title: Validation of G6PD Point-of-Care Tests among Healthy Volunteers in Yangon, Myanmar.
abstract: Primaquine and other 8-amnoquinoline based anti-malarials can cause haemolysis in subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Correct diagnosis of G6PD status in patients is crucial for safe treatment of both relapsing stages of Plasmodium vivax and transmitting forms of Plasmodium falciparum. Lack of suitable point-of-care tests has hampered a much needed wide use of primaquine for malaria elimination. In this study we have assessed the performances of two qualitative tests, the fluorescent spot test (FST) and the G6PD CareStart test (CST), against the gold standard quantitative spectrophotometric assay in a population of 1000 random adult healthy volunteers living in Yangon, Myanmar. The prevalence of G6PD deficiency in the Bamar, Karen and in the whole sample set was 6.6% (10.1% in males), 9.2% (21.0% in males) and 6.8% (11.1% in males) respectively. The FST and CST showed comparable performances with sensitivity over 95% and specificity over 90%, however for cases with severe G6PD activity the FTS had improved performance. If used with a conservative interpretation of the signal, the CareStart test has the potential to be used in the field and, by allowing a wider use of primaquine, to help malaria elimination.
authors.affiliation: Department of Medical Research (Lower Myanmar), Yangon, Republic of the Union of Myanmar.
authors.forename: Nwe Nwe
authors.initials: NN
authors.lastname: Oo
authors.affiliation: Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.
authors.forename: Germana
authors.initials: G
authors.lastname: Bancone
authors.affiliation: Department of Medical Research (Lower Myanmar), Yangon, Republic of the Union of Myanmar.
authors.forename: Lwin Zar
authors.initials: LZ
authors.lastname: Maw
authors.affiliation: Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.
authors.forename: Nongnud
authors.initials: N
authors.lastname: Chowwiwat
authors.affiliation: Diagnostics Program, PATH, Seattle, WA, United States of America.
authors.forename: Pooja
authors.initials: P
authors.lastname: Bansil
authors.affiliation: Diagnostics Program, PATH, Seattle, WA, United States of America.
authors.forename: Gonzalo J
authors.initials: GJ
authors.lastname: Domingo
authors.affiliation: Department of Medical Research (Lower Myanmar), Yangon, Republic of the Union of Myanmar.
authors.forename: Moh Moh
authors.initials: MM
authors.lastname: Htun
authors.affiliation: Department of Medical Research (Lower Myanmar), Yangon, Republic of the Union of Myanmar.
authors.forename: Kyaw Zin
authors.initials: KZ
authors.lastname: Thant
authors.affiliation: Department of Medical Research (Lower Myanmar), Yangon, Republic of the Union of Myanmar.
authors.forename: Ye
authors.initials: Y
authors.lastname: Htut
authors.affiliation: Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.|Centre for Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
authors.forename: Francois
authors.initials: F
authors.lastname: Nosten
mesh_terms: D000328:Adult; D000962:Antimalarials / Q000627:therapeutic use; D004867:Equipment Design; D005260:Female; D005453:Fluorescence; D005954:Glucosephosphate Dehydrogenase / Q000097:blood*; D005955:Glucosephosphate Dehydrogenase Deficiency / Q000097:blood* / Q000175:diagnosis* / Q000453:epidemiology; D064368:Healthy Volunteers; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy; D016780:Malaria, Vivax / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D002052:Myanmar / Q000453:epidemiology; D010963:Plasmodium falciparum / Q000187:drug effects; D010966:Plasmodium vivax / Q000187:drug effects; D019095:Point-of-Care Systems; D011319:Primaquine / Q000627:therapeutic use; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
chemical_list: D000962:Antimalarials; D011933:Reagent Kits, Diagnostic; D005954:Glucosephosphate Dehydrogenase; D011319:Primaquine