Omega Diagnostics has achieved the Certificate d'Europe (CE) certification on its Visitect Covid-19 antigen test for self use.
It provides an accurate rapid test for the detection of the nucleoprotein of the virus in nasal swabs only.
Independent, multi-centre validations, showed a sensitivity of 93.2%, based on 103 samples with cycle threshold values less than 25, and 97.8% specificity, based on 230 RT-qPCR negative samples.