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Field validation of a magneto-optical detection device (Gazelle) for portable point-of-care Plasmodium vivax diagnosis

A major challenge for malaria is the lack of tools for accurate and timely diagnosis in the field which are critical for case management and surveillance. Microscopy along with rapid diagnostic tests are the current mainstay for malaria diagnosis in most endemic regions. However, these methods prese...

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Autores principales: Valdivia, Hugo O., Thota, Priyaleela, Braga, Greys, Ricopa, Leonila, Barazorda, Keare, Salas, Carola, Bishop, Danett K., Joya, Christie A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8219132/
https://www.ncbi.nlm.nih.gov/pubmed/34157032
http://dx.doi.org/10.1371/journal.pone.0253232
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author Valdivia, Hugo O.
Thota, Priyaleela
Braga, Greys
Ricopa, Leonila
Barazorda, Keare
Salas, Carola
Bishop, Danett K.
Joya, Christie A.
author_facet Valdivia, Hugo O.
Thota, Priyaleela
Braga, Greys
Ricopa, Leonila
Barazorda, Keare
Salas, Carola
Bishop, Danett K.
Joya, Christie A.
author_sort Valdivia, Hugo O.
collection PubMed
description A major challenge for malaria is the lack of tools for accurate and timely diagnosis in the field which are critical for case management and surveillance. Microscopy along with rapid diagnostic tests are the current mainstay for malaria diagnosis in most endemic regions. However, these methods present several limitations. This study assessed the accuracy of Gazelle, a novel rapid malaria diagnostic device, from samples collected from the Peruvian Amazon between 2019 and 2020. Diagnostic accuracy was compared against microscopy and two rapid diagnostic tests (SD Bioline and BinaxNOW) using 18ssr nested-PCR as reference test. In addition, a real-time PCR assay (PET-PCR) was used for parasite quantification. Out of 217 febrile patients enrolled and tested, 180 specimens (85 P. vivax and 95 negatives) were included in the final analysis. Using nested-PCR as the gold standard, the sensitivity and specificity of Gazelle was 88.2% and 97.9%, respectively. Using a cutoff of 200 parasites/μl, Gazelle’s sensitivity for samples with more than 200 p/uL was 98.67% (95%CI: 92.79% to 99.97%) whereas the sensitivity for samples lower than 200 p/uL (n = 10) was 12.5% (95%CI: 0.32% to 52.65%). Gazelle’s sensitivity and specificity were statistically similar to microscopy (sensitivity = 91.8, specificity = 100%, p = 0.983) and higher than both SD Bioline (sensitivity = 82.4, specificity = 100%, p = 0.016) and BinaxNOW (sensitivity = 71.8%, specificity = 97.9%, p = 0.002). The diagnostic accuracy of Gazelle for malaria detection in P. vivax infections was comparable to light microscopy and superior to both RDTs even in the presence of low parasitemia infections. The performance of Gazelle makes it a valuable tool for malaria diagnosis and active case detection that can be utilized in different malaria-endemic regions.
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spelling pubmed-82191322021-07-07 Field validation of a magneto-optical detection device (Gazelle) for portable point-of-care Plasmodium vivax diagnosis Valdivia, Hugo O. Thota, Priyaleela Braga, Greys Ricopa, Leonila Barazorda, Keare Salas, Carola Bishop, Danett K. Joya, Christie A. PLoS One Research Article A major challenge for malaria is the lack of tools for accurate and timely diagnosis in the field which are critical for case management and surveillance. Microscopy along with rapid diagnostic tests are the current mainstay for malaria diagnosis in most endemic regions. However, these methods present several limitations. This study assessed the accuracy of Gazelle, a novel rapid malaria diagnostic device, from samples collected from the Peruvian Amazon between 2019 and 2020. Diagnostic accuracy was compared against microscopy and two rapid diagnostic tests (SD Bioline and BinaxNOW) using 18ssr nested-PCR as reference test. In addition, a real-time PCR assay (PET-PCR) was used for parasite quantification. Out of 217 febrile patients enrolled and tested, 180 specimens (85 P. vivax and 95 negatives) were included in the final analysis. Using nested-PCR as the gold standard, the sensitivity and specificity of Gazelle was 88.2% and 97.9%, respectively. Using a cutoff of 200 parasites/μl, Gazelle’s sensitivity for samples with more than 200 p/uL was 98.67% (95%CI: 92.79% to 99.97%) whereas the sensitivity for samples lower than 200 p/uL (n = 10) was 12.5% (95%CI: 0.32% to 52.65%). Gazelle’s sensitivity and specificity were statistically similar to microscopy (sensitivity = 91.8, specificity = 100%, p = 0.983) and higher than both SD Bioline (sensitivity = 82.4, specificity = 100%, p = 0.016) and BinaxNOW (sensitivity = 71.8%, specificity = 97.9%, p = 0.002). The diagnostic accuracy of Gazelle for malaria detection in P. vivax infections was comparable to light microscopy and superior to both RDTs even in the presence of low parasitemia infections. The performance of Gazelle makes it a valuable tool for malaria diagnosis and active case detection that can be utilized in different malaria-endemic regions. Public Library of Science 2021-06-22 /pmc/articles/PMC8219132/ /pubmed/34157032 http://dx.doi.org/10.1371/journal.pone.0253232 Text en https://creativecommons.org/publicdomain/zero/1.0/This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 (https://creativecommons.org/publicdomain/zero/1.0/) public domain dedication.
spellingShingle Research Article
Valdivia, Hugo O.
Thota, Priyaleela
Braga, Greys
Ricopa, Leonila
Barazorda, Keare
Salas, Carola
Bishop, Danett K.
Joya, Christie A.
Field validation of a magneto-optical detection device (Gazelle) for portable point-of-care Plasmodium vivax diagnosis
title Field validation of a magneto-optical detection device (Gazelle) for portable point-of-care Plasmodium vivax diagnosis
title_full Field validation of a magneto-optical detection device (Gazelle) for portable point-of-care Plasmodium vivax diagnosis
title_fullStr Field validation of a magneto-optical detection device (Gazelle) for portable point-of-care Plasmodium vivax diagnosis
title_full_unstemmed Field validation of a magneto-optical detection device (Gazelle) for portable point-of-care Plasmodium vivax diagnosis
title_short Field validation of a magneto-optical detection device (Gazelle) for portable point-of-care Plasmodium vivax diagnosis
title_sort field validation of a magneto-optical detection device (gazelle) for portable point-of-care plasmodium vivax diagnosis
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8219132/
https://www.ncbi.nlm.nih.gov/pubmed/34157032
http://dx.doi.org/10.1371/journal.pone.0253232
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