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
New
Gold Member
Hybrid Pipette
SWITCH
Gold Member
Quality Control Material
iPLEX Pro Exome QC Panel
Gold Member
Immunochromatographic Assay
CRYPTO Cassette
Urine Chemistry Control
Dropper Urine Chemistry Control
Latest Immunology News
- Chip Captures Cancer Cells from Blood to Help Select Right Breast Cancer Treatment
- Blood-Based Liquid Biopsy Model Analyzes Immunotherapy Effectiveness
- Signature Genes Predict T-Cell Expansion in Cancer Immunotherapy
- Molecular Microscope Diagnostic System Assesses Lung Transplant Rejection
- Blood Test Tracks Treatment Resistance in High-Grade Serous Ovarian Cancer
- Luminescent Probe Measures Immune Cell Activity in Real Time
- Blood-Based Immune Cell Signatures Could Guide Treatment Decisions for Critically Ill Patients
- Novel Tool Predicts Most Effective Multiple Sclerosis Medication for Patients
- Companion Diagnostic Test for CRC Patients Identifies Eligible Treatment Population
- Novel Tool Uses Deep Learning for Precision Cancer Therapy
- Companion Diagnostic Test Identifies HER2-Ultralow Breast Cancer and Biliary Tract Cancer Patients
- Novel Multiplex Assay Supports Diagnosis of Autoimmune Vasculitis
- Blood Test Predicts Immunotherapy Efficacy in Triple-Negative Breast Cancer
- Simple Genetic Testing Could Predict Treatment Success in Multiple Sclerosis Patients
- Novel Gene Signature Predicts Immunotherapy Response in Advanced Kidney Cancers
- New Technology Deciphers Immune Cell Communication to Predict Immunotherapy Response
Channels
Clinical Chemistry
view channel
VOCs Show Promise for Early Multi-Cancer Detection
Early cancer detection is critical to improving survival rates, but most current screening methods focus on individual cancer types and often involve invasive procedures. This makes it difficult to identify... Read more
Portable Raman Spectroscopy Offers Cost-Effective Kidney Disease Diagnosis at POC
Kidney disease is typically diagnosed through blood or urine tests, often when patients present with symptoms such as blood in urine, shortness of breath, or weight loss. While these tests are common,... Read more
Molecular Diagnostics
view channel
Simultaneous Analysis of Three Biomarker Tests Detects Elevated Heart Disease Risk Earlier
Accurately identifying individuals at high risk of heart attack remains a major challenge, especially when traditional indicators like cholesterol and blood pressure appear normal. Elevated levels of three... Read more
New Biomarker Panel to Improve Heart Failure Diagnosis in Women
Heart failure affects millions worldwide, yet many women are still misdiagnosed or diagnosed too late. Although heart failure broadly means the heart cannot pump enough blood to the body’s cells, its two... Read more
Hematology
view channel
Microvesicles Measurement Could Detect Vascular Injury in Sickle Cell Disease Patients
Assessing disease severity in sickle cell disease (SCD) remains challenging, especially when trying to predict hemolysis, vascular injury, and risk of complications such as vaso-occlusive crises.... Read more
ADLM’s New Coagulation Testing Guidance to Improve Care for Patients on Blood Thinners
Direct oral anticoagulants (DOACs) are one of the most common types of blood thinners. Patients take them to prevent a host of complications that could arise from blood clotting, including stroke, deep... Read more
Viscoelastic Testing Could Improve Treatment of Maternal Hemorrhage
Postpartum hemorrhage, severe bleeding after childbirth, remains one of the leading causes of maternal mortality worldwide, yet many of these deaths are preventable. Standard care can be hindered by delays... Read more
Pioneering Model Measures Radiation Exposure in Blood for Precise Cancer Treatments
Scientists have long focused on protecting organs near tumors during radiotherapy, but blood — a vital, circulating tissue — has largely been excluded from dose calculations. Each blood cell passing through... Read moreMicrobiology
view channel
15-Minute Blood Test Diagnoses Life-Threatening Infections in Children
Distinguishing minor childhood illnesses from potentially life-threatening infections such as sepsis or meningitis remains a major challenge in emergency care. Traditional tests can take hours, leaving... Read more
High-Throughput Enteric Panels Detect Multiple GI Bacterial Infections from Single Stool Swab Sample
Gastrointestinal (GI) infections are among the most common causes of illness worldwide, leading to over 1.7 million deaths annually and placing a heavy burden on healthcare systems. Conventional diagnostic... Read more
Pathology
view channel
Hydrogel-Based Technology Isolates Extracellular Vesicles for Early Disease Diagnosis
Isolating extracellular vesicles (EVs) from biological fluids is essential for early diagnosis, therapeutic development, and precision medicine. However, traditional EV-isolation methods rely on ultra... Read more
AI Tool Improves Accuracy of Skin Cancer Detection
Diagnosing melanoma accurately in people with darker skin remains a longstanding challenge. Many existing artificial intelligence (AI) tools detect skin cancer more reliably in lighter skin tones, often... Read more
Technology
view channel
AI Saliva Sensor Enables Early Detection of Head and Neck Cancer
Early detection of head and neck cancer remains difficult because the disease produces few or no symptoms in its earliest stages, and lesions often lie deep within the head or neck, where biopsy or endoscopy... Read more
AI-Powered Biosensor Technology to Enable Breath Test for Lung Cancer Detection
Detecting lung cancer early remains one of the biggest challenges in oncology, largely because current tools are invasive, expensive, or unable to identify the disease in its earliest phases.... Read more
Industry
view channel
Co-Diagnostics Forms New Business Unit to Develop AI-Powered Diagnostics
Co-Diagnostics, Inc. (Salt Lake City, UT, USA) has formed a new artificial intelligence (AI) business unit to integrate the company's existing and planned AI applications into its Co-Dx Primer Ai platform.... Read more
