XPhyto Therapeutics and its diagnostics development partner 3a-diagnostics GmbH have received EU approval for their COVID-19 RT-PCR test system – Covid-ID Lab.
The companies have received a CE mark for the in vitro diagnostic (OVD) test for the detection of SARS-CoV-2, which causes COVID-19.
The Covid-ID Lab diagnostic can produce rapid results, with a single 20-minute PCR Cycle plus five-minute detection process.
In a statement, XPhyto said that many widely available standard PCR instruments can be used to run the test, with results collected after the PCR cycle via ‘easy-to-read’ optical indicator strips on a fluidics platform.
During XPhyto’s validation of the assay, the limit of detection for SARS-CoV-2 RNA was determined to be 104.73 c/PCR within a 95% confidence interval.
In addition, specificity of 100% against 19 other pathogens of serious respiratory infections was demonstrated on a respiratory verification panel.
"Our test is one of the fastest PCR-based COVID-19 tests currently approved. With a sample collection to result time of 25 minutes, Covid-ID Lab combines the speed of a rapid screening test with the accuracy of a PCR diagnostic," said Hugh Rogers, chief executive officer and director of XPhyto.
"Covid-ID Lab is designed for point-of-care testing, particularly in satellite and small-scale labs, such as transportation hubs, borders, care facilities, schools, pharmacies and hospitality settings," he added.