Academic Journal
Clinical performance validation of the STANDARD G6PD test: A multi-country pooled analysis.
| Title: | Clinical performance validation of the STANDARD G6PD test: A multi-country pooled analysis. |
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| Authors: | Wondimagegn Adissu, Marcelo Brito, Eduardo Garbin, Marcela Macedo, Wuelton Monteiro, Sandip Kumar Mukherjee, Jane Myburg, Mohammad Shafiul Alam, Germana Bancone, Pooja Bansil, Sampa Pal, Abhijit Sharma, Stephanie Zobrist, Andrew Bryan, Cindy S Chu, Santasabuj Das, Gonzalo J Domingo, Amanda Hann, James Kublin, Marcus V G Lacerda, Mark Layton, Benedikt Ley, Sean C Murphy, Francois Nosten, Dhélio Pereira, Ric N Price, Arunansu Talukdar, Daniel Yilma, Emily Gerth-Guyette |
| Source: | PLoS Neglected Tropical Diseases, Vol 17, Iss 10, p e0011652 (2023) |
| Publisher Information: | Public Library of Science (PLoS), 2023. |
| Publication Year: | 2023 |
| Collection: | LCC:Arctic medicine. Tropical medicine LCC:Public aspects of medicine |
| Subject Terms: | Arctic medicine. Tropical medicine, RC955-962, Public aspects of medicine, RA1-1270 |
| More Details: | IntroductionScreening for G6PD deficiency can inform disease management including malaria. Treatment with the antimalarial drugs primaquine and tafenoquine can be guided by point-of-care testing for G6PD deficiency.Methods and findingsData from similar clinical studies evaluating the performance of the STANDARD G6PD Test (SD Biosensor, South Korea) conducted in Bangladesh, Brazil, Ethiopia, India, Thailand, the United Kingdom, and the United States were pooled. Test performance was assessed in a retrospective analysis on capillary and venous specimens. All study sites used spectrophotometry for reference G6PD testing, and either the HemoCue or complete blood count for reference hemoglobin measurement. The sensitivity of the STANDARD G6PD Test using the manufacturer thresholds for G6PD deficient and intermediate cases in capillary specimens from 4212 study participants was 100% (95% Confidence Interval (CI): 97.5%-100%) for G6PD deficient cases with 60% on the reference assay. The negative predictive value for females with G6PD activity >60% was 99.6% (95% CI 99.1%-99.8%) on capillary specimens. Sensitivity among 396 P. vivax malaria cases was 100% (69.2%-100.0%) for both deficient and intermediate cases. Across the full dataset, 37% of those classified as G6PD deficient or intermediate resulted from true normal cases. Despite this, over 95% of cases would receive correct treatment with primaquine, over 87% of cases would receive correct treatment with tafenoquine, and no true G6PD deficient cases would be treated inappropriately based on the result of the STANDARD G6PD Test.ConclusionsThe STANDARD G6PD Test enables safe access to drugs which are contraindicated for individuals with G6PD deficiency. Operational considerations will inform test uptake in specific settings. |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 1935-2727 1935-2735 |
| Relation: | https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0011652&type=printable; https://doaj.org/toc/1935-2727; https://doaj.org/toc/1935-2735 |
| DOI: | 10.1371/journal.pntd.0011652&type=printable |
| DOI: | 10.1371/journal.pntd.0011652 |
| Access URL: | https://doaj.org/article/6046749186634df9825ceec3ba9bb654 |
| Accession Number: | edsdoj.6046749186634df9825ceec3ba9bb654 |
| Database: | Directory of Open Access Journals |
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| ISSN: | 19352727 19352735 |
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| DOI: | 10.1371/journal.pntd.0011652&type=printable |
| Published in: | PLoS Neglected Tropical Diseases |
| Language: | English |