For Emergency Use Authorization Only | For in vitro diagnostic use | Rx Only
On March 26, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for BGI’s Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 which the WHO has classified as a pandemic. The highly sensitive test can return results from bronchoalveolar lavage fluid (BALF) and throat swabs within three hours. Hospitals and reference laboratories can run the test on Applied Biosystems 7500 Real-Time PCR System. BGI’s novel coronavirus detection test now has global approvals through U.S. FDA, Europe’s CE-IVD, and China’s NMPA.
Simple RT-PCR manual workflow from viral RNA extraction to final results can be completed in 3 hours.
Product Catalog Number
1. Limit of Detection (LoD): 100 copies/mL (BALF); 150 copies/mL (Throat Swabs)
In silico analysis was performed and the assay was mapped to 284 complete SARS-CoV-2 genomes of human host in GenBank and GISAID databases as of March 10th, 2020. Primer and probes sequences for Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV had 100% homology to all SARS-CoV-2 isolates analyzed.
3. Analytical Specificity
Cross-reactivity of the Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV was evaluated using both in silico analysis and by wet testing pathogens. No cross-activity was found in the tested pathogens as shown in the table below.
Intended Use and Emergency Use Authorization Information
Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in throat swab and bronchoalveolar lavage fluid (BALF) samples from individuals suspected of COVID-19 by their healthcare provider. Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV is for use only under Emergency Use Authorization (EUA). Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
Results are for the detection of SARS-CoV-2 RNA that are detectable in throat swab and bronchoalveolar lavage fluid (BALF) samples during infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
Testing with the Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV is only for use under the Food and Drug Administration’s Emergency Use Authorization.
Products from BGI that are related to COVID-19 are regulated and only available to clinical and diagnostic laboratories. If you are a consumer looking for a COVID-19 test, please see your health care provider for medical advice. For additional COVID-19 information, visit the CDC or WHO sites.
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In the United States:
– 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 SARS-CoV-2, 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 the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.