Performance of the CareStartTM G6PD DeficiencyScreening Test, a Point-of-Care Diagnostic forPrimaquine Therapy Screening

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 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. Citation: Kim S, Nguon C, Guillard B, Duong S, Chy S, et al. (2011) Performance of the CareStart G6PD Deficiency Screening Test, a Point-of-Care Diagnostic for Primaquine Therapy Screening. PLoS ONE 6(12): e28357. doi:10.1371/journal.pone.0028357 Editor: Ruth D. Ellis, Laboratory of Malaria Immunology and Vaccinology, United States of America Received August 22, 2011; Accepted November 7, 2011; Published December 2, 2011 Copyright: 2011 Kim et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Funding: This work was supported by grant from WHO Regional Office for the Western Pacific. Didier Ménard is supported by the French Ministry of Foreign Affairs and Kevin Baird by the Wellcome Trust. The CareStart G6PD deficiency screening test was provided by the manufacturer (Access Bio). Access Bio has developed the second generation of CareStart G6PD deficiency screening test. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing Interests: The authors have declared that no competing interests exist. * E-mail: [email protected]