Ortho Clinical Diagnostics and EKF Diagnostics Collaborate for Assay
|
By LabMedica International staff writers Posted on 17 Oct 2017 |
|
Image: The VITROS 5600 integrated system (Photo courtesy of Ortho Clinical Diagnostics).
Ortho Clinical Diagnostics (Raritan, NJ, USA) and EKF Diagnostics (Wales, UK) have entered into an agreement that allows Ortho customers to access the Beta-Hydroxybutyrate (BHB) assay, an important marker used in conjunction with clinical findings and other lab tests for the diagnosis and management of ketoacidosis and its main causative factor, diabetic ketoacidosis (DKA). The fully automated assay is now available for use on Ortho's VITROS 4600 chemistry system and the VITROS 5600 integrated system.
Ortho’s in vitro diagnostics products and services for the clinical laboratory and immunohematology communities include blood typing products, sophisticated testing technologies, automation, information management and interpretation tools. EKF Diagnostics, through its wholly owned subsidiary, Stanbio Laboratory, manufactures a comprehensive range of clinical chemistry reagents, rapid tests and benchtop chemistry analyzers. EKF Diagnostics' enzymatic BHB assay is used primarily for determining both the presence and degree of ketosis in suspected DKA cases and produces a quantitative value that is specific to the BHB “ketone body.”
Ortho and EKF Diagnostics are collaborating to provide the BHB assay as a validated MicroTip Partnership Assay (MPA) application in the US and Canada. This MPA utilizes the user defined assay feature, which provides the capability to program assay parameters as defined in the EKF- Stanbio Assay Application Sheet. The BHB LiquiColor assay has been CLIA classified by the U.S. Food and Drug Administration as a MODERATE complexity assay on the VITROS 4600 Chemistry System and VITROS 5600 Integrated System.
"Ortho is committed to delivering a broad menu of assays to our customers in the clinical lab, whether through in-house development or collaborations like the one with EKF," said Ortho's Chief Operating Officer Robert Yates.
"Diabetic ketoacidosis is a serious condition, and our collaboration with Ortho Clinical Diagnostics will help to deliver the important BHB assay to their existing customers," said EKF's Diagnostics Head of Sales, Gilbert Mejia.
Ortho’s in vitro diagnostics products and services for the clinical laboratory and immunohematology communities include blood typing products, sophisticated testing technologies, automation, information management and interpretation tools. EKF Diagnostics, through its wholly owned subsidiary, Stanbio Laboratory, manufactures a comprehensive range of clinical chemistry reagents, rapid tests and benchtop chemistry analyzers. EKF Diagnostics' enzymatic BHB assay is used primarily for determining both the presence and degree of ketosis in suspected DKA cases and produces a quantitative value that is specific to the BHB “ketone body.”
Ortho and EKF Diagnostics are collaborating to provide the BHB assay as a validated MicroTip Partnership Assay (MPA) application in the US and Canada. This MPA utilizes the user defined assay feature, which provides the capability to program assay parameters as defined in the EKF- Stanbio Assay Application Sheet. The BHB LiquiColor assay has been CLIA classified by the U.S. Food and Drug Administration as a MODERATE complexity assay on the VITROS 4600 Chemistry System and VITROS 5600 Integrated System.
"Ortho is committed to delivering a broad menu of assays to our customers in the clinical lab, whether through in-house development or collaborations like the one with EKF," said Ortho's Chief Operating Officer Robert Yates.
"Diabetic ketoacidosis is a serious condition, and our collaboration with Ortho Clinical Diagnostics will help to deliver the important BHB assay to their existing customers," said EKF's Diagnostics Head of Sales, Gilbert Mejia.
Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
Complement 3 (C3) Test
GPP-100 C3 Kit
Gold Member
Fully Automated Cell Density/Viability Analyzer
BioProfile FAST CDV
Latest Industry News
- Thermo Fisher and Bio-Techne Enter Into Strategic Distribution Agreement for Europe
- ECCMID Congress Name Changes to ESCMID Global
- Bosch and Randox Partner to Make Strategic Investment in Vivalytic Analysis Platform
- Siemens to Close Fast Track Diagnostics Business
- Beckman Coulter and Fujirebio Expand Partnership on Neurodegenerative Disease Diagnostics
- Sysmex and Hitachi Collaborate on Development of New Genetic Testing Systems
- Sysmex and CellaVision Expand Collaboration to Advance Hematology Solutions
- BD and Techcyte Collaborate on AI-Based Digital Cervical Cytology System for Pap Testing
- Medlab Middle East 2024 to Address Transformative Potential of Artificial Intelligence
- Seegene and Microsoft Collaborate to Realize a World Free from All Diseases and Future Pandemics
- Medlab Middle East 2024 to Highlight Importance of Sustainability in Laboratories
- Fujirebio and Agappe Collaborate on CLIA-Based Immunoassay
- Medlab Middle East 2024 to Highlight Groundbreaking NextGen Medicine
- bioMérieux Acquires Software Company LUMED to Support Fight against Antimicrobial Resistance
- Roche Acquires LumiraDx's Point of Care Technology for USD 295 Million
- Bruker Acquires IVD Manufacturer ELITech Group and Cell Imaging Company Phasefocus
Channels
Clinical Chemistry
view channel
3D Printed Point-Of-Care Mass Spectrometer Outperforms State-Of-The-Art Models
Mass spectrometry is a precise technique for identifying the chemical components of a sample and has significant potential for monitoring chronic illness health states, such as measuring hormone levels... Read more.jpg "Image: Reaching speeds up to 6,000 RPM, this centrifuge forms the basis for a new type of inexpensive, POC biomedical test (Photo courtesy of Duke University)")
POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection
Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics.... Read more
Highly Reliable Cell-Based Assay Enables Accurate Diagnosis of Endocrine Diseases
The conventional methods for measuring free cortisol, the body's stress hormone, from blood or saliva are quite demanding and require sample processing. The most common method, therefore, involves collecting... Read more
