COVID-19 Antigen Rapid Test for Professional & Self testing (CE 1434 OTC) (Nasal Swab)

Short Description:

1: EC Certificate NO.1434 for self -testing OTC

2: TGA has approved for self-tests (home use tests) in Australia

3: Designed for qualitative detection of SARS-CoV-2 antigen test in Nasal swabs.

4: COVID-19 Antigen Test Cassette is a rapid chromatographic immunoassay for the qu

alitative detection of COVID-19 antigen in nasal swab specimen to aid in the diagnosis of COVID-19 viral infection.

  • Certificate: TGA for self-tests, CE 1434 for self-testing
  • Test Time: within 15 mins
  • Sensitivity: 95.1% 95% Cl: (91.36%~97.34%)
  • Specificity: 100.00% 95% Cl: (99.00%~100.00%)
  • Sample: Nasal swab
  • Storage condition: 2-30 °C
  • Shelf Life: 24 Months
  • Package: 1T, 2T, 5T, 10T, 20T, 25T-
  • Product Detail

    Product Tags

    Product Overview


    Specimen Collection And Preparation

    1.Nasal swab Specimen collection
    Tilt the patient's head back 70 degrees,and insert the swab into the LEFT nostril and gently push the swab until a slight resistance is met (less than one inch into the nostril). When the swab is in place, rotate in a circular motion for 15 seconds.Remove the swab from nostril and repeat steps on RIGHT nostril, removing the swab when finished.

    2. Do not return the swab to the original paper packaging.
    For best performance, direct specimen should be tested as soon as possible after collection. If immediate testing is not possible, and to maintain best performance and avoid possible contamination, it is highly recommended the specimen is placed in a clean, unused plastic tube labeled with patient information, preserving sample integrity, and capped tightly at room temperature (15-30°C) for up to 1 hour prior to testing.Ensure the swab fits securely within the tube and the cap is tightly closed. If greater than 1 hour delay occurs dispose of sample. A new sample must be collected for testing.

    3.If specimens are to be transported, they should be packed in compliance with performed.local regulations covering the transportation of etiological agents


    You can also use Testsealabs COVID-19 Antigen nasal swab rapid test at home by yourself


    Materials provided
    ● Extraction buffer
    ● Extraction Tube
    ● Package insert
    ● Test devices
    ● Nasal Swab
    Materials required but not provided Timer

    Directions For Use

    Allow the test, specimen, buffer and/or controls to reach room temperature
    15-30℃ (59-86℉) prior to testing


    1.Unscrew the diluent bottle , Unscrew the cap of the extraction tube, Add all of the extraction buffer into the extraction tube
    2.Place the swab specimen in the Extraction tube,Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab
    3.Remove the swab while squeezing the swab head against the inside of the Extraction Tube as you remove it to expel as much liquid as possible from the swab. Discard the swab in accordance with your biohazard waste disposal protocol.
    4.Cover the tube with cap then add 3 drops of the sample into the sample hole vertically.
    5.Read the result after 15 minutes. If you haven't read it for 20 minutes or more, the result is invalid and it is recommended to repeat the test.

    Interpretation Of Results


    Positive: Two lines appear. One line should always appear in the control line region(C), and another one apparent colored line should appear in the test line region.
    NOTE: The intensity of the color in the test line region (T) will vary based on the amount of COVID-19 antigen present in the sample. So any shade of color in the test region (T) should be considered positive
    Negative: One colored line appear in the control region(C).No apparent colored line appear in the test line region.
    Invalid: Control line fail to appear. Insufficient specimen 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 device. If the problem persists, discontinue using the test kit immediately and contact with your local distributor.

  • Previous:
  • Next:

  • Related Products