The Thermo Fisher TaqMan 2019-nCoV Assay Kit v1 and TaqMan 2019-nCoV Control Kit v1 Test and/or TaqPath COVID-19 Combo Kit - This assay is for in-vitro diagnostic use under FDA emergency use authorization (EUA). This test is only authorized for the duration of time the declaration should circumstances exist, justifying the EUA under the FDA emergency tests for detection of SARS-CoV-2 RNA virus and/ or diagnosis of COVID-19 infection under section 564(b)(1) of the act, 21U.S.C.360bbb-3(b)(1), unless the authorization is terminated or revoked. The genetic Sites being tested are OFR1, S Protein, and N Protein.

PLEASE NOTE: The Thermo Fisher TaqMan 2019-nCoV Assay Kit v1 and TaqMan 2019-nCoV Control Kit v1 Test and/or TaqPath COVID-19 Combo Kit is indicated as an aid in the diagnosis of specific agents of respiratory illness and results are meant to be used in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule out co-infection with organisms not included in the Thermo Fisher TaqMan 2019-nCoV Assay Kit v1 and TaqMan 2019-nCoV Control Kit v1 and/or TaqPath COVID-19 Combo Kit. The agent detected may not be the definite cause of this disease.

 
The Panther Fusion® SARS-CoV-2 Assay - This testing method is a real-time RT-PCR in vitro diagnostic test for the qualitative detection of RNA from SARS-CoV-2. SARS-CoV-2 Assay testing is intended for nasal and oropharyngeal (OP) swab specimens obtained for Individuals that meet the clinical and epidemiological criteria for COVID-19 testing. The Panther Fusion® SARS-CoV-2 Assay is for use only under the Emergency Use Authorization (EUA) in the US 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 identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal and oropharyngeal swab specimens during the acute phase of 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.

 
FDA Issued EUA to ThermoFisher
Hologic EUA Fact Sheet

Antibody Testing

SARS-CoV-2 testing (also known as COVID-19 testing) is available to providers who desire their self-pay patients who (a) do not have health insurance, or (b) are not eligible to receive health insurance benefits through state or federally funded health insurance programs, or (c) for providers and/or patients who intentionally choose not to submit a claim to their insurance company or desire to pay cash for the COVID-19 test. The price for the COVID-19 test is $256.65. This price does not include prices for other tests for respiratory pathogens (bacteria and viruses) that are frequently ordered in addition to COVID-19 testing as recommended by the CDC. Please click this link for the price of respiratory pathogens usually tested along with COVID-19. The price for antibody testing is $179 for the IgG antibody and $119 for the IgM antibody.