent Application

WL1 405

Units U/l

Temperature 37

Factor 2757

N of Read 5

Interval 30

Delay 60

Lim Abs 1.5 max

Lin. Limit 700

Norm High 258

Norm Low 0

Decimals 0

Sample Vol 10

Reagent Vol 500

MC15

Procedure:


STABILITY: 4 WEEKS AT 2 - 8° C 5 DAYS AT 15 - 25° C The Monoreagent must be protected from light! Pipette into the cuvette strips in the appropriate way. A free initial cuvette position must be left to perform the optical zero (blank)








ALKALINE PHOSPHATASE FS DGKC

Order information

Cat. No. 1 0401 .. .. …

Notes

1. Please refer to the package insert for

Alkaline phosphatase FS DGKC for detailed information about the test on the following:




2. Manufactured by



5 845 0411 10 02 71

September 2007/3


ALP

Kinetic


WL1 405

Units U/l

Temperature 37

Factor 2757

N of Read 5

Interval 30

Delay 60

Lim Abs 1.5 max

Lin. Limit 700

Norm High 128

Norm Low 42

Decimals 0

Sample Vol 10

Reagent Vol 500

MC15

Procedure:











ALKALINE PHOSPHATASE FS IFCC 37° C

Order information

Cat. No. 1 0441 .. .. …

Notes


Alkaline phosphatase FS IFCC for detailed information about the test on the following:




2. Manufactured by



6 845 0501 10 02 71

September 2007/4


AMYL

Kinetic


WL1 405

Units U/l

Temperature 37

Factor 4554

N of Read 4

Interval 60

Delay 120

Lim Abs 1.4 Max

Lin. Limit 1800

Norm High 100

Norm Low 0

Decimals 0

Sample Vol 10

Reagent Vol 500

MC15

Procedure:


STABILITY: 6 MONTHS AT 2 - 8° C 4 WEEKS AT 15 - 25° C The Monoreagent must be protected from light!









-AMYLASE CC FS Order information

Cat. No. 1 0501 .. .. …

Notes

1. Please refer to the package insert for -Amylase CC FS

for detailed information about the test on the following:




2. Manufactured by



7 845 7102 10 02 71

May 2008/4


APOA

Multi Std – Differential

WL1 578

WL2

Units mg/dl


Point 1/ Conc *

Point 2/ Conc *

Point 3/ Conc *



Temperature 37

Lin. Limit 250

Norm High 190

Norm Low 110

Decimals 1

Sample Vol 20**


Delay 30

Reac. Time 180

*Input by user

MC15

Procedure:


**Samples/Standards are pre-diluted 1+5 with 0.9% NaCl




Blank 400 µl




Go into the Apo A1 programme no. 32. Input the number of samples and the initial position for them and whether a recalibration is needed.





APOLIPOPROTEIN A1 FS Order information

Cat. No. 1 7102 .. .. …

Notes

1. Please refer to the package insert for Apoliporotein A1 FS





2. Manufactured by



8 845 7112 10 02 71

May 2008/4


APOB


WL1 340

WL2

Units mg/dl


Point 1/ Conc *

Point 2/ Conc *

Point 3/ Conc *



Temperature 37

Lin. Limit 250

Norm High 155

Norm Low 75

Decimals 1

Sample Vol 20**


Delay 30

Reac. Time 180

*Input by user

MC15

Procedure:


**SamplesStandards are pre-diluted 1+5 with 0.9% NaCl




Blank 400 µl




Go into the Apo B programme no. 33. Input the number of samples and the initial position for them and whether a recalibration is needed.





APOLIPOPROTEIN B FS Order information

Cat. No. 1 7112 .. .. …

Notes

1. Please refer to the package insert for Apoliporotein B FS





2. Manufactured by



9 845 2601 10 02 71

September 2007/3


GOT

Kinetic


WL1 340

Units U/l

Temperature 37

Factor 1745

N of Read 5

Interval 30

Delay 120

Lim Abs 0.7 min

Lin. Limit 250

Norm High 37

Norm Low 0

Decimals 0

Sample Vol 50

Reagent Vol 500

MC15

Procedure:











ASAT(GOT) FS (IFCC mod.) Order information

Cat. No. 1 2601 .. .. …

Notes


ASAT(GOT) FS (IFCC Mod) for detailed information about the test on the following:




2. Manufactured by



10 845 7012 10 02 71

May 2008/5


ASO

Multi Std - FxT

WL1 546

WL2

Units IU/ml



Point 2 / Conc *Level 1 TruCal ASO




Point 6 / Conc



Temperature 37

Lin. Limit 400

Norm High 200

Norm Low 0

Decimals 0

Sample Vol 10


Delay 30

Reac. Time 180

*Input by user

MC15

Procedure:





