COVID-19 Test Cassette

Product Description

The Rapid Response COVID-19 IgG/IgM Test Cassette is a rapid, qualitative test for the detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG antibodies in human whole blood, serum, or plasma samples, as an aid in the diagnosis of COVID-19 disease. Interpretation of test results are positive (two lines or three lines) and negative (one line). Available for sale to healthcare professionals in United States and Europe (CE marked). Health Canada approval pending for diagnostic use.

Notes for Clinical use in the United States:

On March 16, 2020 the FDA updated its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. The updated policy can be viewed by clicking here.

This test is for professional in vitro diagnostic use only. Read the product insert prior to use. Directions should be read and followed carefully.

Laboratories and healthcare providers must include this information in their patient test report as specified in FDA guidance:

• This test has not been reviewed by the FDA.
• 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.
• Not for the screening of donated blood.

For more information, please contact covid19@btnx.com.

DISCLAIMER; Rapid Response COVID-19 IgG/IgM Test Cassette

• Positive test results (IgG/IgM antibodies present) do not guarantee immunity to reinfection.
• Positive test results (IgG/IgM antibodies present) do not guarantee a patient is no longer an active carrier of the disease.
• Antibody testing should be always be used in conjunction with laboratory testing methods to diagnose active infections.
• Tests must be administered and interpreted by healthcare professionals, subject to the governing regulatory body overseeing diagnostic testing in the region of use.