Questions About Covid-19 Rapid Test Kits (FAQs)

Two types of testing are being conducted in USA 

The 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.

Benefits of Rapid Response  IgM/IgG Antibody Testing

●      Get test results in 10-15 minutes – no lab required

●      No need to send biological samples to laboratory and wait days for results unless they test positive and are at high risk (seniors, underlying health conditions, etc.)

●      Can be conducted by health care workers at point-of-test

●      No FDA approval of test required if conducted by trained health care professional at point-of-test and FDA disclosure statements are provided

●      Save 95% of costs of PCR test – only conduct PCR if test is positive

●      Can be used to test at drive thru testing sites, doctor’s offices, senior care facilities, homeless shelters and other locations by trained professionals

●      Antibody testing is needed to determine population who have contracted Coronavirus since virus first detected in December 2019.

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