Panbio COVID-19 Ag Rapid Test, kit/25T

General description:
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.

Technical specifications:
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 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

Shelf life:
24 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
General recommendations:
·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.

Useful links:
WHO EUAL - IFU can be found here: