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Antigen Rapid Test Package Insert for Self-Testing

Views: 0     Author: Site Editor     Publish Time: 2022-11-17      Origin: Site

Possible Uses

The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a single-use test kit for the detection of SARS-CoV-2,the cause of COVID-19, in self-collected nasal swabs from symptomatic individuals suspected of infection.The specimen was infected with COVID-19 within the first 7 days of symptom onset.The results were used to detect the SARS-CoV-2 nucleocapsid protein antigen.Antigen is usually detectable in upper respiratory tract specimens during the acute phase of infection.Positive results indicate the presence of viral antigens,but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.A positive result indicates the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek additional care from their healthcare provider.A positive result does not exclude bacterial infection or co-infection with other viruses.Negative results do not exclude SARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow-up care from their healthcare provider.The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is intended for use by the layman as a self-test at home and in the workplace (offices,sporting events, airports,schools,etc.The novel coronavirus belongs to the genus Beta.COVID-19 is an acute respiratory infectious disease. People are generally susceptible.At present, patients infected with the new coronavirus are the main source of infection; asymptomatic patients can also become the source of infection.According to the current epidemiological investigation,the incubation period is 1 to 14 days,mostly 3 to 7 days.The main manifestations are fever,fatigue,dry cough and so on.Nasal congestion, runny nose, sore throat, myalgia, and diarrhea in a few cases. Antigen Rapid Test


The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 nucleocapsid protein antigen in human swab specimens.


All information in this package insert prior to performing the test.

• For self-test in vitro diagnostic use only. Do not use after the expiry date.

• Do not eat, drink or smoke in areas where specimens or kits are handled.

• Do not drink the buffers in the kit. Handle buffer with care, avoid contact with skin or eyes, in case of contact, rinse immediately with plenty of running water.

• Store in a dry place at 2-30 °C (36-86 °F), avoiding excessive humidity. Do not use if foil package is broken or opened.

• This test kit is intended as a preliminary test only, recurrent abnormal results should be discussed with a doctor or medical professional.

• Strictly follow the indicated times.

• Use only one test. Do not disassemble and touch the test window of the test box.

• Kit should not be frozen or used after the expiry date printed on the package.

• Keep out of reach of children.

• Children and adolescents should be tested with adults.

• Do not use this test on children under 2 years old.

• Young children should wipe with the help of a second adult.

• Wash hands thoroughly before and after handling.

• Make sure to use an appropriate number of samples for testing.

Too much or too little sample size can skew the results.


• Test cassette

• Package inserts

• Sterile swab

• Extraction buffer

• Biosafety bag


Store as packaged in the sealed pouch at room temperature or refrigerated (2-30 °C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. 


Do not use beyond the expiration date.


1. How does the SARS-CoV-2 antigen rapid test work?

This test is for the qualitative detection of SARS-CoV-2 antigen in self-collected swab specimens. A positive result indicates the presence of SARS-CoV-2 antigens in the specimen.

2. When should tests be used?

SARS-CoV-2 antigen can be detected for acute respiratory infection, and it is recommended to test when at least one of the symptoms suddenly appears: cough, fever, shortness of breath, fatigue, loss of appetite, myalgia.

3. Will the result be incorrect?

As long as the instructions are followed carefully,the results will be accurate.However, if the sample volume is insufficient or the SARS-CoV-2 Antigen Rapid Test becomes wet prior to testing,or if fewer than 3 drops or more than 4 drops of extraction buffer are used, the results may be incorrect.Furthermore,due to immunological principles involved,there is a possibility of false results in rare cases.Consultation with a physician is always recommended for such tests based on immunological principles.

4. If the lines vary in color and intensity, how is the test interpreted?

The color and intensity of the lines are not important for the interpretation of the results.Lines should be even and clearly visible.The test should be considered positive regardless of the color intensity of the test line.

5. What should I do if the result is negative?

A negative result means you are negative,or your viral load is too low to be recognized by the test.However,this test may give incorrectly negative results (false negatives) for some COVID-19 patients.This means that even if you test negative,you could still have COVID-19.If you develop symptoms such as headache,migraine, fever, loss of smell and taste, please contact the nearest medical institution according to the regulations of the local government. Also, you can repeat tests with new test suites. In case of doubt, repeat the test after 1-2 days, as coronavirus cannot be accurately detected at all stages of infection. Distance and hygiene rules must still be observed.Even with a negative test result, distancing and sanitation rules must be followed, and relocation/travel,attending events, etc.Should follow your local COVID guidelines/requirements. 

6. What should I do if the result is positive? 

A positive result means the presence of SARS-CoV-2 antigens.A positive result means you most likely have COVID-19. Immediately self-isolate according to local guidelines and contact your GP/doctor or local health department immediately as directed by your local authority.