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    Rapid SARS-CoV-2 Antigen Test

    Description:

    General information:

    Rapid SARS-CoV-2 Antigen Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of SARS-CoV-2 antigens in the nasopharyngeal/nasal specimen collected by swabs from individuals who are suspected of having COVID-19.

    • Fast results within 15 mins
    • Easy to use - in 3 rapid steps
    • Nasopharyngeal or Nasal specimen
    • All necessary reagents provided (individually packed)
    • Highest accuracy - Sensitivity and Specificity
    • CE and BfArM certified

    Reagents and materials included:

    ① Test cassettes (individually packaged)

    ② Sterile swabs (individually packaged)

    ③ Disposable buffer tubes

    ④ Package insert

    Principle of the test:

    Gold conjugated mouse anti-SARS-CoV-2 N-protein IgG and gold conjugated rabbit nonspecific IgG are pre-coated on the sample pad. SARS-CoV-2 antigen (N protein) can react with the gold conjugated mouse anti-SARS-CoV-2 N-protein IgG and form an immune complex. The specimen will move forward along the test strip. If the specimen contains SARS-CoV-2 antigen (N protein) and the concentration is above the minimum detection limit, the complex will be captured by the mouse anti-SARS-CoV-2 N-protein IgG pre-coated at the test band region, and form a purplish red band. If the specimen does not contain SARS-CoV-2 antigen or the concentration is below the minimum detection limit, there will be no purplish red band shown at the test band region. Regardless of whether the analyte exist in the specimen, the gold conjugated rabbit nonspecific IgG will be captured by the goat anti-rabbit IgG. A purplish red band will appear at the control band region. Only when the control band appears, the correlated result is valid.

    Instructions for use:

    • Nasopharyngeal specimen:

    Insert the swab through one nostril parallel to the palate (not upwards) until resistance is encountered, indicating contact with the nasopharynx. Gently rub and roll the swab over surface of the nasopharynx for 10 times to absorb secretions. Withdraw the swab from the nasal cavity slowly.

    • Nasal specimen:

    Insert the swab into the nasal cavity, gently turn and push the swab into the nasal cavity until it is blocked at the turbinate (about 2.0cm - 2.5cm from the nostril). Rotate the swab 3 times against the wall of the nasal cavity and remove the swab. Use the same sawb to sample the other nostril in the same way to ensure that you get enough samples.

    • Test procedure

    1. Peel off the foil film on the buffer tube.

    2. Insert the fabric tip of the swab into the solution in the buffer tube,

    and rotate it against the inner wall of the buffer tube about 10 times

    to dissolve the specimen in the solution as much as possible.

    3. Squeeze the tip of the swab along the inner wall of the buffer tube to

    keep the liquid in the tube as much as possible, then remove and

    discard the swab.

    4. Press the nozzle cap tightly on to the buffer tube to avoid any leaks.

    Results interpretation:


    Performance characteristics:

    • Nasopharyngeal specimen:
      • Sensitivity 96.3%
      • Specificity 100%
    • Nasal specimen:
      • Sensitivity 95.5%
      • Specificity 99.6%

    Video instructions:

    Cat. No.: ITP16010-TC25
    Package: 25 pcs.


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    Files for download:
    IFU Rapid SARS-CoV-2 Antigen Test - BG
    IFU Rapid SARS-CoV-2 Antigen Test - EN