Serum biosignature strip identifies subclinical and active tuberculosis with high accuracy
Investigators developed and validated a four-plex serum biosignature and a corresponding colloidal gold strip test to identify subclinical and active tuberculosis in a cohort of 280 participants. Using logistic regression on serum PDGFC, CXCL9, CXCL11, and CCL1 levels, the model achieved 97.5% sensitivity in an external validation set, while the visual strip test met a ≥2 positive lines threshold to deliver 96.0% sensitivity, 95.0% specificity, and 95.5% accuracy. The assay outperformed standard smear microscopy, TB DNA testing, and IGRA, particularly in detecting smear-negative subclinical disease. This instrument-minimal, sputum-free platform offers a practical solution for decentralized tuberculosis screening in resource-limited settings.
The original study
A novel serum four-biomarker biosignature and field-deployable colloidal gold strip for accurate identification of subclinical and active tuberculosis.
- Authors
- Feng J, Duan H
- Journal
- Expert review of molecular diagnostics
- Type
- Journal Article
- PMID
- 42852489
Original abstract
BACKGROUND: Current TB diagnostics fail to detect subclinical and paucibacillary cases, hindering End TB Strategy goals. We validated a novel serum four-biomarker biosignature and developed a colloidal gold strip for accurate subclinical and active TB identification. METHODS: 280 participants (HC, PN, STB, ATB; n = 70 each) were enrolled. Serum PDGFC, CXCL9, CXCL11, and CCL1 were measured by ELISA in training (n = 200) and external validation (n = 80) cohorts. Six machine learning algorithms built diagnostic models. A four-plex colloidal gold strip with simplified visual criteria was developed and compared against smear, TB DNA, and IGRA. RESULTS: All biomarkers were significantly elevated in STB/ATB versus HC/PN (p < 0.001), confirming Mtb-specific responses. Logistic regression achieved 97.5% validation sensitivity. The strip using a '≥2 positive lines' criterion yielded 96.0% sensitivity, 95.0% specificity, 95.5% accuracy, and outperformed conventional tests, effectively identifying smear-negative subclinical TB. CONCLUSIONS: This biosignature is a robust TB diagnostic tool. The companion strip offers a rapid, sputum-free, instrument-minimal solution for decentralized screening, bridging biomarker discovery and field application in resource-limited settings.