Ultra-sensitive urinary lipoarabinomannan (LAM) immunoassay for tuberculosis detection: a performance evaluation.

ABSTRACT:

Background

The development of rapid non-sputum tests remains a global priority to accelerate Tuberculosis (TB) diagnosis and treatment initiation. The only WHO-recommended rapid diagnostic test (RDT), the Alere Determine TB Lipoarabinomannan Ag (AlereLAM) has suboptimal sensitivity. A laboratory-based electrochemiluminescence LAM assay (EclLAM) is the current sensitivity benchmark for RDT development and the gold standard for urinary LAM detection. We assessed the diagnostic accuracy of an ultra-sensitive, Plasmonic Fluor-linked Immunosorbent LAM assay (PFLISA-LAM) compared to Sputum Xpert MTB/RIF, sputum culture and urine EclLAM.

Methods

We developed and evaluated the assay performance of PFLISA-LAM. Two sub-studies were conducted using banked urine samples: 1. Preclinical

SUBMITTER: Jiang Q 

PROVIDER: S-EPMC12362013 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature