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

Rapid detection and differentiation between SARS-CoV-2, Influenza A and B

SARS-CoV-2 & Flu A/B
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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
Doctor with patient

Test principle


The SARS‑CoV‑2 & Flu A/B Rapid Antigen Test is a rapid chromatographic immunoassay for the simultaneous detection and differentiation of the nucleocapsid protein antigens of SARS‑CoV‑2, 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 virus3-5

 

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

Structure of Influenza A and B virus6

  • Surface Proteins (SP): HA & NA*
  • Nucleocapsid protein (N)
Influenza A & B illustration

*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.

 

Watch the handling video

Testing process step 1
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.
Testing process step 2

Prepare the sample


A. Insert the swab into an extraction buffer tube. While squeezing the buffer tube, stir the swab more than 10 times.

B. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.

C. 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.

Testing process step 3

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. 

Testing process step 4
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.

Interpret results

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-Influenza A & B test kit

References

 

  1. SD Biosensor, Notification of internal test results for SARS-CoV-2 variants (V6, November 2021)
  2. SARS‑CoV‑2 & Flu A/B Rapid Antigen Test Method Sheet (V1, December 2021)
  3. Masters PS (2006). Advances in Virus Research. Academic Press. 66: 193–292;
  4. Su, S et al. (2016). Trends in Microbiology. 24 (6): 490–502;
  5. Paules CI et al. (2020). JAMA. 2020;323(8):707–708
  6. Francis, Magen & King, Morgan & Kelvin, Alyson. (2019). Back to the Future for Influenza Preimmunity—Looking Back at Influenza Virus History to Infer the Outcome of Future Infections. Viruses. 11. 122. 10.3390/v11020122.

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

  • 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