Feasibility of using Determine TB-LAM to diagnose tuberculosis in HIV-positive patients in programmatic conditions: a multisite study

Background: Determine TB-LAM is a urine-based point-of-care assay for diagnosis of tuberculosis (TB). Objective: To assess the feasibility of using LAM to diagnose TB in adult HIV-positive patients in resource-limited settings. Methods: We performed a multi-centric mixed-methods cross-sectional desc...

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Bibliographic Details
Published in:	Global health action Vol. 12; no. 1; p. 1672366
Main Authors:	Mathabire Rucker, Sekai Chenai, Cossa, Loide, Harrison, Rebecca E., Mpunga, James, Lobo, Sheila, Kisaka Kimupelenge, Patrick, Mandar Kol'Ampwe, Felix, Amoros Quiles, Isabel, Molfino, Lucas, Szumilin, Elisabeth, Telnov, Oleksandr, Ndlovu, Zibusiso, Huerga, Helena
Format:	Journal Article
Language:	English
Published:	United States Taylor & Francis 01-01-2019 Taylor & Francis Ltd Taylor & Francis Group
Subjects:	Africa South of the Sahara - epidemiology Cross-Sectional Studies diagnosis Feasibility Feasibility Studies HIV HIV Infections - drug therapy HIV Infections - epidemiology Human immunodeficiency virus Humans Immune response implementation Interviews as Topic Lipoarabinomannan Lipopolysaccharides low income settings Medical diagnosis Original Point-of-Care Systems Same day Sensitivity and Specificity Sputum - microbiology Tuberculosis Tuberculosis - diagnosis Tuberculosis - epidemiology Africa South of the Sahara Malawi Mozambique diagnosis low income settings implementation tuberculosis Lipoarabinomannan
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Summary:	Background: Determine TB-LAM is a urine-based point-of-care assay for diagnosis of tuberculosis (TB). Objective: To assess the feasibility of using LAM to diagnose TB in adult HIV-positive patients in resource-limited settings. Methods: We performed a multi-centric mixed-methods cross-sectional descriptive study in the Democratic Republic of Congo, Malawi, and Mozambique. We used the study and program monitoring tools to estimate user workload, turn-around time (TAT), and proportion of patients with LAM and sputum-based results. We conducted semi-structured interviews to assess the user acceptability of the LAM. Results: The duration of the LAM testing activity per patient was 27 min (IQR 26-29); staff continued with other duties whilst waiting for the result. More patients had a LAM versus a sputum-based result: 168/213 (78.9%) vs 77/213 (36.1%), p < 0.001 in DRC; 691/695 (99.4%) vs 429/695 (61.7%), p < 0.001 in Malawi; and 646/647 (99.8%) vs 262/647 (40.5%), p < 0.001 in Mozambique. The median TAT in minutes when LAM was performed in the consultation room was 75 (IQR 45-188) in DRC, 29 (IQR 27-39) in Malawi, and 36 (IQR 35-41) in Mozambique. In comparison, the overall median TAT for sputum-based tests (smear or GeneXpert) was 2 (IQR 1-3) days. The median time to the first anti-TB drug dose for LAM-positive patients was 155 (IQR 90-504) minutes in DRC and 90 (IQR 60-117) minutes in Mozambique. The overall inter-reader agreement for the interpretation of the LAM result as positive or negative was 98.9%, kappa 0.97 (95%CI 0.96-0.99). Overall, LAM users found the test easy to perform. Major concerns were use of the reading card and the prior requirement of CD4 results before LAM testing. Conclusion: It is feasible to implement the LAM test in low resource settings. The short TAT permitted same day initiation of TB treatment for LAM-positive patients.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1654-9716 1654-9880
DOI:	10.1080/16549716.2019.1672366