Molecular diagnostic solutions provider BioGX has introduced a CE-IVD marked multi-gene Covid-19 point-of-care (POC) test.

The new three-gene multiplex Covid-19 test uses the company’s Xfree direct sample testing chemistry, which is also used in its Xfree COVID-19 Direct RT-PCR test.

The POC test has been designed to target the N1, RdRp and M gene regions to provide better redundancy in detecting emerging SARS-CoV-2 virus variants.

Used on BioGX’s pixl real-time PCR platform, the new Covid-19 POC test requires only one sample drop, which is directly added to the freeze-dried Xfree chemistry.

The portable pixl platform uses a four-optical channel direct imaging fluorescence, ultra-low-light bio-imager sensor and Peltier-powered thermal cycler to enable precise and reliable molecular diagnostic testing.

It is a 16-well real-time PCR platform that can run up to 80 pooled or 16 individual samples in 45 minutes.

Integration of results interpretation and reporting into the pixl touchscreen instrument increases its ease of use.

BioGX CEO Shazi Iqbal said: “Pixl, combined with our unique Xfree chemistry, offers our customers the ease-of-use and affordability of antigen-based testing with the superior sensitivity and specificity of real-time PCR testing.”

The company is now developing a set of Xfree-pixl tests to enable affordable POC PCR testing.

It noted that the new Xfree Covid-19 three-gene Direct Sample RT-PCR kits can be transported at room temperature across the world, which is the case for all BioGX tests.

BioGX’s Xfree COVID-19 RT-PCR test received emergency use authorisation from the US Food and Drug Administration (FDA) last year.