Detection of tuberculosis using artus® M. tuberculosis PCR Kit and COBAS® AMPLICOR™ Mycobacterium tuberculosis Test
Source: The International Journal of Tuberculosis and Lung Disease, Volume 15, Number 6, June 2011 , pp. 795-798(4)
Abstract:SETTING: Nucleic acid amplification tests can detect Mycobacterium tuberculosis complex rapidly and reliably.
OBJECTIVE: To compare the diagnostic performance of the artus® M. tuberculosis PCR Kit and COBAS® AMPLICOR™ Mycobacterium tuberculosis Test. In the artus assay, an appropriate cycle threshold (Ct) value was determined for positivity.
DESIGN: A total of 238 clinical respiratory specimens were analysed using both the artus and COBAS AMPLICOR assays. In 221 specimens, these results were further compared with culture results.
RESULTS: The overall agreement between artus and COBAS AMPLICOR was 96.2% (229/238). Among the nine (3.8%) discrepant specimens, three (1.3%) were artus-positive and COBAS AMPLICOR-negative, while the other six (2.5%) were artus-negative and COBAS AMPLICOR-positive. Using culture as a standard, the sensitivity and specificity of the artus assay were 97.8% and 85.1%, and those of COBAS AMPLICOR assay were 100% and 86.2%, respectively. The difference was not statistically significant. In the artus assay, the minimum Ct value for the positivity determination was 38.
CONCLUSION: The artus and COBAS AMPLICOR assays showed comparable diagnostic performance and can be confidently used for detection of M. tuberculosis complex. In the artus assay, a Ct value of 38 could be suggested as an appropriate cut-off value.
Document Type: Regular Paper
Affiliations: 1: Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea 2: Department of Laboratory Medicine, Hallym University College of Medicine, Seoul, Korea 3: Green Cross Reference Laboratory, Gyunggi, Korea
Publication date: June 2011
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