Blank 400 µl





Add 80 µl R2 into the sample position in all the cuvettes


Place the cuvette strip immediately in the reading position and press READ

ANTISTREPTOLYSIN O FS Order information

Cat. No. 1 7012 .. .. …

Notes

1. Please refer to the package insert for Antistreptolysin O FS





2. Manufactured by



11 845 0950 10 02 71

May 2008/5


CO2

FxT

WL1 405

Units mmol/l

Temperature 37

Std 30

Factor

Interval 390

Delay 30

Lim Abs Min 0

Lin. Limit 50

Norm High 29

Norm Low 22

Decimals 1

Sample Vol 5

Reagent Vol 500

MC15

Procedure:






Blank 500 µl






BICARBONATE FS Order information

Cat. No. 1 0950 .. .. …

Notes

1. Please refer to the package insert for Bicarbonate FS for





2. Manufactured by



12 845 0821 10 02 71

September 2007/3


BILD

Diff

WL1 546

WL2 630

Units mg/dl

Temperature 37

Std 2.62

Factor

Lin. Limit 10.0

Norm High 0.2

Norm Low 0.0

Decimals 2

Sample Vol 50


Delay 0

Reac. Time 300

MC15

Procedure:





Blank 400 µl






When the reading is completed take out the cuvette strip and add 100 µl R2 to all the cuvettes Place the cuvette strip in the mixing position and press MIX Place the cuvette strip in the reading position and press READ

BILIRUBIN AUTO DIRECT FS Order information

Cat. No. 1 0821 .. .. …

Notes

1. Please refer to the package insert for Bilirubin Auto Direct FS





2. Manufactured by



13 845 0811 10 02 71

September 2007/3


BILT

Diff

WL1 546

WL2 630

Units mg/dl

Temperature 37

Std 4.47

Factor

Lin. Limit 10.0

Norm High 1.2

Norm Low 0.1

Decimals 1

Sample Vol 50

Reagent Vol * 400 + 100

Delay 0

Reac. Time 300

MC15

Procedure:





Blank 400 µl







BILIRUBIN AUTO TOTAL FS

Order information

Cat. No. 1 0811 .. .. …

Notes

1. Please refer to the package insert for Bilirubin Auto Total

FS for detailed information about the test on the following:




2. Manufactured by



14 845 1802 10 02 71

May 2008/4


C3


WL1 340

WL2

Units mg/dl



Point 2 / Conc *Level 1 TruCal Protein







Temperature 37

Lin. Limit 400

Norm High 180

Norm Low 90

Decimals 0

Sample Vol 10


Delay 0

Reac. Time 300

*Input by user

MC15

Procedure:





Blank 500 µl









COMPLEMENT C3c FS

Order information

Cat. No. 1 1802 .. .. …

Notes

1. Please refer to the package insert for Complement C3c FS





2. Manufactured by

DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany d.


15 845 1812 10 02 71

May 2008/4


C4


WL1 340

WL2

Units mg/dl










Temperature 37

Lin. Limit 90

Norm High 40

Norm Low 10

Decimals 0

Sample Vol 10


Delay 0

Reac. Time 300

*Input by user

MC15

Procedure:





Blank 400 µl









COMPLEMENT C4 FS

Order information

Cat. No. 1 1812 .. .. …

Notes

1. Please refer to the package insert for Complement C4 FS





2. Manufactured by



16 845 1130 10 02 71

September 2007/3


CALC

EP

WL1 670

WL2 578

Units mg/dl

Temperature 37

Std 10.0

Factor

Lin. Limit 25.0

Norm High 10.3

Norm Low 8.6

Decimals 1

Sample Vol 10

Reagent Vol 500

Reac. Time 600

MC15

Procedure:





Blank 500 µl







CALCIUM AS FS Order information

Cat. No. 1 1130 .. .. …

Notes

1. Please refer to the package insert for Calcium AS FS for





2. Manufactured by



18 845 1181 10 02 71

September 2009/5


CALC

Diff

WL1 670

WL2 546

Units mg/dl

Temperature 37

Std 10.0

Factor

Lin. Limit 25.0

Norm High 10.3

Norm Low 8.6

Decimals 1

Sample Vol 5


Delay 180

Reac. Time 300

MC15

Procedure:





Blank 400 µl







CALCIUM P FS Order information

Cat. No. 1 1181 .. .. …

Notes

1. Please refer to the package insert for Calcium P FS for





2. Manufactured by



19 845 1401 10 02 71

May 2008/4


CLIN

Kinetic

WL1 405

Units U/l

Temperature 37

Factor 55016

N of Read 4

Interval 60

Delay 120

Lim Abs 0.1 min

Lin. Limit 25000

Norm High 11500

Norm Low 3930

Decimals 0

Sample Vol 10


MC15

Procedure:





Blank 400 µl





Go into the programme no. 39. Input the number of samples and the initial position for them.

