Siemens Healthineers SARS-CoV-2 Testing Portfolio Detects Omicron Variant

Tarrytown

|2021-12-09
  • CLINITEST® Rapid COVID-19 Antigen Test well designed to detect Omicron variant.
  • FTD SARS-CoV-2 Assay, a PCR test, well designed to detect Omicron variant.
  • The lab-based Atellica and ADVIA Centaur SARS-CoV-2 Antigen Assays (CoV2Ag) well designed to detect Omicron variant.

Siemens Healthineers has announced that the company’s SARS-CoV-2 tests are well designed to detect the Omicron SARS-CoV-2 variant. The company recently evaluated the potential impact of the emergent variant on the CLINITEST Rapid COVID-19 Antigen Test,1 the FTD SARS-CoV-2 Assay,2 a PCR test, and the Atellica IM / ADVIA Centaur SARS-CoV-2 Antigen Assay (CoV2Ag)3. On November 26, 2021, both the WHO and ECDC designated the Omicron variant as a variant of concern.4,5 Mutations are normal, abundant, and expected, especially with an RNA virus, and the SARS-CoV-2 is no different. As countries struggle to combat emerging variants, fast and accurate testing is an important tool in containing spread.

To assess the potential impact to the CLINITEST rapid test and the Atellica/ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) Assay, the Siemens Healthineers R&D team analyzed the sequence data of the Omicron variant nucleocapsid protein. This analysis demonstrated >98% sequence homology of the nucleocapsid protein to other SARS-CoV-2 variants.6 Meaning, it is unlikely that the Omicron variant would affect the results.

CLINITEST Rapid COVID-19 Antigen Test

The CLINITEST Rapid COVID-19 Antigen Self-Test has a sensitivity of 97.25 percent and a specificity of 100 percent (compared to a PCR, or nucleic acid-detection method) and provides results in 15 minutes.7 The simple process for collecting a nasal swab and obtaining a result are included in the Instructions for Use. A nasal swab is collected from both nostrils and then the swab is washed in a buffer to reveal a specific protein inside the SARS-CoV-2 virus. The sample is then dispensed onto the test cassette and after 15 minutes the result is visible. The position and number of lines clearly indicate whether the test is positive or negative.

Atellica/ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) Assay

The Siemens Healthineers’ CoV2Ag test shows strong alignment compared with on the market available automated real-time (RT)-PCR testing with sensitivity exceeding 96% and specificity exceeding 99% for the Atellica CoV2Ag test8. While molecular RT-PCR diagnostic testing is the gold standard in accuracy, it lacks the high throughput capability of a lab-based, automated antigen test. With availability of CoV2Ag on the Atellica IM Analyzer, laboratories can significantly increase the SARS-CoV-2 testing capacity with a platform that can run up to 440 tests per hour.

FTD SARS-CoV-2 Assay

Siemens Healthineers has also confirmed, based on in silico analysis, that the FTD SARS-CoV-2 Assay, a PCR-based test, detects the Omicron variant.9 Dual target design makes it possible to detect two different genomic regions of SARS-CoV-2. One benefit of this is a higher sensitivity because it is possible to detect two different genomic regions on the same detection channel, but most important right now, is that it helps to cope with mutations.

Siemens Healthineers offers an evolving menu of single mutation PCR reflex tests that complement our FTD SARS-CoV-2 Assay to identify SARS-CoV-2 variants. Our relationship with A1 Life Sciences allows us to offer research use only tests (RUO)10 that enable laboratories to efficiently detect mutations to discriminate between circulating variants, including Omicron.

“As a leader in laboratory diagnostics, Siemens Healthineers is committed to monitoring all current and emerging variants of concern to ensure the test results remain accurate and reliable,” said Deepak Nath, PhD, President Laboratory Diagnostics, Siemens Healthineers. “Accurate diagnostic tools are a critical factor in allowing public health authorities to combat the spread of virus and protect the health of their populations.”

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Lance Longwell, Phone: (610) 883-0788

E-mail: lance.longwell@siemens-healthineers.com

Follow the press team on Twitter: https://twitter.com/siemenshealthpr

Siemens Healthineers AG (listed in Frankfurt, Germany: SHL) is shaping the future of healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostics, image-guided therapy, in-vivo diagnostics, and innovative cancer care. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers’ ability to provide high-quality, efficient care to patients. In fiscal 2020, which ended on September 30, 2020, Siemens Healthineers generated revenue of €14.5 billion and adjusted EBIT of €2.2 billion. Following the acquisition of Varian Medical Systems, Inc. the company has approximately 66,000 employees worldwide. Further information is available at www.siemens-healthineers.com.

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