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Technical evaluation and usability of a quantitative G6PD POC test in cord blood: a mixed-methods study in a low-resource setting

OBJECTIVES: New point-of-care (POC) quantitative G6PD testing devices developed to provide safe radical cure for Plasmodium vivax malaria may be used to diagnose G6PD deficiency in newborns at risk of severe neonatal hyperbilirubinaemia, improving clinical care, and preventing related morbidity and...

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Autores principales: Bancone, Germana, Gilder, Mary Ellen, Win, Elsie, Gornsawun, Gornpan, Penpitchaporn, Penporn, Moo, Phaw Khu, Archasuksan, Laypaw, Wai, Nan San, Win, Sylverine, Aung, Ko Ko, Hashmi, Ahmar, Hanboonkunupakarn, Borimas, Nosten, Francois, Carrara, Verena Ilona, McGready, Rose
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9748916/
https://www.ncbi.nlm.nih.gov/pubmed/36523222
http://dx.doi.org/10.1136/bmjopen-2022-066529
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author Bancone, Germana
Gilder, Mary Ellen
Win, Elsie
Gornsawun, Gornpan
Penpitchaporn, Penporn
Moo, Phaw Khu
Archasuksan, Laypaw
Wai, Nan San
Win, Sylverine
Aung, Ko Ko
Hashmi, Ahmar
Hanboonkunupakarn, Borimas
Nosten, Francois
Carrara, Verena Ilona
McGready, Rose
author_facet Bancone, Germana
Gilder, Mary Ellen
Win, Elsie
Gornsawun, Gornpan
Penpitchaporn, Penporn
Moo, Phaw Khu
Archasuksan, Laypaw
Wai, Nan San
Win, Sylverine
Aung, Ko Ko
Hashmi, Ahmar
Hanboonkunupakarn, Borimas
Nosten, Francois
Carrara, Verena Ilona
McGready, Rose
author_sort Bancone, Germana
collection PubMed
description OBJECTIVES: New point-of-care (POC) quantitative G6PD testing devices developed to provide safe radical cure for Plasmodium vivax malaria may be used to diagnose G6PD deficiency in newborns at risk of severe neonatal hyperbilirubinaemia, improving clinical care, and preventing related morbidity and mortality. METHODS: We conducted a mixed-methods study analysing technical performance and usability of the ‘STANDARD G6PD’ Biosensor when used by trained midwives on cord blood samples at two rural clinics on the Thailand–Myanmar border. RESULTS: In 307 cord blood samples, the Biosensor had a sensitivity of 1.000 (95% CI: 0.859 to 1.000) and a specificity of 0.993 (95% CI: 0.971 to 0.999) as compared with gold-standard spectrophotometry to diagnose G6PD-deficient newborns using a receiver operating characteristic (ROC) analysis-derived threshold of ≤4.8 IU/gHb. The Biosensor had a sensitivity of 0.727 (95% CI: 0.498 to 0.893) and specificity of 0.933 (95% CI: 0.876 to 0.969) for 30%–70% activity range in girls using ROC analysis-derived range of 4.9–9.9 IU/gHb. These thresholds allowed identification of all G6PD-deficient neonates and 80% of female neonates with intermediate phenotypes. Need of phototherapy treatment for neonatal hyperbilirubinaemia was higher in neonates with deficient and intermediate phenotypes as diagnosed by either reference spectrophotometry or Biosensor. Focus group discussions found high levels of learnability, willingness, satisfaction and suitability for the Biosensor in this setting. The staff valued the capacity of the Biosensor to identify newborns with G6PD deficiency early (‘We can know that early, we can counsel the parents about the chances of their children getting jaundice’) and at the POC, including in more rural settings (‘Because we can know the right result of the G6PD deficiency in a short time, especially for the clinic which does not have a lab’). CONCLUSIONS: The Biosensor is a suitable tool in this resource-constrained setting to identify newborns with abnormal G6PD phenotypes at increased risk of neonatal hyperbilirubinaemia.
