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FDA Fact Sheet - Patients

FDA Fact Sheet - Health Care Providers

 

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.

 

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.

 

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.

 

Features/Benefits:

Rapid results in 15 minutes

Fingerstick Wholeblood  specimen collection

Detects and differentiates IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood via a lateral flow assay

 

Test Summary

Test Name:

RAPID Covid-19 Antibody (IgG/IgM) Test

Alias:

Rapid Covid-19 Antibody Test; Covid-19 Antibody Test 

Classification:

Authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories.

Methodology:

Lateral Flow Chromatographic Immunoassay

Reference Range:

Negative

Result Interpretation: 

  • Positive (Detected) - results are indicative of the detection of IgM and/or IgG antibodies to SARS-CoV-2. This positive result means that an individual has developed an immune response to recent/prior SARS-CoV-2 infection within the limit of detection of the assay.
  • Negative (Not Detected) - results indicate that SARS-CoV-2 antibodies (IgG and/or IgM) was/were not detected in the specimen. However, a low level below the level of detection of SARS-CoV-2 Antibodies could be possible. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, molecular testing for SARS-CoV-2 is necessary.
  • The tests should not be used to diagnose acute SARS-CoV-2 infection.
  • The results of the semi-quantitative test should not be interpreted as an indication or degree of immunity or protection from reinfection.

 

 

Specimen (Preferred):

Fingerstick Wholeblood

Transport Temperature:

N/A

Storage Condition:

Refrigerated Temperature - up to 7 days

-20 degrees Celsius - DO NOT FREEZE WHOLE BLOOD

Turn Around Time:

Standard - 15 minutes

 

FDA Emergency Use Authorization

This test has been authorized by the FDA under an EUA for use by authorized laboratories certified under CLIA, that meet requirements to perform moderate or highcomplexity tests. The 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. 

 

Note: $50.00 fee applied to returned payments.

RAPID Covid-19 Antibody (IgG/IgM) Test

$75.00Price