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COVID-19 ECOTEST Antibody Rapid Test Device

Detect the presence of SARS-CoV-2 IgM and IgG antibodies instantly from a whole blood sample collected from a minimally-invasive fingerstick blood collection process.

verify diagnostics ecotest antibody covid-19

NOW AUTHORIZED
BY HEALTH CANADA

The Assure Tech Ecotest has been authorized for sale by Health Canada.
This test is intended for use by trained healthcare professionals and not for home use or self-testing.

CLIA Waived

Laboratories with a CLIA Certificate of Waiver now authorized:

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 point-of-care fingerstick whole blood specimens. For example; patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

DETECTION WINDOW

Antibodies can be detected 5 to 7 days after symptoms first appear.

COVID detection window antibodies ecotest
COVID detection window antibodies ecotest

TEST PROCEDURE

verify diagnostics covid-19 antibody ecotest how to use

Result Interpretation

NEGATIVE

The coloured line in the control line region (C) changes from blue to red. No line appears in the test line regions M or G.

The result is Negative.


IgM POSITIVE

The coloured line in the control line region (C) changes from blue to red, and a coloured line appears in test line region M.

The result is anti-COVID-19 IgM Positive.


IgG POSITIVE

The coloured line in the control line region (C) changes from blue to red, and a coloured line appears in test line region G.

The result is anti-COVID-19 IgG Positive.

IgG and IgM POSITIVE

The coloured line in the control line region (C) changes from blue to red, and two coloured lines appear in test line regions M and G.

The result is anti-COVID-19 IgM and IgG Positive.


INVALID

Control line is still completely or partially blue, and fails to completely change from blue to red. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new cassette. If the problem persists, discontinue using the kit immediately and contact your distributor.

Clinical Data

IgG IgM assay results

Notice

  1. The authorized use of this test in Canada is limited to trained healthcare professionals. This test shall not be used for self-testing or distributed or sold for home use.
  2. This test has been authorized by FDA under an EUA for use by authorized laboratories.
  3. This test has not been FDA cleared or approved.
  4. 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.
  5. 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.
  6. 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.
  7. This product is intended for professional use and not for home use.
  8. Not for the screening of donated blood.
  9. Find more information about serological testing from Health Canada by clicking here.