Take out the cuvette strip out of the incubating position and add 100 µl R2 to all the cuvettes



CHOLINESTERASE FS Order information

Cat. No. 1 1401 .. .. …

Notes

1. Please refer to the package insert for Cholinesterase FS





2. Manufactured by



20 845 1200 10 02 71

September 2007/3


CL

EP

WL1 500

WL2 630

Units mmol/l

Temperature 37

Std 100

Factor

Lin. Limit 130

Norm High 108

Norm Low 96

Decimals 0

Sample Vol 5

Reagent Vol 500

Reac. Time 180

MC15

Procedure:





Blank 500 µl







CHLORIDE FS Order information

Cat. No. 1 1200 .. .. …

Notes

1. Please refer to the package insert for Chloride FS for





2. Manufactured by



21 845 1300 10 02 71

September 2007/3


CHOL

EP

WL1 500

WL2 630

Units mg/dl

Temperature 37

Std 200

Factor

Lin. Limit 380

Norm High 200

Norm Low 0

Decimals 0

Sample Vol 10

Reagent Vol 500

Reac. Time 600

MC15

Procedure:





Blank 500 µl







CHOLESTEROL FS Order information

Cat. No. 1 1300 .. .. …

Notes

1. Please refer to the package insert for Cholesterol FS for





2. Manufactured by



22 845 1651 10 02 71

May 2008/2


CK-M

Kinetic

Substrate start DS

WL1 340

Units U/l

Temperature 37

Factor 4127

N of Read 4

Interval 60

Delay 180

Lim Abs 1.4 max

Lin. Limit 1000

Norm High 24

Norm Low 0

Decimals 0

Sample Vol 20


MC15

Procedure:

Reagent 1: Mix 1 part of CK-MB DS with 20 parts R1. STABILITY: 6 days at 2 – 8 ° C 24 hrs at 15 – 25 ° C

Reagent 2: R2 is ready to use




Blank 400 µl





Go into the programme no. 40. Input the number of samples and the initial position for them.




CK-MB FS Substrate start with DS

Order information

Cat. No. 1 1651 .. .. …

Notes

1. Please refer to the package insert for CK-MB FS for





2. Manufactured by



23 845 1651 10 02 71

January 2008/3


CK-M

Kinetic


WL1 340

Units U/l

Temperature 37

Factor 8254

N of Read 4

Interval 60

Delay 300

Lim Abs 1.4 Max

Lin. Limit 1000

Norm High 24

Norm Low 0

Decimals 1

Sample Vol 20

Reagent Vol 500

MC15

Procedure:


STABILITY: 2 WEEKS AT 2 - 8° C 24 HOURS AT 15 - 25° C The Monoreagent must be protected from light!

A free initial cuvette position must be left to perform the optical zero (blank). Pipette 500 µl of reagent into the reagent position in the cuvette strips.


Pipette 20 µl sample into the sample position Incubate for a further 2 – 3 minutes at 37°C Go into programme no. 13 . Input the number of samples and the initial position for them.



CK-MB FS Order information

Cat. No. 1 1651 .. .. …

Notes

1. Please refer to the package insert for CK-MB FS for





2. The stability of the reagent on board the analyser is at

least one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany


24 845 1601 10 02 71

January 2008/3


CK-N

Kinetic


WL1 340

Units U/l

Temperature 37

Factor 4127

N of Read 4

Interval 60

Delay 180

Lim Abs 1.4 Max

Lin. Limit 1000

Norm High 195

Norm Low 24

Decimals 0

Sample Vol 20

Reagent Vol 500

MC15

Procedure:



A free initial cuvette position must be left to perform the optical zero (blank). Pipette 500 µl of reagent into the reagent position in the cuvette strips.


Pipette 20 µl sample into the sample position Incubate for a further 2 – 3 minutes at 37°C Go into programme no. 14 . Input the number of samples and the initial position for them.



CK-NAC FS

Order information

Cat. No. 1 1601 .. .. …

Notes

1. Please refer to the package insert for CK-NAC FS for





2. The stability of the reagent on board the analyser is at

least one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany


26 845 1759 10 02 71

May 2008/5


CREA

Diff

WL1 546

WL2 630

Units mg/dl

Temperature 37

Std 2.0

Factor

Lin. Limit 30

Norm High 1.3

Norm Low 0.5

Decimals 2

Sample Vol 10


Delay 180

Reac Time 300

MC15

Procedure:





Blank 400 µl




Go into programme no. 42 . Input the number of samples and the initial position for them and whether a recalibration is needed


When the reading is completed take out the cuvette strip and add 200 µl R2 to all the cuvettes



