COVID-19 Diagnostics: Siemens Healthineers Launches New SARS-CoV-2 Rapid Antigen Test Called CLINITEST That Gives Results In 15 Minutes
: Siemens Healthineers has introduced the CLINITEST Rapid COVID-19 Antigen Test that helps identify SARS-CoV-2 infected individuals in 15 minutes so they can isolate sooner and avoid spreading COVID-19.
The easy-to-use test, which doesn't require specialized laboratory personnel or instruments, offers flexibility to test in locations that benefit from immediate results
The new test is to be launched in CE mark countries with plans also underway to seek U.S. FDA Emergency Use Authorization.
While the world continues to navigate through the COVID-19 pandemic, there is a critical public health need to get ahead of the spread with a fast and simple testing for all.
In order to address this need Siemens Healthineers is launching a rapid and easy-to-use antigen test for the detection of SARS-CoV-2, the virus that causes COVID-19.
The new 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 highly accurate CE marked test which has been developed and tested by a Siemens Healthineers partner demonstrated 96.72% sensitivity and 99.22% specificity based on a clinical study of 317 subjects.
The research was performed using operators with varied credentials at six diverse sites including a hospital, a community clinic, a college campus, and an oncology unit.
Siemens Healthineers intends to meet such testing demand as the pandemic evolves. There are plans to submit the test for FDA Emergency Use Authorization.
Currently there is a growing public need for reliable tests that can quickly identify contagious individuals and help to minimize the spread of COVID-19, especially in high-traffic areas and where people commonly congregate. With quality at the forefront of decision makers’ criteria to determine test reliability, it was critical the clinical study for this test to be assessed at variable clinical conditions that can be expected when implementing a rapid antigen test.
Christoph Pedain, PhD, Head of Point of Care Diagnostics, Siemens Healthineers told Thailand Medical News, “This new rapid antigen test makes testing available to more individuals across a wider variety of settings, particularly in locations that need to test people quickly such as airports or that have limited access to laboratory resources such as schools.”
The new CLINITEST Rapid COVID-19 Antigen Test is easy to administer for healthcare professionals and delivers results quickly using the nasopharyngeal swab method. Once a sample is collected, 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.
Besides 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.
This new rapid antigen test adds to the 15 critical assays Siemens Healthineers offers to detect severe symptoms and better manage critical COVID-19 patients. The company&rsq
uo;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 and imaging solutions from Siemens Healthineers deliver actionable results that aid clinicians in caring for COVID-19 patients.
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