Table 5 Performance of the CareStart™ G6PD RDT for detecting G6PD deficiency in comparison to the reference enzymatic method
| Â | G6PD activity cut-off valuesa | |||||
|---|---|---|---|---|---|---|
≤10 % (≤0.5 U/gHb) | ≤20 % (≤1.0 U/gHb) | ≤30 % (≤1.5 U/gHb) | ≤40 % (≤2.0 U/gHb) | ≤50 % (≤2.5 U/gHb) | ≤60 % (≤3.0 U/gHb) | |
RDT-deficient vs EM-deficient (n) | 9 | 33 | 37 | 39 | 39 | 39 |
RDT-deficient vs EM-normal (n) | 41 | 17 | 13 | 11 | 11 | 11 |
RDT-normal vs EM-normal (n) | 350 | 350 | 349 | 348 | 344 | 341 |
RDT-normal vs EM-deficient (n) | 0 | 0 | 1 | 2 | 6 | 9 |
Sensitivity  % (95 % CI) | 100 (70–100) | 100 (90–100) | 97.4 (87–100) | 95.1 (84–99) | 86.7 (74–94) | 81.3 (68–90) |
Specificity  % (95 % CI) | 90.0 (86–92) | 95.4 (93–97) | 96.4 (94–98) | 96.9 (94–98) | 96.9 (95–98) | 96.9 (94–98) |
PPV  % (95 % CI) | 18.0 (10–31) | 66.0 (52–78) | 74.0 (60–84) | 78.0 (65–87) | 78.0 (65–87) | 78.0 (65–87) |
NPV  % (95 % CI) | 100 (99–100) | 100 (99–100) | 99.7 (98–100) | 99.4 (98–100) | 98.3 (96–99) | 97.4 (95–99) |
% Agreement (Kc)b | 89.8 (0.278) | 95.8 (0.773) | 96.6 (0.822) | 96.8 (0.839) | 95.8 (0.797) | 95.1 (0.767) |