COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is
1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue, and dry cough. Nasal congestion, runny nose, sore throat, myalgia, and diarrhea are found in a few cases.
The Panbio™ COVID-19 Ag Rapid Test Device (nasal) is a high-performance rapid test for patients suspected of current COVID-19 infection.
The Panbio™ enables immediate treatment or isolation measures to minimize transmission.
- Patient-friendly nasal or nasopharyngeal sample collection types.
- Accessible, large-scale testing helps contain the virus spread.
- Fast identification of potentially contagious individuals.
- Test results are obtained in 15 minutes.
- Deploy at a large scale at point-of-care.
- Can be used in a wide variety of non-laboratory settings.
- No special/additional instruments are required.
- A self-contained tube with a “break off” swab minimizes staff exposure.
- The extraction tube is fully enclosed for disposal.
What are the potential benefits and risks of this test?
- The test can determine if you have an active COVID-19 infection.
- 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.
- 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.
- Negative result: The presence of only the control line (C) and no test line (T) within the result, the window indicates a negative result.
- Positive result: The presence of the test line (T) and the control line (C) within the result window, regardless of which line appears first, indicates a positive result.
Caution: The presence of any test line (T), no matter how faint, indicates a positive result.
- Invalid result: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid.
What does it mean if I have an invalid result?
- This may be a result of incorrect test procedures. Wait 24 hours before repeating the test.
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.
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.
HOW TO USE
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 performing 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 a bag provided.
7. Use only the liquid from the Buffer Bottle provided in the kit. The 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 a 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.
Each box of 10 contains:
- 10 Test devices with desiccant in individual foil pouch
- 10 Buffer bottles
- 10 Extraction tubes
- 10 Sterilized nasal swabs for sample collection
- 10 Bags
- 1 Tube rack
- 1 Quick Reference Guide
- 1 Instruction for use
Materials Required but not Provided
• Personal Protective Equipment per local recommendations (i.e. gown/ lab coat, face mask, face shield/eye goggles, and gloves), Timer, Biohazard container.
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All prices are listed in USD.