*For Medical Professional Use Only*
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirusi in human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings.
IgM antibodies will appear within blood as soon as 3-5 days for symptomatic patients and 7 days for asymptomatic patients.
IgG antibodies will appear in blood within 2 weeks after infection.
Over time blood concentrations of both IgM and IgG decrease, where IgM will become undetectable, but IgG will remain elevated.
This test has been authorized by FDA under an EUA for use by authorized laboratories.
This test has not been FDA cleared or approved.
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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.
This product is intended for professional use and not for home use.
Not for the screening of donated blood.
The virus is thought to spread mainly from person-to-person.
- Between people who are in close contact with one another (within about 6 feet).
- Via respiratory droplets produced when an infected person coughs or sneezes.
- These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.
If you develop emergency warning signs for COVID-19 get medical attention immediately. Emergency warning signs include*:
- Difficulty breathing or shortness of breath
- Persistent pain or pressure in the chest
- New confusion or inability to arouse
- Bluish lips or face
*This list is not all inclusive. Please consult your medical provider for any other symptoms that are severe or concerning.
Box of 25 Includes - 25 Test Cassettes, 25 Droppers, 1 Bottle of Buffer, Product Insert
*One bottle of buffer per box. (Each test requires 2 drops of buffer. A bottle of buffer contains 50 drops.)
*Lancets and Alcohol Prep Pads are not included