Compared to microscopy, the value of NAAT lies (i) in its greater positive predictive values with smear-positive specimens in settings in which non-tuberculous mycobacteria are common, and (ii) in the possibility to rapidly confirm

the presence of MTB in 50 – 80% of smear-negative TB cases [4, 5]. Thus, compared to culture, NAAT can detect the presence of MTB weeks earlier for 80 – 90% of patients suspected to have pulmonary TB. These advantages can significantly improve patient care and TB control efforts. There are currently several commercial NAAT methods available of which each uses a different Trametinib manufacturer method to amplify specific nucleic acid sequences of MTBC. These include, for example, the Roche COBAS Amplicor MTB test, the GenProbe Amplified M. tuberculosis Direct test (AMTD), the BD ProbeTec-ET or the Hain GenoType Mycobacteria Direct assay (GTMD). Available real-time polymerase chain reactions (PCR) systems are, for example, the Roche COBAS TaqMan MTB (CTM) test and the Cepheid Xpert MTB test. A series of evaluation studies [6–16] have analysed and compared the accuracy of commercial NAATs in both pulmonary and extrapulmonary TB. They show that most of the NAATs have high and consistent specificity and good positive predictive values but modest and variable sensitivity, particularly in smear-negative and extra-pulmonary TB. An important issue is the implementation Akt inhibitor of NAATs in developing countries

with high TB burden. However, prizes of commercial kits including required precision instruments are not affordable for most of the countries with high TB burden. Therefore, many of these countries use poorly validated in-house PCRs which show more variability in their accuracy [17]. There is a high demand for well validated, affordable commercial NAATs for use in low-resource countries. A novel commercial NAAT, which meets the demands for a low cost system, has been recently introduced. The hyplex® TBC test (BAG Health Care, Lich, Germany) is a qualitative system

for the detection of members of the MTBC and is based Thiamine-diphosphate kinase on multiplex PCR followed by reverse hybridisation to specific oligonucleotide probes and ELISA detection. In the present study we performed a clinical evaluation of the hyplex® TBC test using well-characterised TB and non-TB samples. PCR data were compared to the results of conventional microscopy and culture techniques. Finally, the potential impact of hyplex® TBC test on laboratory diagnostics of TB was assessed. Results In the present study, we performed a comprehensive clinical evaluation of the hyplex® TBC PCR in order to estimate and optimise its diagnostic potential. A total of 581 clinical specimens from our frozen archive were included comprising 292 TB samples and 289 non-TB samples (Table 1). Table 1 Classification of samples Clinical group Samples (n) TB POSITIVE 292 1. infection with M. tuberculosis, culture and smear positive 230 2. infection with M. tuberculosis, culture positive, smear negative 62 TB NEGATIVE 289 3.