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    COVID-19 ANTIGEN SKYTEST Brochure

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    rian
    1. The document provides instructions for using a COVID-19 Antigen Rapid Test Cassette, including extracting samples from nasopharyngeal or oropharyngeal swabs or swabs in viral transport media. 2. The test procedure involves transferring extracted sample to the test cassette and interpreting results, which are positive if two lines appear within 15 minutes and negative if one line appears. 3. Performance data shows the test has a sensitivity of 91.4% and specificity of 100% compared to PCR for COVID-19 detection.

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    COVID-19 ANTIGEN SKYTEST Brochure

    Uploaded by

    rian
    51 views1 page
    1. The document provides instructions for using a COVID-19 Antigen Rapid Test Cassette, including extracting samples from nasopharyngeal or oropharyngeal swabs or swabs in viral transport media. 2. The test procedure involves transferring extracted sample to the test cassette and interpreting results, which are positive if two lines appear within 15 minutes and negative if one line appears. 3. Performance data shows the test has a sensitivity of 91.4% and specificity of 100% compared to PCR for COVID-19 detection.

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    1. The document provides instructions for using a COVID-19 Antigen Rapid Test Cassette, including extracting samples from nasopharyngeal or oropharyngeal swabs or swabs in viral transport media. 2. The test procedure involves transferring extracted sample to the test cassette and interpreting results, which are positive if two lines appear within 15 minutes and negative if one line appears. 3. Performance data shows the test has a sensitivity of 91.4% and specificity of 100% compared to PCR for COVID-19 detection.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    51 views1 page

    COVID-19 ANTIGEN SKYTEST Brochure

    Uploaded by

    rian
    1. The document provides instructions for using a COVID-19 Antigen Rapid Test Cassette, including extracting samples from nasopharyngeal or oropharyngeal swabs or swabs in viral transport media. 2. The test procedure involves transferring extracted sample to the test cassette and interpreting results, which are positive if two lines appear within 15 minutes and negative if one line appears. 3. Performance data shows the test has a sensitivity of 91.4% and specificity of 100% compared to PCR for COVID-19 detection.

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    © All Rights Reserved
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    4. Remove the test cassette from the sealed pouch.

    5. Reverse the specimen extraction tube, holding the tube upright,


    transfer 3 drops (approximately 100μL) slowly to the specimen well
    COVID-19 Antigen RAPID TEST CASSETTE (S) of the test cassette, then start the timer.
    6. Wait for colored lines to appear. Interpret the test results at 15
    25 TEST minutes. Do not read results after 20 minutes.
    The COVID-19 Antigen Rapid Test Cassette is a lateral flow
    immunoassay intended for the qualitative detection SARS-
    CoV-2 nucleocapsid antigens innasopharyngeal swab and
    oropharyngeal swab from individuals who are suspected of
    COVID-19 by their healthcare provider.
    Results are for the identification of SARS-CoV-2 Swab in Viral Transport Media (VTM) Test Procedure
    nucleocapsid antigen. Antigen is generally detectable in 1. Insert the swab specimen into the transport tube containing a
    nasopharyngeal swab and oropharyngeal swab during the maximum of 3 mL VTM without denaturing agents.
    acute phase of infection. Positive results indicate the presence 2. Mix the specimen stored in VTM by vortexing.
    of viral antigens, but clinical correlation with patient history 3. Transfer 300μL of the VTM solution containing specimen into the
    and other diagnostic information is necessary to determine extraction tube which contains extraction reagent with a calibrated
    infection status. micropipette. Homogenise mixture by pipetting up and down.
    Positive results do not rule out bacterial infection or co- 4. Cover the extraction tube with a dropper tip tightly, and let the
    infection with other viruses. The agent detected may not be extracted solution stand for one minute.
    the definite cause of disease.
    Negative results do not rule out SARS-CoV-2 infection and
    should not be used as the sole basis for treatment or patient
    management decisions, including infection control decisions.
    Negative results should be considered in the context of a
    patient’s recent exposures, history and the presence of clinical 5. Follow Steps 4 – 6 of the Direct Swab Test Procedure above
    signs and symptoms consistent with COVID-19, and
    INTERPRETATION OF RESULTS
    confirmed with a molecular assay, if necessary for patient
    management.
    The COVID-19 Antigen Rapid Test Cassette is intended for Positive: Two lines appear. One colored line appears at
    use by trained clinical laboratory personnel specifically the control region (C), and another colored line appears at the test
    instructed and trained in vitro diagnostic procedures.. region (T), irregard- less of the intensity of the test line.

    TEST PROCEDURE Negative: One colored line appears at the control region (C),
    Note: Allow the test devices, reagents and specimens to and no line appears at the test region (T).
    equilibrate to room
    temperature (15-30℃ or 59-86℉) prior to testing. Invalid: Control line fails to appear. Insufficient specimen
     Put an extraction tube on the work station. volume or incorrect procedural techniques are the most likely
     Add 0.3 mL (10 drops) of the extraction reagent into the reasons for control line failure. Review the procedure and repeat the
    extraction tube. test using a new test cassette. If the problem persists, discontinue
     Sampling refer to section ‘Specimen Collection’. using the lot immediately and contact your local distributor.
    PERFORMANCE CHARACTERISTICS
    Sensitivity (PPA)= 91.4% (64/70), (95%CI: 82.5%～96.0%)
    Specificity (NPA)= 100% (215/215), (95%CI: 98.2%～100%)
    *The 6 discordant specimens had Ct values of 34, 36, 35.5, 34, 35,
    Direct Swab Test Procedure 33.
    1. Insert the swab specimen into the extraction tube which The PPA is 98.5% (64/65) (95%CI: 91.8%～99.7%) with specimens
    contains extraction reagent. Roll the swab at least 5 times of a Ct count ≤33.
    while pressing the head against the bottom and side of the
    extraction tube. Leave the swab in the extraction tube for one
    minute.
    2. Remove the swab while squeezing the sides of the tube to
    extract the liquid from the swab. The extracted solution will
    be used as test sample.
    3. Cover the extraction tube with a dropper tip tightly

    Manufacturer :
    HANGZHOU CLONGENE BIOTECH CO., LTD
    No. 1 Yichuang Road, Yuhang Sub-district,
    MRI Healthcare - Medika Rekacipta Internasional Yuhang District, 311121 Hangzhou, China
    info@mrihealth.care

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