학술논문
Field evaluation of a prototype tuberculosis lipoarabinomannan lateral flow assay on HIV-positive and HIV-negative patients.
Document Type
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
Source
PLoS ONE, Vol 16, Iss 7, p e0254156 (2021)
Subject
Language
English
ISSN
1932-6203
Abstract
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%, p200cells/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.