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Rapid diagnosis of pulmonary tuberculosis by using Roche AMPLICOR Mycobacterium tuberculosis PCR test
R F D'Amato1, A A Wallman, L H Hochstein
1Department of Pathology, Catholic Medical Center of Brooklyn and Queens, Jamaica, New York 11432, USA.
Journal of Clinical Microbiology
|July 1, 1995
Summary
The Roche AMPLICOR Mycobacterium tuberculosis (MTB) test offers rapid PCR-based diagnosis for pulmonary tuberculosis. This test provides valuable, timely information for tuberculosis diagnosis and control, comparable to traditional culture methods.
Area of Science:
- Microbiology
- Infectious Diseases
- Molecular Diagnostics
Background:
- Pulmonary tuberculosis diagnosis traditionally relies on slow culture methods.
- Rapid diagnostic tools are crucial for effective tuberculosis management and control.
- The Roche AMPLICOR Mycobacterium tuberculosis (MTB) test is a PCR-based assay designed for rapid detection.
Purpose of the Study:
- To evaluate the performance of the Roche AMPLICOR MTB test for diagnosing pulmonary tuberculosis.
- To compare AMPLICOR MTB results with established culture methods and final clinical diagnoses.
- To assess the diagnostic accuracy and turnaround time of the AMPLICOR MTB test.
Main Methods:
- A total of 985 specimens from 372 patients were analyzed.
- Results from the AMPLICOR MTB test were compared against culture results.
- Final clinical diagnoses were used as a reference for evaluating test performance.
Main Results:
- The AMPLICOR MTB test demonstrated high specificity (99.6%) and negative predictive value (97.7%).
- Sensitivity was 66.7% and positive predictive value was 91.7% when compared to resolved cases.
- Test results were available within approximately 6.5 hours of specimen receipt, significantly faster than culture.
Conclusions:
- The AMPLICOR MTB test provides rapid and valuable diagnostic information for pulmonary tuberculosis.
- Its performance is comparable to traditional culture methods, with the advantage of speed.
- This rapid molecular test can aid in the timely diagnosis and control of tuberculosis.