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

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%...

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Main Authors: Nabeta, Pamela (Author) , Seshadri, Pratibha (Author) , Havumaki, Joshua (Author) , Mbhele, Silindile (Author) , Hendricks, Layla (Author) , Perkins, Mark D. (Author) , Nicol, Mark P. (Author) , Denkinger, Claudia M. (Author)
Format: Article (Journal)
Language:English
Published: 19 February 2020
In: Diagnostic microbiology and infectious disease
Year: 2020, Volume: 97, Issue: 2, Pages: 1-6
ISSN:1879-0070
DOI:10.1016/j.diagmicrobio.2020.115026
Online Access:Verlag, lizenzpflichtig, Volltext: https://dx.doi.org/10.1016/j.diagmicrobio.2020.115026
Verlag, lizenzpflichtig, Volltext: http://www.sciencedirect.com/science/article/pii/S0732889319308181
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Author Notes:Pamela Nabeta, Pratibha Seshadri, Joshua Havumaki, Silindile Mbhele, Layla Hendricks, Mark D. Perkins, Mark P. Nicol, Claudia M. Denkinger
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Summary: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.
Item Description:Gesehen am 18.09.2020
Physical Description:Online Resource
ISSN:1879-0070
DOI:10.1016/j.diagmicrobio.2020.115026

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