Abbott Panbio Covid 19 Antigen Self Test Kit
Manufacturer
Abbott
Key Information
Short Description
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).
Dosage Form
Single-use, in vitro (outside the body) visually read rapid immunoassay
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.
Directions for 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.
Safety Information
Side Effects
No side effects mentioned
Alcohol Warning
No warning
Breastfeeding Warning
No warning
Pregnancy Warning
No warning
Interacting Medicines
No interacting drugs mentioned
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
Frequently asked questions
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.