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spelling pubmed-97489162022-12-15 Technical evaluation and usability of a quantitative G6PD POC test in cord blood: a mixed-methods study in a low-resource setting Bancone, Germana Gilder, Mary Ellen Win, Elsie Gornsawun, Gornpan Penpitchaporn, Penporn Moo, Phaw Khu Archasuksan, Laypaw Wai, Nan San Win, Sylverine Aung, Ko Ko Hashmi, Ahmar Hanboonkunupakarn, Borimas Nosten, Francois Carrara, Verena Ilona McGready, Rose BMJ Open Diagnostics OBJECTIVES: New point-of-care (POC) quantitative G6PD testing devices developed to provide safe radical cure for Plasmodium vivax malaria may be used to diagnose G6PD deficiency in newborns at risk of severe neonatal hyperbilirubinaemia, improving clinical care, and preventing related morbidity and mortality. METHODS: We conducted a mixed-methods study analysing technical performance and usability of the ‘STANDARD G6PD’ Biosensor when used by trained midwives on cord blood samples at two rural clinics on the Thailand–Myanmar border. RESULTS: In 307 cord blood samples, the Biosensor had a sensitivity of 1.000 (95% CI: 0.859 to 1.000) and a specificity of 0.993 (95% CI: 0.971 to 0.999) as compared with gold-standard spectrophotometry to diagnose G6PD-deficient newborns using a receiver operating characteristic (ROC) analysis-derived threshold of ≤4.8 IU/gHb. The Biosensor had a sensitivity of 0.727 (95% CI: 0.498 to 0.893) and specificity of 0.933 (95% CI: 0.876 to 0.969) for 30%–70% activity range in girls using ROC analysis-derived range of 4.9–9.9 IU/gHb. These thresholds allowed identification of all G6PD-deficient neonates and 80% of female neonates with intermediate phenotypes. Need of phototherapy treatment for neonatal hyperbilirubinaemia was higher in neonates with deficient and intermediate phenotypes as diagnosed by either reference spectrophotometry or Biosensor. Focus group discussions found high levels of learnability, willingness, satisfaction and suitability for the Biosensor in this setting. The staff valued the capacity of the Biosensor to identify newborns with G6PD deficiency early (‘We can know that early, we can counsel the parents about the chances of their children getting jaundice’) and at the POC, including in more rural settings (‘Because we can know the right result of the G6PD deficiency in a short time, especially for the clinic which does not have a lab’). CONCLUSIONS: The Biosensor is a suitable tool in this resource-constrained setting to identify newborns with abnormal G6PD phenotypes at increased risk of neonatal hyperbilirubinaemia. BMJ Publishing Group 2022-12-13 /pmc/articles/PMC9748916/ /pubmed/36523222 http://dx.doi.org/10.1136/bmjopen-2022-066529 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Diagnostics
Bancone, Germana
Gilder, Mary Ellen
Win, Elsie
Gornsawun, Gornpan
Penpitchaporn, Penporn
Moo, Phaw Khu
Archasuksan, Laypaw
Wai, Nan San
Win, Sylverine
Aung, Ko Ko
Hashmi, Ahmar
Hanboonkunupakarn, Borimas
Nosten, Francois
Carrara, Verena Ilona
McGready, Rose
Technical evaluation and usability of a quantitative G6PD POC test in cord blood: a mixed-methods study in a low-resource setting
title Technical evaluation and usability of a quantitative G6PD POC test in cord blood: a mixed-methods study in a low-resource setting
title_full Technical evaluation and usability of a quantitative G6PD POC test in cord blood: a mixed-methods study in a low-resource setting
title_fullStr Technical evaluation and usability of a quantitative G6PD POC test in cord blood: a mixed-methods study in a low-resource setting
title_full_unstemmed Technical evaluation and usability of a quantitative G6PD POC test in cord blood: a mixed-methods study in a low-resource setting
title_short Technical evaluation and usability of a quantitative G6PD POC test in cord blood: a mixed-methods study in a low-resource setting
title_sort technical evaluation and usability of a quantitative g6pd poc test in cord blood: a mixed-methods study in a low-resource setting
topic Diagnostics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9748916/
https://www.ncbi.nlm.nih.gov/pubmed/36523222
http://dx.doi.org/10.1136/bmjopen-2022-066529
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