Evaluation of the Roche AMPLICOR™ MTB assay for the detection of Mycobacterium tuberculosis in sputum specimens from prison inmates

https://doi.org/10.1016/S0732-8893(97)00029-1Get rights and content

Abstract

The reliability of the Roche Mycobacterium tuberculosis polymerase chain reaction (PCR) assay (AMPLICOR™ MTB) for the diagnosis of pulmonary tuberculosis was evaluated by testing expectorated sputum specimens from 187 inmates in Texas state prisons and comparing the results to culture and medical history. Of the 80 specimens that were culture positive for mycobacteria, 36 specimens from 16 patients grew M. tuberculosis. Forty-six specimens were smear positive for acid-fast bacilli (AFB), and of these, M. tuberculosis was isolated from 24. On initial testing, 52 specimens were PCR positive. Thirty-one of these 52 were culture positive for M. tuberculosis, and 21 were culture negative, resulting in a PCR sensitivity and specificity of 86.1 and 96.1%, respectively. After resolving discrepancies by review of the medical history and repeat testing, PCR sensitivity, specificity, and positive and negative predictive values, respectively, were 92.8, 99.8, 98.1, and 99.2%. For AFB smear-positive specimens, the sensitivity, specificity, and positive and negative predictive values, were 95.8, 100, 100, and 93.3, respectively; whereas, for AFB smear-negative specimens, these values were 87.5, 99.7, 95.5, and 99.4%, respectively. These results confirm the reliability of the AMPLICOR™ MTB assay for direct detection of M. tuberculosis in AFB smear-positive sputum specimens and suggest a potential role in evaluating AFB smear-negative sputum specimens.

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    Citation Excerpt :

    Most studies comparing different commercial amplification kits for therapid identification of MTB report no significant differences in testperformance.92324252627282930 The overall sensitivity of the, AMPLICOR assay in this study was low (culture, 61%; clinical PTB,44%) but was within the range of 33 to 87% reported in the literaturefor smear-negative PTB.23273031323334 It is higher than thesensitivity of 37% reported by Al-Zahrani et al35 in aprospective study of 357 patients suspected of having smear-negativePTB using an in-house PCR.

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This study was supported in part by an educational grant from Roche Diagnostic Systems.

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