We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
Technopath Clinical Diagnostics

Siemens Healthineers

Provides customized electronic systems and advanced imaging, diagnostics, therapy, and healthcare IT solutions for th... read more Featured Products: More products

Download Mobile App





Siemens Healthineers Announces Availability of Molecular Fast Track Diagnostics SARS-CoV-2 Assay Test Kit

By LabMedica International staff writers
Posted on 02 Apr 2020
Print article
Illustration
Illustration
Siemens Healthineers (Erlangen, Germany) has released its molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit used to aid in the diagnosis of infection by the SARS-CoV-2 virus that causes the COVID-19 disease. The test kits are already being shipped within the European Union for research use only (RUO) to expedite availability, while the company continues to pursue Emergency Use Assessment and Listing (EUAL) from the World Health Organization (WHO) for its clinical use. In addition, Siemens Healthineers has begun discussions with the US Food and Drug Administration (FDA) for release of the test under Emergency Use Authorization (EUA). After regulatory approval, the commercial roll-out of the assay is intended in the US and Europe. While the controlled roll-out of the assay for research use is continuing, Siemens Healthineers is simultaneously expanding its production capacity.

The FTD SARS-CoV-2 Assay has been developed by Fast Track Diagnostics, a Siemens Healthineers company. It has been optimized on the Biomerieux EasyMag Extraction System and the Applied Biosystems 7500 Real-time PCR Thermocycler and utilizes the same workflow, including PCR profile, as other FTD Respiratory Disease kits from Siemens Healthineers. It can be run in laboratories simultaneously with FTD Respiratory Pathogens 21, a molecular syndromic testing panel from Siemens Healthineers that identifies 21 different upper respiratory pathogens which can cause acute respiratory infections.

“With this molecular diagnostic assay, we want to make a contribution to fight the current COVID-19 global pandemic by delivering fast and accurate SARS-CoV-2 testing,” said Sebastian Kronmueller, Head of Molecular Diagnostics at Siemens Healthineers. “The Siemens Healthineers assay is designed to help researchers positively identify the virus in less than three hours so that healthcare professionals can proceed as quickly as possible with the necessary next steps on their patients’ triage paths.”

Related Links:
Siemens Healthineers

Gold Supplier
Sample Transport
VACUETTE Transport Line
New
Laboratory Automation System
UniVerse
New
Gold Supplier
Lactate Dehydrogenase (LDH) Assay
LDH 21 FS
New
qPCR Instrument
Q qPCR Instrument

Print article

Channels

Clinical Chem.

view channel
Image: Simoa is an ultra-sensitive immunoassay technology that allow detection of proteins and nucleic acids at lowest possible levels (Photo courtesy of Quanterix)

Plasma Amyloid-β 42/40 Assays Compared in Alzheimer Disease

Blood-based tests for brain amyloid-β (Aβ) pathology are needed for widespread implementation of Alzheimer disease (AD) biomarkers in clinical care and to facilitate patient screening and monitoring of... Read more

Molecular Diagnostics

view channel
Image: The QuikRead go iFOBT is an immunochemical fecal immunochemical test for detection and quantification of human hemoglobin in feces in case of suspected bleeding from the lower gastrointestinal tract (Photo courtesy of Aidian)

Fecal Immunochemical Tubes Sourced to Analyze Gut Microbiome for CRC

Colorectal cancer (CRC) is a challenging public health problem which successful treatment depends on the stage at diagnosis. Recently, CRC-specific microbiome signatures have been proposed as a marker... Read more

Hematology

view channel
Image: Bone marrow aspirate from a patient with peripheral T-cell lymphoma (Photo courtesy of Peter Maslak, MD)

Mutation Analysis Links Angioimmunoblastic T-Cell Lymphoma to Clonal Hematopoiesis

Peripheral T-cell lymphoma (PTCL) is a heterogeneous group of lymphoid tumors and encompass peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and... Read more

Immunology

view channel
Image: The BD LSRFortessa X-20 Cell Analyzer can be configured with up to five lasers to detect up to 20 parameters simultaneously to support ever increasing demands in multicolor flow cytometry (Photo courtesy of BD Biosciences)

Highly Multiplexed Cell Surface Protein Analyzed Via Flow Cytometry

Modern immunologic studies increasingly requires high-dimensional analyses to understand the complex milieu of cell types that comprise the tissue microenvironments of disease. One of the cornerstones... Read more

Pathology

view channel
Image: Characteristic bronchoalveolar lavage findings of diffuse alveolar hemorrhage (Photo courtesy of Peter C. Bauer, MD)

Bronchoalveolar Lavage Cell Pattern Determined for Diffuse Alveolar Hemorrhage

Diffuse alveolar hemorrhage (DAH) is a clinicopathological syndrome that describes the accumulation of intra-alveolar red blood cells originating from the alveolar capillaries. DAH can induce severe respiratory... Read more

Industry

view channel
Image: GastroPanel Quick Test (Photo courtesy of Biohit Healthcare)

Biohit’s Innovative GastroPanel Quick Test Receives CE Mark

Biohit Healthcare’s (Helsinki, Finland) GastroPanel Quick Test, the latest innovation in its unique GastroPanel product family, is now CE marked. The GastroPanel Quick Test is intended for diagnosing... Read more
Copyright © 2000-2021 Globetech Media. All rights reserved.