Lollipop Rapid Saliva Test Kit is an immunochromatographic membrane assay that is used for the detection of SARS-CoV-2 N protein antigens in saliva samples of people suspected of coronavirus infection pneumonia. Antigen testing is generally used during the acute period of infection when samples from a suspected population are tested within 7 days of the onset of symptoms.

Testing time: 10-15 minutes

Sensitivity: 95.83%

Specificity: 98.50%

The reagent membrane on the 2019-nCoV ag lollipop rapid test kit contains the colloidal-gold conjugated with the monoclonal antibodies against Novel coronavirus. The reaction membrane contains the secondary antibodies for Novelcoronavirus, and the polyclonal antibodies against the mouse globulin, which are preimmobolized on the membrane.

Directions for Use

Allow the test device to equilibrate to room temperature (25℃-30℃) prior to testing.

Detection Method 1：

1. After washing your hands, take the test kit out of aluminum foil bag and remove the blue lid of the test lollipop.

2. Lower the tip of the tongue and the upper jaw of the mouth and wait for the saliva to fill the mouth, put the absorbent tip of the testlollipop into the mouth (all the absorbent tip is pressed under the tongue), place the absorbent tip beneath the tongue for 90 seconds.

3. Take out the test lollipop from the mouth and lid the blue of the test lollipop. Place the test lollipop horizontally, read the displayed result within 15 minutes, and the results read after 30 minutes are invalid.

4. Safely throw away the waste into biohazard container.

Detection Method 2：

1. Spit saliva to the saliva collector.

2. Take out the test lollipop, and put the saliva adsorption stick into the saliva collector, start the timer. After about 90 seconds, cover the lid of saliva adsorption stick.

3. Pace the detection lollipop horizontally on the workbench, and read the detection result 15 minutes later.The test result should not be read and interpreted after 30 minutes.

4. Safely throw away the waste into biohazard container.

Interpretation of Results

This kit collects saliva samples from the saliva adsorption stick at the front of the test card, if the sample contains a SARS-CoV-2 N protein antigen, it is identified and bound by antibodies labeled on the surface to form an immune complex.

Positive:

Two colored lines appear. One red-colored line next to “C” and one red-colored line next to “T” indicates SARSCoV-2 positive result.

Negative:

One red-colored line only next to “C” indicates a negative result.

Invalid:

If the red-colored line in the control region “C” is not visible, the result is invalid.

CAUTIONS

1. For in vitro diagnostic useonly.

2. Do not eat, drink, or smoke for at least 30 minutes before the test.

3. Do not use after the expirationdate.

4. Ensurefoilpouchcontaining testdevice is not damaged before opening for use.

5. Perform test at room temperature 15℃ to 30℃.

6. Wear gloves when hanging the samples,avoid touching the reagent ,embrance and sample window.

7. All samples and used accessories should be treated as infectious and diacarded according to local regulations.

8. Avoid using blood samples.

9. Antigen detection cannot be used alone for the diagnosis of SARS-CoV-2 infection, and the infection status should be determined in combination with nucleic acid detection, imaging and other diagnostic information, as well as medical history and contact history.