Repeatability and reproducibility of a handheld quantitative G6PD diagnostic
Issued Date
2022-02-01
Resource Type
ISSN
19352727
eISSN
19352735
Scopus ID
2-s2.0-85124776598
Pubmed ID
35176015
Journal Title
PLoS Neglected Tropical Diseases
Volume
16
Issue
2
Rights Holder(s)
SCOPUS
Bibliographic Citation
PLoS Neglected Tropical Diseases Vol.16 No.2 (2022)
Suggested Citation
Ley B. Repeatability and reproducibility of a handheld quantitative G6PD diagnostic. PLoS Neglected Tropical Diseases Vol.16 No.2 (2022). doi:10.1371/journal.pntd.0010174 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/87379
Title
Repeatability and reproducibility of a handheld quantitative G6PD diagnostic
Author(s)
Author's Affiliation
Faculty of Tropical Medicine, Mahidol University
Université de Strasbourg
Eijkman Institute for Molecular Biology
PATH Seattle
Menzies School of Health Research
George Mason University
Armed Forces Research Institute of Medical Sciences, Thailand
Les Hôpitaux Universitaires de Strasbourg
International Centre for Diarrhoeal Disease Research Bangladesh
Nuffield Department of Medicine
Yale University
Institut Pasteur, Paris
Johns Hopkins School of Medicine
FIND
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Université de Strasbourg
Eijkman Institute for Molecular Biology
PATH Seattle
Menzies School of Health Research
George Mason University
Armed Forces Research Institute of Medical Sciences, Thailand
Les Hôpitaux Universitaires de Strasbourg
International Centre for Diarrhoeal Disease Research Bangladesh
Nuffield Department of Medicine
Yale University
Institut Pasteur, Paris
Johns Hopkins School of Medicine
FIND
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Other Contributor(s)
Abstract
Background The introduction of novel short course treatment regimens for the radical cure of Plasmodium vivax requires reliable point-of-care diagnosis that can identify glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. While deficient males can be identified using a qualitative diagnostic test, the genetic make-up of females requires a quantitative measurement. SD Biosensor (Republic of Korea) has developed a handheld quantitative G6PD diagnostic (STANDARD G6PD test), that has approximately 90% accuracy in field studies for identifying individuals with intermediate or severe deficiency. The device can only be considered for routine care if precision of the assay is high. Methods and findings Commercial lyophilised controls (ACS Analytics, USA) with high, intermediate, and low G6PD activities were assessed 20 times on 10 Biosensor devices and compared to spectrophotometry (Pointe Scientific, USA). Each device was then dispatched to one of 10 different laboratories with a standard set of the controls. Each control was tested 40 times at each laboratory by a single user and compared to spectrophotometry results. When tested at one site, the mean coefficient of variation (CV) was 0.111, 0.172 and 0.260 for high, intermediate, and low controls across all devices respectively; combined G6PD Biosensor readings correlated well with spectrophotometry (rs = 0.859, p<0.001). When tested in different laboratories, correlation was lower (rs = 0.604, p<0.001) and G6PD activity determined by Biosensor for the low and intermediate controls overlapped. The use of lyophilised human blood samples rather than fresh blood may have affected these find-ings. Biosensor G6PD readings between sites did not differ significantly (p = 0.436), whereas spectrophotometry readings differed markedly between sites (p<0.001). Conclusions Repeatability and inter-laboratory reproducibility of the Biosensor were good; though the device did not reliably discriminate between intermediate and low G6PD activities of the lyophilized specimens. Clinical studies are now required to assess the devices performance in practice.