Yonsei Med J.  2008 Aug;49(4):537-544. 10.3349/ymj.2008.49.4.537.

Comparison of In-house PCR with Conventional Techniques and Cobas Amplicor M. tuberculosis(TM) Kit for Detection of Mycobacterium tuberculosis

• Kim MH
• Yang HY
• Suh JT
• Lee HJ

• KMID: 1793188
• DOI: http://doi.org/10.3349/ymj.2008.49.4.537

Abstract

PURPOSE
Polymerase chain reaction (PCR) assay, introduced as a fast and sensitive diagnostic method, is useful in detecting Mycobacterium tuberculosis. The purpose of this study was to evaluate the usefulness of in-house PCR assay in the detection of Mycobacterium tuberculosis by comparing PCR results with conventional diagnostic techniques and Cobas Amplicor M. tuberculosis(TM) kit. MATERIALS and METHODS: We retrospectively assessed the diagnostic yield of in-house PCR method employed for the amplification IS6110 sequences in 2,973 specimens. We also compared in-house PCR with Cobas Amplicor M. tuberculosis(TM) kit in 120 specimens collected from June to July 2006. Routine acid-fast stain (AFS) and culture assay were also performed and analyzed. RESULTS: Of 2,973 cases, 2,832 cases (95.3%) showed consistent results between in house PCR, AFS and culture methods, whereas 141 (4.7%) displayed inconsistent results. The sensitivities, specificities, and positive and negative predictive values of each method were as follows: 77.5%, 99.7%, 95.5%, and 98.0%, respectively for PCR; 49.2%, 100%, 100%, and 95.7%, respectively, for AFS method; and 80.7%, 100%, 100%, and 98.3%, respectively, for culture assay. Consistent results between PCR and Cobas Amplicor M. tuberculosis(TM) kit were shown in 109 cases (90.8%). The sensitivities, specificities, and positive and negative predictive values of each method were as follows: 81.3%, 98.9%, 96.3%, and 93.5% respectively for PCR and 71.9%, 100%, 100%, and 90.7%, respectively, for Cobas Amplicor(TM) kit. CONCLUSION: In-house PCR and Cobas Amplicor(TM) kit show high sensitivity and specificity, and are reliable tests in the diagnosis of tuberculosis.

Keyword

Mycobacterium tuberculosis; in-house polymerase chain reaction assay; Cobas Amplicor M. tuberculosis(TM) kit

MeSH Terms

Humans
Mycobacterium tuberculosis/*genetics/*isolation & purification
Polymerase Chain Reaction/*methods
Sensitivity and Specificity

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