We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Ortho Launches Quantitative COVID-19 IgG Antibody Test with CE Mark

By LabMedica International staff writers
Posted on 06 May 2021

Illustration

Ortho Clinical Diagnostics (Raritan, NJ, USA) has announced that its quantitative COVID-19 IgG antibody test has achieved CE Mark.

Ortho's new VITROS Anti-SARS-CoV-2 IgG Quantitative (QN) Antibody assay provides numerical values traceable to the World Health Organization (WHO) International Standard, which helps standardize SARS-CoV-2 serological methods and allows for unified data comparison across laboratories. This key advantage will help clinicians determine the level of an individual's immune response to SARS-CoV-2 after infection or vaccination and provide public health leaders with a standardized tool to measure changes in patients' antibody levels to better track the spread of the virus.

With 100% specificity and excellent sensitivity, the VITROS Anti-SARS-CoV-2 IgG QN Antibody assay is intended for the qualitative detection and quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma and is processed on Ortho's trusted VITROS system. Up to 6.8 million of Ortho's COVID-19 tests can be processed daily on Ortho's globally installed base of over 5,600 analyzers. Ortho plans to manufacture up to eight million quantitative IgG antibody tests each month.

"Ortho's new quantitative IgG antibody test provides healthcare teams and researchers with a standardized data 'ruler,' to assess immune response, acquired through infection or from vaccines, over time, offering additional data to help manage and understand this devastating virus," said Chockalingam Palaniappan, PhD, chief innovation officer, Ortho Clinical Diagnostics.

Visit expo >

Gold Member

SARS-CoV-2 Reactive & Non-Reactive Controls

Qnostics SARS-CoV-2 Typing

Portable Electronic Pipette
Mini 96

Urine Chemistry Control

Dropper Urine Chemistry Control

Automated Chemiluminescence Immunoassay Analyzer

MS-i3080

Latest COVID-19 News

Channels

Clinical Chemistry

view channel

Image: Schematic diagram of esophageal cancer cell identification research process (Photo courtesy of GE Dianlong)

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

Image: Portable Raman spectroscopy could help detect kidney disease at POC (Photo courtesy of Shutterstock)

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

Image: Mesoporous gold nanoparticles have unique biosensing capabilities (Photo courtesy of The University of Queensland)

Gold Nanoparticles to Improve Accuracy of Ovarian Cancer Diagnosis

Ovarian cancer is considered one of the deadliest cancers, in part because it rarely shows clear symptoms in its early stages, and diagnosis is often complex. Current approaches make it difficult to accurately... Read more

Simultaneous Cell Isolation Technology Improves Cancer Diagnostic Accuracy

Accurate cancer diagnosis remains a challenge, as liquid biopsy techniques often fail to capture the complexity of tumor biology. Traditional systems for isolating circulating tumor cells (CTCs) vary in... Read more

Molecular Diagnostics

view channel

Image: The genomic test measures eight gene activities in a melanoma tumor and combines this data with patient factors like age and tumor thickness (Photo courtesy of 123RF)

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

Urine Test Could Replace Painful Kidney Biopsies for Lupus Patients

Lupus is an autoimmune disorder that causes the immune system to attack the body’s own tissues and organs. Among the five million people living with lupus globally, nearly half develop lupus nephritis,... Read more

Image: The study shows that periodic ctDNA screening after surgery can help guide a decision to begin adjuvant immunotherapy (Photo courtesy of Adobe Stock)

Blood Test Guides Post-Surgical Immunotherapy for Muscle-Invasive Bladder Cancer

After surgery for muscle-invasive bladder cancer, many patients face uncertainty about whether residual cancer cells remain in their bodies. Now, a new international phase 3 study has demonstrated that... Read more

Mitochondrial DNA Mutations from Kidney Stressors Could Predict Future Organ Decline

Kidney-related diseases are alarmingly common: chronic kidney disease (CKD) affects more than one in seven U.S. adults, while about 20% of hospitalized adults are diagnosed with acute kidney injury (AKI).... Read more

Hematology

view channel

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

Image: New research points to protecting blood during radiation therapy (Photo courtesy of 123RF)

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

Image: Platelets sequester cfDNA during circulation (Murphy L. et al., Science, 2025; DOI: 10.1126/science.adp3971)

Platelets Could Improve Early and Minimally Invasive Detection of Cancer

Platelets are widely recognized for their role in blood clotting and scab formation, but they also play a crucial role in immune defense by detecting pathogens and recruiting immune cells.... Read more

Image: The microfluidic device for passive separation of platelet-rich plasma from whole blood (Photo courtesy of University of the Basque Country)

Portable and Disposable Device Obtains Platelet-Rich Plasma Without Complex Equipment

Platelet-rich plasma (PRP) plays a crucial role in regenerative medicine due to its ability to accelerate healing and repair tissue. However, obtaining PRP traditionally requires expensive centrifugation... Read more

Immunology

view channel

Image: The new liquid biopsy model can predict patient response to immune checkpoint therapies (Photo courtesy of 123RF)

