SARS-CoV-2 Rapid Antigen Test Nasal

Reliable, rapid chromatographic immunoassay for the qualitative detection of nucleocapsid antigen present in human nasal samples

SARS-CoV-2 Rapid Antigen Test Nasal

Convenient sampling, quick results

 

The SARS-CoV-2 Rapid Antigen Test Nasal provides rapid results for fast decision making at the Point of Care. Nasal sampling is less invasive, which can reduce patient discomfort, and minimize the duration of the procedure as well as the risk of sneezing or coughing. Nasal swab samples may be self-collected by patients under supervision, offering further protection for healthcare professionals.

SARS-CoV-2-Antigen-test-nasal-kit

Fast and simple

 

  • Simple sampling through a nasal swab (lower nasal area)
  • Getting a quick result within 15-30 minutes
  • No need for a follow-up appointment to discuss the result
  • Self Sampling: Sample taken by the patient (under professional supervision)
  • Simple test execution, no pipetting steps, no complex processes

High quality

 

  • Samples taken by qualified personnel: relative sensitivity: 90.6%, relative specificity: 98.6%
  • Samples taken by patients: relative sensitivity: 84.4%, relative specificity: 99.2%
  • Known mutations (UK, South Africa, Brazil) do not affect the test performance
  • For symptomatic as well as asymptomatic subjects
  • No influence from mRNA vaccines (Pfizer, Moderna)

Accessible

 

  • high-performance, instrument-free and reliable Point of Care test
  • Allowing decentralized testing or access to testing in areas where laboratory testing is not available
  • Providing patients with the option to self-collect their nasal sample

Testing the quick and easy way

 

Testing process for the SARS-CoV-2 Rapid Antigen Test Nasal15

Test kit information

 

The kit is ready for use and contains all equipment needed to perform a test.

 

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
  • Positive and negative controls
SARS-CoV-2-Antigen-test-nasal-kit

Collecting the nasal sample from left and right nostril

Testing process

1a.

Insert the sterile swab into the nostril with the most secretion. While rotating the swab, insert the swab 2 cm (slightly less than 1 inch) parallel to the palate (not upwards) towards the throat into the nostril until resistance is met at turbinates. Do not apply pressure. 

Rotate the swab 4 times for about 15 seconds against the nasal wall and remove it from the nostril.

Testing process

1b.

Repeat step 1a. with the same swab in the other nostril.

Note: Samples must be collected from both nostrils using the same swab.

Preparing a sample

Testing process

2a.

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

Testing process

2b.

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

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

Testing process

2c.

Press the nozzle cap tightly onto the tube. Continue with 3a. Performing a test.

Performing a test & interpreting results

Testing process

3a.

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

Testing process

3b.

Read the test result at 15 to 30 min.

WARNING! Risk of incorrect results. Do not read the test result after 30 min.

Testing process

4.

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, the test should be considered to have been performed properly. If no control line is visible the test is invalid. 

In case of a positive result, a colored line appears in the lower section of the result window. This is the test line (T). Even if the test line is very faint or not uniform, the test result should be interpreted as a positive result.

Healthcare professional talking to patient

An aid in identifying individuals infected by SARS-CoV-215

 

The SARS‑CoV‑2 Rapid Antigen Test Nasal is a rapid chromatographic immunoassay for the qualitative detection of SARS‑CoV‑2 nucleocapsid antigen present in human nasal samples.

This test is intended to detect antigen from SARS‑CoV‑2 in individuals suspected of COVID‑19 or with known or suspected exposure to SARS‑CoV‑2. This product is intended for professional use in laboratory and Point of Care environments, or self-collection under the supervision of a healthcare worker.

 

The benefit of having a SARS-CoV-2 antigen test available

 

The SARS-CoV-2 virus causes respiratory tract infection. It is transmitted mainly via respiratory droplets after close contact, and primary viral replication is presumed to occur in mucosal epithelium of the upper respiratory tract (nasal cavity and pharynx).1 At these locations viral load peaks within the first week after symptom onset, and then declines.2

A SARS-CoV-2 antigen test detects the presence of the SARS-CoV-2 virus from part of the upper respiratory tract swab specimens by identifying a nucleoprotein that is carried by the virus. The test identifies current infection during the acute phase of COVID-19, while the virus is still present in large quantities in the respiratory tract.

At Roche Diagnostics we believe wide accessibility to such high-performance, instrument-free and reliable Point of Care tests can contribute significantly to better managing the ongoing pandemic crisis.

Features of the SARS-CoV-2 Rapid Antigen Test Nasal

 

In comparison to the existing Roche SARS-CoV-2 Rapid Antigen Test, the SARS-CoV-2 Rapid Antigen Test Nasal collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified and faster testing procedure.1 This testing method can help reduce overall patient discomfort, particularly in sensitive individuals such as children, elderly people and/or people with disabilities.

Besides being less invasive, the test also provides patients with the option to self-collect their nasal sample under the supervision of a healthcare professional. Through reduced physical contact, this method of testing can help to decrease the risk of exposure to the virus for healthcare professionals.

Coronavirus close up

Roche’s response to the COVID-19 pandemic

Our commitment to help put a stop to the COVID-19 pandemic

References

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SARS-CoV-2 Rapid Antigen Test Nasal characteristics

  • Assay format

    Lateral flow test / immunochromatographic

  • Instrument

    No

  • Testing time

    15-30 minutes

  • Specificity

    98.6%

     

     

     

  • Sensitivity

    90.6% (Ct value ≤ 30)

     

  • Antigen

    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