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Table 5 Performance of CareStart G6PD biosensor against genotyping

From: Assessment of CareStart G6PD rapid diagnostic test and CareStart G6PD biosensor in Mauritania

Performance

Cut-off levels

< 10%

< 30%

< 80%

Cut-off value (IU/g Hb)

0.53

1.60

4.27

All patients except AA- and BA- females

 n (%)

8 (2.7)

30 (10.2)

108 (36.6)

 Sensitivity (%; 95% CI)

57.1 (18.4–90.1)

85.7 (42.1–99.6)

100 (59.0–100)

 Specificity (%; 95% CI)

98.6 (96.5–99.6)

91.7 (87.8–94.6)

64.9 (59.1–70.4)

 Positive predictive value (%; 95% CI)

50.0 (23.8–76.2)

20.0 (13.3–28.9)

6.5(5.6–7.5)

 Negative predictive value (%; 95% CI)

99.0 (97.6–99.6)

99.6 (97.7–99.9)

100

Patients without severe anaemia*

 n (%)

7 (2.6)

27 (9.9)

102 (37.4)

 Sensitivity (%; 95% CI)

50.0 (11.8–88.2)

83.3 (35.9–99.6)

100 (54.1–100)

 Specificity (%; 95% CI)

98.5 (96.2–99.6)

91.8 (87.8–94.8)

64.0 (58.0–69.8)

 Positive predictive value (%; 95% CI)

42.9 (17.6–72.6)

18.5 (11.7–28.0)

5.9 (5.1–6.8)

 Negative predictive value (%; 95% CI)

98.9 (97.5–99.5)

99.6 (97.6–99.9)

100

  1. Data were analyzed in a total of 295 patients, including females characterized to be BA heterozygote, except for 5 AA− and 23 BA− heterozygous females, and a subset of patients without severe anaemia (n = 273), as defined by the World Health Organization (WHO) [40]. The number (n) of patients denotes those whose glucose-6-phosphate dehydrogenase (G6PD) activity was less than 10%, 30% or 80% of the normal G6PD activity determined by CareStart G6PD biosensor. 100% G6PD activity was defined as 5.34 International Units/g haemoglobin (IU/g Hb) in the present study, as shown in Table 4. 95% CI 95% confidence interval