Validation of G6PD Point-of-Care Tests among Healthy Volunteers in Yangon, Myanmar

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 Plasm...

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Published inPloS one Vol. 11; no. 4; p. e0152304
Main Authors Oo, Nwe Nwe, Bancone, Germana, Maw, Lwin Zar, Chowwiwat, Nongnud, Bansil, Pooja, Domingo, Gonzalo J., Htun, Moh Moh, Thant, Kyaw Zin, Htut, Ye, Nosten, Francois
Format Journal Article
LanguageEnglish
Published United States Public Library of Science 01.04.2016
Public Library of Science (PLoS)
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ISSN1932-6203
1932-6203
DOI10.1371/journal.pone.0152304

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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.
AbstractList 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.
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.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.
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.
Audience Academic
Author Bancone, Germana
Thant, Kyaw Zin
Nosten, Francois
Chowwiwat, Nongnud
Htun, Moh Moh
Maw, Lwin Zar
Domingo, Gonzalo J.
Oo, Nwe Nwe
Htut, Ye
Bansil, Pooja
AuthorAffiliation 1 Department of Medical Research (Lower Myanmar), Yangon, Republic of the Union of Myanmar
Agency for Science, Technology and Research—Singapore Immunology Network, SINGAPORE
3 Diagnostics Program, PATH, Seattle, WA, United States of America
4 Centre for Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom
2 Shoklo Malaria Research Unit, Mahidol–Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand
AuthorAffiliation_xml – name: 4 Centre for Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom
– name: 1 Department of Medical Research (Lower Myanmar), Yangon, Republic of the Union of Myanmar
– name: 2 Shoklo Malaria Research Unit, Mahidol–Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand
– name: 3 Diagnostics Program, PATH, Seattle, WA, United States of America
– name: Agency for Science, Technology and Research—Singapore Immunology Network, SINGAPORE
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2016 Oo et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.
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Competing Interests: The authors have declared that no competing interests exist.
Conceived and designed the experiments: NNO GB GJD KZT YH FN. Performed the experiments: LZM NC MMH. Analyzed the data: GB PB GJD FN. Contributed reagents/materials/analysis tools: NNO LZM YH. Wrote the paper: NNO GB PB GJD KZT YH FN.
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Snippet Primaquine and other 8-amnoquinoline based anti-malarials can cause haemolysis in subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Correct...
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SubjectTerms Adult
Antimalarials - therapeutic use
Biochemistry
Biology and Life Sciences
Blood tests
Care and treatment
Dehydrogenases
Dosage and administration
Drug dosages
Enzymes
Equipment Design
Erythrocytes
Female
Fluorescence
Glucose
Glucose 6 phosphate dehydrogenase
Glucosephosphate dehydrogenase
Glucosephosphate Dehydrogenase - blood
Glucosephosphate Dehydrogenase Deficiency - blood
Glucosephosphate Dehydrogenase Deficiency - diagnosis
Glucosephosphate Dehydrogenase Deficiency - epidemiology
Health aspects
Healthy Volunteers
Hematology
Humans
Laboratories
Malaria
Malaria, Falciparum - drug therapy
Malaria, Vivax - drug therapy
Male
Males
Medical research
Medicine
Medicine and Health Sciences
Middle Aged
Mutation
Myanmar - epidemiology
Phosphates
Plasmodium falciparum
Plasmodium falciparum - drug effects
Plasmodium vivax
Plasmodium vivax - drug effects
Point of care testing
Point-of-Care Systems
Primaquine
Primaquine - therapeutic use
Reagent Kits, Diagnostic
Sensitivity and Specificity
Spectrophotometry
Vector-borne diseases
Volunteers
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Title Validation of G6PD Point-of-Care Tests among Healthy Volunteers in Yangon, Myanmar
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http://dx.doi.org/10.1371/journal.pone.0152304
Volume 11
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