This test has been authorized by the FDA under an Emergency Use Authorization for use only by authorized laboratories in a manner consistent with the EUA, and only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; this test has not been FDA cleared or approved.
Please review the EUA and other import documentation by following the links in the “Product Details” section below.
Please direct any feedback regarding the performance of this test kit directly to BGI at firstname.lastname@example.org.
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 COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
50 reactions per kit. The BGI SARS-CoV-2 detection test is highly sensitive and can detect as low as 100 viral copies/mL for bronchoalveolar lavage fluid (BALF) sample.
Samples are collected from throat (oropharyngeal) swabs, nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates, or bronchoalveolar lavage fluid (BALF).
The FDA has also expanded the EUA label to include the use of specific automation system and viral RNA extraction kit. The integrated workflow addresses a severe sample preparation bottleneck for large-scale, community-based testing. Using one automation system, lab can complete 960 tests in one 8-hour shift per day. That would be 4800 tests per week for 5 working days per week.