Registration Date 11 Sep 2022
Revision Date 11 Sep 2022

COVID-19 Antigen Test


Medicine Medical Supplies

Covid-19 test


COVID-19 detection


Rapid detection

Manufacturer's Description

Coronavirus disease 2019 (COVID-19) is a contagious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). People with COVID-19 have had a wide range of symptoms, often including fever, cough, headache, fatigue, breathing difficulties, and loss of smell and taste.

The Centers for Disease Control and Prevention (CDC) recommends that anyone with any signs or symptoms of COVID-19 to get tested, regardless of vaccination status or prior infection. People who have symptoms or were potentially exposed to the virus should stay away from others pending test results, and follow the advice of your health care provider or a public health professional.

In light of the COVID-19 emergency, Radetec Diagnostics has decided to apply its optimised quantum dots – LFA technology for the development of a rapid antigen test for COVID-19. Widespread testing is considered one of the key elements to alleviate some of the current restrictions and getting back to normal. The more tests are performed, the clearer is the picture on who is infected and thus who needs to be isolated. However, current PCR tests are labour intensive and can only provide a response after 1 or 2 days. If quick-response antigen tests are deployed across the world, they could play a crucial role in stopping the spread of COVID-19.

The Radetec’s COVID-19 rapid test is a robust, disposable and easy to use diagnostic kit. The kit works by directly detecting the virus in nasopharyngeal swab specimens collected from the respiratory mucosa or saliva sample. The samples are the same used for PCR test, thus perfectly integrating in the current workflow. The kit consists of a solution to dilute the collected swab, a cassette to run the sample and a portable reader. Once the sample is added to the cassette, no further user interaction is needed and the result can be visualised from the reader after about 10 min.

Radetec’s test will detect the virus in the early stages of infection, allowing for rapid diagnosis and decision support in the treatment of the infection, as well as preventing the spread of the infection. Radetec’s COVID-19 rapid test will be an in-vitro diagnostic (IVD) Class III medical device, intended to be used by trained clinicians for point-of-care screening of (but not limited to):

individuals prior to entering closed public venues, such as airplanes, cruise ships or concerts;
employees working in businesses far away from clinics, such as mines, offshore platforms and remote operations;
individuals working or visiting high-risk facilities, such as retirement homes.
The ease-of-use of Radetec’s technology should make it suitable for home testing, helping to make COVID-19 faster and more accessible.