Performance of BinaxNOW G6PD deficiency point-of-care diagnostic in P. vivax-infected subjects

• Published in: The American journal of tropical medicine and hygiene Vol. 92; no. 1; pp. 22 - 27
• Main Authors: Osorio, Lyda, Carter, Nick, Arthur, Preetam, Bancone, Germana, Gopalan, Sowmya, Gupta, Sandeep K, Noedl, Harald, Kochar, Sanjay K, Kochar, Dhanpat K, Krudsood, Srivicha, Lacerda, Marcus V, Llanos-Cuentas, Alejandro, Rueangweerayut, Ronnatrai, Srinivasan, Ramadurai, Treiber, Moritz, Möhrle, Jörg J, Green, Justin
• Format: Journal Article
• Language: English
• Published: United States The American Society of Tropical Medicine and Hygiene 01.01.2015
• Subjects: Antimalarials - therapeutic use; Glycogen Storage Disease Type I - diagnosis; Humans; Malaria, Vivax - drug therapy; Plasmodium; Point-of-Care Systems; Sensitivity and Specificity; ISEW, Thailand; ISE, Peru; ASW, Brazil; India
• ISSN: 0002-9637; 1476-1645
• DOI: 10.4269/ajtmh.14-0298

Accurate diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency is required to avoid the risk of acute hemolysis associated with 8-aminoquinoline treatment. The performance of the BinaxNOW G6PD test compared with the quantitative spectrophotometric analysis of G6PD activity was assessed in 356 Plasmodium vivax-infected subjects in Brazil, Peru, Thailand, and India. In the quantitative assay, the median G6PD activity was 8.81 U/g hemoglobin (range = 0.05-20.19), with 11 (3%) subjects identified as deficient. Sensitivity of the BinaxNOW G6PD to detect deficient subjects was 54.5% (6 of 11), and specificity was 100% (345 of 345). Room temperatures inadvertently falling outside the range required to perform the rapid test (18-25°C) together with subtlety of color change and insufficient training could partially explain the low sensitivity found. Ensuring safe use of 8-aminoquinolines depends on additional development of simple, highly sensitive G6PD deficiency diagnostic tests suitable for routine use in malaria-endemic areas.