Panbio COVID-19 Ag Rapid Test Device - User Product Training FOR EXTERNAL USE

Panbio™ COVID-19 Ag
Rapid Test Device

User Product Training

FOR EXTERNAL USE

Panbio™ COVID-19 Ag Rapid Test Device

• In vitro diagnostic rapid test for qualitative detection of SARS-CoV-2
  antigen (Ag)
• Detects nucleocapsid protein inside the SARS-CoV-2 virus

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Intended Use

Panbio™ COVID-19 Ag Rapid Test Device is an in vitro diagnostic rapid test for the
qualitative detection of SARS-CoV-2 antigen (Ag) in human nasopharyngeal swab
specimens from individuals who meet COVID-19 clinical and/or epidemiological criteria.

Panbio™ COVID-19 Ag Rapid Test Device is for professional use only and is intended to be
used as an aid in the diagnosis of SARS-CoV-2 infection. The product may be used in any
laboratory and non-laboratory environment that meets the requirements specified in the
Instructions for Use and local regulation.

The test provides preliminary test results. Negative results don’t preclude SARS-CoV-2
infection and they cannot be used as the sole basis for treatment or other management
decisions. Negative results must be combined with clinical observations, patient history,
and epidemiological information. The test is not intended to be used as a donor screening
test for SARS-CoV-2.

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Product Information
Cat No/REF:     41FK10

Sample Type:    Nasopharyngeal swab
Quantity:       25 tests/kit

Storage:        2-30°C
Shelf Life:     12 months

Test Time:      15 minutes
                do not read results after 20 minutes

Multiple
Language IFU:   English            Italian
                German             Portuguese
                Spanish            Russian
                French

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Kit Contents: Everything Needed to Run a Test

MATERIALS PROVIDED                                REQUIRED BUT NOT PROVIDED
• 25 Test devices with desiccant in               •   Personal protective equipment (PPE)
  individual foilpouch                            •   Protective gloves
• 1 Buffer (1 x 9 ml/bottle)                      •   Timer
• 25 Extraction tubes                             •   Biohazard container
• 25 Extraction tube caps
• 25 Sterilized nasopharyngeal swabs for sample
  collection
• 1 Positive control swab
• 1 Negative control swab
• 1 Tube rack
• 1 Quick reference guide (Nasopharyngeal)
• 1 Instructions for use

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Specifications
PERFORMANCE
• Sensitivity: 91.4% (94.1% for samples with Ct values ≤33)
• Specificity: 99.8%

SPECIFICATIONS
• Test time: 15 minutes (do not read results after 20 minutes)
• Storage: 2°C–30°C
• CE Mark
• WHO EUL
• Sample Type: Nasopharyngeal swab

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Test Preparation
                   Read instructions prior to using the
                   Panbio COVID-19 Ag test kit.

                   Comply with personal safety
                   guidelines including the use of
                   personal protective equipment.

                   Collect all items required for
                   running a test.

                   Allow all components to come to
                   room temperature (15 - 30◦C) before
                   use.

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Test Preparation
                   Check expiry date on the back of the
                   test device pouch. Assure pouch is not
                   damaged.

                   Remove test device from pouch just
                   before testing.

                   Place on a flat surface and write
                   patient ID on device

Test Preparation

                   Hold buffer bottle vertically to dispense
                   buffer fluid into the extraction tube to the
                   marked line (about 300µl)

                   If multiple extraction tubes are in tube
                   rack, label the extraction tube.

                   Place the extraction tube into the
                   provided tube rack.

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Sample Collection

                                                               Using the nasopharyngeal swab provided
                                                               in test kit, collect the sample as shown. **

                                                               Gently rub and roll swab 3 – 4 times.
                                                               Leave swab in place for a few seconds
                                                               before removing slowly.

                                                               Place the swab into the extraction tube
                                                               immediately.

** If a training reference is needed for the nasopharyngeal swab technique, one can be found here from the New England
   Journal of Medicine: https://www.nejm.org/doi/full/10.1056/NEJMvcm2010260
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Test Procedure

                 Swirl the swab tip in the buffer fluid,
                 pushing into side of extraction tube,
                 at least 5 times.

                 Squeeze the swab against the
                 extraction tube wall with your fingers.

                 Break the swab at breakpoint as
                 shown and close cap.

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Test Procedure

                 Open the dropping nozzle cap and add
                 5 drops of sample vertically into
                 sample well of test device.

                 Close nozzle with cap and dispose the
                 extraction tube into biohazard waste.

                 Start a timer for 15 minutes to read
                 the test result. DO NOT read after 20
                 minutes.
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Simple Results Interpretation

                                           Invalid

            NOTE: the presence of any test line (T), no
            matter how faint, indicates a positive result.
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Full Test Method

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Test Limitations Reminder

1. The contents of this kit are to be used for the professional and qualitative detection of SARS-CoV-2
   antigen from a nasopharyngeal swab sample. Other specimen types may lead to incorrect results and
   must not be used.
2. Failure to follow the instructions for the test procedure and interpretation of test results may adversely
   affect test performance and/or produce invalid results.
3. A negative test result may occur if the specimen was collected, extracted or transported improperly. A
   negative test result does not eliminate the possibility of SARS-CoV-2 infection and should be confirmed
   by viral culture or a molecular assay or ELISA.
4. Positive test results do not rule out co-infections with other pathogens.
5. For further information on immune status, additional follow-up testing using other laboratory methods
   is recommended.
6. Test results must be evaluated in conjunction with other clinical data available to the physician.
7. Reading the test results earlier than 15 minutes or later than 20 minutes may give incorrect results.
8. Panbio™ COVID-19 Ag Rapid Test Device is not intended to detect from defective (non-infectious) virus
   during the later stages of viral shedding that might be detected by PCR molecular tests.
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Quality Control

INTERNAL
Control line (C) on the test device is a procedural control and indicates the procedure is
performed properly and reagents are working.

EXTERNAL
Controls provided in test kit should be used to:
-   Verify user can perform test and interpret results correctly
-   Ensure test reagents are working and test performed correctly
It is recommended to run controls:
-   With each new operator prior to testing on patient samples
-   When receiving a new shipment
-   At periodic intervals according to local Regulations

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Key Points to Remember
•    Follow instructions for use, in order to achieve accurate results
•    Prepare all test components before specimen collection
•    Always wear personal protective equipment including protective gloves when handling
     specimens
•    Ensure the correct amount of buffer is added to extraction tube
•    Only use dedicated nasopharyngeal swabs provided for sample collection
•    Test devices are single use only
•    Treat all specimens as potentially infectious samples
•    Discard all items into appropriate biohazard containers
•    Do not mix components of the test kits

© 2020 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners. Any photos displayed are for illustrative purposes only.
Any person depicted in such photos is a model. 120007278-01 10/20