Evidence map›Paper›PMID 40598435›Full record

ArticleTropical medicine and health2025

Evaluation of the PATHFAST TB LAM Ag assay as a treatment monitoring tool for pulmonary tuberculosis in Nairobi, Kenya.

Fred Orina, Mayu Hikone, Nobuo Saito, Jane Ong'ang'o, Andrew Nyerere, Edinah Songoro, Helen Meme

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Article in Tropical medicine and health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

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4citing papers in PubMed
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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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4 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

7 authors.

Fred Orina *Center for Respiratory Disease Research, Kenya Medical Research Institute, Nairobi, Kenya.
Mayu Hikone *Kenya Research Station, Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan.
Nobuo SaitoKenya Research Station, Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan. nsaito@nagasaki-u.ac.jp.
Jane Ong'ang'oCenter for Respiratory Disease Research, Kenya Medical Research Institute, Nairobi, Kenya.
Andrew NyerereDepartment of Medical Microbiology, College of Health Sciences, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
Edinah SongoroDepartment of Medical Microbiology, College of Health Sciences, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
Helen MemeCenter for Respiratory Disease Research, Kenya Medical Research Institute, Nairobi, Kenya.

Funding

Japan Agency for Medical Research and Development 24jk0110031h0001
6 · The paper itself

Abstract

backgroundTreatment monitoring is important in pulmonary tuberculosis (PTB) management, since prolonged treatment necessitates regular assessments to prevent treatment failure and the emergence of drug-resistant strains. However, the lack of a simple, rapid, and reliable treatment monitoring tool (TMT) remains a major challenge. We evaluated the utility of measuring sputum lipoarabinomannan (LAM) concentration by the PATHFAST TB LAM Ag assay (PHC Corporation, Tokyo, Japan) as a TMT in patients with PTB in Nairobi, Kenya.

methodsWe retrospectively analyzed sputum LAM levels via the PATHFAST TB LAM Ag assay from a Nairobi cohort of patients with PTB and compared these results with conventional microbiological tests (acid-fast bacilli [AFB] smear microscopy; mycobacterial growth indicator tube [MGIT] culture). Stored sputum pellets processed with N-acetyl-L-cysteine (NALC)-NaOH were used for LAM measurement. Serial LAM concentrations measured every 2 weeks over an 8-week period were compared across bacterial load categories to assess correlations with AFB smear grades and culture results using the Kruskal-Wallis and Mann-Whitney U tests.

resultsThe 98 patients included here had a median age of 37 years (Interquartile Range: 27-44). The majority were men (74/98, 75.5%) and the MGIT culture was positive for 89 (90.8%) of them. Patients with elevated baseline LAM concentrations showed a significant reduction in LAM levels with treatment (90% median reduction by week 8), whereas those with low baseline LAM concentrations did not show a declining trend. Sputum LAM levels were significantly higher in culture-positive samples compared to culture-negative samples (23.8 pg/mL vs. 10.8 pg/mL, P < 0.001). Sputum LAM levels showed a significant correlation with AFB smear grades, with median concentrations increasing progressively from 11.3 pg/mL in smear-negative samples to 19.7 pg/mL in scanty/1 + samples, and 46.7 pg/mL in 2 + /3 + samples (P = 0.0001). LAM levels were significantly higher in culture-positive/AFB-positive sputum samples (viable bacilli) than in culture-negative/AFB-positive samples (non-viable bacilli) (P < 0.0001).

conclusionOur findings revealed that sputum LAM concentration declined during TB treatment, particularly among patients with high baseline levels, and correlated with AFB smear grades and culture results. Additionally, LAM concentrations differed between culture-positive and culture-negative samples among AFB smear-positive samples. Further prospective studies are needed to assess LAM levels as a TMT.

Indexed as

BiomarkerLipoarabinomannanPulmonary tuberculosisTreatment monitoring tool

Identifiers

PMID40598435
PMCPMC12210661

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.