Siemens Begins Shipping COVID-19 Total Antibody Test and Molecular Test Kit Globally

Siemens Healthineers (Erlangen, Germany) has begun worldwide shipping of its laboratory-based total antibody test to detect the presence of SARS-CoV-2 IgM and IgG antibodies in blood.

The total antibody test allows for identification of patients who have developed an adaptive immune response, which indicates recent infection or prior exposure. 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. The test received the CE mark and data has demonstrated 100% sensitivity and 99.8% specificity.

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’ Dimension Vista and Dimension EXL systems also are being pursued, with a view to realize clinical reach. Siemens is prepared to ramp up production as the pandemic evolves with capacity exceeding 50 million tests per month across its platforms starting in June. The company intends to develop an IgG test to provide flexibility for testing needs as the pandemic evolves.

“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.”

Siemens has also begun globally shipping of its molecular PCR Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit, which secured FDA EUA on May 5. The FTD SARS-CoV-2 Assay is also CE marked for diagnostic use in the EU since April 24. In method comparison studies, the real-time PCR test has shown 100% positive percentage agreement and 100% negative percentage agreement. 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. The FTD SARS-CoV-2 Assay can be run on equipment widely used in laboratories worldwide and may be run simultaneously with Siemens’ FTD Respiratory Pathogens 218 and FTD FLU/HRSV8 molecular syndromic testing panels that identify a wide range of pathogens that can cause acute respiratory infections. Sample-to-answer time, including extraction and generating the result, takes two-three hours, depending upon the molecular system and lab resources employed. To meet demand, the company plans to ship more than 2.5 million molecular PCR tests per month worldwide as its production capacity increases in May and June.

“I’m proud of our team who saw the societal need and mobilized very quickly to bring this high-quality, diagnostic test to the US 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.”