Roche Diagnostics we believe wide accessibility to such high-performance, instrument-free and reliable Point of Care tests

This testing method can help to 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.

Rapid Point of Care testing for SARS-CoV-2 antigens with results in 15-30 minutes

• Fast triaging and decision making to help control further virus spreading
• Support healthcare systems with the strategy to perform extensive testing
• Highly accurate: 98.6% Specificity / 90.6% Sensitivity

Less invasive and more convenient testing

• Reduced patient discomfort for sensitive individuals such as children or elderly people
• Simplified and faster testing procedure
• Supervised self-collection of samples upon preference of tested individuals

Increase protection of healthcare workers

• Reduced risk of coughing and sneezing during specimen collection
• Supervised self-collection to keep a physical distance between HCP and patient
• Reduced duration of sampling procedure

The SARS-CoV-2 Roche Antigen Nasal Test is able to quickly and reliably detect specific antigen of SARS-CoV-2 in 15 minutes with a specificity of 98.6 % and a sensitivity of 90.6 % (Ct ≤ 30). 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.

In collaboration with our partner, SD Biosensor, Roche is planning on an accelerated distribution in large quantities around the world, responding to the increasing need for testing where it is needed.

The following components are included in the kit:

• Test device (individually in a foil pouch with desiccant)
• Extraction buffer tube and buffer tube rack
• Nozzle cap
• Sterile swab
• Instruction for Use and Quick Reference Guide
• Positive and negative controls

What is rapid antigen testing?

Antigen tests detect proteins specific to a virus that appears in infected individuals, which indicates active infection. Rapid antigen testing is beneficial because of its portability, ease of use, and rapid time to result.

These tests are designed to detect a live virus in people who are highly infectious, whether they are displaying symptoms or not. Their rapid turnaround time allows for mass testing in workplaces and schools without the need for expensive laboratory equipment and analysis.

What Is An Antigen Lateral Flow Test?

Lateral flow antigen tests work by taking a sample from the nose or back of the throat and testing that sample for the presence of antigens, the signature proteins of the virus. They show results visually, in the same way as many pregnancy tests.

How Quickly Does the Roche Nasal Rapid COVID-19 Antigen Test Deliver a Result?

An Antigen lateral flow test kits provide a visual, easy to read result in as little as 15-30 minutes, which means those who test positive can be instructed to isolate quickly and minimise exposure of COVID-19 in your school, workplace or community.

A positive test should be confirmed by a government approved CPR test.

Has the Roche Nasal Rapid COVID-19 Antigen Test kit been validated by the UK Government

The Roche Nasal test has been tested by the UK Government against the new Covid-19 variants Click Here

Why are Positive and Negative controls included?

External  Controls  may  be  used  to  demonstrate  that  the  reagents  and  assay  procedure are perform  correctly.  A  Positive  Control  Swab  and  Negative  Control  Swab  are  included  as  External  Controls.   Positive  and  Negative  Control  Swabs  can be  used  once  for  an  untrained  operator  and  may be  necessary  by  your  internal  quality control procedures.

What is the Difference Between an Antibody and an Antigen Test?

An antibody test is a blood test to determine if you’ve already been exposed to COVID-19 and have developed the relevan antibodies.

It works by detecting antibodies to SARS COV-2 infection in your blood or serum. ROCHE Antibody Test Kit Link

A lateral flow (LFT) antigen test looks for an active COVID-19 infection such as the SARS-CoV-2 virus. If your antigen test is positive, you should self-isolate at home and follow government guidance.

Does my Roche Nasal Antigen Testing Kit Contain Everything Needed To Perform The Test?

The Roche Rapid Lateral Flow COVID-19 testing kits come supplied with all the necessary tools to carry out the test. No extra equipment is needed. The packs include individual components of the test kits allowing to individually split the box into 25 test kits. This is a very unique and useful feature that allows workplaces to deliver testing with efficiency.

Clear instructions are supplied on how to perform the test and read the results.

While no specialist equipment or laboratory analysis is required, we recommend that these products are used by healthcare professionals or trained and competent people.