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Table 5 Performance of the CareStart™ G6PD RDT for detecting G6PD deficiency in comparison to the reference enzymatic method

From: Glucose-6-phosphate dehydrogenase deficiency among Yemeni children residing in malaria-endemic areas of Hodeidah governorate and evaluation of a rapid diagnostic test for its detection

  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)
  1. G6PD glucose-6-phosphate dehydrogenase, RDT rapid diagnostic test, EM enzymatic method, CI confidence interval, PPV positive (deficient) predictive value, NPV negative (normal) predictive value, U/gHb units per gram haemoglobin, Kc Cohen’s kappa coefficient
  2. aCalculated from the median value of 5.0 that is equivalent to 100 % activity
  3. b% Agreement was calculated by the summation of the number of deficient and normal cases by both RDT and EM divided by the total number of cases and was found significant between RDT and EM at all cut-off activities with p < 0.001