All of 911OccMed’s antigen test offerings utilize tests that have received emergency use authorization from the FDA.

See individual fact sheets and test information above for specifics. 

The Assure COVID-19 IgG/IgM Rapid Test Device, a test for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 (often referred to as COVID-19 or the novel coronavirus) in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood.

The Assure COVID-19 IgG/IgM Rapid Test Device is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.

September 23, 2020 and the FDA guidance, “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency” issued on March 16, 2020 (updated May 11, 2020). The

• FDA issued this guidance to help accelerate the availability of novel coronavirus (COVID-19) tests developed by laboratories and commercial manufacturers during the public health emergency. This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by laboratories certified under CLIA, that meet requirements to perform waived, moderate or high complexity test.
• This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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.
• Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. The sensitivity of the EcoTest COVID-19 IgG/IgM Rapid Test Device early after infection is unknown. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
• Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

Covid Clinic is offering the Quidel Corporation Sofia 2 FLU + SARS Antigen FIA Test. This test has received an emergency use authorization from the FDA.

The specimen is collected by a nasal swab. The cotton swab does not need to be inserted far into the nose and is rotated in a circle around the entire inside edge of each nostril at least three times. Results are generally available within 60 minutes although result time may vary from location to location.

The Rapid RT-PCR COVID-19 Test is a molecular, in vitro diagnostic test utilizing end point reverse transcriptase polymerase chain reaction (RT-PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA. The four steps utilized to perform the test are lysis of the virus, reverse transcription of viral RNA to cDNA, nucleic acid amplification, and detection.

The Rapid RT-PCR COVID-19 Test has been released under FDA Emergency Use Authorization (EUA) for the detection of nucleic acid from SARS-CoV-2 (the virus responsible for COVID-19 infection), and can be used in applications that require molecular/ RT-PCR testing. Please consult your state health department for additional information regarding specific uses (such as pre and post travel requirements). Many travel restrictions require a RT-PRC, molecular, or NAAT test be conducted prior to arrival at the destination. The Rapid RT-PCR COVID-19 test satisfies most travel requirements; however, it is the purchaser’s responsibility to verify the test will be accepted for travel prior to purchase.