Molecular Diagnostics
view channel
Urine Test to Revolutionize Lyme Disease Testing
Lyme disease is the most common animal-to-human transmitted disease in the United States, with around 476,000 people diagnosed and treated annually, and its incidence has been increasing.... Read more
Simple Blood Test Could Enable First Quantitative Assessments for Future Cerebrovascular Disease
Cerebral small vessel disease is a common cause of stroke and cognitive decline, particularly in the elderly. Presently, assessing the risk for cerebral vascular diseases involves using a mix of diagnostic... Read more
New Genetic Testing Procedure Combined With Ultrasound Detects High Cardiovascular Risk
A key interest area in cardiovascular research today is the impact of clonal hematopoiesis on cardiovascular diseases. Clonal hematopoiesis results from mutations in hematopoietic stem cells and may lead... Read more
Hematology
view channel
Next Generation Instrument Screens for Hemoglobin Disorders in Newborns
Hemoglobinopathies, the most widespread inherited conditions globally, affect about 7% of the population as carriers, with 2.7% of newborns being born with these conditions. The spectrum of clinical manifestations... Read more
First 4-in-1 Nucleic Acid Test for Arbovirus Screening to Reduce Risk of Transfusion-Transmitted Infections
Arboviruses represent an emerging global health threat, exacerbated by climate change and increased international travel that is facilitating their spread across new regions. Chikungunya, dengue, West... Read more
POC Finger-Prick Blood Test Determines Risk of Neutropenic Sepsis in Patients Undergoing Chemotherapy
Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections,... Read more
First Affordable and Rapid Test for Beta Thalassemia Demonstrates 99% Diagnostic Accuracy
Hemoglobin disorders rank as some of the most prevalent monogenic diseases globally. Among various hemoglobin disorders, beta thalassemia, a hereditary blood disorder, affects about 1.5% of the world's... Read moreImmunology
view channel
Diagnostic Blood Test for Cellular Rejection after Organ Transplant Could Replace Surgical Biopsies
Transplanted organs constantly face the risk of being rejected by the recipient's immune system which differentiates self from non-self using T cells and B cells. T cells are commonly associated with acute... Read more
AI Tool Precisely Matches Cancer Drugs to Patients Using Information from Each Tumor Cell
Current strategies for matching cancer patients with specific treatments often depend on bulk sequencing of tumor DNA and RNA, which provides an average profile from all cells within a tumor sample.... Read more
Genetic Testing Combined With Personalized Drug Screening On Tumor Samples to Revolutionize Cancer Treatment
Cancer treatment typically adheres to a standard of care—established, statistically validated regimens that are effective for the majority of patients. However, the disease’s inherent variability means... Read more
Microbiology
view channel
Enhanced Rapid Syndromic Molecular Diagnostic Solution Detects Broad Range of Infectious Diseases
GenMark Diagnostics (Carlsbad, CA, USA), a member of the Roche Group (Basel, Switzerland), has rebranded its ePlex® system as the cobas eplex system. This rebranding under the globally renowned cobas name... Read more
Clinical Decision Support Software a Game-Changer in Antimicrobial Resistance Battle
Antimicrobial resistance (AMR) is a serious global public health concern that claims millions of lives every year. It primarily results from the inappropriate and excessive use of antibiotics, which reduces... Read more
New CE-Marked Hepatitis Assays to Help Diagnose Infections Earlier
According to the World Health Organization (WHO), an estimated 354 million individuals globally are afflicted with chronic hepatitis B or C. These viruses are the leading causes of liver cirrhosis, liver... Read more
1 Hour, Direct-From-Blood Multiplex PCR Test Identifies 95% of Sepsis-Causing Pathogens
Sepsis contributes to one in every three hospital deaths in the US, and globally, septic shock carries a mortality rate of 30-40%. Diagnosing sepsis early is challenging due to its non-specific symptoms... Read morePathology
view channel
Robotic Blood Drawing Device to Revolutionize Sample Collection for Diagnostic Testing
Blood drawing is performed billions of times each year worldwide, playing a critical role in diagnostic procedures. Despite its importance, clinical laboratories are dealing with significant staff shortages,... Read more.jpg "Image: The Aperio GT 450 DX has received US FDA 510(k) clearance (Photo courtesy of Leica Biosystems)")
Use of DICOM Images for Pathology Diagnostics Marks Significant Step towards Standardization
Digital pathology is rapidly becoming a key aspect of modern healthcare, transforming the practice of pathology as laboratories worldwide adopt this advanced technology. Digital pathology systems allow... Read more
First of Its Kind Universal Tool to Revolutionize Sample Collection for Diagnostic Tests
The COVID pandemic has dramatically reshaped the perception of diagnostics. Post the pandemic, a groundbreaking device that combines sample collection and processing into a single, easy-to-use disposable... Read more
Technology
view channel
New Diagnostic System Achieves PCR Testing Accuracy
While PCR tests are the gold standard of accuracy for virology testing, they come with limitations such as complexity, the need for skilled lab operators, and longer result times. They also require complex... Read more
DNA Biosensor Enables Early Diagnosis of Cervical Cancer
Molybdenum disulfide (MoS2), recognized for its potential to form two-dimensional nanosheets like graphene, is a material that's increasingly catching the eye of the scientific community.... Read more
Self-Heating Microfluidic Devices Can Detect Diseases in Tiny Blood or Fluid Samples
Microfluidics, which are miniature devices that control the flow of liquids and facilitate chemical reactions, play a key role in disease detection from small samples of blood or other fluids.... Read more