COVID-19 rapid test for home use (nasal swab)

A rapid test for the qualitative detection of novel coronavirus antigens in human nasal swab specimens.

It is intended for personal use without prior professional training as a rapid test method for novel coronavirus infection.

It is suitable for users over 15 years old. Users under 15 years of age should be tested with assistance of adults. Both symptomatic and asymptomatic infections can be tested.

The test results can be interpreted quickly in 15 minutes.

Accuracy = 99.04%

Sensitivity = 96.4%

Specificity = 99.8%

Accuracy: Compared with the RT-PCR Assay, the probability of correct results by the rapid test kit, including both positive and negative patients.

Sensitivity: Compared with the RT-PCR Assay, among patients infected with SARS-CoV-2 virus, the probability of correct detection by the rapid test kit.

Specificity: Compared with the RT-PCR Assay, among patients who have not been infected with SARS-CoV-2 virus, the probability of correct detection by the rapid test kit.

Important! Negative test results do not completely rule out being infected with SARS-CoV-2. If you continue to suspect any symptoms, further testing is strongly recommended. Call the family doctor hotline 1220.

Test principle:

This product uses the double antibody sandwich method to detect the SARS-CoV-2 N protein. When the sample contains the coronavirus antigen, both the test line (C) and the control line (T) will appear, and the result will be positive. When the sample does not contain the coronavirus antigen or no coronavirus antigen is detected, the test line (T) will not appear, only control line (C) will appear.

Specimen collection and preparation:

Allow test device extraction reagent and specimens to equilibrate to room temperature (15 ~ 30 ℃) prior to testing. Please keep the temperature at 15 ~ 30 ℃ and the humidity at 20%-80% during the whole test.

Blow your nose several times before collecting the specimen. Clean your hands and make sure they are dry before starting the test.

1. Open the package and take out the test device. Identify the observation window and specimen well (S). The test should be performed within one hour of opening the package.
2. Unscrew the cap of the extraction tube counterclockwise.
3. Press on the pre-drilled circle on the outer box and make a hole. Then insert the bottom of the antigen extraction tube into the hole.
4. Remove the sterilized swab from its packaging.
5. Relax your head naturally. Carefully insert the swab into the nostril. The tip of the swab should be inserted up to 2 cm until resistance is met.
6. Roll the swab firmly around the inside of the nostril, making 5 complete circles. Using the same swab, repeat this process for the other nostril to ensure an adequate amount of specimen is collected.
7. Withdraw the swab from the nasal cavity.

Test procedure:

1. Put the swab specimen into the extraction tube, rotate the swab for about 10 seconds, and press the swab head against the tube wall 3 times to release the antigen in the swab.
2. Tighten the cap of the extraction tube clockwise.
3. Unscrew the small white cap on top of the extraction tube.
4. Hold the extraction tube vertically and add two drops of the test specimens into the specimen well (S). Start the timer.
5. Read result at 15 minutes. Do not read results after 30 minutes.
6. Please put all used materials in the enclosed collection bag for proper disposal. The test kit can be disposed of with normal household waste in compliance with the applicable local regulations.

Interpretation of test results:

1. POSITIVE: If both the control line (C) and the test line (T) appear, it indicates that SARS-CoV-2 antigen has been detected and the result is positive.
   • Currently, there is a suspected infection with COVID-19.
   • Contact your doctor or local health department immediately.
   • Comply with the local self-isolation guidelines.
   • Perform a PCR test for confirmation.
2. NEGATIVE: If there is only a control line (C) and the test line (T) is colorless, it indicates that SARS-CoV-2 antigen has not been detected and the result is negative. Continue to comply with all applicable rules regarding contacts and protective measures. Even if the test is negative, there may be an infection. In case of doubt, repeat the test after 1-2 days because the coronavirus cannot be accurately detected at all stages of infection.
3. INVALID: If the control line (C) is not observed, the test is considered to be invalid whether the test line (T) is visible or not. A new test needs to be performed using a new test device. If the test result is invalid, it may be caused by incorrect test procedures. Please repeat the test. If the test result is still invalid, please contact your doctor or COVID-19 testing center.

Precautions:

1. This test kit is only used for in vitro diagnosis.
2. This test kit is only used to detect coronavirus antigen in human nasal swab specimens. The results of other specimens may be wrong.
3. This test kit is only used for qualitative detection and cannot indicate the quantity of SARS-CoV-2 antigen in the specimen.
4. This test kit is only a clinical auxiliary diagnostic tool. If the result is positive, it is recommended to use other methods for further examination and the doctor’s diagnosis shall prevail.
5. This test does not determine the aetiology of the respiratory infection caused by micro-organisms other than the SARS-CoV-2 virus.
6. This test can detect both the viable and the non-viable SARS-CoV-2 virus. The accuracy of the test depends on the quality of the swab sample. False negative results may be given following poor sampling.
7. Any failure to follow the test procedure may negatively impact the performance of the test and/or invalidate the test result.
8. If the result of the test is negative, yet clinical symptoms persist, it is advised that you carry out additional tests using other clinical methods. A negative result at no time rules out the presence of antigens of the SARS-CoV-2 virus in the sample, as they may be present but at a level inferior to the minimum detection level of the test, or if the sample has been collected incorrectly.
9. A negative result does not rule out infection with the SARS-CoV-2 virus, particularly in people who have come into contact with the virus. Follow-up tests with molecular diagnostics should be scheduled to rule out infection in these people. Persons who show symptoms of the disease but have a negative result until infection is ruled out should follow country-specific restrictions.
10. This test is not a substitute for a medical consultation, or for the result of a biological analysis carried out in a medical analysis laboratory.
11. Positive test results do not exclude the possibility of co-infections of other pathogens.

Store at 4℃~30℃, and it is valid for 24 months.

After the aluminum foil bag is unsealed, the test device should be used as soon as possible and within one hour (15 ~ 30℃), humidity ≤80%).