New Pregnancy Assay Receives CE Marking and FDA Clearance
|
By LabMedica International staff writers Posted on 20 Jan 2014 |
|
![Image: The new high standard \"Access Total βhCG (5th IS)\" assay for pregnancy determination from Beckman Coulter Diagnostics (Photo courtesy of Beckman Coulter).](https://globetechcdn.com/mobile_labmedica/images/stories/articles/article_images/2014-01-20/MMS-003.gif "Image: The new high standard \\"Access Total βhCG (5th IS)\\" assay for pregnancy determination from Beckman Coulter Diagnostics (Photo courtesy of Beckman Coulter).")
Image: The new high standard \"Access Total βhCG (5th IS)\" assay for pregnancy determination from Beckman Coulter Diagnostics (Photo courtesy of Beckman Coulter).
The approved new pregnancy determination assay features a broad dynamic range and is the first to standardize to the World Health Organization's latest international standard.
To help move reproductive health management forward, Beckman Coulter Diagnostics of Beckman Coulter (Brea, CA, USA) has received the CE marking and US Food and Drug Administration (FDA) 510(k) clearance for its new "Access Total βhCG (5th IS)" assay. It is the first βhCG assay standardized to the highly purified World Health Organization (WHO) 5th International Standard (IS) for glycoprotein chorionic gonadotropin. The βhCG assay is critical in routine and emergency diagnosis as it is frequently ordered on women of childbearing-age who require treatment, which could potentially be harmful to a fetus. The expanded utility of the assay has also been CE Mark approved for Down syndrome assessment during pregnancy.
“As the first manufacturer to standardize to the WHO 5th IS, the new βhCG assay is an example of Beckman Coulter’s continuing dedication to lead the way in this important diagnostic field,” said John Blackwood, senior vice president of Product Management for Beckman Coulter Diagnostics; “The new assay is just one example of the innovations that comprise Beckman Coulter’s reproductive health portfolio—the most comprehensive immunoassay reproductive panel available on the market.”
The assay features a broad dynamic range with automatic onboard dilution capability, reducing the need for manual sample dilutions. As a part of the standardization, reference ranges have been updated to include additional populations that include women over the age of 40, postmenopausal women, and men. Additionally, in response to changing laboratory environments and the challenges faced in collecting serum samples, Beckman Coulter has further improved the Total βhCG (5th IS) to make it more resilient to preanalytical factors.
"Access" reproductive solutions are part of a comprehensive assay menu featured on the Access and UniCel Immunoassay Systems.
Related Links:
Beckman Coulter
To help move reproductive health management forward, Beckman Coulter Diagnostics of Beckman Coulter (Brea, CA, USA) has received the CE marking and US Food and Drug Administration (FDA) 510(k) clearance for its new "Access Total βhCG (5th IS)" assay. It is the first βhCG assay standardized to the highly purified World Health Organization (WHO) 5th International Standard (IS) for glycoprotein chorionic gonadotropin. The βhCG assay is critical in routine and emergency diagnosis as it is frequently ordered on women of childbearing-age who require treatment, which could potentially be harmful to a fetus. The expanded utility of the assay has also been CE Mark approved for Down syndrome assessment during pregnancy.
“As the first manufacturer to standardize to the WHO 5th IS, the new βhCG assay is an example of Beckman Coulter’s continuing dedication to lead the way in this important diagnostic field,” said John Blackwood, senior vice president of Product Management for Beckman Coulter Diagnostics; “The new assay is just one example of the innovations that comprise Beckman Coulter’s reproductive health portfolio—the most comprehensive immunoassay reproductive panel available on the market.”
The assay features a broad dynamic range with automatic onboard dilution capability, reducing the need for manual sample dilutions. As a part of the standardization, reference ranges have been updated to include additional populations that include women over the age of 40, postmenopausal women, and men. Additionally, in response to changing laboratory environments and the challenges faced in collecting serum samples, Beckman Coulter has further improved the Total βhCG (5th IS) to make it more resilient to preanalytical factors.
"Access" reproductive solutions are part of a comprehensive assay menu featured on the Access and UniCel Immunoassay Systems.
