Health Canada Approved COVID-19 Antigen Rapid Test Kits

PRODUCT INFORMATION


    For Rapid Testing Services, please call us at 360-820-1331 or email us at rapidresponse@aurorabiomed.com

    Rapid Response® COVID-19 Antigen Rapid Test 

    In just 15 minutes, the Rapid Response® COVID-19 Antigen Rapid Test can detect the SARS-CoV-2 viral nucleoprotein antigens through visual interpretation of color development. The test is intended for use with Nasal and Nasopharyngeal swab specimens within 6 days of symptom onset.

    Each Box Contains:

    25 Test cassettes, 25 individually packed swabs,  25 extraction tubes, 25 nozzles, 1 tube stand and 1 package 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
    • Health Canada Approved
    • All necessary reagents provided & no equipment needed

    Resources:

    Fastep 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

    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: 94.3 % (84.6% ~ 98.1%)
    • Relative Specificity: 98.3 % (95.1% ~ 99.4%)
    • Overall Agreement: 97.4 % (94.4% ~ 98.48%)
    • Health Canada Approved and CE certified
    • No additional instrument required to read the results

    Resources:

    STANDARD Q COVID-19 Ag Test

    STANDARD Q COVID-19 Ag Test is a rapid chromatographic immunoassay for the qualitative detection of specific antigens to COVID-19 present in human nasopharynx. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of COVID-19 infection.

    Each Box Contains:

    25 Test cassettes, 25 individually packed swabs, 25 Extraction tubes, 25 extraction tubes, 25 nozzles, 1 tube stand and 1 package insert

    Specification:

    • Sample Type: Nasopharyngeal swab
    • Detection Method: Colloidal Gold
    • Detection Time: 15 -30 minutes
    • Relative Sensitivity: 95 %
    • Relative Specificity: 99.35 %
    • Health Canada Approved, WHO EUL
    • All necessary reagents provided & no equipment needed

    Resources:

    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

    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.

    Get more information

    Request more information on Aurora’s Health Canada Approved Coronavirus (COVID-19) Rapid Test Kits:

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