Sign up here for GlobalData's free bi-weekly Covid-19 report on the latest information your industry needs to know.
Biotecon Diagnostics has launched microproof SARS-CoV-2 Screening / Identification kits to assist the diagnosis of Covid-19 through the in vitro qualitative detection of the virus.
The screening kit detects the E gene (E) for Betacoronavirus, while the identification kit targets the SARS-CoV-2 specific RNA-dependent RNA polymerase (RdRp) gene.
While the E gene assay is advised for screening for SARS-CoV-2, SARS-CoV and other SARS-related CoVs, the RdRp gene assay is used for the specific confirmation of SARS-CoV-2.
Conducting large-scale testing has proven effective in stemming the spread of the coronavirus in many of the hardest-hit countries, the company noted.
Biotecon Diagnostics CEO Dr Kornelia Berghof-Jäger said: “I am extremely proud of our team of scientific researchers and experts, who in a short space of time have managed to develop, manufacture and market such high-quality real-time PCR tests for the qualitative detection of SARS-CoV-2.
“It is the latest addition to a whole coronavirus product portfolio we have aimed at expanding the availability of diagnostic testing and supporting the massively impacted healthcare systems.
“In addition to our own kits and analytical instruments, we have entered into agreements with several partners worldwide to be able to meet the growing demand for viral RNA extraction and identification of the coronavirus.”
The company developed the assays for Covid-19 diagnosis based on the World Health Organization (WHO) reference methods and adapted it according to the Charité protocol for the detection of SARS-CoV-2.
Biotecon’s microproof SARS-CoV-2 Screening / Identification kits are available immediately for purchase and are approved ‘for research use only’.
They are yet to receive CE-IVD in the EU and emergency use authorisation (EUA) from the Food and Drug Administration (FDA) in the US.