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.
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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.