Enabling rapid response to COVID-19 worldwide
On January 30, 2020, WHO declared that the COVID-19 outbreak constitutes a public health emergency of international concern (PHEIC). With the number of deaths due to COVID-19 surpassing the total number of deaths from the 2003 SARS outbreak, a great deal of work remains to be done.
Learn more about LGC, Biosearch Technologies’s ability to support the global response to Coronavirus in addition to other industry news and events.
Find updates on the scale of the global epidemic
The Centers for Disease Control and Prevention (CDC) in the United States is keeping an updated map of countries with confirmed COVID-19 cases — see it here
The 2019-nCoV CDC-qualified Probe and Primer Kit for SARS-CoV-2 is intended to be used in conjunction with methods and reagents defined in the Instructions for Use outlined in the re-authorized EUA, CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel.
Please review the below items listed in Section FF of the EUA
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the detection of nucleic acid from 2019-nCoV, not for any other viruses or pathogens, and;
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of SARS-CoV-2 under Section 564(b)(1) of the Act, 21 U.S.C. ยง 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
The customer shall be solely responsible for making sure that the way any products supplied are used are in compliance with all applicable laws and regulations, and to obtain any necessary regulatory approvals and/or intellectual property rights that may be required for the customer's intended use.