Performance evaluation of the PANA RealTyper™ CRE Kit for detecting carbapenemase genes in Gram-negative bacilli

Objectives The spread of carbapenemase-producing organisms has been continuously reported over the past decade. Rapid and accurate detection of carbapenemase production is essential for adequate infection control and appropriate antimicrobial treatment in the clinical setting. In this study, the performance of the newly developed PANA RealTyper™ CRE Kit (PANAGENE, Daejeon, South Korea) for the detection of six common carbapenemase genes (blaKPC, blaGES, blaIMP, blaNDM, blaVIM and blaOXA-48-like) was evaluated. Methods A total of 479 non-duplicate clinical isolates of Gram-negative bacilli, including 391 carbapenemase-producers and 88 non-producers, were tested. Conventional PCR and sequencing were performed as reference methods for performance evaluation of the PANA RealTyper™ CRE Kit. Results The PANA RealTyper™ CRE Kit showed a reliable performance for the detection of carbapenemase-producing organisms compared with the monoplex PCR system, with sensitivity and specificity values both >95%, with only a few discrepant results for six types of carbapenemase genes. Conclusion This kit is rapid and accurate for simultaneously detecting various carbapenemase genes in a single reaction and could contribute to early decisions for appropriate antimicrobial treatment in the clinical setting.