ABSTRACT This study compared the analytical performance of three commercial real-time PCR assays for the detection of monkeypox virus (MPV) DNA, on their own platforms and/or on open platforms, were evaluated at the virology laboratory of Grenoble-Alpes University Hospital (CHUGA): the VIASURE monkeypox virus real-time PCR Reagents on the BD MAX System; the MPXV AMP Kit on the Alinity m system; and the Altona RealStar Zoonotic Orthopoxvirus PCR Kit 1.0 on the Argene System (EMAG, ESTREAM Biomérieux, and LC480 Roche). Results obtained on these platforms were compared to those from the French National Reference Center (NRC) for orthopoxviruses. A total of 52 samples were selected by the NRC and the CHUGA: 8 dilutions of MPV culture supernatant, 2 supernatants from cowpox and vaccinia virus cultures, 32 clinical samples (20 positive/12 negative), and 10 external quality control samples from the “Quality Control for Molecular Diagnostics” (QCMD) program. The sensitivity and specificity of the three assays, compared to the NRC assay, were 100% on the samples tested. All positive samples were correctly identified as positive with all three assays, and all negative samples were negative for MPV detection. Overall, the cycle threshold (Ct) values obtained with the VIASURE, Abbott, and Altona assays were lower than those obtained with the NRC PCR in 84.38%, 81.25%, and 75.86% of positive samples, respectively. In conclusion, all three assays demonstrated good analytical performance and were suitable for MPV detection. IMPORTANCE Mpox is an emerging zoonotic disease caused by the monkeypox virus, mostly reported in Africa. In 2022, an outbreak characterized mainly by anogenital rash in MSM (men having sex with men) occurred in Europe. In 2024, many cases of infection were reported, presenting with generalized skin rashes. Detection of monkeypox virus DNA in biological samples is crucial for diagnosis, interruption of transmission chains, treatment initiation, and vaccination. During the European outbreak in 2022, numerous companies rapidly developed qPCR kits. In France, the performance of these kits has been evaluated by the French National Reference Center (NRC) for orthopoxviruses. The Grenoble-Alpes University Hospital collaborated with the NRC to evaluate three available assays on its own platforms and/or on open platforms available in its virology laboratory. All three assays demonstrated good analytical performance and can be used with confidence.
Usal et al. (Thu,) studied this question.