Abbott Panbio Covid 19 Antigen Self-Test is a single-use, in vitro (outside the body) visually read rapid immunoassay that uses a human nasal swab specimen for the qualitative detection of nucleocapsid protein SARS-CoV-2 antigen (Ag).

Introduction:
The Panbio COVID-19 Antigen Self-Test is intended to be used manually by untrained lay users (self-testing) in a private setting to aid in the diagnosis of an active SARS-CoV-2 infection. The test is a lateral flow test that detects the nucleocapsid protein antigen of the Coronavirus SARS-CoV-2 in a swab from the mid-turbinate nasal region.

Dosage Form:
Single-use, in vitro (outside the body) visually read rapid immunoassay

Side Effects:

• No side effects mentioned

How to Use:
The test procedure involves collecting a nasal sample using a swab, extracting the sample using a buffer solution, and then performing the test using a test device. The test results are then read and interpreted.

How it Works:
The test works by detecting the nucleocapsid protein antigen of the Coronavirus SARS-CoV-2 in a swab from the mid-turbinate nasal region. The test is a lateral flow test that uses a buffer solution to extract the antigen from the swab sample.

Quick Tips:

• Use the test device only once
• Keep the test device flat on the table during the test
• Do not touch the test device during the test
• Use the provided swab only for nasal (mid-turbinate) specimen collection

Interacting Drugs:

• No interacting drugs mentioned

FAQs:

• What is an antigen?
  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.


• What is the difference between a molecular, antigen and antibody test?
  There are three main types of COVID-19 tests. Molecular tests (also known as PCR tests) detect the genetic material of the coronavirus. The Panbio COVID-19 Antigen Self-Test is an antigen test. Antigen tests detect coronavirus proteins. Antibody tests detect antibodies produced by your body's immune system in response to a previous COVID-19 infection.


• Will this test hurt?
  The nasal swab may cause slight discomfort. It is important to follow the nasal swab collection steps as indicated in the procedure.


• How accurate is the test?
  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.


• Can this test be used on children?
  The test can be used for all ages. Children under 14 years old should be supported by an adult.


• Will this test tell me if I have been infected with COVID-19 in the past?
  No, this is an antigen test that only detects an active infection. Antibody tests can detect past infections.


• Does the product expire?
  Yes, the test has an expiration date printed on the box, and should not be used after that date.


• Can I use my own swab or other swabs?
  No - only use the components included in the test kit.


• I'm pregnant. Can I use the test?
  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.


• Does this test detect the new variants?
  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.


• Can I use this test more than once?
  No – each test can only be used once.


• How do I dispose of a used test?
  Place the swab, tube, and test device into the included disposal bag. Seal the bag tightly. Throw away the bag in a waste bin.


• What does it mean if I have a positive result?
  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.


• What does it mean if I have a negative result?
  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.


• I'm feeling unwell but my test is negative. What should I do?
  If symptoms continue and the rapid antigen test results are negative, individuals should immediately be tested by RT-PCR per ICMR Advisory, as the coronavirus may not be detectable in the very early phases of infection. You are also advised to continue following local guidelines for self-isolation and consult your doctor.