The Wondfo 2019-nCoV Antigen Test is an antigen test that is to detect the presence of protein fragments (antigen) from the 2019-nCoV in nasal swab specimen.

There are different kinds of tests for diagnosing COVID-19. 

Molecular tests (also known as PCR tests) detect genetic material from the virus.

The Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is an antigen test which detects small parts or proteins from the virus. Antigen tests are very specific for the virus  but are not as sensitive as molecular tests.

Another type of test is an antibody test. A COVID-19 antibody test detects antibodies that have been made by your immune system in response to a previous COVID-19 infection.

No, the disposable sterile swab is not sharp and it should not hurt. Sometimes the swab can feel slightly uncomfortable or tickly.

Swabbing both nostrils gives you the best chance of collecting sufficient sample to generate an accurate result. It has been observed in some cases that only one nostril has detectable virus, so it is important to collect from both nostrils. Correct swabbing is important to obtain a correct result.

A positive result means that you may have COVID-19 disease. If you have a POSITIVE result, follow the guidance from your local State or Territory Health Department for guidance on confirmation testing if necessary, and if unwell seek medical assistance. It is likely you will be asked to isolate yourself at home to avoid spreading the virus to others, wear a face mask when recommended and wash your hands regularly with soap and water. A positive result does not in any way guarantee that you are or will be immune and therefore cannot (or can no longer) become infected.

A negative result means the virus that causes COVID-19 was not found in your sample.

A negative test result does not guarantee that you do not or have never had COVID-19, nor does it confirm whether or not you are currently contagious. Do you have cold symptoms in addition to the negative at-home test? Since the at-home test does not provide complete certainty, you should assume that you have COVID-19. Repeated testing (within 1-3 days) is recommended in case of ongoing suspicion of infection, exposure to occupational risk or being in a high risk setting. In the meantime, try to avoid leaving your home and have as little contact as possible with others, including the peopleyou live with. Use disposable tissues and throw them straight in the bin. Sneeze and cough into the crook of your elbow. Wash your hands regularly and wear a face mask. 

Are your symptoms getting worse (difficulty breathing, high fever, etc.)? Follow the guidance from your local State or Territory Health Department for guidance on confirmation testing if necessary, and if unwell seek medical assistance.

The test has been shown in field clinical evaluations performed by professional health care persons to correctly identify 91.63% (230 out of 251) of 2019-nCoV positive samples (known as the test’s sensitivity) and 99.84% (622 out of 623) of 2019-nCoV negative samples (known as the test’s specificity), when compared with RT-PCR test.

The test has also been shown in field clinical evaluations performed by lay users to correctly identify 92.96% (66/71) of 2019-nCoV positive samples and 98.53% (335/340) of 2019-nCoV negative samples, when compared with RT-PCR test.

Detection Limit:

The detection limit of Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is 457 TCID50/mL.

It is possible for this test to give an incorrect negative (false negative) result”. This means that you could still have COVID-19 even though the test result is negative. If your result is negative and you still experience symptoms related to COVID-19，such as fever, cough and/or shortness of breath, you should follow the guidance from your local State or Territory Health Department for guidance on confirmation testing if necessary, and if unwell seek medical assistance.

There is a very small chance that this test gives you a positive result that is incorrect (false positive). If you get a positive result, you should self-isolate and follow the guidance from your local State or Territory Health Department for guidance on confirmation testing if necessary, and if unwell seek medical assistance.

If there is no colored band appears at control line (C) within 15 minutes of performing the test, then the test has not worked. You should test again, using a new test, taking care to follow the instruction.

Possible Risks:

• Discomfort during the sampling
•  Incorrect test results (see Interpreting Results and Limitations Sections).