Prospective multicentre accuracy evaluation of the FUJIFILM SILVAMP TB LAM test for the diagnosis of tuberculosis in people living with HIV demonstrates lot-to-lot variability

There is an urgent need for rapid, non-sputum point-of-care diagnostics to detect tuberculosis. This prospective trial in seven high tuberculosis burden countries evaluated the diagnostic accuracy of the point-of-care urine-based lipoarabinomannan assay FUJIFILM SILVAMP TB LAM (FujiLAM) among inpati...

Full description

Saved in:
Bibliographic Details
Published in:PloS one Vol. 19; no. 5; p. e0303846
Main Authors: Székely, Rita, Sossen, Bianca, Mukoka, Madalo, Muyoyeta, Monde, Nakabugo, Elizabeth, Hella, Jerry, Nguyen, Hung Van, Ubolyam, Sasiwimol, Chikamatsu, Kinuyo, Macé, Aurélien, Vermeulen, Marcia, Centner, Chad M., Nyangu, Sarah, Sanjase, Nsala, Sasamalo, Mohamed, Dinh, Huong Thi, Ngo, The Anh, Manosuthi, Weerawat, Jirajariyavej, Supunnee, Mitarai, Satoshi, Nguyen, Nhung Viet, Avihingsanon, Anchalee, Reither, Klaus, Nakiyingi, Lydia, Kerkhoff, Andrew D., MacPherson, Peter, Meintjes, Graeme, Denkinger, Claudia M., Ruhwald, Morten
Format: Journal Article
Language:English
Published: United States Public Library of Science 31.05.2024
Public Library of Science (PLoS)
Subjects:
Accuracy
Adult
Analysis
Antigens
Biomarkers
Blood
Blood culture
CD4 antigen
Cell culture
COVID-19
Decision making
Diagnosis
Diagnostic systems
Diagnostic tests
Female
HIV
HIV (Viruses)
HIV Infections - complications
HIV Infections - diagnosis
HIV testing
Human immunodeficiency virus
Humans
Lipopolysaccharides - urine
Male
Medical diagnosis
Medical examination
Microscopy
Middle Aged
Mycobacterium tuberculosis - isolation & purification
Prospective Studies
Quality control
Sensitivity
Sensitivity and Specificity
Sputum
Sputum - microbiology
Trainers
Tuberculosis
Tuberculosis - diagnosis
Urine
Variability
South Africa
Vietnam
Malawi
United States > US
Tanzania
Uganda
Zambia
Thailand
ISSN:1932-6203, 1932-6203
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:There is an urgent need for rapid, non-sputum point-of-care diagnostics to detect tuberculosis. This prospective trial in seven high tuberculosis burden countries evaluated the diagnostic accuracy of the point-of-care urine-based lipoarabinomannan assay FUJIFILM SILVAMP TB LAM (FujiLAM) among inpatients and outpatients living with HIV. Diagnostic performance of FujiLAM was assessed against a mycobacterial reference standard (sputum culture, blood culture, and Xpert Ultra from urine and sputum at enrollment, and additional sputum culture ≤7 days from enrollment), an extended mycobacterial reference standard (eMRS), and a composite reference standard including clinical evaluation. Of 1637 participants considered for the analysis, 296 (18%) were tuberculosis positive by eMRS. Median age was 40 years, median CD4 cell count was 369 cells/ul, and 52% were female. Overall FujiLAM sensitivity was 54·4% (95% CI: 48·7–60·0), overall specificity was 85·2% (83·2–87·0) against eMRS. Sensitivity and specificity estimates varied between sites, ranging from 26·5% (95% CI: 17·4%–38·0%) to 73·2% (60·4%–83·0%), and 75·0 (65·0%–82·9%) to 96·5 (92·1%–98·5%), respectively. Post-hoc exploratory analysis identified significant variability in the performance of the six FujiLAM lots used in this study. Lot variability limited interpretation of FujiLAM test performance. Although results with the current version of FujiLAM are too variable for clinical decision-making, the lipoarabinomannan biomarker still holds promise for tuberculosis diagnostics. The trial is registered at clinicaltrials.gov (NCT04089423).
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 14
content type line 23
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0303846