For in vitro diagnostic use only
WHAT IS THE CORONAVIRUS ANTIBODY DETECTION TEST?
A finger-prick test that detects the presence of IgM and IgG antibodies to SARS-CoV-2 virus that causes the Coronavirus (COVID-19). It works like a home pregnancy test and delivers a result in 15 minutes. This test is different from the diagnostic tests that only confirms whether someone has an active infection. Note: This batch of tests expires on September 10th.
HOW IT WORKS
When the body is exposed to a virus, the immune system begins to produce antibodies to fight the virus and future infections from it. Those antibodies remain behind after the virus is cleared from the body, which the tests detect. This confirms a previous infection and possible immunity. These tests could be especially useful in cases with very mild or no symptoms.
Five institutions in China demonstrated 87.3% sensitivity and 100% specificity in a clinical trial of IgM and IgG rapid serology test for SARS-CoV-2 compared with traditional PCR tests.
- Sensitivity 87.3%
- Specificity 100%
- 5 Test cassettes
- 1 Buffer reagent solution bottle
- 5 Safety lancets
- 5 Capillary samplers
- 1 Package insert
- Open the package only when ready to use and place on a clean flat surface
- Wash your hands with soap and water
- Gently push down on the Pressure Activated Safety Lancet to prick your middle finger (only remove the cap when ready to use otherwise you could engage the needle after which it will permanently retract and is no longer usable)
- Apply gentle, steady pressure
- Use the pipette to drop the blood in both wells marked "S"
- Squeeze 2 drops of buffer solution in each well
- Wait 15 mins to read the results
- A line should appear in "C" which is the control and means the test is valid
- If either "T" line appears then it's positive for that antibody
ABOUT THE TEST DISTRIBUTOR
A leader in innovative diagnostics and early cancer detection products, BioResponse conducted a study to independently confirm performance of its rapid immunoassays. It involved over 50 patients being treated at five hospitals and medical practices in the United States.This study evaluated patients previously tested for SARS-CoV-2 by the standard molecular diagnostic tests. According to Michael S. Lebowitz, Ph.D., BioResponse's Chief Scientific Officer, the test results were found to be statistically consistent with the manufacturer's report. The test was evaluated using 188 clinical samples. It is manufactured in China and approved by the China FDA.
NOTE: This test is only for use by healthcare professionals and not for at-home testing.
U.S. REGULATORY STATUS
Notified FDA under the provisions outlined in Section D of Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (EUA pending).
- 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