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Access Bio 通过研究、开发和制造体外快速诊断试验、生物传感器和分子诊断产品,Access致力于预防和早期诊断传染病。早期准确诊断是有效治疗的关键。我们的核心的体外诊断技术包括化学、生化和分子生物学产品。访问生物努力建立一个基础,为所有人的福祉。
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Specifications
- Test TypeQualitative point-of-care test
- Assay MethodVisual dye colorization method
- InterpretationNormal vs. deficient
- SpecimenWhole blood
- Specimen Volume2 ㎕
- Result Time10 minutes
- Package Size25 or 50 tests/box
- Other Specifications Marked, Simple and easy to use, Broad range of assay temperature(18~32℃), Room temperature storage
G6PD deficiency
G6PD deficiency is a genetic disorder, resulting in no or low G6PD activity. People with G6PD deficiency should not take primaquine, an antimalarial drug, and other drugs with high oxidative stress because it could cause serious side effects such as acute hemolysis.
Features & Benefits
- True Point-Of-Care Test for G6PD with >95% Sensitivity * for WHO classification Ⅰ&Ⅱ (<10% of normal activity)
- CareStart™ G6PD RDT is a visual screening test that identifies G6PD deficient patients using whole blood sample.
Performance test result
Results of Access Bio's G6PD Performance Test :Institute Pasteur, Cambodi | ||
---|---|---|
Cutoff Value(%) | <30% | |
CareStart™ G6PD RDT | Sensitivity (95% CL) | 100% |
Specificity | 97% |
Source:
“A field trial to evaluate the performance of a point-of-care diagnostic for screening G6PD Deficiency in a falciparum and vivax malaria endemic area of Westem Cambodia.” American Society of Tropical Medicine and Hygiene (November, 2013)
Test Procedure
1
Gently hold the bottom part of the pipette and touch the blood drop with the open end of the capillary tube.(CAUTION : Do not cover the hole!)
2
Let the blood flow into the capillary tube.
3
Cover and press the hole to release the blood into the sample well. Add 2 drops of Assay Buffer (100㎕) immediay after to the buffer well.
4
Read result in 10 minutes.
Interpretation of the Test Result
NORMAL
A distinct purple color appears in the reading window within 10 min.
DEFICIENT
No color change or a very faint purple color appears in the reading window within 10 min(A borderline result is read as deficient.)
INVALID
No blood migration or incomplete blood migration in window.
Product | Cat. No. | Package Size | Components |
---|---|---|---|
CareStart™ G6PD RDT | RGP-M02582 | 25 tests/box | Alcohol, Lancets, Pipettes, Assay buffer, Instruction for use |
RGP-M05082 | 50 tests/box | Alcohol, Lancets, Pipettes, Assay buffer, Instruction for use |