Performance of Second Generation Cortisol Assay Evaluated
|
By LabMedica International staff writers Posted on 21 Dec 2016 |
|
Image: The cobas e 411 fully automated, random access system for immunoassay analysis (Photo courtesy of Roche Diagnostics).
Untreated disorders of the adrenocortical system, such as Cushing’s or Addison’s disease, can be fatal, and accurate quantification of a patient’s cortisol levels is vital for diagnosis. A straightforward diagnostic approach is of essential importance, and accurate quantification of cortisol levels plays a key role in the diagnosis of patients with suspected disease.
Cortisol levels are often measured from a patient’s serum or plasma, which reflects total cortisol, both free and bound. However, in patients with liver disease, and for those receiving estrogen treatments or with critical illness, total serum cortisol levels may be difficult to interpret because of the variation in binding proteins.
Laboratory scientists at the Hospital of the University of Munich (Munich, Germany) and their colleagues performed a technical evaluation of the Elecsys Cortisol II assay (Roche Diagnostics GmbH, Mannheim, Germany) between June and November 2014 at four European investigational sites: three in Germany (Munich, Heidelberg, and Leipzig) and one in Belgium (Ghent). All sites used cobas e 411 analyzers for the Cortisol II assay experiments and in addition to a cobas e 411 system, the Leipzig site utilized a cobas e 601 analyzer. The Cortisol II assay was also compared with in-house isotope dilution liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays.
The team reported that for the method comparison studies, the serum samples covered a measuring range of 1.7 to 1,735 nmol/L and the saliva samples from 1.5 to 209.5 nmol/L. For the 405 serum samples, the agreement between the Cortisol II assay and LC-MS/MS was high, and the mean bias for serum samples measured on the Cortisol II assay compared with LC-MS/MS was 14.55 nmol/L. The correlation coefficient for the relationship between the Cortisol II assays versus LC-MS/MS for 253 saliva samples was 0.993, and for these comparisons, the mean bias was 2.56 nmol/L.
The authors concluded that for the Cortisol II assay, they observed a degree of between-laboratory and between-production lot reproducibility and agreement with several assays of higher metrological order that they consider compatible with the diagnostic use of this assay. The Cortisol II assay will be beneficial to endocrinologists in assessing patients with adreno-cortisol disorders. The study was published on November 29, 2016, in the journal Clinical Chemistry and Laboratory Medicine.
Related Links:
Hospital of the University of Munich
Roche Diagnostics
Cortisol levels are often measured from a patient’s serum or plasma, which reflects total cortisol, both free and bound. However, in patients with liver disease, and for those receiving estrogen treatments or with critical illness, total serum cortisol levels may be difficult to interpret because of the variation in binding proteins.
Laboratory scientists at the Hospital of the University of Munich (Munich, Germany) and their colleagues performed a technical evaluation of the Elecsys Cortisol II assay (Roche Diagnostics GmbH, Mannheim, Germany) between June and November 2014 at four European investigational sites: three in Germany (Munich, Heidelberg, and Leipzig) and one in Belgium (Ghent). All sites used cobas e 411 analyzers for the Cortisol II assay experiments and in addition to a cobas e 411 system, the Leipzig site utilized a cobas e 601 analyzer. The Cortisol II assay was also compared with in-house isotope dilution liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays.
The team reported that for the method comparison studies, the serum samples covered a measuring range of 1.7 to 1,735 nmol/L and the saliva samples from 1.5 to 209.5 nmol/L. For the 405 serum samples, the agreement between the Cortisol II assay and LC-MS/MS was high, and the mean bias for serum samples measured on the Cortisol II assay compared with LC-MS/MS was 14.55 nmol/L. The correlation coefficient for the relationship between the Cortisol II assays versus LC-MS/MS for 253 saliva samples was 0.993, and for these comparisons, the mean bias was 2.56 nmol/L.
The authors concluded that for the Cortisol II assay, they observed a degree of between-laboratory and between-production lot reproducibility and agreement with several assays of higher metrological order that they consider compatible with the diagnostic use of this assay. The Cortisol II assay will be beneficial to endocrinologists in assessing patients with adreno-cortisol disorders. The study was published on November 29, 2016, in the journal Clinical Chemistry and Laboratory Medicine.
