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

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 ORCID: https://orcid.org/0000-0002-0329-9613, Meintjes, Graeme, Denkinger, Claudia M. and Ruhwald, Morten (2024) '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'. PLoS ONE, Vol 19, Issue 5, e0303846.

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Abstract

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).

Item Type:	Article
Corporate Authors:	FujiLAM Study Consortium
Subjects:	WC Communicable Diseases > Virus Diseases > Acquired Immunodeficiency Syndrome. HIV Infections > WC 503 Acquired immunodeficiency syndrome. HIV infections WC Communicable Diseases > Virus Diseases > Acquired Immunodeficiency Syndrome. HIV Infections > WC 503.5 Complications WF Respiratory System > Tuberculosis > WF 200 Tuberculosis (General) WF Respiratory System > Tuberculosis > WF 220 Diagnosis. Prognosis
Faculty: Department:	Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):	https://doi.org/10.1371/journal.pone.0303846
SWORD Depositor:	JISC Pubrouter
Depositing User:	JISC Pubrouter
Date Deposited:	06 Jun 2024 13:07
Last Modified:	06 Jun 2024 13:07
URI:	https://archive.lstmed.ac.uk/id/eprint/24673

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