TY - JOUR
T1 - First clinical assessment of a prototype assay to detect the enzymatic activity of β-lactamase as a marker for pulmonary tuberculosis
AU - Nabeta, Pamela
AU - Seshadri, Pratibha
AU - Havumaki, Joshua
AU - Mbhele, Silindile
AU - Hendricks, Layla
AU - Perkins, Mark D.
AU - Nicol, Mark P.
AU - Denkinger, Claudia M.
PY - 2020/6
Y1 - 2020/6
N2 - 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.
AB - 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.
KW - Diagnosis
KW - TB REaD™
KW - Tuberculosis
KW - β-Lactamase
UR - http://www.scopus.com/inward/record.url?scp=85081576121&partnerID=8YFLogxK
U2 - 10.1016/j.diagmicrobio.2020.115026
DO - 10.1016/j.diagmicrobio.2020.115026
M3 - Article
C2 - 32173144
VL - 97
JO - Diagnostic Microbiology and Infectious Disease
JF - Diagnostic Microbiology and Infectious Disease
SN - 0732-8893
IS - 2
M1 - 115026
ER -