What is ASSURANCE AB™?

The ASSURANCE AB™ COVID-19 IgM/IgG Rapid Antibody Test is a rapid test for the qualitative detection of IgM and IgG antibodies associated with the SARS-CoV-2 virus.

ASSURANCE AB™ is a single-use, self-contained test that provides results in 15 minutes, helping authorities, employers and healthcare workers make informed decisions to contain the spread of COVID-19.

ASSURANCE AB™ is intended for individuals who display signs and symptoms of COVID-19, individuals who were exposed to someone infected with COVID-19, or individuals who want qualitative information about whether or not they have IgM or IgG SARS-CoV-2 antibodies.

ASSURANCE AB™ is for use by laboratories and healthcare workers at the point-of-care.

What is antibody testing?

Antibody assays have the ability to detect past infections and indicate probable immunity. Antibodies are long-lasting and may be detected in the bloodstream several years after infection.

ASSURANCE AB™ detects the presence of antibodies IgM and IgG, developed in response to the SARS-CoV-2 virus.

  • IgM: develop EARLY after SARS-CoV-2 virus exposure
  • IgG: develop LATER after SARS-CoV-2 virus exposure; indicates long-term immunity

ASSURANCE AB™ Benefits

  • Results in 15 minutes
  • Highly accurate (92% sensitivity (CI95% 89.4-95.7%); 100% specificity (CI95% 96.8-100%))
  • NO laboratory equipment required
  • NO specialized training required, easy-to-use
  • Test kits can be stored and used at room temperature
  • Reduces risk of spreading the virus to healthcare workers administering tests or technicians processing tests
  • Provides actionable information to all patients to help determine if a COVID-19 viral PCR test is needed
  • Provides insightful information for when it is safe for individuals to go back to work and resume normal activities of daily life
  • Antibody testing is improved over nasopharyngeal swab testing by the fact that antibodies are more uniformly present in blood sampling

How does it work?

ASSURANCE AB™ is a lateral flow immunoassay used to qualitatively detect IgM and IgG antibodies of the SARS-CoV-2 virus in human serum, plasma or whole blood. The test uses monoclonal mouse anti-human IgM and a monoclonal mouse anti-human IgG conjugated to colloidal gold, each embedded into the sample pad. These respectively react with the IgM and/or IgG SARS-CoV-2 antibodies, if present in human serum, plasma or whole blood specimens, forming conjugate/SARS-CoV-2 antibody complex. The test control is goat anti-mouse IgG, also embedded into the sample pad.

As the mixture is allowed to migrate along the test strip, the conjugate/SARS-CoV-2 antibody complex is captured by recombinant SARS-CoV-2 antigen immobilized on a membrane forming a colored test line in each test region. There are three (3) test regions that include, 1) test control, 2) IgM test region, and 3) IgG test region. The test control line is a specific indicator that the test is functioning correctly and will appear on all test strips. The IgM test line and/or IgG test line will appear when there is the presence of antibodies in the blood sample. The cassette is dual targeted, with IgM and IgG detected in the same cassette but physically separated, testing each antibody independently.

ASSURANCE AB™ detects the presence of IgM and IgG antibodies to the SARS-CoV-2 virus.

  • IgM: antibodies developed EARLY after being exposed to the SARS-CoV-2 virus. This indicates an initial antibody response has developed
  • IgG: antibodies developed LATER after being exposed to the SARS-CoV-2 virus. This indicates longer-term immunity is developing and infection risk to others is decreasing.  Patients should consult a healthcare provider about appropriate adjustments to daily activities

ASSURANCE AB™ Test Adminstration

ASSURANCE AB™ requires a small sample of the patient’s blood, usually collected via fingerstick (or heelstick, for babies). Blood and diluent are dispensed onto the self-contained testing cassette. Once applied, results appear on testing device within 15 minutes.

Results indicate the presence of antibodies, developed in response to the SARS-CoV-2 virus associated with the COVID-19 pandemic. Testing cassettes are embedded with a control sample to ensure valid results.

Understanding ASSURANCE AB™ Results

What does a positive test result mean?

A positive test result indicates that the patient has been exposed to the SARS-CoV-2 virus and has developed antibodies associated with immunity. A patient with a positive test result may or may not be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions. Please refer to Instructions For Use.

 

What does a negative test result mean?

A negative test result indicates that the patient has not developed detectable antibodies associated with the SARS-CoV-2 virus and most likely does not have immunity to the virus. A person with a negative test result may or may not be contagious. Please refer to Instructions For Use.

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Frequently Asked Questions

How quickly do I get results?

Positive results will appear on the device within minutes. We recommend that negative results be confirmed 15 minutes after diluent is applied.

What equipment is needed to generate test results?

Assurance AB™ is a self-contained device. No laboratory equipment is required to attain results.

When will Assurance AB™ be available to healthcare providers?

Assurance AB™ is available for immediate distribution.

Has this been approved by the FDA?

ASSURANCE AB™, for use by laboratories and healthcare workers at the point-of-care, has not been approved by the FDA. The FDA does not intend to object to the development and distribution of serology tests by commercial manufacturers or laboratories that identify antibodies to SARS-CoV-2, where 1) the test has been validated, 2) notification has been provided to FDA, and 3) information along the lines of the following is included in the test reports:

  • This test has not been reviewed by the FDA.
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • 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 policy is limited to such testing in laboratories or by healthcare workers at the point-of-care.

What’s included in a test kit (for laboratories or by healthcare workers at the point-of-care)?

The test kit provided to laboratories and healthcare workers at the point-of-care includes:

  • ASSURANCE AB™ test cassette (50 units)
  • Lancet (50 units)
  • Pipette (50 units)
  • Diluent solution (two (2) 0.5 oz bottles)
  • Instructions For Use
  • Fact Sheet
  • Quick Reference Guide

What are antibodies?

Antibodies are blood proteins produced by healthy patients in response to and for counteracting specific foreign materials (antigens). Antibodies combine chemically with substances which the body recognizes as alien, such as bacteria, viruses, and foreign proteins in the blood. Each antibody attacks one particular antigen and helps to clear the foreign agent form the patient’s bloodstream.

Additional Information

Instructions for Use

Point of Care

Quick Reference Guide

Point of Care

COVID-19 Guidance

U.S. Food and Drug Administration

Fact Sheet

Point of Care

Manufacturing Overview

Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test

Manufacturing, Partner and Other Support Documents

FDA Confirmation of PRED EUA Application

March 23, 2020

Dablood Representative of Foreign Manufacturer Letter to FDA

March 25, 2020

Dablood Manufacturer FDA EUA Notification to FDA

March 25, 2020

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