Diagnostic accuracy of 3 urine lipoarabinomannan tuberculosis assays in HIV-negative outpatients.

The Journal of Clinical Investigation
Tobias BrogerClaudia M Denkinger

Abstract

BACKGROUNDInadequate tuberculosis (TB) diagnostics are a major hurdle in the reduction of disease burden, and accurate point-of-care tests (POCTs) are urgently needed. We assessed the diagnostic accuracy of Fujifilm SILVAMP TB lipoarabinomannan (FujiLAM) POCT for TB diagnosis in HIV-negative outpatients and compared it with Alere Determine TB LAM Ag (AlereLAM) POCT and a laboratory-based ultrasensitive electrochemiluminescence LAM research assay (EclLAM).METHODSIn this multicenter diagnostic test accuracy study, we recruited HIV-negative adults with symptoms suggestive of pulmonary TB presenting to outpatient health care centers in Peru and South Africa. Urine samples were tested using FujiLAM, AlereLAM, and EclLAM, and the diagnostic accuracy was assessed against a microbiological reference standard (MRS) and a composite reference standard.RESULTSThree hundred seventy-two HIV-negative participants were included and the prevalence of microbiologically confirmed TB was 30%. Compared with the MRS, the sensitivities of AlereLAM, FujiLAM, and EclLAM were 10.8% (95% confidence interval [CI] 6.3%-18.0%), 53.2% (95% CI 43.9%-62.1%), and 66.7% (95% CI 57.5%-74.7%), respectively. The specificities of AlereLAM, FujiLAM, and EclLAM were 9...Continue Reading

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Citations

Sep 29, 2020·The Journal of Clinical Investigation·Elisa H IgnatiusWilliam R Bishai
Jan 7, 2021·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Tobias Broger, Mark P Nicol
Mar 30, 2021·The Lancet. Microbe·Morten RuhwaldMadhukar Pai
May 1, 2021·Journal of Clinical Medicine·Patricia Comella-Del-BarrioJosé Domínguez
May 4, 2021·Frontiers in Microbiology·Julio FloresLeslie Chavez-Galan
Jul 3, 2021·Journal of Clinical Medicine·Patricia Comella-Del-BarrioJosé Domínguez
Apr 2, 2021·Journal of Clinical Microbiology·Amy OreskovicBarry R Lutz
May 14, 2021·Journal of Clinical Microbiology·Emily MacLean, Ruvandhi R Nathavitharana
May 26, 2021·Respiration; International Review of Thoracic Diseases·Coenraad F N KoegelenbergChristoph Lange

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Methods Mentioned

BETA
antigen assay
fluorescence microscopy
sandwich immunoassay

Software Mentioned

R package eulerr
AlereLAM
EclLAM

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