Field evaluation of a prototype tuberculosis lipoarabinomannan lateral flow assay on HIV-positive and HIV-negative patients.

Field evaluation of a prototype tuberculosis lipoarabinomannan lateral flow assay on HIV-positive and HIV-negative patients.

Detection of tuberculosis at the point-of-care (POC) is limited by the low sensitivity of current commercially available tests. We describe a diagnostic accuracy field evaluation of a prototype urine Tuberculosis Lipoarabinomannan Lateral Flow Assay (TB-LAM LFA) in both HIV-positive and HIV-negative...

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Autores principales: John T Connelly, Alfred Andama, Benjamin D Grant, Alexey Ball, Sandra Mwebe, Lucy Asege, Martha Nakaye, Brianda Barrios Lopez, Helen V Hsieh, David Katumba, Job Mukwatamundu, Mayimuna Nalubega, Victoria M Hunt, Stephen Burkot, Harisha Ramachandraiah, Alok Choudhary, Lech Ignatowicz, Bernhard H Weigl, Christine Bachman, Jerry Mulondo, Fred Semitala, William Worodria, Abraham Pinter, Beston Hamasur, David Bell, Adithya Cattamanchi, Akos Somoskovi
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Lenguaje:EN
Publicado: Public Library of Science (PLoS) 2021
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Acceso en línea:https://doaj.org/article/8640c5dc88a34357989c24e52f8fab15
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spelling oai:doaj.org-article:8640c5dc88a34357989c24e52f8fab152021-12-02T20:04:51ZField evaluation of a prototype tuberculosis lipoarabinomannan lateral flow assay on HIV-positive and HIV-negative patients.1932-620310.1371/journal.pone.0254156https://doaj.org/article/8640c5dc88a34357989c24e52f8fab152021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0254156https://doaj.org/toc/1932-6203Detection of tuberculosis at the point-of-care (POC) is limited by the low sensitivity of current commercially available tests. We describe a diagnostic accuracy field evaluation of a prototype urine Tuberculosis Lipoarabinomannan Lateral Flow Assay (TB-LAM LFA) in both HIV-positive and HIV-negative patients using fresh samples with sensitivity and specificity as the measures of accuracy. This prototype combines a proprietary concentration system with a sensitive LFA. In a prospective study of 292 patients with suspected pulmonary tuberculosis in Uganda, the clinical sensitivity and specificity was compared against a microbiological reference standard including sputum Xpert MTB/RIF Ultra and solid and liquid culture. TB-LAM LFA had an overall sensitivity of 60% (95%CI 51-69%) and specificity of 80% (95%CI 73-85%). When comparing HIV-positive (N = 86) and HIV-negative (N = 206) patients, there was no significant difference in sensitivity (sensitivity difference 8%, 95%CI -11% to +24%, p = 0.4351) or specificity (specificity difference -9%, 95%CI -24% to +4%, p = 0.2051). Compared to the commercially available Alere Determine TB-LAM Ag test, the TB-LAM LFA prototype had improved sensitivity in both HIV-negative (difference 49%, 95%CI 37% to 59%, p<0.0001) and HIV-positive patients with CD4+ T-cell counts >200cells/μL (difference 59%, 95%CI 32% to 75%, p = 0.0009). This report is the first to show improved performance of a urine TB LAM test for HIV-negative patients in a high TB burden setting. We also offer potential assay refinement solutions that may further improve sensitivity and specificity.John T ConnellyAlfred AndamaBenjamin D GrantAlexey BallSandra MwebeLucy AsegeMartha NakayeBrianda Barrios LopezHelen V HsiehDavid KatumbaJob MukwatamunduMayimuna NalubegaVictoria M HuntStephen BurkotHarisha RamachandraiahAlok ChoudharyLech IgnatowiczBernhard H WeiglChristine BachmanJerry MulondoFred SemitalaWilliam WorodriaAbraham PinterBeston HamasurDavid BellAdithya CattamanchiAkos SomoskoviPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 7, p e0254156 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
John T Connelly
Alfred Andama
Benjamin D Grant
Alexey Ball
Sandra Mwebe
Lucy Asege
Martha Nakaye
