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

BACKGROUND: The spread of carbapenemase-producing organisms (CPOs) has been continuously reported over the past decade. The rapid and accurate detection of carbapenemase production is essential for adequate infection control and appropriate antimicrobial treatment in clinical fields. We evaluated the performance of the newly developed PANA RealTyper™ CRE Kit (PANAGENE, Daejeon, Korea) for the detection of six common carbapenemase genes (blaKPC , blaGES , blaIMP , blaNDM , blaVIM , and blaOXA-48-like ).

METHODS: A total of 479 nonduplicated clinical isolates of gram-negative bacilli, including 391 carbapenemase producers and 88 carbapenemase nonproducers, were tested in this study. For the performance evaluation of the PANA RealTyper™ CRE Kit, conventional PCR and sequencing were performed as reference methods.

RESULTS: The PANA RealTyper™ CRE Kit showed a reliable performance for the detection of CPOs compared to the monoplex PCR system, and the sensitivity and specificity were both >95%, with only a few discrepant results for six types of carbapenemases.

CONCLUSION: This kit is rapid and accurate for simultaneously detecting variable carbapenemase genes in a single reaction and could contribute to early decisions for appropriate antimicrobial treatment in clinical fields.