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Health Canada Approved COVID-19 Antigen & Antibody Rapid Test

Health Canada Approved
COVID-19 Antigen Rapid Test

The Health Canada Approved COVID-19 Antigen Rapid Test device is a lateral flow in-vitro immunoassay intended to be used for the qualitative detection of the SARS-CoV-2 viral nucleoprotein. This device will detect both viable and nonviable viral particles in nasopharyngeal secretions.

rapid covid-19 antigen test kit contents

Each Box Contains

20x Test cassettes, 20x individually packed swabs, 20x Extraction tubes, 20x extraction tubes, 20x nozzles, 1x tube stand and 1x package insert

Specification:

  • Sample Type: Nasopharyngeal swab
  • Detection Method: Colloidal Gold
  • Detection Time: 15 minutes
  • Relative Sensitivity: 97.7 % (93.3% ~ 99.2%)
  • Relative Specificity: 99.1 % (98.4% ~ 99.5%)
  • Overall Agreement: 99.0 % (98.2% ~ 99.4%)
  • Health Canada Approved and CE certified
  • No additional instrument required to read the results

Results and Interpretation

Want more detail on how to interpret the Health Canada Approved COVID-19 Antigen Rapid Test? See our article here!

possible results from the covid-19 antigen test

POSITIVE: Both the Antigen test line (T) and the control line (C) are colored in the COVID-19 Antigen Rapid Test Cassette.

NEGATIVE: One coloured line appears in the control region. No apparent coloured line appears in the Antigen test region.

INVALID: Control line fails to appear. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette.

NOTE:

The colour intensity in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only and cannot determine the concentration of analytes in the specimen.

Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

This test is intended for professional use only and should not be used as the sole basis for the diagnosis of an infection.

To find more information about serological testing from Health Canada, click here.

Limitations

  1. This test is recommended for Healthcare professional use only.
  2. The test procedure, precautions and interpretation of results for this test must be followed strictly when testing. Failure to follow the Test Procedure and Interpretations of Test Results may adversely affect test performance and/or invalidate the Test Result.
  3. The test should be used for the qualitative detection of SARS-CoV-2 antigen in human nasopharyngeal swab specimens. Neither the quantitative value nor the rate of SARS-CoV-2 antigen concentration can be determined by this qualitative test.
  4. A negative test result may occur if the level of antigen in a sample is below the detection limit of the test.
  5. Positive test results do not differentiate between SARS-CoV and SARS-CoV-2.
  6. Positive test results do not rule out co-infections with other pathogens.
  7. False-negative test results are more likely during peak activity when prevalence of disease is high.
  8. False-positive test results are more likely during periods of low SARS-CoV-2 activity when prevalence is moderate to low.

Health Canada Approved
COVID-19 IgM/IgG Antibody Rapid Test

The Health Canada Approved COVID-19 Antibody Rapid Test is a lateral flow in-vitro immunoassay intended to 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.

antibody COVID-19 rapid test kit contents

Each Box Contains

20x Test Devices, 20x Disposable Pipettes, 20x Alcohol Prep Pads, 20x Sterile Safety Lancets, 1x sample diluent and 1x instructions for use (IFU).

Specification:

  • IgG sensitivity: 90.0%, specificity: 100.0%. IgM sensitivity: 100.0%, specificity: 98.8%.
  • Overall positive agreement rate of 80.8%, negative agreement rate of 100.0%.
  • Sample Type: Fingertip blood, whole blood sample, serum and plasma
  • Detection Method: Colloidal Gold
  • Detection Time: 10 – 15 minutes
  • Suitable for Point of Care Testing, CLIA waived
  • FDA EUA approved; CE Certified, Health Canada approved

Results and Interpretation

Want more detail on how to interpret the Health Canada Approved COVID-19 IgM/IgG Antibody Rapid Test? See our article here!

shows the different valid results on a COVID-19 antibody test cassette

IgG and IgM POSITIVE (left): Both the test lines and the quality control line are colored in the COVID-19 IgM/IgG Antibody Test Cassette.

IgG POSITIVE (middle): Two lines appear on the COVID-19 IgM/IgG Antibody Test Cassette. One coloured line appears in the control line region, and another coloured line appears in the IgG test line region. The result is positive for SARS-CoV-2 specific-IgG antibodies.

IgM POSITIVE (right): Two lines appear on the COVID-19 IgM/IgG Antibody Test Cassette. One coloured line appears in the control line region, and another coloured line appears in the IgM test line region. The result is positive for SARS-CoV-2 specific-IgM antibodies.

graphic representation of a valid negative antibody test result on a rapid test cassette

NEGATIVE: One coloured line appears in the control region. No apparent coloured line appears in the IgG or IgM test region.

graphic representation of invalid results on antibody rapid test cassettes

INVALID: Control line fails to appear. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette.

To find more information about serological testing from Health Canada, click here.

Limitations

  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.

Frequently Asked Questions

Pursuant to Section 5 of the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, made by the Minister of Health on February 18, 2020, The FaStep Rapid COVID-19 IgG/IgM Rapid Test Device and Rapid COVID-19 Antigen Test (both distributed by Aurora) are now authorized for sale or importation in Canada.

No, these rapid tests do not need any additional instruments to read the results. These test kits are self-contained, containing all the tools you need from sample collection to result reading.

This test has been designed to act as a supplementary test for suspected cases of negative coronavirus nucleic acid detection or in conjunction with nucleic acid detection in the diagnosis of suspected cases. Results from nucleocapsid protein antigen testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 (COVID-19) infection or to inform infection status.

The test is for use by trained laboratory or healthcare professionals. This assay is not intended for at-home testing or self-testing. Laboratories are required to report all results to the appropriate public health authorities.

This test is not for the screening of donated blood.

We are currently accepting pre-orders for these kits

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