antigen test
SARS-CoV-2 and influenza A/B

Fast answers, combined
Rapid detection and differentiation between SARS-CoV-2, Influenza A and Influenza B virus with a truly integrated test requiring a single sample to optimise patient care.

Key benefits
✓ Reliable test performance
✓ Quick answers in as little as 15 minutes
✓ S upport differential detection of SARS-CoV-2, influenza virus A and influenza virus B
✓ S imple operation, only 4 steps required
✓ Fully integrated test, only one scope and one sample required
✓ O ptimised formulation to detect antigens against different dominant variants of SARS-CoV-2
✓ Access to testing in areas where laboratory testing is not available
✓ Data matrix code on each test device for easier sharing of results

Performing the test
Easy to perform and quick results within 15 - 30 min*

step 1
Collection of nasopharyngeal sample
Insert a sterile cotton swab into the patient's nostril. Rotate the swab 3 to 4 times against the nasopharyngeal surface and then leave the swab in place for 10 seconds to absorb the secretions. Pull the swab out of the nasal cavity.

step 2
Sample preparation
A. Place the swab in an extraction buffer tube. While squeezing the buffer tube, stir the swab at least 10 times.
B. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
C. Press the cap of the mouthpiece firmly onto the tube.
(Warning!) Failure to squeeze the tube may lead to incorrect results due to excess buffer in the swab.

step 3
Performing the test
Place the test device on a flat surface and apply 4 drops of the extracted sample at a 90° angle to the sample opening of the test device.

step 4
Read the results
Read the test result after 15 to 30 minutes. Do not touch or move the test device until the result can be read.
(Warning!) Test results read before 15 minutes or after 30 minutes may be incorrect.

* Before using the SARS-CoV-2 & Flu A/B rapid antigen test, carefully read the instructions for use provided in the kit.

Information on test kits
Each kit contains 25 individually packaged, ready-to-use tests.
The following components are required for a test and are included in the kit:
✓ Device testing
✓ Mouthpiece cap
✓ Extraction buffer tube
✓ Buffer tube holder
✓ Sterile nasopharyngeal smears
✓ 1 set of positive and negative cotton swabs for quality control
✓ Instructions for use
✓ Brief instructions

Digital connectivity
The SARS-CoV-2 Rapid Antigen Test 2.0 is equipped with a 2D data matrix code and a unique identifier printed on each test cassette. The 2D code complies with the general industry standard GS1 and can be read and interpreted by any IT system compatible with standard 2D data matrix codes.
Data matrix code
The 2D data matrix code is unique to each test device.
The following elements are encoded in a digitally readable format:
Lot number
Expiry date
GTIN (global trade item number)
Reference to source entity (ie identification of manufacturing plant)
Serial number (ie 6-digit ID printed on the test cassette - unique per lot range)
The unique identification of each test device allows one-to-one assignment of test results to individuals. This facilitates storage of test results under the corresponding patient ID in electronic medical records. Digital reading of the data matrix code can lead to more efficient processes, especially in testing environments
with high throughput.

Features of SARS-CoV-2 and influenza A/B rapid antigen test
Assay format: Lateral flow test / immunochromatographic
Instrument: No
Time testing: 15-30 minutes
Antigen: Nucleocapsid protein (N)
Sample material: Nasopharyngeal smear
Reagents: mAb anti-Influenza virus A and B antibody, mAb anti-SARS-CoV-2 antibody, mAb anti-chicken IgY antibody, mAb anti-Influenza virus A and B antibody-gold conjugate, mAb anti-SARS-CoV-2 antibody-gold conjugate and purified chicken IgY antibody-gold conjugate