Evaluation of an automatic polymerase chain reaction assay for identification of Mycobacterium tuberculosis in respiratory specimens
Journal
Journal of the Formosan Medical Association
Journal Volume
97
Journal Issue
3
Pages
204-209
Date Issued
1998
Author(s)
Abstract
We evaluated the performance of an automatic polymerase chain reaction (PCR) detection system for identification of Mycobacterium tuberculosis (MTB) test. The results were compared with those obtained from acid-fast microscopy, conventional culture, and clinical hospital. In cases of discrepancy between the results of the COBAS AMPLICOR MTB test and culture, the medical hospital of the patient was reviewed, the COBAS AMPLICOR MTB test was repeated, and the gene encoding M. tuberculosis superoxide dismutase was screened using PCR (SOD-PCR). Fourteen samples were excluded because the internal control test result was negative. Of 57 specimens that were culture positive for Mycobacterium species, 40 appeared to have growth of M. tuberculosis and 21 were smear positive for acid-test bacteria. The sensitivity, specificity, and positive and negative predictive values for the COBAS AMPLICOR MTB test evaluated at our laboratory were 85.0% (34/40), 99.3% (544/548), 89.5% (34/38), and 98.9% (544/550), respectively. Three specimens that were culture positive for M. tuberculosis but negative by COBAS AMPLICOR MTB test were positive when rechecked by both COBAS AMPLICOR MTB test and SOD-PCR. Among the four specimens with positive' reactions on both COBAS AMPLICOR MTB test and SOD-PCR that were culture negative, two were from patients who had been receiving antituberculosis treatment, one was from a patient who had been treated for tuberculosis for 1 year, and the other was from a patient who died of sepsis with adult respiratory distress syndrome. In more than 70% of smear-negative and culture-positive specimens and 86.4% of smear-positive specimens, M. tuberculosis was identified by the COBAS AMPLICOR MTB test within 10 hours after receipt of the specimens. Our data show that the COBAS AMPLICOR MTB test provides rapid and accurate detection of M. tuberculosis in respiratory specimens.
SDGs
Other Subjects
acid fast bacterium; article; bacterium culture; bacterium identification; controlled study; diagnostic accuracy; human; intermethod comparison; laboratory automation; laboratory diagnosis; major clinical study; microscopy; mycobacterium tuberculosis; polymerase chain reaction; sputum culture; sputum smear; tracheobronchial toilet; Adult; Bronchi; Humans; Mycobacterium tuberculosis; Polymerase Chain Reaction; Sensitivity and Specificity; Sputum
Type
journal article