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
New
Silver Member
Vitamin D Assay
EZ Vitamin D Assay
Gold Member
Flocked Fiber Swabs
Puritan® Patented HydraFlock®
Latest Immunology News
- Exhaled Breath Particles Reveal Virus-Specific Antibodies in the Lower Airways
- Roche Gains FDA Clearance for Flexible Respiratory Pathogen Panel
- Prototype Point-of-Care Lateral Flow Test Aims to Improve Neonatal Sepsis Triage
- Compact Immunoanalyzer Gains CE Mark for Testing Across Local Care Settings
- COVID-19 and Flu Combo Test Launches With FDA Clearance
- Immune and Inflammatory Markers May Help Assess CAR T-Cell Complication Risk
- Antibody Profiling Predicts Inflammatory Bowel Disease Years Before Diagnosis
- Immune Profiling Identifies Early Maternal Autoantibodies Linked to Preterm Birth Risk
- Longitudinal Blood Testing Reveals Changes in Allergen Sensitization During Childhood
- Immune Profiling Initiative Aims to Improve Bone Marrow Analysis in Leukemia
- FDA Approval Adds Automated Testing Option for Parvovirus B19 Serology
- 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
Channels
Clinical Chemistry
view channel
Blood Protein Analysis Reveals Menopause-Associated Signals of Brain Aging
Menopause affects women across midlife and is often accompanied by endocrine changes, hot flashes, brain fog and sleep disturbances. Women spend roughly one third of their lives after the menopause transition,... Read more
Cystatin C Testing Helps Distinguish Abemaciclib Effect from Kidney Injury
Kidney function monitoring in breast cancer care often relies on serum creatinine, a routine blood marker used to estimate renal function. However, creatinine increases in patients receiving abemaciclib... Read more
Blood-Based Score May Support Targeted Interventions for Healthier Aging
Chronic diseases frequently accumulate with age, complicating efforts to maintain functional independence in older adults. Studies cited by the investigators indicate that about 60% of people over age... Read more
Noninvasive Tests Offer Alternatives to Biopsy for Assessing Advanced Liver Scarring
Metabolic dysfunction-associated steatotic liver disease (MASLD) affects up to one in three adults worldwide and as many as seven in 10 people with obesity or type 2 diabetes. Its more severe form, metabolic... Read moreMolecular Diagnostics
view channel
Genomic Profiling Predicts Relapse Risk by Subtype in Pediatric Leukemia
B-cell acute lymphoblastic leukemia (B-ALL) is the most common childhood cancer, with more than 90% of patients surviving with modern treatments. Outcomes are worse when the disease returns, however, making... Read more
AI-Supported Approach May Improve Cervical Cancer Screening in Low-Resource Settings
Cervical cancer screening coverage often remains below 15% in low- and middle-income countries. Limited accuracy of visual inspection with acetic acid, together with uneven access to high-quality human... Read more
Hematology
view channel
Newly Certified FISH Probes Support Cytogenetic Testing in Blood Cancers
Hematological malignancies such as non-Hodgkin lymphoma, acute lymphoblastic leukemia, chronic lymphoid leukemia, and multiple myeloma require assessment of key cytogenetic abnormalities.... Read more
Genetic Testing Offers Opportunities for Earlier Blood Disorder Carrier Identification
Inherited hemoglobin disorders can affect oxygen transport, yet individuals who carry only a trait may remain unaware of their status. People with sickle cell trait or beta-thalassemia trait often have... Read more
New Risk-Stratification Tool Predicts Relapse After Blinatumomab in Childhood ALL
Acute lymphoblastic leukemia in children and young people requires careful assessment of relapse risk, particularly as treatment approaches move beyond standard chemotherapy. Traditional relapse predictors... Read more
Microbiology
view channel
Stool Testing Predicts UTI Risk and Guides Antibiotic Selection
Urinary tract infections (UTIs) are a common reason for antibiotic prescribing in general medical practice and can be painful in postmenopausal women, sometimes progressing to kidney infection or life-threatening... Read more
Rapid Host-Response Assay Gains FDA Clearance to Help Distinguish Bacterial and Viral Infections
Bacterial and viral infections often cause similar symptoms, making early differentiation difficult in emergency and urgent care settings. Clinicians may need to begin treatment before traditional diagnostic... Read more
Repeat Prenatal STI Screening and Treatment May Reduce Preterm Births
Preterm birth remains a major obstetric concern and is associated with serious complications in early childhood. Common sexually transmitted infections during pregnancy often cause no symptoms, making... Read more
Decentralized Laboratory Network Improves Detection of Viral Hemorrhagic Fevers in Guinea
Viral hemorrhagic fevers remain a major diagnostic challenge in West Africa because their early symptoms can resemble those of other febrile illnesses. The 2014–2016 Ebola epidemic underscored the need... Read morePathology
view channel
Review Highlights Progress and Validation Needs for AI in Digital Pathology
Pathology remains the gold standard for disease diagnosis, but clinical laboratories face growing demands for faster, more reproducible diagnostic and prognostic workflows. Digital pathology based on whole-slide... Read more
Breakthrough-Designated Cytology Test Supports Oral Cancer Risk Assessment
Oral cavity and oropharyngeal cancers remain a significant diagnostic challenge, with more than 60,000 Americans expected to be diagnosed in 2026 and more than 13,000 expected to die from these cancers.... Read more
AI Pathology Approach Closely Aligns With Breast Cancer Genomic Risk Classification
In early-stage breast cancer, precision oncology relies on biological information to guide personalized treatment decisions. Because access to tissue-based genomic testing may be limited, there is growing... Read more
Technology
view channel
Multi-Agent AI Framework Supports Laboratory Quality and Workflow Monitoring
Clinical laboratories analyze blood, urine, tissue, and other bodily fluids to support disease diagnosis and treatment. Rising test volumes, workforce shortages, and increasingly complex diagnostics are... Read more
Personal PCR Analyzer Aims to Enable At-Home Infectious Disease Testing
PCR amplifies DNA to enable highly accurate testing, but its reliance on complex, expensive laboratory analyzers has traditionally kept many workflows in centralized settings. A new personal DNA analyzer... Read more
Industry
view channel
Illumina Selected to Support National Genomics Study for Personalized Healthcare in Singapore
Singapore’s National Precision Medicine program is using genomic and health data to support more preventive and personalized healthcare. Its latest phase expands beyond healthy volunteers to people with... Read more