CREATININE PAP FS Order information

Cat. No. 1 1759 .. .. …

Notes

1. Please refer to the package insert for Creatinine PAP FS





2. Manufactured by



26 845 1759 10 02 71

April 2011/6


CREA

Diff

WL1 546

WL2 630

Units mg/dl

Temperature 37

Std 2.0

Factor

Lin. Limit 160

Norm High 1.3

Norm Low 0.5

Decimals 2

Sample Vol 10


Delay 180

Reac Time 300

MC15

Procedu re:





Blank 400 µl Std (Optional) 400 µl 10 µl Samples 400 µl 10 µl


Go into programme no. 42 . Input the number of samples and the initial position for them and whether a recalibration is needed


When the reading is completed take out the cuvette strip and add 200 µl R2 to all the cuvettes



CREATININE PAP FS Order information Cat. No. 1 1759 .. .. …

Notes 1. Please refer to the package insert for Creatinine PAP FS





2. Manufactured by


**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized b y it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has sub sequently been tested at a variety of customer laboratories a nd validated by use.

25 845 1711 10 02 71

September 2007/3


CREA

FxT


WL1 500

Units mg/dl

Temperature 37

Std 2.0

Factor

Interval 120

Delay 30

Lim Abs Max 2.5

Lin. Limit 7.5

Norm High 1.3

Norm Low 0.6

Decimals 1

Sample Vol 50

Reagent Vol 500

MC15

Procedure:


STABILITY: 5 HOURS AT 15 – 25 °C




Blank 500 µl







CREATININE FS Order information

Cat. No. 1 1711 .. .. …

Notes

1. Please refer to the package insert for Creatinine FS for





2. Manufactured by



28 845 7045 10 42 71

May 2008/4


CRP

Multi Std - FxT

WL1 500

WL2

Units mg/l


Point 1/ Conc NaCl – 0

Point 2 / Conc *Level 1 TruCal CRP hs







Temperature 37

Lin. Limit 20

Norm High 5

Norm Low 0

Decimals 2

Sample Vol 20


Delay 60

Interval 240

*Input by user

MC15

Procedure:



Reagent 1+2 (Reading zone)


Blank 200 µl + 200 µl

Stds (Optional) 200 µl + 200 µl 20 µl

Samples 200 µl + 200 ml 20 µl





CRP U-hs High sensitive (hs) application

Order information Cat. No. 1 7045 .. .. …

Notes

1. Please refer to the package insert for CRP U-hs FS for





2. Manufactured by



27 845 7002 10 02 71

May 2008/4


CRP


WL1 340

WL2

Units mg/l



Point 2 / Conc *Level 1 TruCal CRP







Temperature 37

Lin. Limit 280

Norm High 5

Norm Low 0

Decimals 0

Sample Vol 20


Delay 0

Reac. Time 180

*Input by user

MC15

Procedure:





Blank 400 µl









CRP FS Order information

Cat. No. 1 7002 .. .. …

Notes

1. Please refer to the package insert for CRP FS for detailed

information about the test on the following:




2. Manufactured by



845 7268 10 02 71

October 2008/1


DMER

Multi Std - FxT

WL1 578

WL2

Units µg/ml


Point 1/ Conc Level 1 Diluent

Point 2 / Conc *Level 2







Temperature 37

Lin. Limit 8.7

Norm High 0.5

Norm Low 0

Decimals 2

Sample Vol 10


Delay 30

Reac. Time 180

*Input by user

MC15

Procedure:





Blank 300 µl




Go into the programme no. X. Input the number of samples and the initial position for them and whether a recalibration is needed.

Add 100 µl R2 into the sample position in all the cuvettes


Place the cuvette strip immediately in the reading position and press READ

D-DIMER FS Order information

Cat. No. 1 7268 .. .. …

Notes

1. Please refer to the package insert for D-Dimer FS for





2. Manufactured by



30 845 1360 10 02 71

May 2008/4


FCHO

EP

WL1 500

WL2 630

Units mg/dl

Temperature 37

Std 200

Factor

Lin. Limit 250

Norm High 200

Norm Low 0

Decimals 0

Sample Vol 10

Reagent Vol 500

Reac. Time 600

MC15

Procedure:





Blank 500 µl







FREE CHOLESTEROL FS Order information

Cat. No. 1 1360 .. .. …

Notes

1. Please refer to the package insert for Free Cholesterol FS





2. Manufactured by



31 45 7059 10 02 71

May 2008/4


FERR

Multi Std - FxT

WL1 578

WL2

Units ng/ml



Point 2 / Conc *Level 1 TruCal Ferritin






Temperature 37

Lin. Limit 1000

Norm High 300

Norm Low 30

Decimals 1

Sample Vol 10


Delay 30

Interval 180

*Input by user

MC15

Procedure:












FERRITIN FS Order information

Cat. No. 1 7059 .. .. …

Notes

1. Please refer to the package insert for Ferritin FS for

detailed information about the test on the following

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding - Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison Reference Ranges Literature

