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

Pamela Nabeta, Pratibha Seshadri, Joshua Havumaki, Silindile Mbhele, Layla Hendricks, Mark D. Perkins, Mark P. Nicol, Claudia M. Denkinger

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Article number115026
JournalDiagnostic Microbiology and Infectious Disease
DOIs
Publication statusE-pub ahead of print - 19 Feb 2020

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