The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.

Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds that cause respiratory, enteric, hepatic and neurological diseases. Four viruses – 229E, OC43, NL63, and HKU1 are prevalent and typically cause common cold symptoms in immunocompromised individuals. Three other strains SARS-CoV, MERS-CoV, and SARS-CoV-2 (COVID-19) are can be transmitted from between non-human vertebrates to humans.

Warning

• This test has been authorized by the FDA under a EUA for professional use. This test has not been FDA cleared or approved.
• 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 the 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.
• 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.
• This product is intended for professional use and not for home use.

Read: Clinical Trial Summary of COVID 19 IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma)

FACT SHEET FOR HEALTHCARE PROVIDERS

See the diagram below and detailed COVID rapid test instructions available here.

• This test has not been FDA cleared or approved. This test has been authorized by the FDA under a EUA for use by authorized laboratories. It is a point of care test for
  fingerstick whole blood specimens only. The user should be trained in the procedure. Wear appropriate protective attire for your safety when handling patient samples.
• 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 the 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.
• Read the complete Quick Reference Instructions before performing the test. For technical assistance, please call (800) 618-5829.
• There should be a blue line in the control region (next to “C”) before testing, discard the device if there is no blue line.
• Due to the risk of false-positive results, confirmation of positive results should be considered using second, different IgG or IgM assay.

​

WARNING: This Coronavirus COVID-19 rapid test not been reviewed by FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 (COVID-19) infection or to inform infection status.

This test is FDA approved for professional use during the SARS-CoV-2 pandemic according to FDA Emergency Use Authorization. The test is recommended for medical professionals use in medical offices and/or laboratories.

FDA authorizes this test for POC use using fingerstick blood samples. This authorization means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers, and emergency rooms rather than having to be sent to a central lab for testing.