EUA APPROVED AS OF 7/6/20
CLIA-WAIVED AS OF 9/23/20
*FIRST (AND ONLY) RAPID ANTIBODY TEST FOR COVID-19 TO GET CLIA WAIVED
The Assure COVID-19 IgG/IgM Rapid Test Device is a rapid lateral flow chromatographic
immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to
SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and
fingerstick whole blood. The Assure COVID-19 IgG/IgM Rapid Test Device is intended for use as an
aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or
prior infection. At this time, it is unknown for how long antibodies persist following infection and if the
presence of antibodies confers protective immunity. The Assure COVID-19 IgG/IgM Rapid Test Device
should not be used to diagnose acute SARS-CoV-2 infection.
Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to
perform moderate or high complexity tests.
This test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Results are for the detection of SARS-CoV-2 antibodies. The IgG and IgM antibodies to SARS-CoV-2
are generally detectable in blood several days after initial infection, although the duration of time
antibodies are present post-infection is not well characterized. Individuals may have detectable virus
present for several weeks following seroconversion.
Laboratories within the United States and its territories are required to report all positive results to the
appropriate public health authorities.
The sensitivity of Assure COVID-19 IgG/IgM Rapid Test Device early after infection is unknown.
Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct
testing for SARS-CoV-2 is necessary.
False positive results for Assure COVID-19 IgG/IgM Rapid Test Device may occur due to
cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive
results, confirmation of positive results should be considered using second, different IgG or IgM assay.
The Assure COVID-19 IgG/IgM Rapid Test Device is only for use under the Food and Drug
Administration’s Emergency Use Authorization.
The novel coronavirus belongs to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main
source of infection; asymptomatic infected people can also be an infectious source. Based on the current
epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main
manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia
and diarrhea are found in a few cases.