Anti Body Testing
A Rapid Test For The Detection of COVID-19 (Coronavirus)
The COVID-19 IgG and IgM Rapid Serology Fingerstick Antibody Test Kit are used for the qualitative detection of SARS-CoV-2 antibodies in whole blood, serum, or plasma. Serology testing allows the determination of active infection and whether someone has built up an immunity to the virus based on past exposure. The fingerstick is easy to administer and offers reliable results at 10 minutes that remain valid for 15 minutes.
What is the process
- Prick patient’s finger
- Wick blood into capillary
- Drop blood onto cassette
- Add buffer
- Results in 10 minutes
Serology testing helps the healthcare provider to determine if the patient has the virus (IgM) and also if the patient is immune (IgG). Serology testing provides accurate results in 10 minutes (sensitivity and specificity >95%).
The manufacturers are compliant with the FDA requirement that if a company is selling a serological test and a) it is validated, b) FDA is notified and c) its labeling is qualified, i.e. it is not represented as being the sole basis for diagnosing the Coronavirus or to inform of infection status, then it can be sold without an Emergency Use Authorization (EUA). The manufactures have registered with the FDA for a EAU.
A negative antibody test result does 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 HKU1m NL63, OC43, or 229E