critical importance of understanding g6pd

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Critical Importance of Understanding G6PD in Drug Therapy Options

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Page 1: Critical Importance of Understanding G6PD

Critical Importance of Understanding G6PD in Drug Therapy OptionsProduct Analyzer Description

Reagent

G7583-180 Open Channel R1: 10 x 6 mL, R2 1 x 120 mL

Lyse

Control

G7583-LYS 1 x 100 mL

G7583-CTL Lyophilized 2 x 0.5 mL Deficient Ctl2 x 0.5 mL Intermediate Ctl2 x 0.5 mL Normal Ctl

ORDERING INFORMATION: G6PD

Reagent

H7504-120 Open Channel 1 x 120 mL

ORDERING INFORMATION: HEMOGLOBINProduct Analyzer Description

Control

Standard

H7506-6 3 x 2 mL

H7506-STD 1 x 2 mL

REFERENCES1. Beutler, Ernest. “G6PD Deficiency.” The American Society of Hematology, vol. 84, no. 11, 25 Aug. 1994, pp. 3613–3636.

2. Bubp, Jeff. “Caring for Glucose-6-Phosphate Dehydrogenase (G6PD)–Deficient Patients: Implications for Pharmacy.” P&T, vol. 40, no. 9, Sept. 2015, pp. 572–574.

3. Frank, Jennifer. “Diagnosis and Management of G6PD Deficiency.” American Family Physician, vol. 72, no. 7, 1 Oct. 2005, pp. 1277–1282.

4. Murray, Clinton. “Prevalence of Glucose-6-Phosphate Dehydrogenase Deficiency in U.S. Army Personnel.” Military Medicine, vol. 171, Sept. 2006, pp. 905–907.

5. “A Genetic Deficiency That Can Lead to Anemia.” G6PD, Indiana Hemophilia & Thrombosis Center, INC., www.ihtc.org/G6PD/.

6. Pal, Sampa, et al. “Evaluation of a Novel Quantitative Test for Glucose-6-Phosphate Dehydrogenase Deficiency: Bringing Quantitative Testing for Glucose-6-Phosphate Dehydrogenase Deficiency Closer to the Patient.” US National Library of Medicine National Institues of Health, The American Society of Tropical Medicine and Hygiene, 2018, www.ncbi.nlm.nih.gov/pmc/articles/PMC6335905/pdf/tpmd180612.pdf.

800.445.9853www.medtestdx.com

BR-G7583-01

Applications available for wide range of analyzers

Page 2: Critical Importance of Understanding G6PD

Exploration of G6PD Deficiency

400 MillionPeopleWorldwidelive withG6PDDeficiency1,2

Class Level of Severity G6PD Activity(% of Normal)

Units per Gram ofHemoglobin (U/g Hb)

I

III

II

V

High

Mild to Moderate

High

None

Severe enzyme deficiency

10% - 60%

<10%

>150%

0.12

1.3 - 7.1

0.13 - 0.12

>17.7

Most common enzymatic blooddisorder

Requires a medical diagnosis; labscreening always required

Exposure to specific triggers may result inhemolytic crisis*

Treatment can help, but this condition cannot be cured

IV Mild to None 60% - 150% 7.2 - 17.7

Why Testing Matters

It is critical to understand the patient’s exact level of severity prior to and during medical therapies, such as chemotherapy, to eliminate the risk of severe adverse reactions

An individual’s G6PD enzyme activity may shift throughout their life making it important to know their current level of severity in order to maintain a healthy lifestyle 2

Key Facts:

Early diagnosis of G6PD deficiency in newborns enables health care professionals to educate parents on which triggers to avoid that may cause a hemolytic crisis 3

Performing G6PD screenings on militarypersonnel eliminates the risk of adverse reactionsfrom common anti-malaria drugs such as Primaquine, Chloroquine and its derivatives 4

ImprovedPatient

Outcomes

UnparalledAccuracy

StreamlinedSolution

“ Pointe brandGlucose-6-Phosphate

Dehydrogenase (G6PD) is the only 510(k) cleared, CE marked quantitative reagent manufactured

in the USA.

“Quantitative test results provides a specific level of severity (see table 1, column 2)

Elimination of a qualitative screen by starting with quantitative screen

Run our hemoglobin assay concurrently on the same analyzer as the G6PD assay

Correlation Coefficient of 0.994

Manufactured under ISO 13485standards

Enzymatic method assay requires nocalibrator

Time savings with 5-minute lysing step

One source supplier of reagent, lyse, control and hemoglobin assay

A Few of the MANY Triggers Include: Rasburicase, Vitamin K, Sulfa Drugs, Quinolone Antibiotics, Nitrofurantoin, Aspirin, Primaquine, Penicillamine, Fava Beans 5

The Pointe Brand G6PD is the Superior Choice

*Hemolytic crisis can result in death

1,2

Table 1: The levels of G6PD deficiency as defined by the World Health Organization (WHO)

SuperiorOperations

Eliminate subjective test results from visual observation of color change

Reduction in scrap-rate due to 24 month shelf-life

Onboard lyse capabilities

Pointe brand reagents for G6PD spectrophotometry testing isconsidered the gold standard for the sensitive and accuratequantitative determination of G6PD in blood.6 Unlike other G6PDassays, which require a total of 30 minutes of sample preparationsteps, the Pointe brand G6PD assay requires only a single 5-minute lysing step and can be on-board lysed, reducing the time to resultsof the determination of G6PD activity levels in whole blood.

