NEW YORK – A lot of kits from LGC Biosearch Technologies has been validated at the US Centers for Disease Control and Prevention and is now authorized for emergency use in the detection of SARS-CoV-2, the virus that causes coronavirus disease COVID-19.
Specifically, primer and probe kits from LGC Biosearch's lot number 143503 are now authorized for use under the CDC's emergency use authorization for the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel.
The CDC coronavirus test received EUA on Feb. 4. In order to meet increased testing demand and to supply high-complexity CLIA labs creating lab-developed tests for emergency use, the FDA subsequently authorized certain CDC-validated kit lots from Integrated DNA Technologies.
LGC Biosearch said that it has manufactured a batch of 625 kits in the authorized lot, and they are now approved for sale and shipment to any public health or private laboratory running an EUA lab-developed test. Each kit contains enough probe and primer reagents for 1,000 reactions, equivalent to 1,000 tests, the firm said.
"Efforts are underway to build 1,000 kits per week going forward, equivalent to 1,000,000 tests," said Brian Kim, LGC Biosearch Technologies president and managing director. "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."
Petaluma, California-based LGC Biosearch Technologies is the oligo manufacturing division of UK-based LGC. The company also manufactures Black Hole Quencher dyes as well as other dyes and components for diagnostic kit developers that are also used in the CDC's EUA test protocol. It has previously provided detection solutions for other viruses, including seasonal influenza, H1N1, Chikungunya, Zika, and Ebola.