25 x Covid & Flu A/B Rapid Antigen Tests

Rapid answers, combined.

With similar symptoms for SARS-CoV-2 and Influenza A and B, healthcare professionals need to quickly determine which infection is potentially present.​ The SARS-CoV-2 & Flu A/B Rapid Antigen Test helps healthcare professionals at the point of care to quickly diagnose and differentiate infections with any of the three respiratory viruses and aid in pursuing appropriate courses of action, including patient and pandemic management decisions. Also, it enables scaling up test capacities during flu season to meet the need for extensive testing during peak periods.

Key features

• Reliable test performance
• Rapid answers in only 15 minutes
• Supports optimised patient care based on the differentiation of SARS-CoV-2 and Influenza A and B
• Easy handling, only 4 steps needed
• Fully integrated test, only one strip and one sample are needed
• Detects SARS-CoV-2, including Delta and Omicron variants¹

Test principle

The SARSCoV2 & Flu A/B Rapid Antigen Test is a rapid chromatographic immunoassay for the simultaneous detection and differentiation of the nucleocapsid protein antigens of SARSCoV2, influenza virus A and influenza virus B present in the human nasopharynx. It can be used to assess whether a person currently has any of the three viral respiratory infections by providing a qualitative result showing coloured bands indicating the presence of a specific antigen, based on the nucleocapsid protein of the different pathogens.²

Structure of -SARS-CoV-2 virus^3-5

• Nucleocapsid protein (N)
• Envelope protein (E)
• Membrane glycoprotein (M)
• Spike protein (S)

Structure of Influenza A and B virus⁶

• Surface Proteins (SP): HA & NA*
• Nucleocapsid protein (N)

*Hemagglutinin (H or HA), Neuraminidase (N or NA)

How to perform a test

Testing process for the SARS-CoV-2 & Flu A/B Rapid Antigen Test only takes a few steps.

Nasopharyngeal swab

1. Insert a sterile swab into the nostril of the patient
2. Rotate the swab 3-4 times against the nasopharyngeal surface, then leave the swab in place for 10 seconds to absorb secretions.
3. Withdraw the swab from the nasal cavity.

Prepare the sample

1. Insert the swab into an extraction buffer tube. While squeezing the buffer tube, stir the swab more than 10 times.
2. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
3. Press the nozzle cap tightly onto the tube.

WARNING! Failure to squeeze the tube can lead to incorrect results due to excess buffer in the swab.

Drop of sample

Place the test device on a flat surface and apply 4 drops of extracted sample at a 90° angle to the specimen well of the test device.

Read the test result in 15-30 min.

WARNING! Do not read test result after 30 minutes. It may give a false result.

Interpreting the results

A colored line appears in the top section of the result window to show that the test is working properly. This is the control line (C). Even if the control line is faint or not uniform, the test should be considered to have been performed properly. If no control line is visible, the test is invalid. In the case of an invalid result, perform QC and repeat the test.

In case of a positive result, one or more colored lines appear in the lower section of the result window. These are the test lines of SARS-CoV-2 (S), Influenza A (A) and Influenza B (B). Even if the test line is very faint or not uniform, the test result should be interpreted as a positive result.

Test kit content

Each kit contains 25 individually packaged, ready-to-use tests.

The following components are needed for a test and included in the kit:

• Test devices
• Nozzle caps
• Extraction buffer tube
• Buffer tube holder
• Sterile nasopharyngeal swabs
• 1 set of positive and negative quality controls
• Instructions for Use
• Quick Reference Guide

SARS-CoV-2 & Flu A/B Rapid Antigen Test​ characteristics

• Assay format Lateral flow test / immunochromatographic

• Instrument No
• Testing time 15-30 minutes
• SARS-CoV-2 Specificity 98.59%
• SARS-CoV-2 Sensitivity 84.85%

• Influenza A Specificity 100%

• Influenza A Sensitivity 81.16%

• Influenza B Specificity 99.04%

• Influenza B Sensitivity 100%

• Antigen Nucleocapside protein

• Sample material Nasopharyngeal Swab

Related Documents:

SARS-CoV-2 Flu A_B Rapid Antigen Test Pack insert

Notification of internal test results for SARS-CoV-2 variants (Version 7.08)