SARS-CoV-2 Rapid Antigen Test 2.0

sars cov 2 rapid antigen test 2.0

This product is currently only available in the Republic of Ireland. Please speak to your local Roche representative for more information.

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Key features
  • Enhanced performance compared to previous version: 99.00% relative sensitivity and 99.75% relative specificity1
  • Detection of SARS-CoV-2 infection in symptomatic and asymptomatic individuals1
  • Optimised composition to detect antigens against several dominant variants of the virus1
  • No instrument required
  • Enables access to testing in areas where laboratory testing is not available
  • Rapid answers in only 15 minutes
  • Data matrix code on each test device for facilitated result sharing

Performing a test

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

rapid antigen test 2.0 step 1

Collection of nasopharyngeal sample


Tilt the patient’s head back slightly (approximately at a 70° angle). Insert a sterile swab into the nostril of the patient, reaching the surface of the posterior nasopharynx. Rotate the swab 3-4 times against the nasopharyngeal surface.

rapid antigen test 2.0 step 2
Sample preparation



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

rapid antigen test 2.0 step 3
Performing a test



Apply 4 drops of extracted specimen to the specimen well of the test device.



Dispense the specimen at 90 degree angle to allow for free-falling drops drops and avoid bubbles.


rapid antigen test 2.0 step 4
Read the results



Read the test at 15 to 30 minutes.



Test results that are read before 15 minutes or after 30 minutes may be incorrect. 


Failure to squeeze the tube can lead to incorrect results.

*Before using the SARS-CoV-2 Rapid Antigen Test 2.0, carefully read the Instructions for Use and all included warnings and precautions.

Result interpretation

Test results are quick and easy to read


rapid antigen test 2.0 positive result
Positive test result


If both colored lines C and T are visible, even if they are faint or not uniform, the test result is positive. This means the test detected the virus protein in the sample. The tested person is very likely infected with SARS-CoV-2.


Control line C: Indicates that the test is working correctly

Test line T: Visibile if SARS-CoV-2 antigen was detected

rapid antigen test 2.0 negative result
Negative test result


A visible control line C alone means the test worked correctly. The test result is negative. No virus protein could be detected in the sample. The tested person is unlikely infected with SARS-CoV-2.

rapid antigen test 2.0 error result
Invalid test result


If a control line (C) is not visible, or only the line marked with a T, the result must be considered invalid. The test is not working correctly and you should perform another test using a different test kit.

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 device (individually in a foil pouch with desiccant)
  • Extraction buffer tube and buffer tube rack
  • Nozzle cap
  • Sterile swab
  • Instructions For Use and Quick Reference Guide
covid rapid antigen test kit 2.0
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 cata 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)
covid 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.


  1. Roche Diagnostics. SARS-CoV-2 Rapid Antigen Test 2.0, Package Insert 2022-05, V1.0; Relative sensitivity and relative specificity are compared to RT-PCR.

SARS-CoV-2 Rapid Antigen Test 2.0​ characteristics

  • Assay format

    Lateral flow test / immunochromatographic / qualitative

  • Instrument


  • Testing time

    15-30 minutes

  • SARS-CoV-2 Sensitivity*


  • SARS-CoV-2 Specificity*



  • Antigen

    Nucleocapsid protein (N)

  • Sample material

    Nasopharyngeal swab

  • Reagents

    mAb anti-SARS-CoV-2 antibody, mAb anti-chicken IgY, mAb anti-SARS-CoV-2 antibody‑gold conjugate, Purified chicken IgY‑gold conjugate


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