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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Comparing accuracy of lipoarabinomannan urine tests for diagnosis of pulmonary tuberculosis in children from four African countries: a cross-sectional study
The Lancet Infectious Diseases, Volume 21, No. 3, Year 2021
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Description
Background: A sensitive and specific non-sputum-based test would be groundbreaking for the diagnosis of childhood tuberculosis. We assessed side by side the diagnostic accuracy of the urine-based lipoarabinomannan assays Fujifilm SILVAMP TB LAM (FujiLAM) and Alere Determine TB LAM Ag (AlereLAM) for detection of childhood tuberculosis. Methods: In this cross-sectional study, we tested urine samples from children younger than 15 years with presumed pulmonary tuberculosis. Children were consecutively recruited from four dedicated outpatient childhood tuberculosis clinics in The Gambia, Mali, Nigeria, and Tanzania. Biobanked urine samples were thawed and tested using FujiLAM and AlereLAM assays. We measured diagnostic performance against a microbiological reference standard (confirmed tuberculosis) and a composite reference standard (confirmed and unconfirmed tuberculosis). Sensitivity and specificity were estimated with bivariate random-effects meta-analyses. Findings: Between July 1, 2017, and Dec 1, 2018, we obtained and stored urine samples from 415 children. 63 (15%) children had confirmed tuberculosis, 113 (27%) had unconfirmed tuberculosis, and 239 (58%) were unlikely to have tuberculosis. 61 children were HIV-positive (prevalence 15%). Using the microbiological reference standard, the sensitivity of FujiLAM was 64·9% (95% CI 43·7–85·2; positive in 40 of 63 confirmed samples) and the sensitivity of AlereLAM was 30·7% (8·6–61·6; 19 of 63). The specificity of FujiLAM was 83·8% (95% CI 76·5–89·4; negative in 297 of 352 unconfirmed and unlikely samples) and the specificity of AlereLAM was 87·8% (79·0–93·7; 312 of 352). Against the composite reference standard, both assays had decreased sensitivity; the sensitivity of FujiLAM was 32·9% (95% CI 24·6–41·9; positive in 58 of 176 confirmed and unconfirmed samples) and the sensitivity of AlereLAM was 20·2% (12·3–29·4; 36 of 176). The specificity of FujiLAM was 83·3% (95% CI 71·8–91·7; negative in 202 of 239 unlikely samples) and the specificity of AlereLAM was 90·0% (81·6–95·6; 216 of 239). Interpretation: By comparison with AlereLAM, FujiLAM showed higher sensitivity and similar specificity. FujiLAM could potentially add value to the rapid diagnosis of tuberculosis in children. Funding: German Federal Ministry of Education and Research, the Global Health Innovative Technology Fund, the UK Research and Innovation Global Challenges Research Fund, and the UK Medical Research Council. © 2021 Elsevier Ltd
Authors & Co-Authors
Nkereuwem, Esin
Gambia, Banjul
Medical Research Council Laboratories Gambia
Togun, Toyin Omotayo
Gambia, Banjul
Medical Research Council Laboratories Gambia
United Kingdom, London
Faculty of Infectious and Tropical Diseases
Gomez, Marie P.
Gambia, Banjul
Medical Research Council Laboratories Gambia
Székely, Rita
Switzerland, Geneva
Foundation for Innovative new Diagnostics, Switzerland
Macé, Aurélien
Switzerland, Geneva
Foundation for Innovative new Diagnostics, Switzerland
Jobe, Dawda
Gambia, Banjul
Medical Research Council Laboratories Gambia
Schumacher, Samuel G.
Switzerland, Geneva
Foundation for Innovative new Diagnostics, Switzerland
Kampmann, Beate B.
Gambia, Banjul
Medical Research Council Laboratories Gambia
United Kingdom, London
London School of Hygiene & Tropical Medicine
Denkinger, Claudia Maria
Switzerland, Geneva
Foundation for Innovative new Diagnostics, Switzerland
Germany, Heidelberg
Universitätsklinikum Heidelberg
Abok, Ibrahim Ishaya
Unknown Affiliation
Diarra, Bassirou
Unknown Affiliation
Ebonyi, Augustine Odo
Unknown Affiliation
Egere, Uzochukwu E.
Unknown Affiliation
Jallow, Musa
Unknown Affiliation
Konaté, Bakary
Unknown Affiliation
Mahiga, Hellen
Unknown Affiliation
Ntinginya, Nyanda Elias
Unknown Affiliation
Olomi, Willyhelmina
Unknown Affiliation
Sabi, Issa
Unknown Affiliation
Saidy, Binta
Unknown Affiliation
Sanogo, Moumine S.
Unknown Affiliation
Sillah, Abdou K.
Unknown Affiliation
Sylla, Mariam Moustapha
Unknown Affiliation
Statistics
Citations: 27
Authors: 23
Affiliations: 5
Identifiers
Doi:
10.1016/S1473-3099(20)30598-3
ISSN:
14733099
Research Areas
Infectious Diseases
Maternal And Child Health
Study Design
Cross Sectional Study
Study Approach
Quantitative
Study Locations
Gambia
Mali
Nigeria
Tanzania