A Rapid Test For The Detection of COVID-19 (Coronavirus)
The COVID-19 lgG and lgM Rapid Serology Fingerstick Antibody Test Kit is used for the qualitative detection of SARS-CoV-2 antibodies in whole blood. Serology testing allows 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. It looks like a pregnancy test.
Why Serology Testing for COVID-19?
- Typically, lgM peaks at day 5
- lgG peaks at 14-21 days
- lgM appears first and then slowly drops off. As lgM disappears and lgG picks up, this indicates the patient is likely entering recovery and at some point no longer contagious.
- lgM and lgG are helpful bio-markers to make determinations of patient’s immune status, whether or not they are contagious, recovering, etc
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 an EUA.