Therapy Areas: Cardiovascular
Siemens Healthineers Now Shipping Worldwide Total Antibody Test and Molecular Test Kit for COVID-19 with Expanded Capacity
26 May 2020 - - German technology company Siemens' Siemens Healthineers business is shipping worldwide its laboratory-based total antibody test to detect the presence of SARS-CoV-2 IgM and IgG antibodies in blood, the company said.

The test received the CE mark and data has demonstrated 100% sensitivity and 99.8 % 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 m 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 analyzer, which can run up to 440 tests per hour 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.

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, 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.

Siemens Healthineers also announced that the FDA issued an EUA on May 5 for its molecular PCR Fast Track Diagnostics SARS-CoV-2 Assay 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 % positive agreement and 100% negative 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.

Sample-to-answer time, including extraction and generating the result, takes 2-3 hours, depending on the molecular system and lab resources employed.

To meet demand, the company plans to ship more than 2.5 m 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 218 and FTD FLU/HRSV8 molecular syndromic testing panels that identify a wide range of pathogens that can cause acute respiratory infections.

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 hematology, 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.
Login
Username:

Password:


Related Headlines