Page 3: Critical Importance of Understanding G6PD

Exploration of G6PD Deficiency

400 MillionPeopleWorldwidelive withG6PDDeficiency1,2

Class Level of Severity G6PD Activity(% of Normal)

Units per Gram ofHemoglobin (U/g Hb)

I

III

II

V

High

Mild to Moderate

High

None

Severe enzyme deficiency

10% - 60%

<10%

>150%

0.12

1.3 - 7.1

0.13 - 0.12

>17.7

Most common enzymatic blooddisorder

Requires a medical diagnosis; labscreening always required

Exposure to specific triggers may result inhemolytic crisis*

Treatment can help, but this condition cannot be cured

IV Mild to None 60% - 150% 7.2 - 17.7

Why Testing Matters

It is critical to understand the patient’s exact level of severity prior to and during medical therapies, such as chemotherapy, to eliminate the risk of severe adverse reactions

An individual’s G6PD enzyme activity may shift throughout their life making it important to know their current level of severity in order to maintain a healthy lifestyle 2

Key Facts:

Early diagnosis of G6PD deficiency in newborns enables health care professionals to educate parents on which triggers to avoid that may cause a hemolytic crisis 3

Performing G6PD screenings on militarypersonnel eliminates the risk of adverse reactionsfrom common anti-malaria drugs such as Primaquine, Chloroquine and its derivatives 4

ImprovedPatient

Outcomes

UnparalledAccuracy

StreamlinedSolution

“ Pointe brandGlucose-6-Phosphate

Dehydrogenase (G6PD) is the only 510(k) cleared, CE marked quantitative reagent manufactured

in the USA.

“Quantitative test results provides a specific level of severity (see table 1, column 2)

Elimination of a qualitative screen by starting with quantitative screen

Run our hemoglobin assay concurrently on the same analyzer as the G6PD assay

Correlation Coefficient of 0.994

Manufactured under ISO 13485standards

Enzymatic method assay requires nocalibrator

Time savings with 5-minute lysing step

One source supplier of reagent, lyse, control and hemoglobin assay

A Few of the MANY Triggers Include: Rasburicase, Vitamin K, Sulfa Drugs, Quinolone Antibiotics, Nitrofurantoin, Aspirin, Primaquine, Penicillamine, Fava Beans 5

The Pointe Brand G6PD is the Superior Choice

*Hemolytic crisis can result in death

1,2

Table 1: The levels of G6PD deficiency as defined by the World Health Organization (WHO)

SuperiorOperations

Eliminate subjective test results from visual observation of color change

Reduction in scrap-rate due to 24 month shelf-life

Onboard lyse capabilities

Pointe brand reagents for G6PD spectrophotometry testing isconsidered the gold standard for the sensitive and accuratequantitative determination of G6PD in blood.6 Unlike other G6PDassays, which require a total of 30 minutes of sample preparationsteps, the Pointe brand G6PD assay requires only a single 5-minute lysing step and can be on-board lysed, reducing the time to resultsof the determination of G6PD activity levels in whole blood.

Page 4: Critical Importance of Understanding G6PD

Critical Importance of Understanding G6PD in Drug Therapy OptionsProduct Analyzer Description

Reagent

G7583-180 Open Channel R1: 10 x 6 mL, R2 1 x 120 mL

Lyse

Control

G7583-LYS 1 x 100 mL

G7583-CTL Lyophilized 2 x 0.5 mL Deficient Ctl2 x 0.5 mL Intermediate Ctl2 x 0.5 mL Normal Ctl

ORDERING INFORMATION: G6PD

Reagent

H7504-120 Open Channel 1 x 120 mL

ORDERING INFORMATION: HEMOGLOBINProduct Analyzer Description

Control

Standard

H7506-6 3 x 2 mL

H7506-STD 1 x 2 mL

REFERENCES1. Beutler, Ernest. “G6PD Deficiency.” The American Society of Hematology, vol. 84, no. 11, 25 Aug. 1994, pp. 3613–3636.

2. Bubp, Jeff. “Caring for Glucose-6-Phosphate Dehydrogenase (G6PD)–Deficient Patients: Implications for Pharmacy.” P&T, vol. 40, no. 9, Sept. 2015, pp. 572–574.

3. Frank, Jennifer. “Diagnosis and Management of G6PD Deficiency.” American Family Physician, vol. 72, no. 7, 1 Oct. 2005, pp. 1277–1282.

4. Murray, Clinton. “Prevalence of Glucose-6-Phosphate Dehydrogenase Deficiency in U.S. Army Personnel.” Military Medicine, vol. 171, Sept. 2006, pp. 905–907.

5. “A Genetic Deficiency That Can Lead to Anemia.” G6PD, Indiana Hemophilia & Thrombosis Center, INC., www.ihtc.org/G6PD/.

6. Pal, Sampa, et al. “Evaluation of a Novel Quantitative Test for Glucose-6-Phosphate Dehydrogenase Deficiency: Bringing Quantitative Testing for Glucose-6-Phosphate Dehydrogenase Deficiency Closer to the Patient.” US National Library of Medicine National Institues of Health, The American Society of Tropical Medicine and Hygiene, 2018, www.ncbi.nlm.nih.gov/pmc/articles/PMC6335905/pdf/tpmd180612.pdf.

800.445.9853www.medtestdx.com

BR-G7583-01

Applications available for wide range of analyzers