Evaluation of the diagnostic performance of a commercial molecular assay for the screening of suspected monkeypox cases in Sri Lanka

Abstract

BackgroundThe main objective of the present study was to compare the diagnostic performance of the commercial LightMix Modular Monkeypox Virus (MPXV) qPCR (TIB Molbiol, Germany) assay with the in-house nonvariola orthopox/monkeypox generic real-time PCR assay (ICMR-NIV, Pune) for the screening of (MPXV) cases at Medical Research Institute (MRI) in Sri Lanka. Furthermore, clinical and sociodemographic data of suspected /confirmed cases received at MRI for the MPXV screening were also analyzed. MethodsThe diagnostic performance of the commercial LightMix Modular MPXV qPCR assay with the in-house nonvariola orthopox/monkeypox generic real-time PCR assay for the screening of suspected MXPV cases was evaluated using standard methods with minor modifications. Socio-demographic and clinical profiles of suspected and confirmed MPXV cases were also analyzed. ResultsThe commercial LightMix Modular MPXV assay was able to detect MPXV with 100% sensitivity and specificity with non-variola orthopox/monkeypox generic rtPCR assay. During the period of study, from the total of 25 samples tested, only 2 were MPXV-positive (males). The most common symptoms of suspected MPXV cases were lesions or rashes (92%). ConclusionsWith the continually increasing number of cases, access to MPXV testing should be made more widely available. The commercial LightMix Modular MPXV (TIB Molbiol) qPCR assay offers comparable performance to the non-variola orthopox/monkeypox generic real time PCR assay for MPXV detection during the present outbreak.