2. Manufactured by



33 845 2801 10 02 71

September 2007/3


GGT

Kinetic


WL1 405

Units U/l

Temperature 37

Factor 1309

N of Read 4

Interval 60

Delay 60

Lim Abs 1.500 max

Lin. Limit 230

Norm High 55

Norm Low 0

Decimals 0

Sample Vol 50

Reagent Vol 500

MC15

Procedure:











GAMMA GT FS (IFCC stand) Order information

Cat. No. 1 2801 .. .. …

Notes

1. Please refer to the package insert for Gamma-GT FS (Szasz

mod./ IFCC stand) for detailed information about the test on the following:




2. Manufactured by



34 845 2801 10 02 71

September 2007/3


GGT

Kinetic


WL1 405

Units U/l

Temperature 37

Factor 1158

N of Read 4

Interval 60

Delay 60

Lim Abs 1.500 max

Lin. Limit 230

Norm High 49

Norm Low 0

Decimals 0

Sample Vol 50

Reagent Vol 500

MC15

Procedure:











GAMMA GT FS (Szasz mod.) Order information

Cat. No. 1 2801 .. .. …

Notes

1. Please refer to the package insert for Gamma-GT FS (Szasz

mod./ IFCC stand) for detailed information about the test on the following:




2. Manufactured by



35 845 2411 10 02 71

May 2008/4


GLDH

Kinetic

WL1 340

Units U/l

Temperature 37

Factor 1485

N of Read 4

Interval 60

Delay 30

Lim Abs 0.3 min

Lin. Limit 120

Norm High 7

Norm Low 0

Decimals 1

Sample Vol 50


MC15

Procedure:





Blank 400 µl









GLDH FS DGKC

Order information

Cat. No. 1 2411 .. .. …

Notes

1. Please refer to the package insert for GLDH FS DGKC for

the detailed information about the test on the following: Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics concerning; Measuring Range Specificity/Interferences Sensitivity/Limit of Detection

Precision (Reproducibility, Repeatability) Method Comparison Reference Ranges Literature 2. Manufactured by



36 845 2500 10 02 71

September 2007/3


GLUC

EP

WL1 500

WL2 630

Units mg/dl

Temperature 37

Std 100

Factor

Lin. Limit 400

Norm High 115

Norm Low 70

Decimals 0

Sample Vol 5

Reagent Vol 500

Reac. Time 600

MC15

Procedure:





Blank 500 µl







GLUCOSE GOD FS Order information

Cat. No. 1 2500 .. .. …

Notes

1. Please refer to the package insert for Glucose GOD FS for





2. Manufactured by



37 845 2511 10 02 71

September 2007/3


GLUC

EP


WL1 340

WL2 630

Units mg/dl

Temperature 37

Std 100

Factor

Lin. Limit 500

Norm High 115

Norm Low 70

Decimals 0

Sample Vol 5

Reagent Vol 500

Reac. Time 300

MC15

Procedure:






Blank 500 µl







GLUCOSE HEXOKINASE FS

Order information

Cat. No. 1 2511 .. .. …

Notes

1. Please refer to the package insert for Glucose Hexokinase





2. Manufactured by



38 845 3329 10 02 71

May 2008/5


HBA1

Multi Std - EP

WL1 630

WL2 Select pos 8 ( (empty)

Units %



Point 2 / Conc *Level 1 TruCal HbA1c






Temperature 37

Lin. Limit 15

Norm High 6

Norm Low 4

Decimals 2

Sample Vol 10

Reagent Vol 300 + 100 + 50

Reac. Time 240

*Input by user

MC15

Procedure:


The end point incubation must be switched on before measurement. To do this go to 4: Utilities, option 12: E.P. Incubation, select 1:Y


Pipette 300 µl Reagent 1 (reading zone)

Incubate for 5 minutes in the incubation block

Go into the programme no. 50. Input the number of samples and the initial position for them and whether a recalibration is

needed.

Pipette 10 µl Sample (Sample zone)

Mix and incubate at 37°C for 3 minutes in the incubation block

After 3 min of incubation add 100 µl R2 into the reading zone in the cuvettes

Mix and incubate at 37°C for a further 2 minutes in the incubation block

After 2 min of incubation add 50 µl R3 into the sample zone in the cuvettes

Place the cuvette strip in the mixing position and press MIX Place the cuvette strip in the reading position and press READ

one HbA1c FS 3 Component System

Order information

Cat. No. 1 3329 .. .. …

Notes

1. Please refer to the package insert for oneHbA1c FS for





2. Manufactured by



40 845 3521 10 02 71

September 2007/3


HDL

Diff

WL1 578

WL2 670

Units mg/dl

Temperature 37

Std 99.8

Factor

Lin. Limit 180

Norm High 80

Norm Low 35

Decimals 0

Sample Vol 5


Delay 280

Reac. Time 300

MC15

Procedure:





Blank 400 µl







HDL-C IMMUNO FS Order information Cat. No. 1 3521 .. .. …

Notes

1. Please refer to the package insert for HDL-C Immuno FS





2. Manufactured by



41 845 7202 10 02 71

May 2008/4


IGA


WL1 578

WL2

Units mg/dl








Temperature 37

Lin. Limit 900

Norm High 400

Norm Low 70

Decimals 0

Sample Vol 30**


Delay 0

Reac. Time 300

*Input by user This application has been prozone tested up to 9200 mg/dl and no ambiguous results were observed.

