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. 2011;6(12):e28357.
doi: 10.1371/journal.pone.0028357. Epub 2011 Dec 2.

Performance of the CareStart™ G6PD deficiency screening test, a point-of-care diagnostic for primaquine therapy screening

Saorin Kim  1 , Chea Nguon, Bertrand Guillard, Socheat Duong, Sophy Chy, Sarorn Sum, Sina Nhem, Christiane Bouchier, Magali Tichit, Eva Christophel, Walter R J Taylor, John Kevin Baird, Didier Menard
Affiliations

Performance of the CareStart™ G6PD deficiency screening test, a point-of-care diagnostic for primaquine therapy screening

Saorin Kim et al. PLoS One. 2011.

Abstract

Development of reliable, easy-to-use, rapid diagnostic tests (RDTs) to detect glucose-6-phosphate dehydrogenase (G6PD) deficiency at point of care is essential to deploying primaquine therapies as part of malaria elimination strategies. We assessed a kit under research and development called CareStart™ G6PD deficiency screening test (Access Bio, New Jersey, USA) by comparing its performance to quantitative G6PD enzyme activity using a standardized spectrophotometric method ('gold standard'). Blood samples (n = 903) were collected from Cambodian adults living in Pailin province, western Cambodia. G6PD enzyme activities ranged from 0 to 20.5 U/g Hb (median 12.0 U/g Hg). Based on a normal haemoglobin concentration and wild-type G6PD gene, the normal values of G6PD enzymatic activity for this population was 3.6 to 20.5 U/g Hg (95(th) percentiles from 5.5 to 17.2 U/g Hg). Ninety-seven subjects (10.7%) had <3.6 U/g Hg and were classified as G6PD deficient. Prevalence of deficiency was 15.0% (64/425) among men and 6.9% (33/478) among women. Genotype was analyzed in 66 G6PD-deficient subjects and 63 of these exhibited findings consistent with Viangchang genotype. The sensitivity and specificity of the CareStart™ G6PD deficiency screening test was 0.68 and 1.0, respectively. Its detection threshold was <2.7 U/g Hg, well within the range of moderate and severe enzyme deficiencies. Thirteen subjects (1.4%, 12 males and 1 female) with G6PD enzyme activities <2 U/g Hg were falsely classified as "normal" by RDT. This experimental RDT test here evaluated outside of the laboratory for the first time shows real promise, but safe application of it will require lower rates of falsely "normal" results.

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Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. Map of Cambodia locating the four selected villages in Pailin province, Cambodia, 2010.
Figure 2
Figure 2. Design of the CareStart™ G6PD deficiency screening test and interpretation of the results.
Panel A, no color change for sample with deficient G6PD enzymatic activity; Panel B, distinct purple color for sample with normal G6PD enzymatic activity.
Figure 3
Figure 3. Distribution of the G6PD enzymatic activity (U/g Hb) values of 903 individuals enrolled in four villages of the Pailin province, Cambodia, 2010.
Figure 4
Figure 4. Distribution of the G6PD enzymatic activity (U/g Hb) reference values according to gender, of 147 G6PD-normal individuals (see criteria in Statistical analysis section) enrolled in four villages of the Pailin province, Cambodia, 2010.
(Panel A: Total population, Panel B: Male population and Panel C: Female population).
Figure 5
Figure 5. Distribution of the G6PD enzymatic activity (U/g Hb) values, according to the CareStart™ G6PD deficiency screening test results of 903 individuals enrolled in four villages of the Pailin province, Cambodia, 2010.
See this image and copyright information in PMC

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