Evaluation of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency in Brazil.

<h4>Background</h4>Glucose-6-phosphate dehydrogenase (G6PD) deficiency is a common enzyme deficiency, prevalent in many malaria-endemic countries. G6PD-deficient individuals are susceptible to hemolysis during oxidative stress, which can occur from exposure to certain medications, includ...

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Autores principales:	Stephanie Zobrist, Marcelo Brito, Eduardo Garbin, Wuelton M Monteiro, Suellen Clementino Freitas, Marcela Macedo, Aline Soares Moura, Nicole Advani, Maria Kahn, Sampa Pal, Emily Gerth-Guyette, Pooja Bansil, Gonzalo J Domingo, Dhelio Pereira, Marcus Vg Lacerda
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/254024eec84e41229a3ea11608103049
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spelling	oai:doaj.org-article:254024eec84e41229a3ea116081030492021-12-02T20:23:39ZEvaluation of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency in Brazil.1935-27271935-273510.1371/journal.pntd.0009649https://doaj.org/article/254024eec84e41229a3ea116081030492021-08-01T00:00:00Zhttps://doi.org/10.1371/journal.pntd.0009649https://doaj.org/toc/1935-2727https://doaj.org/toc/1935-2735<h4>Background</h4>Glucose-6-phosphate dehydrogenase (G6PD) deficiency is a common enzyme deficiency, prevalent in many malaria-endemic countries. G6PD-deficient individuals are susceptible to hemolysis during oxidative stress, which can occur from exposure to certain medications, including 8-aminoquinolines used to treat Plasmodium vivax malaria. Accordingly, access to point-of-care (POC) G6PD testing in Brazil is critical for safe treatment of P. vivax malaria.<h4>Methodology/principal findings</h4>This study evaluated the performance of the semi-quantitative, POC STANDARD G6PD Test (SD Biosensor, Republic of Korea). Participants were recruited at clinics and through an enriched sample in Manaus and Porto Velho, Brazil. G6PD and hemoglobin measurements were obtained from capillary samples at the POC using the STANDARD and HemoCue 201+ (HemoCue AB, Sweden) tests. A thick blood slide was prepared for malaria microscopy. At the laboratories, the STANDARD and HemoCue tests were repeated on venous samples and a quantitative spectrophotometric G6PD reference assay was performed (Pointe Scientific, Canton, MI). G6PD was also assessed by fluorescent spot test. In Manaus, a complete blood count was performed. Samples were analyzed from 1,736 participants. In comparison to spectrophotometry, the STANDARD G6PD Test performed equivalently in determining G6PD status in venous and capillary specimens under varied operating temperatures. Using the manufacturer-recommended reference value thresholds, the test's sensitivity at the <30% threshold on both specimen types was 100% (95% confidence interval [CI] venous 93.6%-100.0%; capillary 93.8%-100.0%). Specificity was 98.6% on venous specimens (95% CI 97.9%-99.1%) and 97.8% on capillary (95% CI 97.0%-98.5%). At the 70% threshold, the test's sensitivity was 96.9% on venous specimens (95% CI 83.8%-99.9%) and 94.3% on capillary (95% CI 80.8%-99.3%). Specificity was 96.5% (95% CI 95.0%-97.6%) and 92.3% (95% CI 90.3%-94.0%) on venous and capillary specimens, respectively.<h4>Conclusion/significance</h4>The STANDARD G6PD Test is a promising tool to aid in POC detection of G6PD deficiency in Brazil.<h4>Trial registration</h4>This study was registered with ClinicalTrials.gov (identifier: NCT04033640).Stephanie ZobristMarcelo BritoEduardo GarbinWuelton M MonteiroSuellen Clementino FreitasMarcela MacedoAline Soares MouraNicole AdvaniMaria KahnSampa PalEmily Gerth-GuyettePooja BansilGonzalo J DomingoDhelio PereiraMarcus Vg LacerdaPublic Library of Science (PLoS)articleArctic medicine. Tropical medicineRC955-962Public aspects of medicineRA1-1270ENPLoS Neglected Tropical Diseases, Vol 15, Iss 8, p e0009649 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270
