Evaluation of two tuberculosis PCR assays for routine use in a clinical setting of low population and low tuberculosis prevalence

Today, there are numerous different molecular diagnostic assays for the detection of tuberculosis (TB), allowing the optimization of rapid detection of TB according to the clinical need. In this study, two high-throughput TB PCR assays with combined antimicrobial resistance detection, Anyplex (TM) II MTB/MDR (Seegene) and RealTime MTB + RealTime MTB RIF/INH Resistance (Abbott Molecular), were evaluated for routine use in a clinical setting of low population and low TB prevalence in Finland. The RealTime MTB assay was 100% concordant (22/22 positive, n = 169) with the reference methods (culture and Xpert MTB/RIF PCR assay, Cepheid). However, with a limitation of four separate PCR cycles per kit, the routine use in a low TB-prevalence setting would easily lead to wasting most of the RIF/INH Resistance reagents. The Anyplex (TM) II MTB/MDR assay usability was more adaptive to suit the clinical setting but the assay sensitivity was considerably lower (86%, 19/22 positive, n = 76) being closer to the sensitivity of smear microscopy. The findings of this study suggest that the evaluated high-throughput MTB/MDR assays are evidently suboptimal for routine use in a low population, low TB-prevalence setting. In addition, neither of the two assays covers non-tuberculous mycobacteria and could therefore not fully replace acid-fast staining as the initial screening method.Peer reviewe