Related Links:
Hospital of the University of Munich
Roche Diagnostics
Latest Immunology News
- AI Tool Predicts Cancer Patients’ Response to Immunotherapy
- Molecular Profiling Improves Diagnosis for Children with High Risk Cancers
- Blood Test Measures Immune Response to Epstein-Barr Virus in MS Patients
- AI Predicts Tumor-Killing Cells with High Accuracy
- Diagnostic Blood Test for Cellular Rejection after Organ Transplant Could Replace Surgical Biopsies
- AI Tool Precisely Matches Cancer Drugs to Patients Using Information from Each Tumor Cell
- Genetic Testing Combined With Personalized Drug Screening On Tumor Samples to Revolutionize Cancer Treatment
- Testing Method Could Help More Patients Receive Right Cancer Treatment
- Groundbreaking Test Monitors Radiation Therapy Toxicity in Cancer Patients
- State-Of-The Art Techniques to Investigate Immune Response in Deadly Strep A Infections
- Novel Immunoassays Enable Early Diagnosis of Antiphospholipid Syndrome
- New Test Could Predict Immunotherapy Success for Broader Range Of Cancers
- Simple Blood Protein Tests Predict CAR T Outcomes for Lymphoma Patients
- Cell Sorter Chip Technology to Pave Way for Immune Profiling at POC
- Chip Monitors Cancer Cells in Blood Samples to Assess Treatment Effectiveness
- Automated Immunohematology Approaches Can Resolve Transplant Incompatibility
Channels
Molecular Diagnostics
view channel
Novel Immune-Based Biomarker Helps Detect Ovarian Cancer Years before Diagnosis
High-grade ovarian cancer (HGOC) ranks as the fifth-leading cause of cancer-related death among women. Over 90% of cases are diagnosed at advanced stages after the cancer has spread, posing significant... Read more
New Blood Test Identifies Children with Rare Heart Condition
Hypertrophic cardiomyopathy (HCM) is a hereditary condition that leads to the thickening of the heart muscle and is the most frequent cause of sudden death among children and teenagers. There is no cure... Read more
Advanced Liquid Biopsy Technology Detects Cancer Earlier Than Conventional Methods
Liquid biopsy technology has yet to fully deliver on its significant potential. Traditional methods have focused on a narrow range of cancer-associated mutations that are often present in such low quantities... 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.jpg "Image: The AI tool predicts whether someone’s cancer will respond to immune checkpoint inhibitors (Photo courtesy of National Cancer Institute)")
AI Tool Predicts Cancer Patients’ Response to Immunotherapy
Immune checkpoint inhibitors are a form of immunotherapy drug that enables immune cells to target and destroy cancer cells. At present, the Food and Drug Administration has approved two predictive biomarkers... Read more
Molecular Profiling Improves Diagnosis for Children with High Risk Cancers
Cancer remains the leading cause of disease-related death among children in most developed nations, and approximately one-fourth of these patients are diagnosed with aggressive, high-risk, or relapsed... Read more
.jpg "Image: The AI predictive model identifies the most potent cancer killing immune cells for use in immunotherapies (Photo courtesy of Shutterstock)")
Microbiology
view channel
Rapid UTI Test Cuts Detection Time from 3 days to 45 Minutes
Antimicrobial Resistance (AMR), also known as antibiotic resistance or superbugs, is a silent but growing pandemic where bacteria have become resistant to lifesaving antibiotics due to decades of overuse and misuse.... Read more
POC STI Test Shortens Time from ED Arrival to Test Results
In a 2024 sexually transmitted infections (STIs) surveillance report by the World Health Organization (WHO), over 2.5 million cases were recorded, alongside a rise in the inappropriate use of antibiotics... Read more
Integrated Solution Ushers New Era of Automated Tuberculosis Testing
Tuberculosis (TB) is responsible for 1.3 million deaths every year, positioning it as one of the top killers globally due to a single infectious agent. In 2022, around 10.6 million people were diagnosed... Read more
Automated Sepsis Test System Enables Rapid Diagnosis for Patients with Severe Bloodstream Infections
Sepsis affects up to 50 million people globally each year, with bacteraemia, formerly known as blood poisoning, being a major cause. In the United States alone, approximately two million individuals are... Read morePathology
view channel
New Technique Reveals Earliest Signs of Genetic Mutations
Mutations are alterations in the molecular "letters" that constitute the DNA code, which serves as the blueprint for all living cells. While some of these changes may be inconsequential, others can lead... Read more
New WHO Reporting System for Lung Cytopathology to Enhance Diagnostic Accuracy
Lung cancer continues to be the most common cause of cancer-related deaths worldwide and ranks as the second most frequently diagnosed cancer in both men and women. The role of lung cytopathology, which... Read more
Self-Taught AI Tool Diagnoses and Predicts Severity of Common Lung Cancer
A computer program powered by artificial intelligence (AI) and trained on nearly half a million tissue images can effectively diagnose cases of adenocarcinoma, the most prevalent type of lung cancer.... Read more
Novel AI-Powered Method for Tissue Analysis Improves Understanding of Disease Pathology
Scientists at Brown University (Providence, RI, USA) and the University of Michigan (Ann Arbor, MI, USA) have created a groundbreaking computational technique to examine complex tissue data, potentially... Read moreTechnology
view channel
Microneedle Patch Detects Skin Cancer Early
Wearable bioelectronics has emerged as a significant innovation in healthcare, especially in the field of biosensing, providing a new method to monitor individual health for both diagnostic and therapeutic purposes.... Read more
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
Industry
view channel
Roche and Hitachi High-Tech Extend 46-Year Partnership for Breakthroughs in Diagnostic Testing
Roche (Basel, Switzerland) and Hitachi High-Tech (Tokyo, Japan) have renewed their collaboration agreement, committing to a further 10 years of partnership. This extension brings together their long-standing... Read more
Danaher and Johns Hopkins University Collaborate to Improve Neurological Diagnosis
Unlike severe traumatic brain injury (TBI), mild TBI often does not show clear correlations with abnormalities detected through head computed tomography (CT) scans. Consequently, there is a pressing need... Read more
Beckman Coulter and MeMed Expand Host Immune Response Diagnostics Partnership
Beckman Coulter Diagnostics (Brea, CA, USA) and MeMed BV (Haifa, Israel) have expanded their host immune response diagnostics partnership. Beckman Coulter is now an authorized distributor of the MeMed... Read more_1.jpg "Image: Thermo Fisher will distribute Bio-Techne products across Europe (Photo courtesy of 123RF)")
