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SARS-CoV-2 & FluA/B Rapid Antigen Test

SARS-CoV-2 & FluA/B Rapid Antigen Test

Rapid answers, combined

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

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

Key benefits

  • Reliable test performance
  • Rapid answers in only 15 minutes
  • Support in the differential detection of SARS-CoV-2, Influenza virus A, and Influenza virus B
  • Easy handling, only 4 steps needed
  • Fully integrated test, only one application area and single sample are needed
  • Optimized composition to detect antigens against several dominant variants of the SARS-CoV-2
  • Access to testing in areas where laboratory testing is not available
  • Data matrix code on each test device for facilitated result sharing

Performing the test

Simple to perform and fast results within 15 – 30 min*

covid flu combo Testing process step 1

Collection of nasopharyngeal sample

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

sars cov 2 combo flu Testing process step 2

Sample preparation

A. Insert the swab into 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 nozzle cap tightly onto the tube.

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

sars cov 2 combo flu Testing process step 3

Performing the test

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. 

sars cov 2 combo flu Testing process step 4

Read the results

Read the test result at 15 to 30 minutes. Do not touch or move the test device until the result can be read.

WARNING! Test results that are 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 that are provided in the kit.

Results interpretation

Coronavirus combo test results

Positive results

Influenza A & B illustration

Postive results co-infection

Note: Co‑infection with influenza A, B and/or SARS‑CoV‑2 is possible. Test results are not intended to rule in or rule out other infections.

Coronavirus illustration

Negative test result

Coronavirus illustration

Invalid test result

Test kit information

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 cap
  • Extraction buffer tube
  • Buffer tube holder
  • Sterile nasopharyngeal swabs
  • 1 set of positive and negative quality control swabs
  • Instructions for use
  • Quick Reference Guide
SARS-CoV-2-Influenza A & B test kit

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 is compliant with the common industry standard GS1 and thus 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 (i.e. production factory identification)
  • Serial number (i.e. 6-digit ID printed on the test cassette - unique per lot range)
rapid antigen test device

 

 

The unique identification of each test device enables a one to one assignment of test results to individual persons. This facilitates storage of test results under the respective patient ID in Electronic Medical Records. A digital readout of the data matrix code can lead to more efficient processes, especially in testing environments
with a high throughput.

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

  • Assay format

    Lateral flow test / immunochromatographic

  • Instrument

    No

  • Testing time

    15-30 minutes

  • Antigen

    Nucleocapsid protein (N)

  • 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

Clinical evaluation in symptomatic patients

  • SARS-CoV-2 Sensitivity*

    95.24% (Ct=<30)

  • SARS-CoV-2 Specificity*

    99.35%

     

  • Influenza A Sensitivity*

    100% (Ct=<30)

     

  • Influenza A Specificity*

    99.75%

Test performance using retrospective clinical specimens

  • Influenza B Sensitivity*

    100%

  • Influenza B Specificity*

    100.00%

*Relative sensitivity and relative specificity are compared to RT-PCR.

References

  1. Roche Diagnostics. SARS-CoV-2 & Flu A/B Rapid Antigen Test, Package insert, 2022-06, V2.0.

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

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    Technical Documents

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