Field evaluation of a novel semi-quantitative point-of-care diagnostic for G6PD deficiency in Indonesia

The WHO recommends routine testing of G6PD activity to guide radical cure in patients with Plasmodium vivax malaria. Females may have intermediate G6PD enzyme activity and to date, only complex diagnostics are able to reliably identify them. The semi-quantitative G6PD diagnostic "One Step G6PD...

Full description

Saved in:

Bibliographic Details
Published in:	PloS one Vol. 19; no. 4; p. e0301506
Main Authors:	Sadhewa, Arkasha, Panggalo, Lydia V, Nanine, Illene, Price, Ric N, Thriemer, Kamala, Satyagraha, Ari W, Ley, Benedikt
Format:	Journal Article
Language:	English
Published:	United States Public Library of Science 30-04-2024 Public Library of Science (PLoS)
Subjects:	Adolescent Adult Biology and Life Sciences Care and treatment Child Diagnosis Evaluation Female Glucose-6-phosphate dehydrogenase deficiency Glucosephosphate Dehydrogenase - blood Glucosephosphate Dehydrogenase - metabolism Glucosephosphate Dehydrogenase Deficiency - diagnosis Humans Indonesia Malaria, Vivax - blood Malaria, Vivax - diagnosis Male Medical research Medicine and Health Sciences Medicine, Experimental Middle Aged People and Places Point-of-Care Systems Primary health care Research and Analysis Methods Science Policy Sensitivity and Specificity Spectrophotometry - methods Young Adult Indonesia
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	The WHO recommends routine testing of G6PD activity to guide radical cure in patients with Plasmodium vivax malaria. Females may have intermediate G6PD enzyme activity and to date, only complex diagnostics are able to reliably identify them. The semi-quantitative G6PD diagnostic "One Step G6PD Test" (Humasis, RoK; "RDT") is a lateral flow assay that can distinguish deficient, intermediate, and normal G6PD status and offers a simpler diagnostic alternative. G6PD status of participants enrolled in Malinau and Nunukan Regencies and the capital Jakarta was assessed with the RDT, and G6PD activity was measured in duplicate by reference spectrophotometry. The adjusted male median (AMM) of the spectrophotometry measurements was defined as 100% activity; 70% and 30% of the AMM were defined as thresholds for intermediate and deficient G6PD status, respectively. Results were compared to those derived from spectrophotometry at the clinically relevant G6PD activity thresholds of 30% and 70%. Of the 161 participants enrolled, 10 (6.2%) were G6PD deficient and 12 (7.5%) had intermediate G6PD activity by spectrophotometry. At the 30% threshold, the sensitivity of the RDT was 10.0% (95%CI: 0.3-44.5%) with a specificity of 99.3% (95%CI: 96.4-100.0%); the positive predictive value was 50.0% (95%CI: 1.3-98.7%) and the negative predictive value 94.3% (95%CI: 89.5-97.4%). The corresponding figures at the 70% threshold were 22.7% (95%CI: 7.8-45.4%), 100.0% (95%CI: 97.4-100.0%), 100.0% (95%CI: 47.8-100.0%) and 89.1% (95%CI: 83.1-93.5%), respectively. While there is a dire need for an easy-to-use, economical, semi-quantitative diagnostic for the point of care, the observed performance of the "One Step G6PD Test" in its current form was insufficient to guide antimalarial treatment.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Competing Interests: The authors have declared that no competing interests exist.
ISSN:	1932-6203 1932-6203
DOI:	10.1371/journal.pone.0301506