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SARS-CoV-2 Antigen Self Test Nasal

SARS-CoV-2 Antigen Self Test Nasal
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Key benefits

  • Enhanced performance: 95.80% relative sensitivity and 100.00% relative specificity1
  • Detection of all major Variants of Concern (VoC) including Delta and Omicron variants1
  • Rapid answers: Results in only 15 minutes
  • Access to testing: Even in areas where laboratory testing is not available
  • Easy repetitive self-testing by patients at home or similar. 
  • Simple handling procedure
  • Increased user protection: Virus inactivation by extraction buffer after 2 minutes.
  • Worrying symptoms can be put into perspective

Performing a test

Simple to perform and fast results in 15 to 30 minutes*

sars cov 2 antigen self test nasal procedure step 1

Collecting a nasal sample

Insert the swab into one nostril. Slowly slide it approx. 2 cm forward. Rotate the swab 4 times (for approx. 15 seconds) against the lining of the nasal wall, before removing it. Repeat in other nostril using the same swab.

sars cov 2 antigen self test nasal procedure step 2

Sample preparation

 

Insert the swab into an extraction buffer tube, squeeze the tube and stir the swab more than 10 times. Remove the swab while squeezing the sides of the tube. Press the nozzle cap tightly onto the tube.

sars cov 2 antigen self test nasal procedure step 3

Performing a test

 

Add 4 drops of extracted sample vertically into the specimen well of the test device.

sars cov 2 antigen self test nasal procedure 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.

WARNING! Failure to squeeze the tube can lead to incorrect results.

*Before using the Sars-Cov-2 Antigen Self Test Nasal, carefully read the Instructions for Use and all included warnings and precautions. Wash your hands or use hand sanitizer before and after performing the test. 

Interpreting results

Test results are quick and easy to read

rapid antigen test nasal 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: visible if SARS-CoV-2 antigen was detected

rapid antigen test nasal 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 nasal 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.

SARS-CoV-2 Antigen Self Test Nasal handling procedure
Test kit information

Each kit contains 5 individually packaged, ready-to-use tests.
The following components are needed for a test and are included in the kit:

  • Test devices
  • Extraction buffer tubes
  • Nozzle caps
  • Sterile swabs
  • Buffer tube holder
  • Instructions for use
  • Quick Reference Guide
sars cov 2 antigen self test nasal kit

References

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

Intended use

This test is an in vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) in patient specimens.* The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae. This test is intended to be used as a diagnostic as well as a screening tool.

*For a list of approved specimen types, please contact your local Roche representative.

SARS-CoV-2 Antigen Self Test Nasal characteristics

  • Assay format

    Lateral flow test / immunochromatographic / qualitative 

  • Instrument

    No

  • Testing time

    15-30 minutes

  • Specificity*

    100.00%

     

     

     

     

     

     

     

  • Sensitivity*

    95.80% 

     

     

     

  • Antigen

    Nucleocapsid protein (N)

  • Sample material

    Nasal swab

     

     

     

  • Reagents

    mAb anti-COVID19 antibody, mAb anti-Chicken IgY, mAb anti-COVID-19 antibody‑gold conjugate, Purified chicken IgY‑gold conjugate

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