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

Background:The 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 non-variola 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.Methods:The 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.Results:The 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%).Conclusions:With 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.