An evaluation study of a commercial PCR-based test applied in routine diagnostics of tuberculosis (TB) was performed. 511 different sputum samples and 220 bronchoalveolar washings we examined in a parallel manner using Amplicor(tm) MTB test, smear microscopy (SMI) and culture. Additionally, 21 other specimens were examined. Samples with discrepant results underwent further analysis including hybridization with DNA-probes and clinical examination of patients. Compared vs. confirmed TB infection, Amplicor provided considerably higher sensitivity (98.85%) then SMI and culture (63.38%). Also specificity of Amplicor (98.92%), PPV (96.64%) and NPV (99.63%) were high.

Keywords: Mycobacterium tuberculosis, Polymerase Chain Reaction, amplicor