COVID-19 Testing Kits

Overview of the 2019-Novel Coronavirus testing program at the Genetics & IVF Institute’s Molecular Infectious Disease Laboratory. 

In response to the widespread distribution of 2019-Novel Coronavirus in the United States and worldwide, the Molecular Infectious Disease Laboratory (MIDL) of Genetics & IVF Institute (GIVF) has internally validated the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. 2019-nCoV is the virus that can cause a variety of disease states known collectively as COVID-19 disease in infected individuals and thus the term COVID-19 is used interchangeably with 2019-nCoV, the causative virus.

The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel is a molecular diagnostic test that aids in the detection of 2019-nCoV and diagnosis of COVID-19 in individuals and is based on state-of-the-art nucleic acid amplification and fluorescence detection technology. This RT-PCR assay is intended for the qualitative detection of 2019-nCoV RNA in upper respiratory (nasopharyngeal or oropharyngeal swabs) and lower respiratory specimens (bronchoalveolar lavage, sputum, etc.) collected from individuals who are suspected to have 2019-nCoV infection or exhibit COVID-19 symptoms. Positive results are indicative of active infection with 2019-nCoV but do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude 2019-nCoV infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The guidelines for testing are dictated by clinical and/or epidemiological criteria* and in accordance with local or state health department updates. In order to aid the public health sector when communities return to full employment, testing criteria should be extended to all essential employees in both public and private facilities in order to identify infected from uninfected individuals to eliminate viral transmission in the workplace and for those personnel interfacing with the public.

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Disclaimer: The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel has not been approved by the FDA and is only for use under the Food and Drug Administration’s Emergency Use Authorization. Testing in the United States is limited to laboratories such as ours certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests. Pursuant to the requirements of CLIA '88, this laboratory has established the test's accuracy and precision. This PCR test is performed pursuant to a licensing agreement with Roche Molecular Systems, Inc.

* The original testing criteria is based on clinical and epidemiological signs and symptoms associated with 2019-nCoV infection, contact with a probable or confirmed 2019-nCoV case, history of travel to geographic locations where 2019-nCoV cases were detected, or other epidemiologic links for which 2019-nCoV testing may be indicated as part of a public health investigation.