Panbio™ COVID-19 Antigen Self-Test

Antigens are proteins that are part of the COVID-19 virus. If the test detects antigens in your swab sample, it means that the COVID-19 virus is present in your body.

There are three main types of COVID-19 tests. Molecular tests detect the genetic material of the coronavirus. The Panbio™ COVID-19 Antigen Self-Test is an antigen test. Antigen tests detects coronavirus proteins. Both molecular and antigen tests can tell you if you have an active infection. Antibody tests detect antibodies produced by your body‘s immune system in response to a previous COVID-19 infection. Antibody tests cannot be used to diagnose an active COVID-19 infection.

When the foam end of the swab is inserted in your nose, the nasal swab is not sharp and it should not hurt. Sometimes the swab can feel slightly uncomfortable or tickly. If you feel pain, stop the test and seek advice from a healthcare provider.

The Panbio™ COVID-19 Antigen Self-Test has been shown in clinical evaluations, performed by healthcare professionals, to correctly identify 98.1% of positive specimens and 99.8% of negative specimens. All samples were confirmed positive and negative by a RT-PCR test approved by the US FDA for emergency use. 

In clinical evaluations with 102 self-test users, the Panbio™ COVID-19 Antigen Self-Test correctly identified 100.0% of negative samples, and 95.2% of positive samples. All samples were confirmed as positive and negative by Panbio™ COVID-19 Ag Rapid Test Device (Nasopharyngeal).

The test can be used for all ages. Children under 14 years should be supported by an adult.

No, this is an antigen test that only detects an active infection. Antibody tests can detect past infections.

The test has an expiration date printed on the box, and should not be used after that date.

No - only use the components included in the test kit.

Yes. Pregnancy had no impact on the performance of the test, as described in the "Which interferences can occur?" section in the Instructions for Use.

Abbott is intently monitoring the mutations of the COVID-19 virus so we can ensure our tests can detect them, as we do with many viruses. We have conducted a thorough analysis of known variants that we’ve been able to study, and we are confident that our tests remain effective at identifying these strains. The test looks for proteins inside the COVID-19 virus that it needs to survive, and those proteins are less likely to mutate.

No – each test can only be used once.

Place the swab, tube, and test device into the included disposal bag. Seal the bag tightly. Throw away the bag in a waste bin.

A positive test result means that proteins of the virus that causes COVID-19 have been found in your nasal swab sample. It is likely that you will need to perform self-isolation at home to prevent the spread of COVID-19. A positive result does not rule out coinfection with other pathogens. Please follow local guidelines for social distancing to limit the spread of the virus. All positive results must be confirmed with a  laboratory PCR test.

A negative test result means that it is unlikely that you have COVID-19 at the time of testing. The test did not detect any antigens in your nasal swab sample, but it is possible that your test gave a false negative test result. False negative test results can be caused by several factors:

• The amount of antigen in the swab sample may decrease over the duration of the infection.
• The test was performed after the first 7 days of symptom onset.
• The test may be negative before you develop symptoms.
• The test was not performed per the instructions.
• Specimen collection, extraction or transport was not preformed correctly.

If symptoms continue, you should repeat the test after 1-2 days, as the coronavirus may not be detectable in the early phases of infection. You are also advised to continue following guidelines for self-isolation and consult your doctor.