Panbio Ag Rapid

Test Device 41FK11/41FK21
In vitro diagnostic rapid test for qualitative detection of SARS-CoV-2
antigen (Ag)

(NASAL)

About the Test

Introduction
The Coronavirus disease (COVID-19) is an infectious disease caused by a
newly discovered coronavirus, severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2)1
. The SARS-CoV-2 is a β-coronavirus, which is an enveloped
non-segmented positive-sense RNA virus2
. It is spread by human-to-human
transmission via droplets or direct contact, and infection has been estimated to
have a mean incubation period of 6.4 days and a basic reproduction number of
2.24-3.58. Among patients with pneumonia caused by SARS-CoV-2, fever was
the most common symptom, followed by cough3
. The main IVD assays used for
COVID-19 employ real-time reverse transcriptase-polymerase chain reaction
(RT-PCR) that takes a few hours4
. The availability of a cost-effective, rapid pointof-care diagnostic test is critical to enable healthcare professionals to aid in the
diagnosis of patients and prevent further spread of the virus5
. Antigen tests will play
a critical role in the fight against COVID-196
.

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.

Kit Variants

• 41FK11 No 2D barcode printed on the contained test devices
• 41FK21 Contains test devices with a 2D barcode printed on the test device,
which encodes traceability information for the product
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 room
temperature.
2. The Buffer bottle may be opened and resealed for each assay. The Buffer cap
should 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