Non-invasive hemoglobin measurement devices require refinement to match diagnostic performance with their high level of usability and acceptability.

Anemia remains an important global health problem. Inexpensive, accurate, and noninvasive solutions are needed to monitor and evaluate anemia in resource-limited settings. We evaluated the performance of multiple point-of-care hemoglobin devices, including a novel noninvasive smartphone application...

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Autores principales:	Melissa F Young, Kelley Raines, Farhad Jameel, Manal Sidi, Shaiana Oliveira-Streiff, Paula Nwajei, Katherine McGlamry, Jiangda Ou, Alawode Oladele, Parminder S Suchdev
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/34b75d6aef864c4f847cb652a6e17fab
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spelling	oai:doaj.org-article:34b75d6aef864c4f847cb652a6e17fab2021-12-02T20:06:54ZNon-invasive hemoglobin measurement devices require refinement to match diagnostic performance with their high level of usability and acceptability.1932-620310.1371/journal.pone.0254629https://doaj.org/article/34b75d6aef864c4f847cb652a6e17fab2021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0254629https://doaj.org/toc/1932-6203Anemia remains an important global health problem. Inexpensive, accurate, and noninvasive solutions are needed to monitor and evaluate anemia in resource-limited settings. We evaluated the performance of multiple point-of-care hemoglobin devices, including a novel noninvasive smartphone application tested on Apple® and Android® cell phones, Masimo Pronto®, and HemoCue® Hb-301 and Hb-801, against a gold-standard hematology analyzer (reference hemoglobin) using venous blood. We examined correlations between hemoglobin devices and reference hemoglobin, device accuracy (average bias, Bland-Altman plots, clinical performance) and classification bias (sensitivity, specificity) among 299 refugees (10mo-65y) in Atlanta, GA. Semi-structured interviews (n = 19) with participants and staff assessed usability and acceptability. Mean reference hemoglobin was 13.7 g/dL (SD:1.8) with 12.5% anemia. Noninvasive hemoglobin devices were not well correlated with reference hemoglobin (Apple® R2 = 0.08, Android® R2 = 0.11, Masimo Pronto® R2 = 0.29), but stronger correlations were reported with HemoCue® Hb-301 (R2 = 0.87) and Hb-801 (R2 = 0.88). Bias (SD) varied across each device: Apple®: -1.6 g/dL (2.0), Android®: -0.7 g/dL (2.0), Masimo Pronto®: -0.4 g/dL (1.6), HemoCue® Hb-301: +0.4 g/dL (0.7) and HemoCue® Hb-801: +0.2 g/dL (0.6). Clinically acceptable performance (within ± 1 g/dL of reference hemoglobin) was higher for the invasive devices (HemoCue® Hb-301: 90.3%; HemoCue® Hb-801: 93.4%) compared to noninvasive devices (Apple®: 31.5%; Android®: 34.6%; Masimo Pronto®: 49.5%). Sensitivity and specificity were 63.9% and 48.2% for Apple®, 36.1% and 67.6% for Android®, 45.7% and 85.3% for Masimo Pronto®, 54.3% and 97.6% for HemoCue® Hb-301, and 66.7% and 97.6% for HemoCue® Hb-801. Noninvasive devices were considered easy to use and were the preferred method by participants. Among the only studies to compare multiple point-of-care approaches to hemoglobin testing, the diagnostic ability of HemoCue® was comparable to reference hemoglobin, while noninvasive devices had high user acceptability but considerable biases. Improvements in noninvasive device performance and further testing in anemic populations are recommended before broader use.Melissa F YoungKelley RainesFarhad JameelManal SidiShaiana Oliveira-StreiffPaula NwajeiKatherine McGlamryJiangda OuAlawode OladeleParminder S SuchdevPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 7, p e0254629 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Melissa F Young Kelley Raines Farhad Jameel Manal Sidi Shaiana Oliveira-Streiff Paula Nwajei Katherine McGlamry Jiangda Ou Alawode Oladele Parminder S Suchdev Non-invasive hemoglobin measurement devices require refinement to match diagnostic performance with their high level of usability and acceptability.
