COVID-19 Antigen Rapid Test Kits

PRODUCT INFORMATION


    Our COVID-19 rapid tests are for screening purposes only, we are not a clinic and we do NOT issue COVID-19 Travel Certificates.

    Artron
    COVID-19 Antigen Rapid Test

    artron-rapid-antigen-test

    Each Kit Contains:

    • 25 Test cassettes with desiccant in individual pouch
    • 25 Extraction tubes sealed with sample extraction buffer (300µL/tube)
    • 25 Extraction tube caps
    • 25 Nasal swabs
    • 1 Tube rack
    • 1 Instruction for use

    Specification:

    • Sample Type: Nasal swab
    • Detection Method: Colloidal Gold
    • Detection Time: 20 minutes
    • Relative Sensitivity: 91.3 %
    • Relative Specificity: 99.56 %
    • Interim order # 327866
    • All necessary reagents provided & no equipment needed

    CovClear (2/25/50-Pack)
    COVID-19 Rapid Antigen Test

    covclear-rapid-antigen-test

    Each Kit Contains:

    • 2/25/50 Lateral flow assay strips
    • 2/25/50 Chase buffer ampules
    • 2/25/50 Vials
    • 2/25/50 Locking caps
    • 2/25/50 Individually wrapped swabs
    • 2/25/50 Instructions for use
    • 2/25/50 Quick reference guides

    Specification:

    • Sample Type: Nasal swab
    • Detection Time: 20 minutes
    • Sensitivity/PPA: 95.5 %
    • Specificity/NPA: 100 %
    • Manufactured in the United States
    • Interim order #330172
    • Materials required but not provided: a pair of gloves and timer

    Standard Q
    COVID-19 Antigen Rapid Test 

    standard-q-rapid-antigen-test

    Each Kit Contains:

    • 25 Test devices
    • 25 Extraction buffer tubes
    • 25 Nozzle caps
    • 25 Sterile swabs
    • 1 STANDARD COVID-19 Ag Positive Control swab
    • 1 STANDARD Respiratory Negative Control Swab
    • 2 Buffer tube racks
    • 1 Instructions for use

    Specification:

    • Sample Type: Nasal swab
    • Detection Method: Colloidal Gold
    • Detection Time: 15-30 minutes
    • Relative Sensitivity: 97.12% for nasal swab
    • Relative Specificity: 100 % for nasal swab
    • Interim order: #328889
    • All necessary reagents provided & no equipment needed

    Boson
    COVID-19 Rapid Antigen Test

    boson-antigen-test-kit

    *Application: lab-based only

    Each Kit Contains:

    • 20 Individually packed test cards
    • 2 sample buffers (4mL/each)
    • 20 Individually packed sterilized swabs
    • 20 Individually packed extraction tubes
    • 1 Tube rack
    • 1 Instruction for use

    Specification:

    • Sample Type: Nasopharyngeal swab
    • Detection Method: Colloidal Gold
    • Detection Time: 15-20  minutes
    • Relative Sensitivity: 93.75 %
    • Relative Specificity: 98.04 %
    • Interim order #323096

    Rapid Response®
    COVID-19 Antigen Rapid Test 

    btnx-rapid-antigen-test

    Each Kit Contains:

    5-pack25-pack
    5 Test cassettes25 Test cassettes
    5 Individually packed swabs25 Individually packed swabs
    5 Individually packed buffers2 Bottles of extra buffer liquid
    5 Tubes and nozzles25 Tube and Nozzles
    1 Tube stand1 Tube stand
    1 Product insert1 Product insert

    Specification:

    • Sample Type: Nasal and Nasopharyngeal swab
    • Detection Method: Colloidal Gold
    • Detection Time: 15 minutes
    • Relative Sensitivity: 95.60 % for NP swab; 90.20% for nasal swab
    • Relative Specificity: 100 % for NP swab; 100% for nasal swab
    • Interim order: #321669
    • All necessary reagents provided & no equipment needed

    FaStep
    COVID-19 Antigen Rapid Test

    fastep-antigen-test

    Each Kit Contains:

    20 Test cassettes, 20 Individually packed swabs, 20 Extraction buffers, 1 Tube stand, 1 Product insert

    Specification:

    • Sample Type: Nasal and Nasopharyngeal swab
    • Detection Method: Colloidal Gold
    • Detection Time: 15 minutes
    • Relative Sensitivity: 94.3 % (84.6% ~ 98.1%)
    • Relative Specificity: 98.3 % (95.1% ~ 99.4%)
    • Overall Agreement: 97.4 % (94.4% ~ 98.48%)
    • Interim order: #321478
    • CE certified
    • No additional instrument required to read the results

    QuickVue At-Home OTC (2/25-pack)
    COVID-19 Antigen Rapid Test

    quick-vue-at-home-rapid-antigen-test

    Each Kit Contains:

    • 2/25 Individually wrapped sterile foam swabs
    • 2/25 Individually packed  single-use strips
    • 2/25 Pre-filled tubes
    • 1 Tube holder
    • 2/25 Nasal swabs
    • 1 Instruction Sheet
    • 1 Fact sheet for individuals

    Specification:

    • Sample Type: Nasal swab
    • Detection Method: Colloidal Gold
    • Detection Time: 10 minutes
    • Interim order #331681

    Resources

    Product Insert (pdf)
    Health Canada Authorization Letter (pdf)
    Training video

    Not sure which test to order? Read the product comparison review by our product specialists and choose the antigen test that best suits you.

    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. These devices differ in sample collection method, packaging, and sensitivity. Please speak to our product specialist to determine which one is right for your organization.

    Results and Interpretation

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

    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.

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

    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.

    Frequently Asked Questions

    The regulations around COVID testing for travel is highly dependent on the country you are traveling to. While rapid antigen tests may be accepted in some countries, these tests need to be performed and signed-off by a trained individual, doctor, or pharmacist. 

    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.

    Yes! Aurora Biomed Inc. holds a Medical Device Establishment License from Health Canada.

    Please interpret the result of rapid antigen and antibody tests within 15-30 minutes. The result is not valid if you check again in a few hours.

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