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Siemens Healthineers Obtains CE Mark for COVID-19 Rapid Antigen Self-Test

NEW YORK ─ Siemens Healthineers on Tuesday announced that it has obtained CE marking for its Clinitest Rapid COVID-19 Antigen Self-Test for unsupervised self-testing, including testing at home, by people with or without symptoms who are age 12 and older.

The Erlangen, Germany-based company said that its nasal swab test can also be conducted for children younger than 12 when the samples are collected by or under the supervision of an adult.

"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," Christoph Pedain, head of point-of-care diagnostics at Siemens Healthineers, said in a statement.

The Clinitest Rapid COVID-19 Antigen Self-Test is an immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. A nasal swab is collected from both nostrils and washed in a buffer to detect the protein. The sample is then dispensed onto a test cassette and after 15 minutes the result is visible, with the position and number of lines indicating whether the test is positive or negative.

According to Siemens Healthineers, the test has a sensitivity of 97.25 percent and a specificity of 100 percent compared to PCR.

The test comes in packs of one, five, and 20, with the five- and 20-test packages available as either multiuse test buffer bottles or tubes prefilled with the test buffer.

On Monday, Siemens Healthineers raised its fiscal year 2021 revenue outlook for rapid COVID-19 antigen tests, saying it expects revenues to be around €750 million ($901.6 million), up from a previous assumption of €300 million to €350 million.