description	Anemia remains an important global health problem. Inexpensive, accurate, and noninvasive solutions are needed to monitor and evaluate anemia in resource-limited settings. We evaluated the performance of multiple point-of-care hemoglobin devices, including a novel noninvasive smartphone application tested on Apple® and Android® cell phones, Masimo Pronto®, and HemoCue® Hb-301 and Hb-801, against a gold-standard hematology analyzer (reference hemoglobin) using venous blood. We examined correlations between hemoglobin devices and reference hemoglobin, device accuracy (average bias, Bland-Altman plots, clinical performance) and classification bias (sensitivity, specificity) among 299 refugees (10mo-65y) in Atlanta, GA. Semi-structured interviews (n = 19) with participants and staff assessed usability and acceptability. Mean reference hemoglobin was 13.7 g/dL (SD:1.8) with 12.5% anemia. Noninvasive hemoglobin devices were not well correlated with reference hemoglobin (Apple® R2 = 0.08, Android® R2 = 0.11, Masimo Pronto® R2 = 0.29), but stronger correlations were reported with HemoCue® Hb-301 (R2 = 0.87) and Hb-801 (R2 = 0.88). Bias (SD) varied across each device: Apple®: -1.6 g/dL (2.0), Android®: -0.7 g/dL (2.0), Masimo Pronto®: -0.4 g/dL (1.6), HemoCue® Hb-301: +0.4 g/dL (0.7) and HemoCue® Hb-801: +0.2 g/dL (0.6). Clinically acceptable performance (within ± 1 g/dL of reference hemoglobin) was higher for the invasive devices (HemoCue® Hb-301: 90.3%; HemoCue® Hb-801: 93.4%) compared to noninvasive devices (Apple®: 31.5%; Android®: 34.6%; Masimo Pronto®: 49.5%). Sensitivity and specificity were 63.9% and 48.2% for Apple®, 36.1% and 67.6% for Android®, 45.7% and 85.3% for Masimo Pronto®, 54.3% and 97.6% for HemoCue® Hb-301, and 66.7% and 97.6% for HemoCue® Hb-801. Noninvasive devices were considered easy to use and were the preferred method by participants. Among the only studies to compare multiple point-of-care approaches to hemoglobin testing, the diagnostic ability of HemoCue® was comparable to reference hemoglobin, while noninvasive devices had high user acceptability but considerable biases. Improvements in noninvasive device performance and further testing in anemic populations are recommended before broader use.
format	article
author	Melissa F Young Kelley Raines Farhad Jameel Manal Sidi Shaiana Oliveira-Streiff Paula Nwajei Katherine McGlamry Jiangda Ou Alawode Oladele Parminder S Suchdev
author_facet	Melissa F Young Kelley Raines Farhad Jameel Manal Sidi Shaiana Oliveira-Streiff Paula Nwajei Katherine McGlamry Jiangda Ou Alawode Oladele Parminder S Suchdev
author_sort	Melissa F Young
title	Non-invasive hemoglobin measurement devices require refinement to match diagnostic performance with their high level of usability and acceptability.
title_short	Non-invasive hemoglobin measurement devices require refinement to match diagnostic performance with their high level of usability and acceptability.
title_full	Non-invasive hemoglobin measurement devices require refinement to match diagnostic performance with their high level of usability and acceptability.
title_fullStr	Non-invasive hemoglobin measurement devices require refinement to match diagnostic performance with their high level of usability and acceptability.
title_full_unstemmed	Non-invasive hemoglobin measurement devices require refinement to match diagnostic performance with their high level of usability and acceptability.
title_sort	non-invasive hemoglobin measurement devices require refinement to match diagnostic performance with their high level of usability and acceptability.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/34b75d6aef864c4f847cb652a6e17fab
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Non-invasive hemoglobin measurement devices require refinement to match diagnostic performance with their high level of usability and acceptability.

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