ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022
Diagnostic Accuracy of the Cepheid 3-gene Host Response Fingerstick Blood Test in a Prospective, Multi-site Study: Interim Results.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 74 papers, 2 of them syntheses that pooled it.
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Who cites it
74 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Gene signature discovery and systematic validation across diverse clinical cohorts for TB prognosis and response to treatment.PLoS computational biology · 2023Pooled it
- Increasing reproducibility, robustness, and generalizability of biomarker selection from meta-analysis using Bayesian methodology.PLoS computational biology · 2022Pooled it
- Performance of 2 Finger-Stick Blood Tests to Triage Adults With Symptoms of Pulmonary Tuberculosis: A Prospective Multisite Diagnostic Accuracy Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Trial
- Evaluation of the Xpert MTB Host Response assay for the triage of patients with presumed pulmonary tuberculosis: a prospective diagnostic accuracy study in Viet Nam, India, the Philippines, Uganda, and South Africa.The Lancet. Global health · 2024Trial
- Treatment Strategy for Rifampin-Susceptible Tuberculosis.The New England journal of medicine · 2023Trial
- Antibody therapy reverses biological signatures of COVID-19 progression.Cell reports. Medicine · 2022Trial
- Blood transcriptomic signatures predict poor outcomes in drug-susceptible pulmonary tuberculosis in Brazil.American journal of respiratory and critical care medicine · 2026Article
- Closing gaps through innovation in the tuberculosis pathology value chain.Journal of clinical tuberculosis and other mycobacterial diseases · 2026Review
- Predicting trajectories of illness using RNA velocity of whole blood.Nature communications · 2026Observational
- The Utility of a Three-gene Host Response to Discriminate Tuberculous Meningitis From Other Infections in Children.The Pediatric infectious disease journal · 2026Article
- Accuracy and clinical utility of near-point-of-care blood tests for predicting incident tuberculosis in exposed contacts in high burden settings: a multi-country observational cohort study.Research square · 2026Article
- Machine-Learning-Derived, Mechanistically Informed Transcriptomic Signature to Diagnose Active Tuberculosis and Guide Host-Directed Therapy.Diagnostics (Basel, Switzerland) · 2026Article
- Diagnostic Accuracy of Tuberculosis Screening Tests in a Prospective Multinational Cohort: Chest Radiography With Computer-Aided Detection, Xpert Tuberculosis Host Response, and C-Reactive Protein.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- Blood-based cepheid 3-gene host response test for TB disease: diagnostic performance at a specialized respiratory hospital in China.BMC infectious diseases · 2026Article
- Rapid Molecular Diagnostics of Tuberculosis: What Do We Have, What Do We Need?Pulmonary medicine · 2026Review
- Evaluation of the performance of promising host transcriptional biosignatures in predicting TB progression during a 1-year prospective cohort study in Indian household contacts.Frontiers in tuberculosis · 2026Article
- Advancing leprosy risk prediction through identification of a whole blood host transcriptomic biomarker signature including non-coding genes.Scientific reports · 2025Article
- Identification of serum tRNA-derived small RNAs biosignature for diagnosis of tuberculosis.Emerging microbes & infections · 2025Article
- 3-Gene-TB-SCORE Accuracy for Tuberculosis Disease Diagnosis Is Not Affected by Immune-Mediated Inflammatory Disease Comorbidity.International journal of molecular sciences · 2025Article
- Deep immune profiling delineates hallmarks of disease heterogeneity in extrapulmonary tuberculosis.Nature communications · 2025Article
14 more citing papers are in PubMed but not listed here.
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21 authors.
Funding
Abstract
backgroundThe development of a fast and accurate, non-sputum-based point-of-care triage test for tuberculosis (TB) would have a major impact on combating the TB burden worldwide. A new fingerstick blood test has been developed by Cepheid (the Xpert MTB Host Response [MTB-HR] prototype), which generates a "TB score" based on messenger RNA (mRNA) expression of 3 genes. Here we describe the first prospective findings of the MTB-HR prototype.
methodsFingerstick blood from adults presenting with symptoms compatible with TB in South Africa, The Gambia, Uganda, and Vietnam was analyzed using the Cepheid GeneXpert MTB-HR prototype. Accuracy of the Xpert MTB-HR cartridge was determined in relation to GeneXpert Ultra results and a composite microbiological score (GeneXpert Ultra and liquid culture) with patients classified as having TB or other respiratory diseases (ORD).
resultsWhen data from all sites (n = 75 TB, 120 ORD) were analyzed, the TB score discriminated between TB and ORD with an area under the curve (AUC) of 0.94 (95% confidence interval [CI], .91-.97), sensitivity of 87% (95% CI, 77-93%) and specificity of 94% (88-97%). When sensitivity was set at 90% for a triage test, specificity was 86% (95% CI, 75-97%). These results were not influenced by human immunodeficiency virus (HIV) status or geographical location. When evaluated against a composite microbiological score (n = 80 TB, 111 ORD), the TB score was able to discriminate between TB and ORD with an AUC of 0.88 (95% CI, .83-.94), 80% sensitivity (95% CI, 76-85%) and 94% specificity (95% CI, 91-96%).
conclusionsOur interim data indicate the Cepheid MTB-HR cartridge reaches the minimal target product profile for a point of care triage test for TB using fingerstick blood, regardless of geographic area or HIV infection status.
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