Easy Check is a serologic test (commonly called an antibody test). Serology is the study of blood in relation to the body's immune response. Serology tests can detect the presence of antibodies made by our immune systems to fight infections, in this case antibodies (IgM and IgG) against the SARS-CoV-2 virus that causes COVID-19.
Health experts stress the critical role of antibody testing in the fight against COVID-19. The Easy Check antibody test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. These insights can help individuals understand their exposure history and help people and companies evaluate risk factors when making crucial decisions. With Easy Check's rapid results, it can be a powerful tool in monitoring exposure for essential healthcare workers, and serve as a complementary diagnostic. And from a population health perspective, scalable testing data can help inform researchers in their effort to reduce the level of social and economic restrictions globally.
The Easy Check COVID-19 IgM/IgG antibody test provides significant benefits over traditional lab-based diagnostic technologies.
The Easy Check COVID-19 IgM/IgG antibody test is a lateral flow immunochromatographic assay for detection of SARS-CoV-2 IgM/IgG antibodies in human blood specimens. This test differentiates IgM and IgG immunoglobins (antibodies) specific to SARS-CoV-2 in a single test, rapidly and affordably.
1Deposit 10 uL of blood sample into the handheld testing device.
2Add 1 drop of Assay Buffer.
3Read the test results at 10 minutes.
25 Test Devices
4mL Assay Buffer
25 Blood Transfer Pipettes
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.
Easy Check COVID-19 IgM/IgG is not for the detection or diagnosis of COVID-19. It is intended for use as an aid in identifying individuals who have antibodies to SARS-CoV-2, and are likely to have previously been exposed to COVID-19. It is important to note that, according to FDA findings, a positive antibody test does not rule out the possibility of a current infection. This test should not be used as the sole criteria for diagnosis of COVID-19.
The Easy Check COVID-19 IgM/IgG test has been rigorously evaluated in multiple studies by Truvian in collaboration with a number of well-respected institutions, and is designed to meet the variety of standards and requirements set forth by the FDA for EUA. Accuracy specifications are determined by testing confirmed COVID-19 positive and negative samples on the Easy Check COVID-19 IgM/IgG test.