Product News: Siemens Healthineers’ CLINITEST Rapid COVID-19 Antigen Test achieves CE Mark for easier specimen collection

14 Jan 2021

Siemens Healthineers has announced CE mark has been achieved to use anterior nose swab sampling for the CLINITEST Rapid COVID-19 Antigen Test. This sampling method promises to be less cumbersome and time consuming for both the provider and the patient. The CLINITEST Rapid COVID-19 Antigen Test is a point-of-care cassette test that does not require laboratory instruments or specialized lab personnel to administer, and it delivers results in 15 minutes. The test first became available under CE Mark in October 2020 using the nasopharyngeal swab method.

To evaluate clinical performance using the anterior nose swab sampling method, a study was conducted in the United States with 237 subjects, 109 of which were confirmed to be positive with a PCR test. The study results confirmed 97.3% sensitivity and 100% specificity when compared with the results of a U.S. FDA Emergency Use Authorized rt-PCR assay—the latter with samples obtained from the nasopharynx.

The anterior nose swab sampling method can be deployed easily, and an updated Instructions For Use document will be available to download from the following Siemens Healthineers website.
Since the initial launch in October 2020, customers continue to report excellent results.  “The test has performed very well in the hands of practitioners,” stated Professor Oswald Wagner, Head of Department of Laboratory Medicine from AKH Vienna and Vice Rector for Clinical Affairs of Medical University of Vienna. “The test meets our expectations of rapid antigen tests excellently."

"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," said Christoph Pedain, PhD, Head of Point of Care Diagnostics at Siemens Healthineers. "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 adds.

Updated Study Data for Nasopharyngeal Sampling

To further underpin the clinical performance of the CLINITEST Rapid COVID-19 Antigen Test, updated clinical data on the test's nasopharyngeal swab sampling method is now available. A study of 865 enrolled subjects and 119 positives demonstrated 98.3% sensitivity and 99.6% specificity. 

The datasets for both anterior nose sampling and nasopharyngeal sampling comply with the latest requirements of most major regulatory authorities, for example the German Paul Ehrlich Institute.

The CLINITEST Rapid COVID-19 Antigen Test is easy to administer and delivers results quickly. Once a sample is collected using either the anterior nose swab method or the nasopharyngeal swab method, the swab is inserted into a tube with special liquid to extract the target molecule. This liquid is then dispensed onto a test cassette and, in 15 minutes, a positive or negative result is clearly indicated. The test is manufactured by Healgen Scientific and distributed by Siemens Healthineers.

In addition to the CLINITEST Rapid COVID-19 Antigen Test, Siemens Healthineers offers an extensive diagnostics portfolio to aid in the prognosis, treatment and follow up of COVID-19 patients. The company’s broad and differentiated menu includes antibody and molecular SARS-CoV-2 tests, and hematology, coagulation, cardiac, respiratory, inflammation and infectious disease panels. Blood gas testing, for example the RAPIDPoint® and epoc® systems, as well as imaging solutions from Siemens Healthineers deliver actionable results that aid clinicians in caring for COVID-19 patients.

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