Siemens Healthineers Receives CE Mark for COVID-19 Antigen Test

February 11, 2021 - Siemens Healthineers recently announced that it received the CE mark to use anterior nose swab sampling for its COVID-19 antigen test.

The CLINITEST Rapid COVID-19 Antigen Test is a point-of-care cassette test that does not require laboratory tools or specialized lab personnel to administer. Results are available in 15 minutes. 

"The CLINITEST Rapid COVID-19 Antigen Test offers providers and patients flexibility regarding how to test without compromising on the quality of patients' results and without having to obtain a different test kit," Christoph Pedain, PhD, head of point of care diagnostics at Siemens Healthineers, said in the announcement.

"With the test values achieved, the rapid antigen test now represents an essential pillar in the fight against Covid-19, in addition to vaccination," Pedain added. 

An anterior nose swab sampling for an antigen test can be less time consuming and therefore more convenient for both providers and patients. 

To evaluate clinical performance using this testing method, Siemens Healthineers mentioned a US study that enrolled 237 subjects, 109 of which were confirmed to be positive with a PCR test.

The study results confirmed 97.3 percent sensitivity and 100 percent specificity versus another FDA emergency use authorized rt-PCR assay. The samples in the second test were obtained from the nasopharynx. 

The outcomes of the study followed the latest requirements of most regulatory authorities, which is that the number of positive tests must be more than 100 as a minimum for clinical evidence to enable market access, Siemens Healthineers explained. 

The anterior nose swab sampling method can be used with existing test kits in the field, which ensures a more simplified application and broader use in professional care settings.

In addition to the CLINITEST Rapid COVID-19 Antigen Test, Siemens Healthineers diagnostics portfolio also includes antibody and molecular SARS-CoV-2 tests.

At the end of July, FDA authorized the first two COVID-19 serology tests that displayed an estimated quantity of antibodies present in a patient’s blood.

Both tests from Siemens Healthineers, the ADVIA Centaur COV2G and Atellica IM COV2G, are known as “semi-quantitative” tests, which means they estimate the quantity of a patient’s antibodies that can fight COVID-19.

Then at the end of November, the company launched its COVID-19 antibody test, COV2G, which was previously proven to measure neutralizing antibodies. 

COV2G is an enhanced version of Siemens Healthineers assay, which became available last summer.

The COV2G tests became the fifth antibody test from Siemens Healthineers to receive authorization that showed specificity of greater than 99 percent. 

Currently, Siemens Healthineers antibody tests are available on one of the largest installed bases of automated immunoassay analyzers in the world, as well as in countries that accept the CE mark worldwide, the company said in the November announcement. 

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. And less invasive testing methods are beneficial to both patients and providers.

Last week, Roche received the CE mark for its new self-administered COVID-19 antigen test, which will become available in countries accepting the CE mark by the middle of this month.

In comparison to Roche’s existing SARS-CoV-2 rapid antigen test, Elecsys Anti-SARS-CoV-2 S, the new SARS-CoV-2 Rapid Antigen Test Nasal collects the sample from the front area of the nose instead of the nasopharynx. 

This testing method is faster and less invasive, which helps to reduce patient discomfort, especially in sensitive individuals including children, the elderly, and individuals with disabilities. 

Additionally, the SARS-CoV-2 Rapid Antigen Test Nasal provides patients with the option to self-collect their nasal sample under the supervision of a healthcare provider, which can help to reduce exposure to the coronavirus for both patients and providers.