Abbott Panbio Antigen Self Test Kit (COVID 19)
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.
PRODUCT INFO
CONTENTS
• 1 Instructions for Use
• 1 Test Device
• 1 Tube
• 1 Blue Cap
• 1 Buffer Bottle
• 1 Swab
• 1 Bag
STORAGE and STABILITY
1. Store the test kit in a cool, dry place (at 2-30 °C). Do not freeze the kit or its
components.
2. Do not use the test kit beyond the expiration date as indicated on the outer package.
3. Perform the test immediately after removing the Test Device from the protective
packaging.
4. Do not store the test kit in direct sunlight.
WARNINGS and PRECAUTIONS
1. For in vitro diagnostic use only.
2. Read instructions prior to preforming the test. Follow all instructions to achieve
accurate results.
3. Do not eat or smoke while handling specimens.
4. Wash hands thoroughly before and after the test is completed.
5. Clean up spills thoroughly using an appropriate disinfectant.
6. Dispose of all specimens, reaction kits and potentially contaminated materials (i.e.
Swab, Tube, Test Device) in bag provided.
7. Use only the liquid from the Buffer Bottle provided in the kit. Use of other liquids will
lead to inaccurate results.
8. Keep the test kit out of reach of children.
9. 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.
10. The provided Swab should be used only for nasal (mid-turbinate) specimen collection.
11. The Swab, Buffer Bottle and Test Device are single use. Do not reuse.
12. Do not dip the Swab into buffer or other liquid before inserting the Swab into the nose.
13. 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.
14. If you have stored the kit in the refrigerator, store the kit at room temperature (15 to
30°C) for 30 minutes before use.
15. Do not use the test kit if the pouch is damaged or the seal is broken.
16. Direct swab specimen should be tested immediately after collection.
How accurate is the Panbio™ COVID-19 Antigen Self-Test?
The Panbio™ COVID-19 Antigen Self-Test has been shown in clinical evaluations, performed
by professional health care persons, to correctly identify 99.8% (403 out of 404) of SARSCoV-2 negative nasal samples with a confidence interval of 98.6% to 100.0% (known as test
specificity). The test correctly identified 98.1% (102 out of 104) SARS-CoV-2 positive nasal
samples with a confidence interval of 93.2% to 99.8% (known as test sensitivity).
In a clinical evaluation of 483 asymptomatic patients the Panbio™ COVID-19 Antigen
Self-Test showed a sensitivity of 93.8% (confidence interval: 79.2% to 99.2%) of SARSCoV-2 positive samples at lower Ct (cycle threshold, values of ≤30) which corresponds to
higher virus concentrations. In this study, the specificity was 100.0% (433 out of 433) with a
confidence interval of 99.2% to 100.0%.
All samples were confirmed positive and negative by a RT-PCR test approved by the US
FDA for emergency use.
What is the best time to read the results?
15 minutes.
RETURN & REFUND POLICY
No return or refund of items due to hygiene purposes.
SHIPPING INFO
Call GoAid.SG at 96492693 for info about shipping or delivery.