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CareStart™ G6PD RDT*

Specifications

  • Test Type Qualitative point-of-care test
  • Assay Method Visual dye colorization method
  • Interpretation Normal vs. deficient
  • Specimen Whole blood
  • Specimen Volume 2 ㎕
  • Result Time 10 minutes
  • Package Size 25 or 50 tests/box
  • Other Specifications CE 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㎕) immediately 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
* Not For Sale in USA

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