Brianda Barrios Lopez
Helen V Hsieh
David Katumba
Job Mukwatamundu
Mayimuna Nalubega
Victoria M Hunt
Stephen Burkot
Harisha Ramachandraiah
Alok Choudhary
Lech Ignatowicz
Bernhard H Weigl
Christine Bachman
Jerry Mulondo
Fred Semitala
William Worodria
Abraham Pinter
Beston Hamasur
David Bell
Adithya Cattamanchi
Akos Somoskovi
Field evaluation of a prototype tuberculosis lipoarabinomannan lateral flow assay on HIV-positive and HIV-negative patients.
description Detection of tuberculosis at the point-of-care (POC) is limited by the low sensitivity of current commercially available tests. We describe a diagnostic accuracy field evaluation of a prototype urine Tuberculosis Lipoarabinomannan Lateral Flow Assay (TB-LAM LFA) in both HIV-positive and HIV-negative patients using fresh samples with sensitivity and specificity as the measures of accuracy. This prototype combines a proprietary concentration system with a sensitive LFA. In a prospective study of 292 patients with suspected pulmonary tuberculosis in Uganda, the clinical sensitivity and specificity was compared against a microbiological reference standard including sputum Xpert MTB/RIF Ultra and solid and liquid culture. TB-LAM LFA had an overall sensitivity of 60% (95%CI 51-69%) and specificity of 80% (95%CI 73-85%). When comparing HIV-positive (N = 86) and HIV-negative (N = 206) patients, there was no significant difference in sensitivity (sensitivity difference 8%, 95%CI -11% to +24%, p = 0.4351) or specificity (specificity difference -9%, 95%CI -24% to +4%, p = 0.2051). Compared to the commercially available Alere Determine TB-LAM Ag test, the TB-LAM LFA prototype had improved sensitivity in both HIV-negative (difference 49%, 95%CI 37% to 59%, p<0.0001) and HIV-positive patients with CD4+ T-cell counts >200cells/μL (difference 59%, 95%CI 32% to 75%, p = 0.0009). This report is the first to show improved performance of a urine TB LAM test for HIV-negative patients in a high TB burden setting. We also offer potential assay refinement solutions that may further improve sensitivity and specificity.
format article
author John T Connelly
Alfred Andama
Benjamin D Grant
Alexey Ball
Sandra Mwebe
Lucy Asege
Martha Nakaye
Brianda Barrios Lopez
Helen V Hsieh
David Katumba
Job Mukwatamundu
Mayimuna Nalubega
Victoria M Hunt
Stephen Burkot
Harisha Ramachandraiah
Alok Choudhary
Lech Ignatowicz
Bernhard H Weigl
Christine Bachman
Jerry Mulondo
Fred Semitala
William Worodria
Abraham Pinter
Beston Hamasur
David Bell
Adithya Cattamanchi
Akos Somoskovi
author_facet John T Connelly
Alfred Andama
Benjamin D Grant
Alexey Ball
Sandra Mwebe
Lucy Asege
Martha Nakaye
Brianda Barrios Lopez
Helen V Hsieh
David Katumba
Job Mukwatamundu
Mayimuna Nalubega
Victoria M Hunt
Stephen Burkot
Harisha Ramachandraiah
Alok Choudhary
Lech Ignatowicz
Bernhard H Weigl
Christine Bachman
Jerry Mulondo
Fred Semitala
William Worodria
Abraham Pinter
Beston Hamasur
David Bell
Adithya Cattamanchi
Akos Somoskovi
author_sort John T Connelly
title Field evaluation of a prototype tuberculosis lipoarabinomannan lateral flow assay on HIV-positive and HIV-negative patients.
title_short Field evaluation of a prototype tuberculosis lipoarabinomannan lateral flow assay on HIV-positive and HIV-negative patients.
title_full Field evaluation of a prototype tuberculosis lipoarabinomannan lateral flow assay on HIV-positive and HIV-negative patients.
title_fullStr Field evaluation of a prototype tuberculosis lipoarabinomannan lateral flow assay on HIV-positive and HIV-negative patients.
title_full_unstemmed Field evaluation of a prototype tuberculosis lipoarabinomannan lateral flow assay on HIV-positive and HIV-negative patients.
title_sort field evaluation of a prototype tuberculosis lipoarabinomannan lateral flow assay on hiv-positive and hiv-negative patients.
publisher Public Library of Science (PLoS)
publishDate 2021
url https://doaj.org/article/8640c5dc88a34357989c24e52f8fab15
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