Panbio Covid 19 Antigen Self Test Kit

Description Of Panbio Covid 19 Antigen Self Test Kit : The 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). 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. Children under 14 years should be supported by an adult.

Key Benefits of Panbio Covid 19 Antigen Self Test Kit:

• The test can determine if you have an active COVID-19 infection and you will know your test results in just 15 minutes.
• The results, along with other information, can help your healthcare provider make informed decisions about your treatment.
• You can help limit the spread of COVID-19 by knowing your infection status and taking appropriate social distancing measures.

Number Of Contents In Sales Package: 1 Instruction guide for Use, 1 Test Device, 1 Tube, 1 Blue Cap, 1 Buffer Bottle, 1 Swab, 1 Bag, 1 Tube Rack

Ingredients: Active ingredients of the test device are antibodies specific to the SARS-CoV-2 nucleocapsid protein antigen.

How to use the Panbio Covid 19 Antigen Self Test Kit:

• Please refer the Image section and follow the instructions prior to using Panbio™ COVID-19 Antigen Self-Test kit to ensure accurate results.
• To use the test, buffer solution is added to the extraction tube, and then a human nasal specimen is collected using the swab provided in the kit.
• After sample collection, the nasal swab is transferred to the extraction tube to extract the Coronavirus proteins.
• Next, 5 drops of extracted sample are applied to the round well on the test device.

Result interpretation of Panbio Covid 19 Antigen Self Test Kit:

• A line in the Control (C) line area within the result reading window will only become visible if the test was performed correctly.
• A line in the Test (T) line area within the result reading window will only become visible if Coronavirus proteins are detected.
• The presence of only a Control (C) line, without visible Test (T) line, indicates the coronavirus proteins are not present.

Do’s and Don’ts for Panbio Covid 19 Antigen Self Test Kit:

•   For in vitro diagnostic use only.
•   Read instructions prior to performing the test. Follow all instructions to achieve accurate results.
•   Do not eat or smoke while handling specimens.
•   Wash hands thoroughly before and after the test is completed.
•   Clean up spills thoroughly using an appropriate disinfectant.
•   Dispose of all specimens, reaction kits and potentially contaminated materials (i.e. Swab, Tube, Test Device) in bag provided.
•   Use only the liquid from the Buffer Bottle provided in the kit. The use of other liquids will lead to inaccurate results.
•   To prevent contamination, only touch the sides of the Test Device and ensure the Swab end only touches the nasal cavity and inside of Tube.
•   The provided Swab should be used only for nasal (mid-turbinate) specimen collection.
•   Each single Test Device, Swab, Tube, Blue Cap, Buffer Bottle and Bag are single-use. Do not reuse individual components. The Tube Rack is reusable.
•   Do not dip the Swab into buffer or other liquid before inserting the Swab into the nose.
•   The provided Buffer Bottle contains <0.1% sodium azide as a preservative which may be toxic if ingested. If you get buffer solution into your eyes rinse for at least 15 minutes under running water. If irritation persists, go to a doctor.
•   If you have stored the kit in the refrigerator, store the kit at room temperature (15 to 30°C) for 30 minutes before use.
•   Do not use the test kit if the pouch is damaged or the seal is broken.
•   Direct swab specimen should be tested immediately after collection.
•   Do not use the test kit beyond the expiration date as indicated on the outer package.
•   Perform the test immediately after removing the Test Device from the protective packaging.

Storage of Panbio Covid 19 Antigen Self Test Kit:

• Store the test kit in a cool, dry place (at 2-30 °C) at protected direct sunlight. Do not freeze the kit or its components.
• Keep the test kit out of reach of children.

Possible risks of Panbio Covid 19 Antigen Self Test Kit:

• Slight discomfort during the nasal sample collection.
• Possible false test results may occur, if symptoms continue, you should repeat the test after 1-2 days, 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.

Panbio™ COVID-19 Antigen Self-Test Frequently Asked Questions for Consumers

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. Antibody tests cannot be used to diagnose an active 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. Discomfort may occur if the swab is inserted beyond the recommended depth. If painful, slightly withdraw the swab to finish the sample collection process.

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?

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. 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.

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. 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 and contact your doctor or local health department immediately.

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. 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 may be negative before you develop symptoms.
• The test was not performed per the instructions.
• Specimen collection, extraction or transport was not performed correctly.

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 as 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.