Clinical evaluation of the diagnostic performances and treatment monitoring of the new PATHFAST TB LAM Ag assay in sputum specimens of patients with tuberculosis or with nontuberculous mycobacteria pulmonary disease.

Clinical evaluation of the diagnostic performances and treatment monitoring of the new PATHFAST TB LAM Ag assay in sputum specimens of patients with tuberculosis or with nontuberculous mycobacteria pulmonary disease.

Publication date: Nov 26, 2025

Diagnosing pulmonary tuberculosis (TB) and monitoring treatment remain challenging. New tools such as the PATHFAST TB LAM assay (PHC Corporation, formerly LSI Medience Corporation, Tokyo, Japan; distributed by BioSynex, France; PF-LAM) may complement microscopy, culture, and NAAT. PF-LAM is an immunoassay quantifying lipoarabinomannan (LAM), a mycobacterial cell wall component, in sputum within 1 hour using an automated chemiluminescent reader. Diagnostic performance was first assessed on 100 sputum samples: 40 culture-positive for Mycobacterium tuberculosis complex (MTBC), 40 culture-positive for nontuberculous mycobacteria (NTM), and 20 culture-negative for both. We then tested 61 longitudinal sputum samples from 19 pulmonary TB patients under treatment. Four additional samples from one patient with NTM pulmonary disease (NTM-PD) were also tested. PF-LAM showed 75% sensitivity for MTBC detection, with a strong correlation between LAM concentration and culture time-to-positivity (Spearman ρ = 0. 915, P

Concepts Keywords
Accurate antigen
Mycobacteria diagnostic
Spearman LAM
Tokyo treatment
Tuberculosis tuberculosis

Semantics

Type Source Name
disease MESH LAM
disease MESH tuberculosis
pathway KEGG Tuberculosis
disease MESH pulmonary disease
disease MESH pulmonary tuberculosis
disease MESH relapse

Original Article

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