Panbio COV-19 Ag RDT,(NASAL) kit/25T

In vitro diagnostic rapid test for qualitative detection of SARS-CoV-2 antigen. (Ag).

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 nasal 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.

Technical specifications:
Technology: Lateral flow immunochromatographic test.
Format: Cassette, 25 tests
Sample type: NASAL swab.
Clinical performance characteristics: Clinical performance evaluation was determined by using an FDA EUA RT-PCR reference method.
Clinical sensitivity: 98.1%
Clinical specificity: 99.8%
Reading time: 15-20 minutes.

Manufacturer product reference: 41FK11

Items supplied with:
·25 x Test devices with desiccant in individual foil pouch.
·1 x Buffer bottle. (9 mL)
·25 x Sterilized nasal 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.
·1 x IFU.

Materials required, but not Provided:
Other important items:
·Personal Protective Equipment per local recommendations (i.e. gown/ lab coat, face mask, face shield/eye goggles and gloves), Timer, Biohazard container.

Shelf life:
24 months (real-time stability studies are ongoing)..

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. Do not open the pouch while components come to room
temperature. Do not freeze the kit or its components.

Packaging & labelling:
Primary packaging: All contents of Panbio COVID-19 Ag Rapid Test Device (NASAL), kit/25 tests.
Secondary packaging: One kit Panbio COVID-19 Ag Rapid Test Device (NASAL) 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.
·Do not mix reagent of different lots or those for other products.
·Do not store the test kit in direct sunlight.

Useful links:
WHO EUAL - IFU can be found here