Siemens Healthineers shipping laboratory-based antibody test to detect SARS-CoV-2 IgM, IgG antibodies

The test received CE mark, data has demonstrated 100 per cent sensitivity, 99.8 percent specificity

Siemens Healthineers recently announced that it is now shipping worldwide its laboratory-based total antibody test (1) to detect the presence of SARS-CoV-2 IgM and IgG antibodies in blood. The test received the CE mark and data has demonstrated 100 per cent sensitivity (2) 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 (3).

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

The antibody test is now available on the largest installed base in the US and one of the largest in the world with 20,000 Siemens Healthineers systems installed worldwide. This includes the Atellica Solution immunoassay analyser, which can run up to 440 tests per hour (4) 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 (neutralising) 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, 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 analysers, 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 (5), with a view to realise clinical reach. The company intends to develop an IgG test to provide flexibility for testing needs as the pandemic evolves (5).

About the Siemens Healthineers SARS-CoV-2 molecular test

Siemens Healthineers also announced that the FDA issued an EUA on May 5 for its molecular PCR Fast Track Diagnostics (FTD) SARS-CoV-2 Assay (6) test kit, which can detect the virus that causes COVID-19. The FTD SARS-CoV-2 Assay also is CE marked for diagnostic use in the EU since April 24. In method comparison studies, the real-time PCR test has shown 100 per cent positive percentage agreement and 100 per cent negative percentage agreement (7). The molecular test, of which more than 500,000 have already been sold in Europe, is compatible with many lab platforms and evaluates two targets in one test tube, detecting two genes with less test preparation. Sample-to-answer time, including extraction and generating the result, takes 2-3 hours, depending on the molecular system and lab resources employed.

“I’m proud of our team who saw the societal need and mobilised very quickly to bring this high-quality, diagnostic test to the US market,” said 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 in May and June. The FTD SARS-CoV-2 Assay can be run on equipment widely used in laboratories worldwide and may be run simultaneously with Siemens Healthineers FTD Respiratory Pathogens 21 8 and FTD FLU / HRSV 8 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 to aid in the prognosis, treatment and follow up of COVID-19 patients. The company’s broad and differentiated menu includes haematology, 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.

References: 

1 CE-marked for sale in the EU. This test has not been reviewed by the FDA. In the US, use of this test is limited to laboratories that are certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity testing. Product availability may vary by country and is subject to regulatory requirements.

2 ≥ 14 days post-PCR positive test

3 Product claims, including intended use, are applicable to the CE-marked assay. These claims have not been authorised by FDA.

4 Dependent upon test mix.

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

6 CE-marked for sale in the EU. This test has not been FDA cleared or approved. This test has been authorised by FDA under an EUA for use by authorised laboratories. This test has been authorised only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorised for the duration of the declaration that circumstances exist justifying the authorisation of emergency use of in vitro diagnostics for detection and / or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21. U.S.C. § 360bbb-3(b)(1), unless the authorisation is terminated or revoked sooner. Product availability may vary by country and is subject to regulatory requirements.

7 In method comparison studies, FTD SARS-CoV-2 has shown Positive Percent Agreement: 100 per cent (91.8-100, 95% per cent CI) and Negative Percent Agreement: 100 per cent (88.7-100, 95 per cent CI) when tested in Copan eSwab nasopharyngeal and oropharyngeal swabs.

8 CE-marked for sale in the EU. Research Use Only (RUO) in the US.