Scientific Principles Behind Our Test

The COVID-19 IgG/IgM Rapid Test Device identifies anti-SARS-CoV-2 IgG/IgM antibodies through visual interpretation of color development.

 

Anti-human IgG and anti-human IgM are used to identify specific antibodies in the human whole blood, serum, or plasma specimen. When specimen is added to the sample well, specific IgM and/or IgG antibodies, if present, will bind to the SARS-CoV-2 antigens conjugated to colored particles on the conjugate pad. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by anti-human IgM and/or anti-human IgG antibodies immobilized on the test region(s). Excess colored particles are captured at the internal control region.

 

The presence of a red band(s) on the test region(s) indicates a positive result for the particular IgG and/or IgM antibodies, and its absence indicates a negative result. A red band at the control region (C) serves as a procedural control, indicating that membrane wicking is working.

Approvals & Validation Studies

On March 10, 2020, FaStep received the EC Declaration of Conformity. See the document here. ​

On July 6, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization for the FaStep Antibody test kit. See the Letter of Authorization here

Frequently Asked Questions

For additional guidance or specific questions on the topics above, please reach us directly at info@preventcare.com.

Address: 3725 Southeast Ocean Boulevard, Stuart, FL, USA

Phone Number: 844-954-2444

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

 

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