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.
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.
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.
Antibodies can be detected 5 to 7 days after symptoms first appear.
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.
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.
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.
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.
- 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.
- This test has been authorized by FDA under an EUA for use by authorized laboratories.
- 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 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.
- This product is intended for professional use and not for home use.
- Not for the screening of donated blood.
- Find more information about serological testing from Health Canada by clicking here.