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

Image: The research provides the first detailed view of how immune cells expand during cancer treatment and how this process can be restored (Photo courtesy of Shutterstock)

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

Molecular Microscope Diagnostic System Assesses Lung Transplant Rejection

Lung transplant recipients face a significant risk of rejection and often require routine biopsies to monitor graft health, yet assessing the same biopsy sample can be highly inconsistent among pathologists.... Read more

Blood Test Tracks Treatment Resistance in High-Grade Serous Ovarian Cancer

High-grade serous ovarian cancer (HGSOC) is often diagnosed at an advanced stage because it spreads microscopically throughout the abdomen, and although initial surgery and chemotherapy can work, most... Read more

Microbiology

view channel

Image: Sugar fingerprints open new possibilities for faster and more reliable diagnosis of fungal infections (Photo courtesy of 123RF)

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

Image: A clinical test and handheld device could quickly classify sepsis patients into two groups (Photo courtesy of Sara Moser/WashU Medicine)

Rapid Sepsis Diagnostic Device to Enable Personalized Critical Care for ICU Patients

Sepsis is a life-threatening condition that occurs when the body’s response to infection spirals out of control, damaging organs and leading to critical illness. Patients often arrive at intensive care... Read more

Image: The CD Chip (top) and The CD² Chip (bottom) (Photo courtesy of YANG Xiao)

Microfluidic Platform Assesses Neutrophil Function in Sepsis Patients

Sepsis arises from infection and immune dysregulation, with neutrophils playing a central role in its progression. However, current clinical tools are unable to both isolate these cells and assess their... Read more

New Diagnostic Method Confirms Sepsis Infections Earlier

Sepsis remains one of the most dangerous medical emergencies, often progressing rapidly and becoming fatal without timely intervention. Each hour of delayed treatment in septic shock reduces patient survival... Read more

Pathology

view channel

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

Image: The AI-based tool combines blood biomarkers and gene activity to more precisely track biological ageing (Photo courtesy of 123RF)

AI-Powered Method Combines Blood Data to Accurately Measure Biological Age

Chronological age tells us how many years we’ve lived, but not how quickly our bodies are ageing. Some people stay healthy well into their 80s or 90s, while others experience decline much earlier.... Read more

AI Tool Detects Cancer in Blood Samples In 10 Minutes

Detecting cancer recurrence or spread often depends on identifying rare tumor cells circulating in the bloodstream — a process known as a liquid biopsy. However, current methods rely on trained specialists... Read more

AI Pathology Analysis System Delivers Comprehensive Cancer Diagnosis

Accurate and timely cancer diagnosis is often limited by complex manual pathology workflows and lengthy turnaround times. Traditional pathology relies heavily on human interpretation, which can delay treatment... Read more

Technology

view channel

Image: Flowing red blood cells are imaged under the high-throughput QPM (Photo courtesy of W. Wang et al./Duke University)

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

Image: The test will combine a serum with a liquid sample and apply it to the biosensor to quantify the virus at the RNA level (Photo courtesy of UCF College of Medicine)

Viral Biosensor Test Simultaneously Detects Hepatitis and HIV

Globally, over 300 million people live with Hepatitis B and C, and 40 million with HIV, according to WHO estimates. Diagnosing bloodborne viruses such as HIV and Hepatitis B and C remains challenging in... Read more

Image: The acoustofluidic device is designed for sample preparation and detection of small extracellular vesicles (Photo courtesy of Tony Jun Huang/Duke University)

Acoustofluidic Device to Transform Point-Of-Care sEV-Based Diagnostics

Rapid and sensitive detection of small extracellular vesicles (sEVs)—key biomarkers in cancer and organ health monitoring—remains challenging due to the need for multiple preprocessing steps and bulky... Read more

AI Algorithm Assesses Progressive Decline in Kidney Function

Chronic kidney disease (CKD) affects more than 700 million people worldwide and remains a major global health challenge. The condition often progresses silently, and many patients remain undiagnosed until... Read more

Industry

view channel

Image: This strategic merger brings together two industry leaders with complementary strengths (Photo courtesy of Advanced Instruments)

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

Bio-Rad and Biodesix Partner to Develop Droplet Digital PCR High Complexity Assays

Bio-Rad Laboratories (Hercules, CA, USA) and Biodesix (Louisville, CO, USA) have expanded their partnership agreement under which Biodesix will conduct the development, clinical validation, and regulatory... Read more

Hologic to be Acquired by Blackstone and TPG

Hologic (Marlborough, MA, USA) has entered into a definitive agreement to be acquired by funds managed by Blackstone (New York, NY, USA) and TPG (San Francisco, CA, USA) in a transaction valued at up to... Read more

Bio-Techne and Oxford Nanopore to Accelerate Development of Genetics Portfolio

Bio-Techne Corporation (Minneapolis, MN, USA) has expanded its agreement with Oxford Nanopore Technologies (Oxford, UK) to broaden Bio-Techne's ability to develop a portfolio of genetic products on Oxford... Read more