covid-19 at home Antigen rapid test kit ( oral )

    COVID-19 Saliva Antigen Rapid Test kit flow assay for the rapid and qualitative detection of antigen human saliva samples.

    US FDA and EU CE certificates

    STABILITYANDSTORAGE

    Allreagentsarereadytouseassupplied.Storeunusedtestdevicesunopenedat2-30°C.If

    storedat2-8°C,ensurethatthetestdeviceisbroughttoroomtemperaturebeforeopening.The

    testdeviceisstableuntiltheexpirationdateprintedonthesealedpouch.Donotfreezethekit

    orexposethekittotemperaturesabove30°C.

    ASSAYPROCEDURE

    Step 1: After the test card is restored to room temperature, open the aluminum foil bag and

    take out the test card.

    Step 2: Take off the top cover of the test card, put the sponge plate under the tongue for 2

    minutes. Then take out the test card and close the cover.

    Step 3: Position the test card horizontally. Read the result within 15-30 minutes. The result is

    invalid over 30 minutes.

    Step 4: Pls rinse the mouth after the testing.

    QUALITY CONTROL

    1. Internal Control: This test contains a built-in control feature, the C line. The C line
    develops after adding specimen and sample diluent. If there is no visible C line, review
    the whole procedure and repeat the test using a new device.
    2. External Control: Good Laboratory Practice recommends using the external controls,
    positive and negative, to assure the proper performance of the assay, particularly under
    the following circumstances:
    a. A new lot of test kit is used.
    b. A new shipment of kits is used.
    c. The temperature during storage of the kit falls outside of 2-30℃.
    d. The temperature of the test area falls outside of 15-30℃.
    e. To verify a higher-than-expected frequency of positive or negative results.
    f. To investigate the cause of repeated invalid results.

    INTERPRETATION OF ASSAY RESULT

    1.NEGATIVE RESULT:

    If only the C line is present, the absence of burgundy color in test

    lines (T) indicates that no novel coronavirus is detected. The result is negative or

    non-reactive.

    2.POSITIVE RESULT:

    In addition to the presence of C line, if the T line develops, the test result indicates that

    novel coronavirus is detected. The result is novel coronavirus positive or reactive.

    Samples with positive results should be confirmed with alternative testing method(s)

    and clinical findings before a diagnosis is made.

    3.INVALID:

    If no C line develops, the assay is invalid regardless of burgundy color in the

    test lines as indicated below. Repeat the assay with a new device.