Bio-Rad Launches Serology Assay for Detection of Coronavirus Antibodies
|
By LabMedica International staff writers Posted on 09 Apr 2020 |
|
Image: Bio-Rad launches serology assay for detection of coronavirus antibodies (Photo courtesy of Bio-Rad Laboratories, Inc.)
Bio-Rad Laboratories, Inc. (Hercules, CA, USA) has launched a blood-based immunoassay kit to identify antibodies to the coronavirus SARS-CoV-2, the virus associated with COVID-19. Preliminary performance of the assay has been established and the kit is now undergoing clinical evaluation in several hospitals to further confirm its clinical performance. Initial data collected on more than 700 samples has demonstrated specificity of above 99%.
Bio-Rad develops, manufactures, and markets a broad range of innovative products for the life science research and clinical diagnostic markets. Its customers comprise university and research institutions, hospitals, public health and commercial laboratories, biotechnology, pharmaceutical, as well as applied laboratories that include food safety and environmental quality. Bio-Rad hasd recently launched a SARS CoV-2 Standard to support laboratory assay validation of coronavirus (COVID-19) testing through its Exact Diagnostics product line. Bio-Rad is providing the SARS CoV-2 Standard to help labs validate their COVID-19 assay results and accelerate access to testing.
Bio-Rad’s immunoassay kit detects total immunoglobulin (IgG, IgM, and IgA), an approach which appears to be more sensitive than assays against a single immunoglobulin. The test was designed for use manually or on an automated immunoassay platform, such as Bio-Rad’s EVOLIS System, which offers high throughput processing and sample traceability. Bio-Rad plans to offer the immunoassay kit globally. In the US, the company intends to use the FDA’s Emergency Use Authorization process to expedite US availability. Bio-Rad believes its blood-based immunoassay kit will help clinicians determine if an individual has been infected by the virus and therefore, has developed an immune response against SARS-CoV-2.
“Using a serology test to support the diagnosis of COVID-19 and to screen populations can provide a more complete understanding of infection rates as well as immunity,” said Dara Wright, Bio-Rad Clinical Diagnostics Group EVP & President. “The detection of antibodies to SARS-CoV-2 on a large scale may be used to guide public authorities in their decisions to lift partial or total containment orders according to the serological status of the population. Molecular and serology testing are highly complementary in this regard.”
Related Links:
Bio-Rad Laboratories, Inc.
Bio-Rad develops, manufactures, and markets a broad range of innovative products for the life science research and clinical diagnostic markets. Its customers comprise university and research institutions, hospitals, public health and commercial laboratories, biotechnology, pharmaceutical, as well as applied laboratories that include food safety and environmental quality. Bio-Rad hasd recently launched a SARS CoV-2 Standard to support laboratory assay validation of coronavirus (COVID-19) testing through its Exact Diagnostics product line. Bio-Rad is providing the SARS CoV-2 Standard to help labs validate their COVID-19 assay results and accelerate access to testing.
Bio-Rad’s immunoassay kit detects total immunoglobulin (IgG, IgM, and IgA), an approach which appears to be more sensitive than assays against a single immunoglobulin. The test was designed for use manually or on an automated immunoassay platform, such as Bio-Rad’s EVOLIS System, which offers high throughput processing and sample traceability. Bio-Rad plans to offer the immunoassay kit globally. In the US, the company intends to use the FDA’s Emergency Use Authorization process to expedite US availability. Bio-Rad believes its blood-based immunoassay kit will help clinicians determine if an individual has been infected by the virus and therefore, has developed an immune response against SARS-CoV-2.
“Using a serology test to support the diagnosis of COVID-19 and to screen populations can provide a more complete understanding of infection rates as well as immunity,” said Dara Wright, Bio-Rad Clinical Diagnostics Group EVP & President. “The detection of antibodies to SARS-CoV-2 on a large scale may be used to guide public authorities in their decisions to lift partial or total containment orders according to the serological status of the population. Molecular and serology testing are highly complementary in this regard.”
Related Links:
Bio-Rad Laboratories, Inc.
