Industry News: LGC COVID-19 detection kits authorized by CDC for emergency use

20 Mar 2020


The Centers for Disease Control and Prevention (CDC) has qualified and approved LGC, Biosearch Technologies’ probe and primer kit for use in COVID-19 diagnostics. LGC, Biosearch Technologies’s probes and primers are part of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. A batch of 625 kits has been manufactured and approved for sale and shipment to any public health or private laboratory operating within their own EUA.

Brian Kim, President and Managing Director, LGC, Biosearch Technologies, said, “LGC plays a important role in the US national response to COVID-19.  As this crisis started to unfold, we began coordinating plans with the CDC and FDA to ramp up production of detection reagents.  We have 625 CDC-qualified lots of SARS-CoV-2 kits available for sale immediately. Each kit contains enough probe and primer reagents for 1,000 reactions, equivalent to 1,000 tests. Efforts are underway to build 1,000 kits per week going forward, equivalent to 1,000,000 tests. We are doing everything we can to scale this capacity and output in order to deliver these critical reagents and help meet America’s testing demands.”

LGC, Biosearch Technologies detection reagents have been approved by the FDA and authorised under the CDC EUA for sale to high complexity CLIA labs. This means testing labs can purchase approved kits from CDC-qualified lot 143503 as of today from LGC, Biosearch Technologies. 

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