spellingShingle	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Stephanie Zobrist Marcelo Brito Eduardo Garbin Wuelton M Monteiro Suellen Clementino Freitas Marcela Macedo Aline Soares Moura Nicole Advani Maria Kahn Sampa Pal Emily Gerth-Guyette Pooja Bansil Gonzalo J Domingo Dhelio Pereira Marcus Vg Lacerda Evaluation of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency in Brazil.
description	<h4>Background</h4>Glucose-6-phosphate dehydrogenase (G6PD) deficiency is a common enzyme deficiency, prevalent in many malaria-endemic countries. G6PD-deficient individuals are susceptible to hemolysis during oxidative stress, which can occur from exposure to certain medications, including 8-aminoquinolines used to treat Plasmodium vivax malaria. Accordingly, access to point-of-care (POC) G6PD testing in Brazil is critical for safe treatment of P. vivax malaria.<h4>Methodology/principal findings</h4>This study evaluated the performance of the semi-quantitative, POC STANDARD G6PD Test (SD Biosensor, Republic of Korea). Participants were recruited at clinics and through an enriched sample in Manaus and Porto Velho, Brazil. G6PD and hemoglobin measurements were obtained from capillary samples at the POC using the STANDARD and HemoCue 201+ (HemoCue AB, Sweden) tests. A thick blood slide was prepared for malaria microscopy. At the laboratories, the STANDARD and HemoCue tests were repeated on venous samples and a quantitative spectrophotometric G6PD reference assay was performed (Pointe Scientific, Canton, MI). G6PD was also assessed by fluorescent spot test. In Manaus, a complete blood count was performed. Samples were analyzed from 1,736 participants. In comparison to spectrophotometry, the STANDARD G6PD Test performed equivalently in determining G6PD status in venous and capillary specimens under varied operating temperatures. Using the manufacturer-recommended reference value thresholds, the test's sensitivity at the <30% threshold on both specimen types was 100% (95% confidence interval [CI] venous 93.6%-100.0%; capillary 93.8%-100.0%). Specificity was 98.6% on venous specimens (95% CI 97.9%-99.1%) and 97.8% on capillary (95% CI 97.0%-98.5%). At the 70% threshold, the test's sensitivity was 96.9% on venous specimens (95% CI 83.8%-99.9%) and 94.3% on capillary (95% CI 80.8%-99.3%). Specificity was 96.5% (95% CI 95.0%-97.6%) and 92.3% (95% CI 90.3%-94.0%) on venous and capillary specimens, respectively.<h4>Conclusion/significance</h4>The STANDARD G6PD Test is a promising tool to aid in POC detection of G6PD deficiency in Brazil.<h4>Trial registration</h4>This study was registered with ClinicalTrials.gov (identifier: NCT04033640).
format	article
author	Stephanie Zobrist Marcelo Brito Eduardo Garbin Wuelton M Monteiro Suellen Clementino Freitas Marcela Macedo Aline Soares Moura Nicole Advani Maria Kahn Sampa Pal Emily Gerth-Guyette Pooja Bansil Gonzalo J Domingo Dhelio Pereira Marcus Vg Lacerda
author_facet	Stephanie Zobrist Marcelo Brito Eduardo Garbin Wuelton M Monteiro Suellen Clementino Freitas Marcela Macedo Aline Soares Moura Nicole Advani Maria Kahn Sampa Pal Emily Gerth-Guyette Pooja Bansil Gonzalo J Domingo Dhelio Pereira Marcus Vg Lacerda
author_sort	Stephanie Zobrist
title	Evaluation of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency in Brazil.
title_short	Evaluation of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency in Brazil.
title_full	Evaluation of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency in Brazil.
title_fullStr	Evaluation of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency in Brazil.
title_full_unstemmed	Evaluation of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency in Brazil.
title_sort	evaluation of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency in brazil.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/254024eec84e41229a3ea11608103049
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Evaluation of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency in Brazil.

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