The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test
Device utilizes lateral flow technology that is used for the qualitative,
differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In
general, antibodies can be detected 1-3 weeks after infection. This test is
intended to screen patients for COVID-19. Combining RNA and Antibody tests can
significantly raise the sensitivity for detecting COVID-19 in infected
individuals. Coronaviruses are enveloped RNA viruses that are distributed broadly
among humans, other mammals, and birds that cause respiratory, enteric, hepatic
and neurological diseases. Four viruses – 229E, OC43, NL63, and HKU1 are
prevalent and typically cause common cold symptoms in immunocompromised
individuals. Three other strains SARS-CoV, MERS-CoV, and SARS-CoV-2 (COVID-19)
are can be transmitted from between non-human vertebrates to humans.
Warning
· This product is intended for professional use and not for home use.
· This test is CLIA Waived - CLIA CERTIFICATE OF WAVER NUMBER REQUIRED FOR PURCHASE.
·
This test has been authorized by the FDA under
a EUA for professional use. 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 the 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.
FACT SHEET FOR HEALTHCARE PROVIDERS
·
This test has not been FDA cleared or approved.
This test has been authorized by the FDA under a EUA for use by authorized
laboratories. It is a point of care test for fingerstick whole blood specimens
only. The user should be trained in the procedure. Wear appropriate protective
attire for your safety when handling patient samples.
·
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 the detection and/or diagnosis of COVID-19 under
Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §
360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
·
Read the complete Quick Reference Instructions
before performing the test. For technical assistance, please call (800)
618-5829.
·
There should be a blue line in the control
region (next to “C”) before testing, discard the device if there is no blue
line.
·
Due to the risk of false-positive results,
confirmation of positive results should be considered using second, different
IgG or IgM assay.
Manufacturer:
Assure Tech. Co., Ltd.
Manufacturer Number:
AZ COVIC-19P
Package Description:
20/ Box