Abbott Panbio Covid 19 Antigen Self Test Kit

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). 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. The Panbio™ COVID-19 Antigen Self-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. The product includes a test device, a bottle with buffer solution, an extraction tube/cap and a nasal swab.

Uses:
This kit is used to determine whether an individual has an active Covid-19 infection.

Product Specifications and Features:

• The test can determine if you have an active COVID-19 infection and provides 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

• Each kit includes 1 swab, 1 bag, 1 tube rack, 1 buffer bottle, 1 tube, 1 blue cap, 1 test device and 1 instruction for use manual

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

• Customer Care Number: 1800 309 0180

Directions For Use:
The following instructions are the test procedure to complete a single test. The 4 tests, 10 tests and 20 tests kits include components to complete multiple tests. If more than one individual will be tested, separate the test components to avoid confusion.

Before starting:

• Scan the QR code on page 1 to download the NAVICA app. Open the app and follow the prompts to complete the test

• Wash or sanitize your hands. Make sure they are dry before starting

Prepare for the test:

• Check the expiration date on the box. Do not use it if the kit is expired

• Ensure the kit is at room temperature for at least 30 minutes prior to use. Open the box and remove 1 each of the components to perform a single test. Do not open individual components until instructed

• Note: A timing device (clock, timer, etc.) is required, but not provided

• Keep buffer bottle upright, twist and pull tab to open the bottle

• Squeeze the liquid from the buffer bottle into the tube. You will need to squeeze at least twice

• Note: Check the liquid level. The liquid should be at or slightly above the fill line on the side of the tube

• Put the Tube into the tube rack before proceeding to the next step

Collect the Nasal Sample:

• Keep fingers away from the swab end

• Open swab protective package at stick end. Take the swab out

• Swab both nostrils. Insert the soft end of the swab straight back into your nostril until resistance is felt (about 2cm). Slowly rotate the swab, gently rubbing it along the insides of your nasal passage at least 5 times. Remove the swab from the nostril

• Using the same swab, repeat the above step in your other nostril. Check: Did you swab BOTH nostrils?

• Insert the swab into the tube. Swirl in the fluid 5 or more times while pushing against the wall of the tube. Pinch the swab tip through the tube to remove any remaining fluid

• Hold the tube firmly with one hand. Lift the swab and locate the break line. Snap the swab handle at the break line. Leave the swab in the tube and discard the stick

• Note: After the swab is inserted in the buffer, the inactivation properties of the buffer plus the physical barrier of the closed extraction tube, help neutralize the COVID-19 virus

• Secure the Blue Cap on the top of the Tube. Return the Tube to the Tube Rack before proceeding to the next step

Perform the test:

• Remove the Test Device from its protective package and place it on a well-lit, flat surface

• Check liquid for bubbles. Wait for any bubbles to disappear as they can lead to inaccurate results. Keep the Tube vertical with the white cap pointed down. Remove the white cap. Do not move the Test Device until the test is finished

• Squeeze 5 drops of liquid from the Tube into the well on the Test Device. Secure white cap back on Tube and wait 15 minutes

• Note: If clogging occurs, gently tap the bottom of the tube to release the blockage. Do not touch the Test Device during this period

• Keep the Test Device flat on the table. After 15 minutes, use the NAVICA app to take a photo of the Test Device and submit your result. The app will automatically submit your result to ICMR and display your test result. Do not read the result earlier than 15 minutes or after 20 minutes

• Note: A Control (C) line may appear in the result window within a few minutes but a Test (T) line may take as long as 15 minutes to appear. Note: After 20 minutes the result might become inaccurate

Read the test result:

Invalid Result (test did not work)
Find the result window. If NO Control (C) line is present, the test did not work and is considered Invalid. This may be the result of an incorrect test procedure and the test should be repeated.

Positive Result
Find the result window and look carefully for two lines. Positive Result: If you see two lines, Control (C) line and Test (T) line, this means COVID-19 was detected. If positive, please contact your doctor or local health department immediately and follow local guidelines for self-isolation.

Negative Result
Find the result window and look for a single line in the window. Negative Result: If you see only the Control (C) line is present, this means COVID-19 was not detected. If the rapid antigen test results are negative and symptoms continue, individuals should immediately be tested by RT-PCR per ICMR Advisory. You are also advised to continue following local guidelines for self-isolation and consult your doctor. Ministry of Health & Family Welfare, Government of India (https://www.mohfw.gov.in)

Dispose of the test kit:

• Place swab, tube and test device into the bag

• Seal the bag tightly

• Throw away the bag in the waste bin

Safety Information:

• 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 the bag provided

• Use only the liquid from the Buffer Bottle provided in the kit. The use of other liquids will lead to inaccurate results

• Keep the test kit out of reach of children

• 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 the 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

Frequently Asked Questions FAQs:

Q. 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. 

Q. 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. 

Q. 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.

Q. 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. 

Q. 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. 

Q. 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. 

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

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

Q. 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. 

Q. 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.  

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

Q. 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.

Q. 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. 

Q. 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.

Q. 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. 

Visit Ministry of Health & Family Welfare, Government of India https://www.mohfw.gov.in