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 test provides preliminary test results and they cannot be used as the sole basis for treatment or other management decisions. The test is not intended to be used as a donor screening test for SARS-CoV-2.
Technology: Lateral flow immunochromatographic test
Format: Cassette, 25 tests
Sample type: Nasopharyngeal swab
Clinical performance characteristics: Clinical performance evaluation was determined by using an FDA EUA RT-PCR reference method.
Clinical sensitivity: 91.4%
Clinical specificity: 99.8%
Reading time: 15-20 minutes
Manufacturer product reference: Abbott, 41FK10
Items supplied with:
·25 x Test devices with desiccant in an individual foil pouch
·1 x Buffer bottle (9 mL)
·25 x Sterilized nasopharyngeal swabs for sample collection
·25 x Extraction tubes
·25 x Extraction tube caps
·1 x Positive control swab
·1 x Negative control swab
·1 x Tube rack
·1 x Quick reference guide (Nasopharyngeal)
·1 x IFU
Materials required, but not Provided:
•Personal Protective Equipment, Timer, Biohazard container
12 months from the date of manufacturing; do not use beyond its expiry date.
Weight & volume:
Estimated weight: 0.44 kg
Estimated volume: 4.312 dm3
Storage & transportation condition:
Must be stored at 2 – 30°C. Protect against direct sunlight. Do not freeze the kit. When stored in a refrigerator, all kit components must be brought to room temperature (15-30 °C) for a minimum of 30 minutes prior to performing the test.
Packaging & labelling:
Primary packaging: All contents of Panbio COVID-19 Ag Rapid Test Device, kit of 25 tests
Secondary packaging: One kit Panbio COVID-19 Ag Rapid Test Device, kit/25 tests
·Do not re-use the test kit.
·Do not use the test kit if the pouch is damaged or the seal is broken.
·Do not mix reagents of different lots.
·Wear personal protective equipment, such as gloves and lab coats when handling kit reagents. Wash hands thoroughly after the tests are done.
The Panbio is a rapid antigen test kit from Abbott that uses a nasal swab to detect the presence of the nucleocapsid protein SARS-CoV-2 antigen (Ag). You can now easily perform a Covid test at home because the Panbio™ COVID-19 Antigen Self-Test is specially designed so that even a layman can do it without any technical training.
The Panbio Corona test kit can be used at home or even in a public place by anyone to identify whether a person is infected with COVID-19.
Specification and Features:
- The Panbio rapid COVID test contains antibodies that can detect the presence of the SARS-CoV-2 nucleocapsid protein antigen in the nasal swab sample.
- The Panbio rapid antigen test for COVID-19 is a complete test kit that contains swab, bag, tube rack, buffer bottle (liquid), test tube, test tube cap, test device, and instruction manual with the help of which anyone can successfully perform the test on themselves or others.
- The speciality of this rapid test kit is that it can provide you with results of whether or not you have the COVID-19 infection in just 15 minutes.
- For most illnesses nowadays, conducting a COVID test before any other treatment has become almost mandatory. Therefore, your primary healthcare physician can use this COVID test kit to determine the necessary course of treatment for you in case of any illness.
- Moreover, the Panbio COVID antigen test allows you to know beforehand whether you have the virus or not so that you can take additional precautionary measures to prevent spreading it to others around you.
Directions for Use:
- Step 1: Install the NAVICA app on your smartphone. Wash your hands & get ready to begin the test.
- Step 2: Pour enough of the liquid from the buffer bottle provided in the Panbio rapid antigen test kit into the test tube till the marked limit.
- Step 3: Peel the swab stick and avoid touching the cotton swab with your hands.
- Step 4: Swirl the cotton swab 5 times each inside both of your nostrils and place the cotton swab stick into the test tube and snap off the extra stick protruding out of the tube.
- Step 5: Close the blue lid on the test tube and let it rest for 15 minutes on the tube rack.
- Step 6: After 15 minutes, open the bottom cap of the test tube to reveal a dropper and pour 5 drops of the liquid onto the Panbio™ rapid antigen testing device.
- Step 7: Wait for 15 to 20 minutes for the results to show up on the testing device.
- Step 8: You can now open the NAVICA app on your smartphone to complete the test.
How to Check Result:
- Positive Result: If both the Control (C) and Test (T) lines appear, it means you have tested positive for COVID-19. Even if the ‘T’ line is slightly visible or faded, it still means the result is positive.
- Negative Result: If only the ‘C’ line appears, it means you have tested negative for COVID-19.
- Invalid Result: If only the ‘T’ line appears, it means the test was invalid and inconclusive. Therefore, you will have to perform the test again with a fresh Panbio Corona test kit.
Q1: How do I dispose of the Panbio test kit after I’m done testing?
Ans: Place the test tube with the swab, the liquid dropper and its cap, as well as the testing device into the plastic bag provided and seal it firmly. Only then can you dispose of this plastic bag in a waste bin.
Q2: How long should I wait if the ‘T’ line does not appear?
Ans: You should wait no longer than 20 minutes because any results that show after 20 minutes are considered inconclusive or invalid.
Q3: How do I ensure that my COVID-19 test does not turn out invalid?
Ans: You can ensure accurate results if you follow these safety procedures:
- Do not touch the cotton end of the swab.
- Touch only the sides of the testing device.
- Do not eat with your hands during the test.
- Do not dip the swab into the liquid before putting it inside your nose.
- Insert the cotton swab immediately into the test tube after you’ve collected the sample from your nose.