Details
RAT Rapid Antigen Test: COVID-19 AG Rapid Test Device (NASAL) (Box of 25)
Quick and effective RAT Rapid Antigen Test.
Complete package – rapid antigen test:
- Test Kits
- Training Package
Read more about RAT:
In vitro diagnostic rapid test for qualitative detection of SARS-CoV-2
antigen (Ag)
Test Principle
Panbio™ COVID-19 Ag Rapid Test Device contains a membrane strip, which is pre-coated with immobilized anti-SARS-CoV-2 antibody on the test line and mouse monoclonal anti-chicken IgY on the control line. Two types of conjugates (human IgG specific to SARS-CoV-2 Ag gold conjugate (binds to the nucleocapsid protein) and chicken IgY gold conjugate) move upward on the membrane chromatographically and react with anti-SARS-CoV-2 antibody and pre-coated mouse monoclonal anti-chicken IgY respectively. For a positive result, human IgG specific to SARS-CoV-2 Ag gold conjugate and anti-SARS-CoV-2 antibody will form a test line in the result window. Neither the test line nor the control line are visible in the result window prior to applying the patient specimen. A visible control line is required to indicate a test result is valid.
Intended Use
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.
The product may be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation.
The test provides preliminary test results. Negative results don’t preclude SARSCoV-2 infection and they cannot be used as the sole basis for treatment or
other management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The test is not
intended to be used as a donor screening test for SARS-CoV-2.
Materials Provided
• 25 Test devices with desiccant in individual foil pouch
• Buffer (1 x 9 ml/bottle)
• 25 Extraction tubes
• 25 Extraction tube caps
• 1 Positive control swab
• 1 Negative control swab
• 25 Sterilized nasal swabs for sample collection
• 1 Tube rack
• 1 Quick Reference Guide
• 1 Instructions 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
Active Ingredients of Main Components
• 1 Test device Gold conjugate: Human IgG specific to SARS-CoV-2 Ag gold
colloid and Chicken IgY – gold colloid, Test line: Mouse monoclonal antiSARS-CoV-2, Control line: Mouse monoclonal anti-Chicken IgY
• Buffer Tricine, Sodium Chloride, Tween 20, Sodium Azide (<0.1%), Proclin 300
Storage and Stability
1. The test kit should be stored at a temperature between 2-30 °C. Do not freeze the kit or its components.
Note: 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 roomtemperature.
2. The Buffer bottle may be opened and resealed for each assay. The Buffer capshould be firmly sealed between each use. The Buffer is stable until expiration
date if kept at 2-30 °C.
3. Perform the test immediately after removing the test device from the foil pouch.
4. Do not use the test kit beyond its expiration date.
5. The shelf life of the kit is as indicated on the outer package.
6. Do not use the test kit if the pouch is damaged or the seal is broken.
7. Direct swab specimens should be tested immediately after collection. If immediate testing is not possible, the swab specimen can be kept in an
extraction tube filled with extraction buffer (300 μl) at room temperature (15-30 °C) for up to two hours prior to testing.