MC15

Procedure:






Blank 400 µl




Go into the IgA programme no. 52. Input the number of samples and the initial position for them and whether a recalibration is needed.





IMMUNOGLOBULIN A FS Order information

Cat. No. 1 7202 .. .. …

Notes

1. Please refer to the package insert for Immunoglobulin A FS





2. Manufactured by



42 845 7239 10 02 71

May 2008/4


IGE

Multi Std - FxT

WL1 578

WL2

Units IU/ml



Point 2 / Conc *Level 1 TruCal IgE







Temperature 37

Lin. Limit 1000

Norm High 100

Norm Low 0

Decimals 1

Sample Vol 5


Delay 30

Interval 180

*Input by user

MC15

Procedure:












IMMUNOGLOBULIN E FS Order information

Cat. No. 1 7239 .. .. …

Notes

1. Please refer to the package insert for Immunoglobulin E FS





2. Manufactured by



43 845 7212 10 02 71

May 2008/4


IGG


WL1 578

WL2

Units mg/dl








Temperature 37

Lin. Limit 3500

Norm High 1600

Norm Low 700

Decimals 0

Sample Vol 20**


Delay 0

Reac. Time 300


MC15

Procedure:






Blank 400 µl




Go into the IGG programme no. 54. Input the number of samples and the initial position for them and whether a recalibration is needed.





IMMUNOGLOBULIN G FS Order information

Cat. No. 1 7212 .. .. …

Notes

1. Please refer to the package insert for Immunoglobulin G FS





2. Manufactured by



44 845 7222 10 02 71

May 2008/4


IGM


WL1 340

WL2

Units mg/dl


Point 1/ Conc NaCl – 0







Temperature 37

Lin. Limit 800

Norm High 230

Norm Low 40

Decimals 0

Sample Vol 50**


Delay 0

Reac. Time 300


MC15

Procedure:






Blank 400 µl




Go into the IgM programme no. 55. Input the number of samples and the initial position for them and whether a recalibration is needed.





IMMUNOGLOBULIN M FS Order information

Cat. No. 1 7222 .. .. …

Notes

1. Please refer to the package insert for Immunoglobulin M FS





2. Manufactured by



45 845 1911 10 02 71

May 2008/4


IRON

Diff

WL1 578

WL2

Units µg/dl

Temperature 37

Std 202

Factor

Lin. Limit 270

Norm High 168

Norm Low 23

Decimals 0

Sample Vol 100


Delay 0

Reac. Time 600

MC15

Procedure:





Blank 400 µl







IRON FS Ferene Order information

Cat. No. 1 1911 .. .. …

Notes

1. Please refer to the package insert for Iron FS Ferene for





2. Manufactured by



46 845 4001 10 02 71

May 2008/4


LACT

Diff

WL1 340

WL2 0

Units mg/dl

Temperature 37

Std *

Factor

Lin. Limit 120.0

Norm High 19.8

Norm Low 4.5

Decimals 1

Sample Vol 5


Delay 180

Reac. Time 300

MC15

Procedure:





Blank 400 µl




Go into programme no. 57. Input the number of samples and the initial position for them and whether a recalibration is needed.



LACTATE FS Order information

Cat. No. 1 4001 .. .. …

Notes

1. Please refer to the package insert for Lactate FS for





2. Manufactured by



47 845 4201 10 02 71

September 2007/3


LDH

Kinetic


WL1 340

Units U/l

Temperature 37

Factor 8095

N of Read 5

Interval 30

Delay 60

Lim Abs 0.700 min

Lin. Limit 2400

Norm High 480

Norm Low 0

Decimals 0

Sample Vol 10

Reagent Vol 500

MC15

Procedure:


STABILITY: 5 DAYS AT 2 - 8° C 8 HOURS AT 15 - 25° C The Monoreagent must be protected from light!









LDH FS DGKC Order information

Cat. No. 1 4201 .. .. …

Notes

1. Please refer to the package insert for LDH.FS DGKC for

the detailed information about the test on the following:




2. Manufactured by



48 845 4211 10 02 71

May 2008/4


LDH

Kinetic


WL1 340

Units U/l

Temperature 37

Factor 8095

N of Read 5

Interval 30

Delay 60

Lim Abs 0.900 max

Lin. Limit 1500

Norm High 248

Norm Low 0

Decimals 0

Sample Vol 10

Reagent Vol 500

MC15

Procedure:


STABILITY: 24 HOURS AT 2 - 8° C 4 HOURS AT 15 - 25° C The Monoreagent must be protected from light!






