COVID-19 Antigen Rapid Test Kit​

Health Canada POC 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

FastEP-Rapid-Antigen-Box-of-20

COVID-19 Antigen Rapid Test Kit​

Results in 15 Minutes

The Health Canada Approved COVID-19 Antigen Rapid Test is for the qualitative detection of SARS-COV-2 antigen. It detects nucleocapsid proteins inside the SARS-COV-2 virus.

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
  • Health Canada Licensed for Point of Care Testing and CE certified
  • No additional instrument required to read the results

For Professional Orders:

Nasopharyngeal / Nasal Swab

The 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 virus in both nasopharyngeal and Nasal secretions. 
Antigen Test Procedure

Results and Interpretation

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.

Detection Window

antibody antigen virus detection window graph

COVID-19 Antigen Rapid Test Results – How do I interpret them?

Results and Interpretation

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.

Detection Window

antibody antigen virus detection window graph
 
 

Clinical Data

PROUDLY CANADIAN