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Enzo Biochem has introduced Covid-19 test kits under the US FDA’s emergency use authorisation (EUA) authority.
The tests were introduced as part of the company’s comprehensive Covid-19 programme.
The Enzo Biochem Covid-19 test kits include a collection system, sample preparation, sample processing and detection products, as well as molecular analytic capabilities.
Additionally, the company said that the test uses in-house diagnostics technology to improve scale, throughput and sensitivity along with more relevant positive control materials.
RNAseP, Enzo’s control, confirms the presence of human mucosa cells in the specimen. This ensures accurate collections.
Enzo CEO Dr Elazar Rabbani said: “Enzo is uniquely positioned to address the Covid-19 pandemic from multiple angles. We have an open molecular diagnostic system with complete capabilities from sample collection to processing, detection and analytics.
“Our open system allows for adaptability with regards to reagents, supplies and instruments. This system can be used for the current Covid-19 crisis, and furthermore, it can be repurposed for any current or future infectious agent diagnosis.
“Our solutions are available as full system product sales or as individual components.”
Overall, the company’s comprehensive Covid- 19 Program includes its molecular diagnostic virus screening products, IgG / IgM serological ELISA products to determine immunity and ELISA platform to detect inflammation.
The programme also features a proprietary drug candidate (SK1-I).
With the test, Enzo Biochem seeks to address the current challenges faced by the healthcare industry, including supply shortages.
In the US, there are more than 869,000 confirmed cases of coronavirus. Globally, the number has reached 2.7 million.