Covid-19 Antigen Test (25) – Nasal – Roche (Individual Tests)

Testing ready to go when you need to know.  Testing is a critical part in fighting this unprecedented global healthcare emergency.  

• The SARS-CoV-2 Rapid Antigen Test Nasal uses a nasal swab to quickly and conveniently collect specimens from people suspected of having an active infection
• Nasal sampling allows for collection of the sample from the front area of the nose instead of the nasopharynx resulting on a less invasive testing experience for patients
• The test also provides patients with the option to self-collect their nasal sample

Reliable, rapid chromatographic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2. 

Roche’s SARS-CoV-2 Rapid Antigen Test Nasal is CE marked.

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 procedure¹. 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. Whether the test could also be used without supervision of a healthcare professional will depend on local regulatory requirements.

Testing the quick and easy way

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

1. Collecting the nasal sample from left and right nostril

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.

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

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

2. Preparing a sample

2a. Insert the swab into an extraction buffer tube. While squeezing the buffer tube, stir the swab more than 10 times.

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.

2c. Press the nozzle cap tightly onto the tube. Continue with 3a. Performing a test.

3. Performing a test

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.

3b. Read the test result at 15 to 30 min.

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

4. Interpreting results

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.

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

More about the SARS-CoV-2 Rapid Antigen Test Nasal

The SARS-CoV-2 Rapid Antigen Test Nasal is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in human nasal specimens. In clinical studies, the SARS-CoV-2 Rapid Antigen Test Nasal showed a relative sensitivity of 90.6% (Ct value ≤ 30; 95 % CI: 75.0 % – 98.0 %) and a specificity of 98.6% for professionally collected samples. For self-collected samples, a sensitivity of 84.4 % (Ct value ≤ 30; 95 % CI: 67.2 % – 94.7 %) and a specificity of 99.2% was detected. Overall, the studies contained 468 symptomatic and asymptomatic individuals². 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, and/or self-collection under the close supervision of a healthcare worker.

About antigen testing

An antigen test detects proteins which are structural or functional components of a pathogen and are thus very specific to that pathogen³. In this case, the test would provide a qualitative “yes/no” answer on the presence of the pathogen in the patient sample and can be offered as a rapid strip test that is performed at the point of care. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a visually detectable signal on the test strip, typically with results ready in 15 minutes. A rapid antigen test can reliably detect individuals with a high viral load allowing healthcare professionals to quickly identify those patients at greatest risk of spreading the infection.⁴

“Rapid testing continues to play an important role in the fight against COVID-19, especially in places when laboratory testing is not available and quick results are needed, such as nursing homes, healthcare facilities, and schools.” said Thomas Schinecker, CEO Roche Diagnostics. “The SARS-CoV-2 Rapid Antigen Test Nasal provides patients with a more comfortable testing experience.”

The launch is a partnership with SD Biosensor Inc.  The test is the latest addition to Roche’s comprehensive COVID-19 portfolio to support healthcare systems in diagnosing SARS-CoV-2 infection.

About Roche’s response to the COVID-19 pandemic

The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need. This new test is an additional step in Roche’s fight against the COVID-19 pandemic, which has already included:

• Launching COVID-19 diagnostic tests for active infection and the detection of antibodies in patients who have been exposed to the virus,
• Investigating treatments from our existing portfolio to better understand their potential to treat patients with COVID-19,
• Increasing manufacturing and supply chain capacity to meet product demand across our portfolio within the wider context of COVID-19 treatment, and
• Ensuring the supply of our existing medicines and diagnostics to patients around the world under exceptional conditions.

Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March 2020 we received FDA Emergency Use Authorisation for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May 2020, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorisation and is available in markets accepting the CE mark. Also, in June of last year we received an FDA EUA for the Elecsys® IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. In July of 2020, we added a Rapid Antibody Test, with SD Biosensor as manufacturing partner, to the portfolio, that allows the detection of antibodies against COVID-19 at the point of care, a Rapid Antigen Test in September and a lab-based Antigen Test in December. Roche is working closely with governments and health authorities around the world,and has significantly increased production to help ensure availability of tests globally.

About SD Biosensor
SD Biosensor is a global bio-diagnostic company that provides in vitro products engrafted with innovative technologies. Established in 2010, SD Biosensor has successfully launched diagnostics of blood glucose, glycated hemoglobin and cholesterols globally. Through these innovative products, they are striving to become a leading global in vitro diagnostic company.

For more information, please visit www.sdbiosensor.com.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

*Production capacities are combined for both the SARS-CoV-2 Rapid Antigen Test (nasopharyngeal) and the new SARS-CoV-2 Rapid Antigen Test Nasal

*Please note, there is a no return policy on this product.

Documents:

Rapid Antigen Test NASAL CE Mark Certificate

Rapid Antigen Test Nasal Factsheet

Rapid Antigen Test Nasal QRG

Rapid Antigen Test NASAL Safety Data Sheets

SARS-CoV-2 Rapid Antigen Test Nasal IFU

Ferguson report

Guidance on use of ADT in the public health system

Dinnes et al 2021 Cochrane Systematic Review of Rapid Antigen Test

Related Documents:

The EU recommends use of rapid Covid-19 antigen tests. Learn more.

In the absence of PCR tests, the French Government have authorised the use of SARS-CoV-2 Antigen Tests.

Options for the Use of V-2 Rapid Antigen Tests. Technical report by European Centre of Disease Prevention and Control (ECDC)

Notification of internal test results for SARS-CoV-2 variants (Version 7.08) 

List of EU approved COVID-19 Rapid Antigen Tests

Agreed by the Health Security Committee on 17 February 2021

See the list here

References
[1] OASH Nasal Specimen Collection Fact Sheet – Updates 2020-11-11
[2] SD Biosensor. (2020). SARS-CoV-2 Rapid Antigen Test Nasal package insert
[3] European Centre for Disease Prevention and Control. Diagnostic testing and screening for SARS-CoV-2. 2020.
[4] Cerutti, Krüger, van Beek, Igloi, Krüttgen, Salvagno

Recommendations For National SARS-CoV-2 Testing Strategies and Diagnostic Capacities

HSE COVID19 Antigen Testing Working Group Antigen Test Validation Summary Report

EU Approved Antigen Tests For Sale at Hibernia Medical

See All Covid-19 Antigen Kits

Summary of Antigen Tests

For a Summary of our Antigen Kits click here.