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 >

Platinum Member

Fully Automatic ACLIA Analyzer

MAGLUMI X8

Gold Member

Universal Transport Solution

Puritan®UniTranz-RT

Automated Clinical Chemistry Analyzer

Envoy 500+

Automated Urinalysis Solution

UN-9000

Latest COVID-19 News

Channels

Clinical Chemistry

view channel

AMH Test Helps Predict Adjuvant Chemotherapy Benefit in Premenopausal Breast Cancer

Hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer can present a difficult treatment decision in premenopausal patients with low recurrence scores.... Read more

Image: The SuperFlex prenatal screening system brings rapid, decentralized biochemistry‑based prenatal screening into small and mid‑sized laboratories (Photo courtesy of Revvity)

Compact Prenatal Screening System Expands Access to Preeclampsia Testing

Preeclampsia affects an estimated 2%–8% of pregnancies and is rising globally with increasing maternal age, diabetes, and hypertension. While international guidelines recommend screening, access often... Read more

Image: Illustration of the new blood test, which uses a DNA chip to detect the tumor’s biological fingerprint (Photo courtesy of Tel Aviv University)

Blood Test on a Chip Offers Low-Cost Lung Cancer Detection Without DNA Sequencing

Lung cancer is the leading cause of cancer deaths worldwide, and screening often yields indeterminate results that prompt invasive workups. Computed tomography (CT) detects small nodules but can flag benign... Read more

Image: The approach supports myocardial infarction diagnosis in resource-limited settings by reducing delays between clinical suspicion and biochemical confirmation (Image Credit: Adobe Stock)

Portable Troponin Assay Brings Heart Attack Diagnosis Closer to Patients

Timely confirmation of myocardial infarction often depends on laboratory testing that may not be immediately available at the point of care. This gap between clinical suspicion and definitive evidence... Read more

Molecular Diagnostics

view channel

Image Credit: iStock

Sequencing-Based Newborn Screening Identifies Pediatric Cancer Risk at Birth

Newborn screening in the United States relies on heel-stick blood spots to identify rare, treatable disorders through biochemical testing, but these programs generally do not assess inherited cancer risk... Read more

Liquid Biopsy Combines Multiple Signals for Cancer Detection in a Single Analysis

Detecting and monitoring cancer often requires repeated tissue biopsies, which are invasive and not always feasible. Liquid biopsy offers a less invasive way to track disease over time, but many assays... Read more

Newborn Screening Program Adds Spinal Muscular Atrophy Testing Across England

Spinal muscular atrophy is a rare but serious genetic condition that can rapidly impair motor function in infants and, in severe cases, compromise breathing and swallowing. Detecting the disorder before... Read more

Whole-Cell Genomic Analysis Expands the Potential of Liquid Biopsy

Liquid biopsy has expanded access to tumor genomics, but most blood-based assays rely on short, degraded fragments of cell-free circulating tumor DNA (ctDNA). Isolating intact circulating tumor cells from... Read more

Hematology

view channel

New Genetic Findings Reveal Cause of Bone Marrow Failure Syndrome

Inherited bone marrow failure syndromes (IBMFS) impair the bone marrow’s ability to produce sufficient healthy blood cells and are associated with an increased risk of early-onset myelodysplastic syndromes (MDS).... Read more

Ultra-Portable Device Enables Finger-Prick Blood Testing at Home

Patients who need frequent blood tests often face repeated clinic visits that burden services and disrupt care. In the UK, millions of tests are performed each year to diagnose disease, guide therapy,... Read more

Age-Specific CBC Reference Intervals Support Pediatric Diagnosis in Vietnam

Complete blood count (CBC) results underpin pediatric evaluation for anemia, infection, inflammation, and platelet disorders. Yet laboratories in Vietnam have largely relied on reference intervals derived... Read more

Spectral Flow Cytometry Assay Enhances MRD Detection in Multiple Myeloma

Minimal residual disease (MRD) monitoring is pivotal in multiple myeloma, where persistent malignant plasma cells drive relapse risk and help guide therapy decisions. In the United States, approximately... Read more

