Siemens Healthineers in Canada Now Shipping Total Antibody Test for COVID-19 with Expanded Capacity

2020-08-18

  • Siemens Healthineers started shipping its total antibody tests in Canada.
  • The total antibody test has demonstrated 100 percent sensitivity and 99.8 percent specificity in identifying SARS-CoV-2 antibodies in as few as 10 minutes.

Siemens Healthineers in Canada announced today that it received Health Canada Interim Order authorization for its laboratory-based total antibody test1 to detect the presence of SARS-CoV-2 IgM and IgG antibodies in blood. The test, which received the CE mark in Europe and FDA approval in USA, has data that has demonstrated 100 percent sensitivity2 and 99.8 percent specificity. The total antibody test allows for identification of patients who have developed an adaptive immune response, which indicates recent infection or prior exposure.

The company is prepared to ramp up production as the pandemic evolves with capacity exceeding 50 million tests per month across its platforms. Siemens Healthineers is poised to increase production at the company’s Walpole (Walpole, Mass., USA) and Glasgow (Newark, Del., USA) facilities.

The antibody test is now available on one of the largest installed base in Canada and one of the largest in the world with 20,000 Siemens Healthineers systems installed worldwide. This includes the Atellica® Solution immunoassay analyzer, which can run up to 440 tests per hour3 and enables a result in just 10 minutes. By detecting both IgM and IgG antibodies, the test provides a clearer clinical picture over a longer period of time as the disease progresses.

Importantly, the test detects antibodies to a key protein on the surface of the SARS-CoV-2 virus—a spike protein, which binds the virus to cells with a distinct human receptor found in lungs, heart, multiple organs and blood vessels. Studies indicate that certain (neutralizing) antibodies to the spike protein can disarm SARS-CoV-2, presumably by interfering with the ability of the virus to bind, penetrate and infect human cells. Multiple potential vaccines in development for SARS-CoV-2 include the spike protein within their focus.

“Not all antibody tests are created equal. A high-quality test that targets the right protein and is highly scalable is essential for antibody testing to help ensure we effectively manage the threat of COVID-19,” said Deepak Nath, PhD, President, Laboratory Diagnostics, Siemens Healthineers. “Siemens Healthineers sought to provide a highly accurate antibody test that could reach millions of people to address the current need for identifying immune response, and also for delivering long-term value as we look toward immunity and vaccination.”

The total antibody test also is available on the company’s expansive installed base of ADVIA Centaur® XP and XPT analyzers, which can test up to 240 samples per hour, with a result in 18 minutes. Comparable tests for Siemens Healthineers Dimension Vista® and Dimension® EXL systems also are being pursued,4 with a view to realize clinical reach. The company intends to develop an IgG test to provide flexibility for testing needs as the pandemic evolves.5

“The availability of this test in Canada couldn’t come at a better time – when testing is needed more than ever to help get our country back to work,” said Sevket On, VP, Zone General Manager, Siemens Healthineers Canada. “We are working with customers and other healthcare providers to ensure they can start testing immediately on the Atellica IM and ADVIVA Centaur XP and XPT analyzers. The test is manufactured in the USA and more than 50 million tests per month will be produced, resulting in a stable supply and widespread availability of the test in Canada.”

“I’m proud of our team who saw the societal need and mobilized very quickly to bring this high-quality, diagnostic test to the Canadian market,” said Deepak Nath. “Siemens Healthineers now offers the broadest portfolio of high-quality tests for SARS-CoV-2 to help address the global pandemic. Our tests arm healthcare professionals with the information they need to accurately detect SARS-CoV-2, assess disease severity and therapeutic response, and aid care management for patients with comorbidities or complications such as escalated immune response or sudden development of coagulation disorders. These tests will assist clinicians with more timely interventions that can result in better patient outcomes.”

To meet demand, the company plans to ship more than 2.5 million molecular PCR tests per month worldwide as production capacity increases over the coming month. The FTD SARS-CoV-2 Assay5 can be run on equipment widely used in laboratories worldwide and may be run simultaneously with Siemens Healthineers FTD Respiratory Pathogens 21 and FTD FLU/HRSV molecular syndromic testing panels that identify a wide range of pathogens that can cause acute respiratory infections.

About Siemens Healthineers Commitment to COVID-19 Testing
In addition to the antibody and molecular tests, Siemens Healthineers offers a broad diagnostics portfolio which may complement the prognosis, treatment and follow up of COVID-19 patients. The company’s broad and differentiated menu includes hematology, coagulation, cardiac, respiratory, inflammation and infectious disease panels. Blood gas and imaging solutions from Siemens Healthineers deliver actionable results that assist clinicians in caring for COVID-19 patients.

For further information, please see: https://www.siemens-healthineers.com/en-ca/laboratory-diagnostics/assays-by-diseases-conditions/infectious-disease-assays/cov2t-assay#The_Scale


Contact for journalists
Alastair Harris-Cartwright, Siemens Healthineers
Phone: +1 (905_ 399-8491; Email: alastair.harris-cartwright@Siemens-Healthineers.com


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 diagnostic, image-guided therapy, and in-vivo diagnostics. 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 2019, which ended on September 30, 2019, Siemens Healthineers, which has approximately 52,000 employees worldwide, generated revenue of €14.5 billion and adjusted profit of €2.5 billion. Further information is available at www.siemens-healthineers.com.

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1This test has been authorized for sale by Health Canada under the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, and has not been licensed under the Health Canada Medical Devices Regulation. This test has been authorized only for the detection of antibodies to SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the Interim Order, for a period of up to one year, unless it is renewed or unless the authorization is cancelled sooner. Product availability may vary by country and is subject to varying regulatory requirements.

2≥ 14 days post-PCR positive test

3Dependent upon test mix.

4Under development. Not available for sale. Future availability cannot be guaranteed.

5This test has been authorized for sale by Health Canada under the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, and has not been licensed under the Health Canada Medical Devices Regulations. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the Interim Order, for a period of up to one year, unless it is renewed or unless the authorization is cancelled sooner. Product availability may vary by country and is subject to varying regulatory requirements.