Siemens Healthineers has obtained CE mark for its CLINITEST Rapid COVID-19 Antigen Self-Test for SARS-CoV-2 virus detection in individuals aged 12 years and above, including at-home testing.
Indicated for symptomatic or asymptomatic self-testing without supervision, the nasal swab test can deliver results in 15 minutes in all types of settings.
Samples from children aged below 12 years must be obtained or supervised by an adult.
The test has 97.25% sensitivity and 100% specificity when compared to a polymerase chain reaction test or nucleic acid detection method.
To carry out the test, a nasal swab is obtained from both nostrils and washed in a buffer to expose a particular protein inside the Covid-19 virus. The specimen is then dropped onto the test cassette and the result is provided in 15 minutes.
Siemens Healthineers point of care diagnostics head Christoph Pedain said: “The CLINITEST Rapid COVID-19 Antigen Self-Test is among the first CE-marked tests for home use, making information about a possible infection with Covid-19 more widely available without long wait times.
“Siemens Healthineers has been able to offer a variety of high-quality tests to address all Covid-19 testing needs and this option makes testing even more convenient for a greater number of people.”
Last November, Siemens Healthineers received CE mark for its SARS-CoV-2 IgG antibody test, enabling its use across Europe and other regions.
In another development, Sentinal Diagnostics has developed two new serological test kits for detecting the total antibodies IgA, IgG and IgM against SARS-CoV-2 Spike (S) and Nucleocapsid (NC) proteins.
Named ‘COVID-19 Anti-S1 Total Ab’ and ‘COVID-19 Anti-NC Total Ab’, the assays are in-vitro diagnostic tests for quantitative and qualitative detection using the immunoturbimetric method.
Integrated with automated analytical platforms, including the Sentinel SENTIFIT 270 Analyser, these tests can potentially process hundreds of results in an hour and thousands in a day.
The two tests can also be used together to detect vaccinated individuals from those who were naturally infected with the virus.
Furthermore, they can be used to understand the spread of Covid-19 in communities.