STANDARD G6PD Test from SD BIOSENSOR

1. Can the STANDARD™G6PD Test be used to support decision-making/provision of radical cure treatment for malaria?

Yes, the STANDARD™G6PD Test has shown in multiple clinical studies that it is readily able to discriminate between G6PD deficient, intermediate, and normal individuals.

2. What is the intended use for the STANDARD G6PD Test?

The STANDARD G6PD system is an enzymatic colorimetric assay intended for the semi-quantitative measurement of G6PD activity and total hemoglobin (T-Hb) concentration in non-anticoagulated capillary (finger-stick) whole blood or venous whole blood (K2-EDTA, sodium heparin, or acid citrate dextrose [ACD]). The STANDARD G6PD Test System is indicated for differentiating normal, intermediate, and deficient G6PD activity levels to aid in the detection of G6PD deficiency in individuals and in the determination of hemoglobin levels. The test will provide results expressed as the ratio of units of G6PD activity per gram of hemoglobin (G6PD U/g Hb) which can be used to determine G6PD status. Samples that generate a G6PD deficient or intermediate result should be assayed using a quantitative G6PD test to verify a deficiency. T-Hb results expressed in grams per deciliter (g/dL) are used to determine G6PD status and not a state of anemia. T-Hb results should be confirmed by a quantitative test when monitoring disease progression or making treatment decisions. The STANDARD G6PD Test System is intended for use by health care professionals in a laboratory or point-of-care environment. The system is for in vitro diagnostic use only. The STANDARD G6PD Test has not been validated for use with neonatal samples. The STANDARD G6PD Analyzer must be used exclusively with the STANDARD G6PD Test Device, STANDARD G6PD Control, and STANDARD G6PD Check strip manufactured by SD BIOSENSOR.

3. Where can I find additional guidance and resources regarding test procedures?

Visit the G6PD diagnostic test resources page for training materials, job aids, and guidance on test procedures.

4. What sample types can this test be used with?

The test is indicated for use with non-anticoagulated capillary (finger-stick) whole blood or venous whole blood (K2-EDTA, sodium heparin, or acid citrate dextrose [ACD]).

Please note that the test is not indicated for use with capillary collection into vacutainers.

1. Where can I buy STANDARD G6PD Test strips?

The STANDARD G6PD Test strips are offered in pack sizes of either 10 or 25 strips per box and can be purchased directly from SD Biosensor.

1. Can I buy more Ezi Tubes?

Please contact your local distributor to inquire about purchasing additional Ezi Tubes. If there is no local distributor in your country, please contact sales@sdbiosensor.com directly.

1. What should I do if I suspect my analyzer is broken or damaged?

Please contact your local customer service and support center if the analyzer is damaged.

1. How can I use the Bluetooth functionality on the device?

Bluetooth functionality is used when connecting to the printer or transferring data to a computer. When Bluetooth functionality is on, the ‘bt’ symbol will appear at the bottom of the screen. When the ‘bt’ symbol is on screen, ‘T-Hb g/dL’ is masked. However, by accessing stored results, users can check the ‘T-Hb g/dL’ value on the screen.

1. This test gives a numeric result for G6PD. So why is this result considered semi-quantitative?

The STANDARD G6PD Test is a quantitative platform for measuring G6PD activity. However, the clinically relevant interpretation of the test is semi-quantitative in terms of whether someone is classified as G6PD deficient, intermediate, or normal, based on their sex, and the G6PD activity value. The resulting output is used to classify results as normal, intermediate, or deficient according to the ranges provided in the label, rather than being used as a quantitative result.

2. Should my laboratory establish our own thresholds to use with the STANDARD G6PD Test?

No. Please note that establishing laboratory-specific thresholds for this test is no longer recommended by the manufacturer. The thresholds provided in the test’s Instructions For Use have been validated across multiple studies and sites.

3. I ran the test twice on samples from the same person but received two different results. Is this right? What if the different results lead to two different classifications of G6PD status?

Variability in individual measurements should be expected for this test, as would be expected of any point-of-care test. The STANDARD G6PD Test is a point-of-care test that condenses, into a 5-minute process, two complex laboratory tests: a G6PD enzyme assay and a hemoglobin concentration measurement. As such the test does not perform the same as these assays which are conducted in a highly controlled setting, with trained staff.

If the G6PD value of an individual is close to a threshold the repeat testing may result in a different classification of the individual. This is most likely to be seen in females with G6PD values close to the intermediate threshold (6 U/g Hb). Rigorous evaluation of the test has shown that misclassification of a G6PD deficient individual as normal as a result of this variability is highly unlikely.