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

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Bibliographic Details
Published in:PloS one 2011-12, Vol.6 (12), p.e28357-e28357
Main Authors: Kim, Saorin, Nguon, Chea, Guillard, Bertrand, Duong, Socheat, Chy, Sophy, Sum, Sarorn, Nhem, Sina, Bouchier, Christiane, Tichit, Magali, Christophel, Eva, Taylor, Walter R J, Baird, John Kevin, Menard, Didier
Format: Article
Language:English
Subjects:
Adults
Antimalarials
Antimalarials - therapeutic use
Cambodia
Cross-Sectional Studies
Dehydrogenases
Diagnostic systems
Diagnostic tests
DNA Primers
DNA Primers - genetics
Drug dosages
Enzymatic activity
Enzyme activity
Enzymes
Epidemiology
Exons
Female
Genotype
Geography
Glucose
Glucose 6 phosphate dehydrogenase
Glucose dehydrogenase
Glucosephosphate Dehydrogenase
Glucosephosphate Dehydrogenase - blood
Glucosephosphate Dehydrogenase Deficiency
Glucosephosphate Dehydrogenase Deficiency - blood
Glucosephosphate Dehydrogenase Deficiency - diagnosis
Glucosephosphate Dehydrogenase Deficiency - epidemiology
Hematology
Hemoglobin
Hemoglobins
Human health and pathology
Humans
Infectious diseases
Laboratories
Life Sciences
Malaria
Male
Males
Medical diagnosis
Medical screening
Medical tests
Medicine
Mercury
Mutation
Parasites
Parasitology
Phosphates
Prevalence
Primaquine
Primaquine - therapeutic use
Quality control
Quality standards
R&D
Reagent Kits, Diagnostic
Reproducibility of Results
Research & development
Screening
Sequence Analysis, DNA
Spectrophotometry
Spectrophotometry - methods
Temperature
Uranium
Vector-borne diseases
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Summary: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
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0028357