Go into programme no. 30. Input the number of samples and the initial position for them.



LDH FS IFCC Order information

Cat. No. 1 4211 .. .. …

Notes

1. Please refer to the package insert for LDH FS IFCC for





2. Manufactured by



49 845 4121 10 02 71

May 2008/4


LDL

Diff

WL1 578

WL2 670

Units mg/dl

Temperature 37

Std *

Factor

Lin. Limit 400

Norm High 130

Norm Low 0

Decimals 0

Sample Vol 5


Delay 280

Reac. Time 300

MC15

Procedure:





Blank 400 µl







LDL-C SELECT FS Order information

Cat. No. 1 4121 .. .. …

Notes

1. Please refer to the package insert for LDL-C Select FS for





2. Manufactured by



50 845 4321 10 02 71

May 2008/5


LIPA

Kin

WL1 578

Units U/l

Temperature 37

Std Input value

Factor

N of Read 3

Interval 60

Delay 120

Lin. Limit 240

Norm High 60

Norm Low 0

Decimals 1

Sample Vol 10


MC15

Procedure:





Blank 400 µl









LIPASE DC FS Order information

Cat. No. 1 4321 .. .. …

Notes

1. Please refer to the package insert for Lipase DC FS for





2. Manufactured by



51 845 7139 10 02 71

May 2008/3


LPA

Multi Std - FxT

WL1 670

WL2

Units mg/dl



Point 2 / Conc *Level 1 TruCal Lp(a) 21







Temperature 37

Lin. Limit 130

Norm High 30

Norm Low 0

Decimals 1

Sample Vol 10


Delay 30

Interval 300

*Input by user

MC15

Procedure:


Premix 2 parts R1 with 1 part R2 making sufficient for the number of tests


Reagent 1+2 premixed

(Reading zone)


Blank 600 µl







Lp(a) 21 FS Order information

Cat. No. 1 7139 .. .. …

Notes

1. Please refer to the package insert for Lp(a) 21 FS for





2. Manufactured by



52 845 4610 10 02 71

September 2007/3


MAG

EP

WL1 546

WL2 670

Units mg/dl

Temperature 37

Std 2.00

Factor

Lin. Limit 5.00

Norm High 2.6

Norm Low 1.8

Decimals 2

Sample Vol 5

Reagent Vol 500

Reac. Time 180

MC15

Procedure:





Blank 500 µl







MAGNESIUM XL FS Order information

Cat. No. 1 4610 .. .. …

Notes

1. Please refer to the package insert for Magnesium XL FS





2. Manufactured by



55 845 5211 10 02 71

May 2008/5


PHOS

EP


WL1 340

WL2 630

Units mg/dl

Temperature 37

Std 5.0

Factor

Lin. Limit 30.0

Norm High 4.5

Norm Low 2.6

Decimals 1

Sample Vol 5

Reagent Vol 500

Reac. Time 300

MC15

Procedure:


STABILITY: 1 YEAR AT 2 – 8° C




Blank 500 µl







PHOSPHATE FS Order information

Cat. No. 1 5211 .. .. …

Notes

1. Please refer to the package insert for Phosphate FS for detailed





2. Manufactured by



56 845 7022 10 02 71

May 2008/6


RF


WL1 340

WL2 630

Units IU/ml



Point 2 / Conc *Level 1 TruCal RF




Point 6 / Conc *Lavel 5 TruCal RF



Temperature 37

Lin. Limit 500

Norm High 15

Norm Low 0

Decimals 1

Sample Vol 25


Delay 0

Reac. Time 300

*Input by user

MC15

Procedure:





Blank (Water) 400 µl










RHEUMATOID FACTOR FS Order information

Cat. No. 1 7022 .. .. …

Notes

1. Please refer to the package insert for Rheumatoid Factor





2. Manufactured by



57 845 2311 10 02 71

September 2007/3


T PR

Diff

WL1 546

WL2 630

Units g/dl

Temperature 37

Std 5.0

Factor

Lin. Limit 15.0

Norm High 8.8

Norm Low 6.6

Decimals 1

Sample Vol 10


Delay 0

Reac. Time 300

MC15

Procedure:





Blank 400 µl







TOTAL PROTEIN FS Order information

Cat. No. 1 2311 .. .. …

Notes

1. Please refer to the package insert for Total Protein FS for





2. Manufactured by



58 845 0210 10 52 71

May 2008/5


URPR

EP

WL1 578

WL2 670

Units mg/l

Temperature 37

Std 1300

Factor

Lin. Limit 3000

Norm High 141

Norm Low 24

Decimals 0

Sample Vol 10

Reagent Vol 500

Reac. Time 300

MC15

Procedure:






