COVID-19 Antibody Test For Healthcare Professional Use

View the manufacturer product insert here.

 

The COVID-19 FaStep Test Device is an in vitro immunoassay for the direct and qualitative identification of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma as an aid in the diagnosis of COVID-19. ​

The test is for professional use only in compliance with high-complexity CLIA requirements.​ Under Policy D of the FDA’s March 16, 2020 guidance this test has been submitted but has not yet been reviewed by the FDA.  Assure Tech has submitted for an Emergency Use Authorization with the FDA for the FaStep Antibody Test (EUA200487).

  

Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.  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.

Steps To Test

Understanding The Results

IgG POSITIVE: The colored line in the control region (C) changes from blue to red, and a colored line appears in the IgG test region. The result is positive for COVID-19 virus specific-IgG antibodies.

IgG and IgM POSITIVE: The colored line in the control region (C) changes from blue to red, and two colored lines should appear in IgG and IgM test regions. The color intensities of the lines do not have to match. The result is positive for IgM and IgG antibodies.

IgM POSITIVE: The colored line in the control region (C) changes from blue to red, and a colored line appears in the IgM test region. The result is positive for COVID-19 virus specific-IgM antibodies.

NEGATIVE: The colored line in the control region (C) changes from blue to red. No line appears in IgM or IgG test regions.

INVALID: Control line (C) is still completely or partially blue, and fails to completely change from blue to red. Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the procedure with a new test device. If the problem persists, discontinue using the test kit immediately and contact us at info@preventcare.com for a replacement test.

FDA Policy for COVID-19 Diagnostic Tests during the Public Health Emergency. Here is the policy.

 

Terms & Conditions


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