First clinical assessment of a prototype assay to detect the enzymatic activity of β-lactamase as a marker for pulmonary tuberculosis

Autor: Silindile Mbhele, Claudia M. Denkinger, Mark P. Nicol, Joshua Havumaki, Pamela Nabeta, Layla Hendricks, Mark D. Perkins, Pratibha Seshadri
Rok vydání: 2019
Předmět:
0301 basic medicine
Microbiology (medical)
Adult
Male
medicine.medical_specialty
Tuberculosis
Point-of-Care Systems
030106 microbiology
Gastroenterology
Sensitivity and Specificity
Fluorescence
beta-Lactamases
Article
03 medical and health sciences
0302 clinical medicine
Pulmonary tuberculosis
Internal medicine
Diagnosis
medicine
Humans
030212 general & internal medicine
Prospective Studies
Prospective cohort study
Tuberculosis
Pulmonary
β-Lactamase
chemistry.chemical_classification
biology
business.industry
Sputum
General Medicine
Mycobacterium tuberculosis
Clinical Enzyme Tests
Middle Aged
medicine.disease
biology.organism_classification
TB REaD™
Confidence interval
Infectious Diseases
Enzyme
chemistry
Mycobacterium tuberculosis complex
Female
Reagent Kits
Diagnostic
business
Pulmonary tb
Biomarkers
Zdroj: Diagnostic Microbiology and Infectious Disease
ISSN: 1879-0070
Popis: The objective was to evaluate the sensitivity and specificity of a novel prototype test, TB REaD™, a reporter enzyme fluorescence–based assay, for pulmonary tuberculosis and to determine the optimal threshold for test positivity. This blinded, prospective study enrolled 250 patients, of which 23.2% were Mycobacterium tuberculosis complex (MTB) culture-positive. At the manufacturer-set threshold, sensitivity of the assay was 93.1% (95% confidence interval [CI] 83.3–98.1) and specificity was 8.9% (95% CI 5.2–13.8). The highest accuracy was seen at a higher threshold: sensitivity 58.6% (95% CI 44.9–71.4), specificity 59.4% (95% CI 52.1%–66.4%), with sensitivity by smear status being 40.0% (95% CI 21.1–61.3) for smear-negative and 72.7% (95% CI 54.5–86.7) for smear-positive. This study demonstrated limited accuracy of the TB REaD™ prototype for detection of pulmonary TB. Further improvements are necessary, potentially exploring probes that are more specific to MTB.
Databáze: OpenAIRE
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