Blank 500 µl







TOTAL PROTEIN UC FS Order information

Cat. No. 1 0210 .. .. …

Notes

1. Please refer to the package insert for Total Protein UC FS





2. Manufactured by



59 845 7252 10 02 71

May 2008/4


TRAN


WL1 578

WL2

Units mg/dl










Temperature 37

Lin. Limit 800

Norm High 360

Norm Low 200

Decimals 0

Sample Vol 30**


Delay 0

Reac. Time 300

*Input by user

MC15

Procedure:






Blank 400 µl









TRANSFERRIN FS Order information

Cat. No. 1 7252 .. .. …

Notes

1. Please refer to the package insert for Transferrin FS for





2. Manufactured by



60 845 5710 10 02 71

September 2007/3


TRIG

EP

WL1 500

WL2 630

Units mg/dl

Temperature 37

Std 200

Factor

Lin. Limit 500

Norm High 200

Norm Low 0

Decimals 0

Sample Vol 10

Reagent Vol 500

Reac. Time 600

MC15

Procedure:





Blank 500 µl







TRIGLYCERIDES FS Order information

Cat. No. 1 5710 .. .. …

Notes

1. Please refer to the package insert for Triglycerides FS for





2. Manufactured by



61 845 1921 10 02 71

May 2008/2


UIBC

Diff

WL1 578

WL2

Units µg/dl

Temperature 37

Std TruCal

Factor

Lin. Limit 750

Norm High 470

Norm Low 120

Decimals 0

Sample Vol 30


Delay 300

Reac. Time 300

MC15

Procedure:





Blank 400 µl







UIBC FS Order information

Cat. No. 1 1921 .. .. …

Notes

1. Please refer to the package insert for UIBC FS





2. Manufactured by



63 845 3115 10 02 71

May 2008/6


UREA

EP

WL1 578

WL2 -

Units mg/dl

Temperature 37

Std 50

Factor

Lin. Limit 300

Norm High 43

Norm Low 17

Decimals 1

Sample Vol 5


Delay 0

Reac. Time 300

MC15

Procedure:

Reagents are ready to use. Reagent 1A needs to be prepared as described

Stds/Controls/Samples must be diluted 1+1 with NaCl

Pipette into the cuvette strips in the appropriate way. Please note samples must be dispensed directly into the reading zone

Reagent 1A (Reading zone)


Blank 250 µl



Incubate for 10 mins at room temperature or 5 mins at 37°C

When the incubation is completed take out the cuvette strip and add 250 µl R2 to all the cuvettes


Incubate for 10 mins at room temperature or 5 mins at 37°C

Go into the programme no 66. Input the number of samples and the initial position for them and whether a recalibration is needed.


UREA CT FS Order information

Cat. No. 1 3115 .. .. …

Notes

1. Please refer to the package insert for Urea CT FS for





2. Manufactured by



62 845 3101 10 02 71

September 2007/4


UREA

FxT


WL1 340

Units mg/dl

Temperature 37

Std 50

Factor

Interval 60

Delay 30

Lim. Abs. 0.5 MAX

Lin. Limit 300

Norm High 43

Norm Low 17

Decimals 0

Sample Vol 5

Reagent Vol 500

MC15

Procedure:






Blank 500 µl







UREA FS Order information

Cat. No. 1 3101 .. .. …

Notes

1. Please refer to the package insert for Urea FS for detailed





2. Manufactured by



64 845 3021 10 02 71

September 2007/3


URIC

EP


WL1 546

WL2 630

Units mg/dl

Temperature 37

Std 6.0

Factor

Lin. Limit 20.0

Norm High 8.2

Norm Low 2.3

Decimals 1

Sample Vol 10

Reagent Vol 500

Reac. Time 600

MC15

Procedure:






Blank 500 µl







URIC ACID FS TBHBA Order information

Cat. No. 1 3021 .. .. …

Notes

1. Please refer to the package insert for Uric Acid FS TBHBA





2. Manufactured by



65 845 3001 10 02 71

September 2007/3


URIC

Diff

WL1 546

WL2

Units mg/dl

Temperature 37

Std 6.0

Factor

Lin. Limit 20.0

Norm High 8.2

Norm Low 2.3

Decimals 1

Sample Vol 10


Delay 240

Reac. Time 300

MC15

Procedure:






Blank 400 µl






When the reading is completed Take out the cuvette strip and add 100 µl R2 to all the cuvettes Place the cuvette strip in the mixing position and press MIX Place the cuvette strip in the reading position and press READ

URIC ACID (TOOS) FS Order information

Cat. No. 1 3001 .. .. …

Notes

1. Please refer to the package insert for Uric Acid FS for





2. Manufactured by



stardust mc15 chemistry parameters alat(gpt) fs (ifcc mod.)

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