Related Links:
Beckman Coulter
Platinum Member
Automated Coagulation Analyzer
Hemolumi H6
Gold Member
Flocked Fiber Swabs
Puritan® Patented HydraFlock®
New
Silver Member
Connectivity Solution
EKF Link
LAIR2 Antibody Pair Set
LAIR2 Antibody Pair [Biotin]
Latest Immunology News
- Blood-Based Immune Aging Map Could Help Spot Disease Risk Earlier
- Blood-Based Immune Signal Could Reveal Lung Cancer Risk Before Tumors Develop
- Prototype Point-of-Care Test Aims to Improve Neonatal Sepsis Diagnosis
- Single-Tier Lyme Disease Test Shows High Sensitivity in Early Infection
- New Web-Based Platform Helps Autoimmune Laboratories Manage Testing Complexity
- Routine Newborn Blood Spots Can Measure GBS Antibody Levels
- New Autoantibody Test Targets Pre-Symptomatic Type 1 Diabetes Screening
- Blood Test Differentiates Bacterial and Viral Infections in Febrile Infants
- HIV Monitoring Strategy Uses Drug Levels to Guide Resistance Testing
- Werfen Expands Automated APS Testing with FDA-Cleared and CE-Marked IgA Reagent
- Blood Biomarker May Predict Colitis Risk in Checkpoint Inhibitor Therapy
- Blood EBV Activity Biomarkers May Predict Multiple Sclerosis Relapse Months Ahead
- New Cellular Map May Help Predict Crohn’s Disease Course in Children
- Temporal Immune Profiling Reveals How Sepsis States Change Over Time
- Study Identifies Immune Cells That Drive Harmful Autoantibody Responses in COVID-19
- Gut “Memory” May Explain Why IBD Flares Return
Channels
Clinical Chemistry
view channel
Hemoglobin Levels May Help Signal Long-Term Dementia Risk
Dementia is a growing health challenge in aging societies, with limited treatment options and no cure. Identifying long-term risk remains difficult, particularly when specialist scans or emerging biomarkers... Read more
Liquid Biopsy Platform Shows Promise for Early Gynecologic Cancer Detection
Gynecologic cancers can be difficult to detect early, particularly when symptoms overlap with benign conditions. Earlier cancer detection remains a diagnostic need in ovarian cancer, described as one of... Read more
Multi-Omics Study Identifies Blood Marker for MASLD Progression
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a major cause of liver-related morbidity and mortality worldwide. As MASLD progresses, fibrosis and liver-related events, including hepatocellular... Read more
Global Survey Finds Pediatric Troponin Testing Lacks Consistent Reference Intervals
Cardiac troponin is released into the blood when heart muscle is damaged and is widely used as a rapid marker of cardiac injury in adults. In children, interpreting troponin results remains difficult because... Read moreMolecular Diagnostics
view channel
Validated Test Predicts Recurrence Risk and Radiation Benefit in Early-Stage Breast Cancer
For women with early-stage invasive breast cancer who undergo breast-conserving surgery, clinicians must assess both the risk of locoregional recurrence and the potential benefit of adjuvant radiation therapy.... Read more
Genomic Screening Expands Detection of Treatable Conditions in Newborns
Conventional newborn screening can miss conditions that lack biochemical biomarkers or present atypically. Initial hearing screens may also fail to detect hearing loss that is later identified through... Read more
Hematology
view channel
New Donor Genetic Marker May Help Predict Stem Cell Transplant Success
Donor selection for hematopoietic stem cell transplantation plays a major role in relapse risk and survival for patients with blood cancers and other blood disorders. Despite advances in genotyping, uncertainty... Read more
Updated Ferritin Thresholds Improve Detection of Iron Deficiency
Iron deficiency is one of the most common health conditions worldwide, yet its nonspecific symptoms can delay diagnosis for months. Variation in testing practices and ferritin thresholds may contribute... Read more
Microbiology
view channel
Rapid Urine Test Aids Diagnosis of Invasive Aspergillosis
Invasive aspergillosis is an uncommon mold infection in the general population but can pose serious risks for people with weakened immune defenses. Diagnosis can be difficult because existing approaches... Read more
Nanodroplet CRISPR Technology Supports Rapid, Multiplexed Mycobacterial Identification
Mycobacterial infections are difficult to diagnose because closely related species can have different clinical and therapeutic implications. Nontuberculous mycobacteria (NTM) are increasingly recognized... Read more
Genomic Workflow Identifies Fungal Pathogens Before Blood Cultures Turn Positive
Fungal bloodstream infections pose a major threat to hospitalized patients. Candida species cause most invasive fungal infections worldwide and are among the leading causes of hospital-acquired bloodstream... Read more
FDA-Cleared Multiplex PCR Test Detects 13 Respiratory Pathogens in a Single Sample
Respiratory tract infections can be difficult to distinguish at presentation because many cause overlapping, nonspecific symptoms and are initially grouped as influenza-like illnesses. Causes span a range... Read morePathology
view channel
AI Histopathology Tool Distinguishes Ewing Sarcoma for Diagnosis
Ewing sarcoma is a rare malignant tumor that mainly affects children, adolescents, and young adults. It usually arises in bone but can also develop in soft tissue, where its microscopic appearance may... Read more
Rapid Mass Spectrometry Test May Aid Glioma Margin Decisions
Glioma brain tumors are highly infiltrative and can extend into nearby healthy brain tissue, making tumor margins difficult to define during surgery. Residual tumor cells may contribute to recurrence and... Read more
Genomic Classifier Predicts Benefit From Adding Hormone Therapy to Salvage Prostate Radiation
Men who have undergone prostatectomy for prostate cancer may later develop a detectable or rising prostate-specific antigen, prompting salvage radiation therapy. A key challenge is determining who is most... Read more
Technology
view channel
Laser-Based Swab Analysis Shows Promise for Detecting Disease-Linked Odor Patterns
Disease-related changes in volatile organic compounds can alter body odor, producing measurable patterns in exhaled breath and bodily fluids. Current analytical methods can be complex, time-consuming,... Read more
Laser-Enhanced Assay Boosts Sensitivity for Colorectal Cancer Biomarker Detection
Colorectal cancer is the third most commonly diagnosed cancer and the second leading cause of cancer-related death worldwide. Early detection remains critical, but cancer biomarkers can produce only faint... Read more
Industry
view channel
Multi-Cancer Screening Blood Test Gains FDA Breakthrough Designation
Natera Inc.’s (Austin, TX, USA) multi-cancer early detection (MCED) assay has received Breakthrough Device designation (BDD) from the U.S. Food and Drug Administration (FDA). The assay analyzes cell-free... Read more
European Approval Expands Liquid Biopsy Use in Advanced Breast Cancer Testing
Estrogen receptor-positive (ER+), HER2-negative advanced breast cancer may require molecular testing to guide treatment selection, with blood-based assays offering a way to identify tumor mutations that... Read more