Gold Member
SARS‑CoV‑2/Flu A/Flu B/RSV Sample-To-Answer Test
SARS‑CoV‑2/Flu A/Flu B/RSV Cartridge (CE-IVD)
New
Gold Member
Automated MALDI-TOF MS System
EXS 3000
New
Homocysteine Quality Control
Liquichek Homocysteine Control
Latest COVID-19 News
- New Immunosensor Paves Way to Rapid POC Testing for COVID-19 and Emerging Infectious Diseases
- Long COVID Etiologies Found in Acute Infection Blood Samples
- Novel Device Detects COVID-19 Antibodies in Five Minutes
- CRISPR-Powered COVID-19 Test Detects SARS-CoV-2 in 30 Minutes Using Gene Scissors
- Gut Microbiome Dysbiosis Linked to COVID-19
- Novel SARS CoV-2 Rapid Antigen Test Validated for Diagnostic Accuracy
- New COVID + Flu + R.S.V. Test to Help Prepare for `Tripledemic`
- AI Takes Guesswork Out Of Lateral Flow Testing
- Fastest Ever SARS-CoV-2 Antigen Test Designed for Non-Invasive COVID-19 Testing in Any Setting
- Rapid Antigen Tests Detect Omicron, Delta SARS-CoV-2 Variants
- Health Care Professionals Showed Increased Interest in POC Technologies During Pandemic, Finds Study
- Set Up Reserve Lab Capacity Now for Faster Response to Next Pandemic, Say Researchers
- Blood Test Performed During Initial Infection Predicts Long COVID Risk
- Low-Cost COVID-19 Testing Platform Combines Sensitivity of PCR and Speed of Antigen Tests
- Finger-Prick Blood Test Identifies Immunity to COVID-19
- Quick Test Kit Determines Immunity Against COVID-19 and Its Variants
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
Urine Test Detects Early Stage Pancreatic Cancer
Pancreatic cancer remains among the hardest cancers to detect early. In the UK, around 10,000 people are diagnosed each year, but only 5% survive beyond five years. Late diagnosis is a major factor—more... Read more
Genomic Test Could Reduce Lymph Node Biopsy Surgery in Melanoma Patients
Accurately determining whether melanoma has spread to the lymph nodes is crucial for guiding treatment decisions, yet the standard procedure—sentinel lymph node biopsy—remains invasive, costly, and unnecessary... Read more
Hematology
view channel
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 more
Immunology
view channel
Blood-Based Liquid Biopsy Model Analyzes Immunotherapy Effectiveness
Immunotherapy has revolutionized cancer care by harnessing the immune system to fight tumors, yet predicting who will benefit remains a major challenge. Many patients undergo costly and taxing treatment... Read more
Signature Genes Predict T-Cell Expansion in Cancer Immunotherapy
Modern cancer immunotherapies rely on the ability of CD8⁺ T cells to rapidly multiply within tumors, generating the immune force needed to eliminate cancer cells. However, the biological triggers behind... Read more
Microbiology
view channel
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
Fast Noninvasive Bedside Test Uses Sugar Fingerprint to Detect Fungal Infections
Candida bloodstream infections are a growing global health threat, causing an estimated 6 million cases and 3.8 million deaths annually. Hospitals are particularly vulnerable, as weakened patients after... Read more
Pathology
view channel
New Molecular Analysis Tool to Improve Disease Diagnosis
Accurately distinguishing between similar biomolecules such as proteins is vital for biomedical research and diagnostics, yet existing analytical tools often fail to detect subtle structural or compositional... Read more
Tears Offer Noninvasive Alternative for Diagnosing Neurodegenerative Diseases
Diagnosing and monitoring eye and neurodegenerative diseases often requires invasive procedures to access ocular fluids. Ocular fluids like aqueous humor and vitreous humor contain valuable molecular information... Read more
Technology
view channel
Cell-Sorting Device Uses Electromagnetic Levitation to Precisely Direct Cell Movement
Sorting different cell types—such as cancerous versus healthy or live versus dead cells—is a critical task in biology and medicine. However, conventional methods often require labeling, chemical exposure,... Read more
Embedded GPU Platform Enables Rapid Blood Profiling for POC Diagnostics
Blood tests remain a cornerstone of medical diagnostics, but traditional imaging and analysis methods can be slow, costly, and reliant on dyes or contrast agents. Now, scientists have developed a real-time,... Read more
Industry
view channel
Qiagen Acquires Single-Cell Omics Firm Parse Biosciences
QIAGEN (Venlo, Netherlands) has entered into a definitive agreement to fully acquire Parse Biosciences (Seattle, WA, USA), a provider of scalable, instrument-free solutions for single-cell research.... Read more
Puritan Medical Products Showcasing Innovation at AMP2025 in Boston
Puritan Medical Products (Guilford, ME, USA), the world’s most trusted manufacturer of swabs and specimen collection devices, is set to exhibit at AMP2025 in Boston, Massachusetts, from November 11–15.... Read more
Advanced Instruments Merged Under Nova Biomedical Name
Advanced Instruments (Norwood, MA, USA) and Nova Biomedical (Waltham, MA, USA) are now officially doing business under a single, unified brand. This transformation is expected to deliver greater value... Read more
