The Panbio™ COVID-19/Flu A&B Panel Self Test is an in vitro (outside the body) diagnostic rapid test for the qualitative detection of COVID-19 and/or Flu A and/or Flu B in human nasal swab samples from individuals suspected of having an active COVID-19 or Flu infection. Panbio™ COVID-19/Flu A&B Panel Self Test is a manual test and is intended to be used by untrained lay users (self testing) in a home setting to aid in the diagnosis of an active COVID-19, Flu A or Flu B infection. The test provides preliminary test results. Negative results don’t exclude COVID-19, Flu A or Flu B infection.

Functionality
The Panbio™ COVID-19/Flu A&B Panel Self Test is a lateral flow test that detects COVID-19 and/or Flu A and/or Flu B in a swab sample from the mid turbinate nasal region (nasal swab). To use the test, a nasal swab is transferred to the buffer tube to extract COVID-19, Flu A and Flu B virus proteins. Next, 4 drops of extracted sample are applied to the round well on the test device. For a positive result, each pathogen of COVID-19, Flu A or Flu B will form a test line in the result window. Neither the test line nor the control line are visible in the result window prior to applying the extracted sample. A visible control line is required to indicate a test result is valid. The test is intended to give a differential diagnosis of an active COVID-19, Flu A or Flu B infection. Individuals under 16 years should be supported by an adult.

Target customer groups
Panbio™ COVID-19/Flu A&B Panel Self Test is a manual test and is intended to be used by untrained lay users (self testing) in a home setting to aid in the diagnosis of an active COVID-19, Flu A or Flu B infection. All Adults and Children age 1yr +

List of ingredients
Gold conjugates Monoclonal anti-SARS-CoV-2, anti-Influenza A, anti-Influenza B and
Chicken IgY coated gold colloid. (Total concentration: 0.433 μg)
Test line Monoclonal anti-SARS-CoV-2, monoclonal anti-Influenza A, monoclonal
anti-Influenza B. (Total concentration: 1.92 μg)
Control Line Monoclonal anti-Chicken IgY (0.48 μg) Extraction buffer Sodium Azide (<0.1 %)

Usage Instructions
BEFORE STARTING: Wash or sanitize your hands. Make sure they are dry before starting.
A. PREPARE FOR THE TEST: Check the expiration date on the box. Do not use if the kit is expired.

Way of storage
2 °C - 30 °C

Caution/Warning
1. For in vitro (outside the body) diagnostic use only.
2. Do not store the test kit in direct sunlight.
3. Keep the test out of reach of children and pets.
4. Read instructions prior to performing the test. Follow all instructions to achieve accurate results.
5. Individuals below 16 years of age and persons with reduced physical, sensory or mental capabilities,
should be swabbed and supervised by an appropriate person responsible for their safety.
6. Do not use the test kit if the pouch is damaged or the seal is broken.
7. Do not eat, drink or smoke while performing the test.
8. Wash hands thoroughly before and after the test is completed.
9. Use only the components provided in the kit.
10. Each test device, swab, buffer tube, nozzle cap and waste bag are for single use.
11. Nasal swab samples should be tested immediately after collection.
12. The sterilized swabs should be used only for nasal sample collection.
13. To avoid contamination, do not touch the head of provided swab when opening the swab pouch.
14. Do not dip the swab into buffer or other liquid before inserting the swab into nose.
15. To avoid contamination, ensure the swab end only touches the nasal cavity and then inside of the
provided buffer tube.
16. Avoid splashing or vapour formation of sample and buffer.
17. Do not dilute the collected swab sample with any solution except for the provided buffer. Use of other
liquids will lead to inaccurate results.
18. The swab should not be used on the test if there is any blood present on the swab as a result of a nose
bleed.
19. To avoid cross-contamination, do not reuse the swabs for sample collection.
20. Do not mix or interchange different samples.
21. Only touch the sides of the test device.
22. Dispose of all used single use components in the waste bag provided and place into waste bin.
23. The perforated hole incorporated in the top of the 4 Test kit box is reusable. The tube rack provided with
the 10 Test or 20 Test kit is reusable.
24. The provided buffer tube contains <0.1 % sodium azide as a preservative which may be toxic if ingested.
If accidental ingestion occurs, rinse your mouth with water immediately and seek medical advice. If the
solution contacts the eye or skin, flush with plenty of water for at least 15 minutes and seek medical
advice7.
25. Clean up any spills thoroughly using an appropriate disinfectant.