Immunology

view channel

Immune Biomarkers May Predict Recurrent Checkpoint Inhibitor Arthritis

Inflammatory arthritis is a recognized immune-related adverse event in patients treated with immune checkpoint inhibitors (ICIs) for cancer. Between 20% and 50% of affected patients experience more than... Read more

Image: The findings highlight the potential of blood-based immune profiling to provide a more comprehensive picture of how patients respond to immunotherapy. (Image Credit: Adobe Stock)

Immune Cell Blood Test May Predict Melanoma Immunotherapy Response

Melanoma remains one of the deadliest skin cancers, although outcomes improve markedly when the disease is detected early. Immunotherapy has extended survival for many patients with advanced melanoma,... Read more

Study Reveals Viral Protein Driving COVID-19-Related Vascular Injury

Lingering symptoms after acute COVID-19 infection remain a clinical challenge, with many patients experiencing fatigue, cognitive problems, and cardiovascular complications months later.... Read more

Study Reveals Immune Mechanism Driving Severe COVID-19 Progression

Severe COVID-19 has highlighted gaps in understanding of early antiviral responses, particularly why some patients deteriorate despite timely care. Type I interferons are central to host defense, yet their... Read more

Microbiology

view channel

Image: The QIAstat-Dx BCID GPF Plus AMR Panel is the first QIAstat-Dx panel for bloodstream infections to receive FDA clearance (Photo courtesy of Qiagen)

FDA Clears One-Hour Panel for Bloodstream Infection and AMR Detection

Bloodstream infections can rapidly progress to sepsis, a life-threatening condition affecting an estimated 1.7 million adults in the U.S. each year. Rapid identification of pathogens and antimicrobial... Read more

Precision Screening Helps Close Hepatitis C Diagnosis and Treatment Gaps

Hepatitis C remains a leading cause of cirrhosis and liver cancer, yet many infections go undiagnosed or untreated because health systems fail to reach those at greatest risk. Although highly effective... Read more

Proteomic Workflow Maps Microbial and Host Responses in Intestinal Inflammation

The intestinal microbiome influences digestion, metabolism, and immunity, yet its complexity makes functional measurements difficult to obtain. DNA surveys can indicate which organisms and potential pathways... Read more

Metagenomic Sequencing Enables Faster Diagnosis of Respiratory Infections in Cystic Fibrosis

Serious lung infections remain a major cause of morbidity among people with cystic fibrosis, a life-threatening genetic disorder characterized by persistent airway colonization and frequent antimicrobial exposure.... Read more

Pathology

view channel

AI Tool Identifies Slide Artifacts to Speed Digital Pathology Diagnosis

Pathology laboratories face growing case volumes, staffing pressures, and increasing diagnostic complexity that can delay results. At the same time, whole-slide images may contain quality defects such... Read more

Image: Through the PCCP, Proscia gains a more efficient pathway to expand Concentriq AP-Dx interoperability while maintaining regulatory oversight (Photo courtesy of Proscia)

FDA-Cleared Digital Pathology Platform Expands Interoperability for Primary Diagnosis

Rising cancer incidence is colliding with a shrinking pathologist workforce, intensifying pressure on diagnostic turnaround times in clinical laboratories. Many labs are adopting digital pathology to manage... Read more

AI Pathology Tool Predicts Relapse Risk in Stage II Colorectal Cancer

Bowel cancer is Australia’s fourth most commonly diagnosed cancer and the second leading cause of cancer death, while remaining the third most common cancer worldwide. In stage-two disease, determining... Read more

AI Pathology Tool Stratifies Rectal Cancer to Guide Chemoradiotherapy

Choosing intensified regimens for locally advanced rectal cancer is challenging because these therapies can cause serious side effects. Colorectal cancer is the fourth-most fatal cancer in the UK, and... Read more

Technology

view channel

Interoperable Data Platform Standardizes Multi-Cancer Blood Test Results

Proteotype Diagnostics has introduced Alchemi, a proprietary data and clinical workflow platform being developed for Enlighten, the company’s investigational blood-based multi-cancer test.... Read more

Training Device Improves Accuracy of Pooled Molecular Diagnostics

High-throughput molecular diagnostics have transformed infectious disease detection, but many workflows remain difficult to execute accurately without extensive training. Sample pooling can cut per‑test... Read more

New CE-Certified Software Advances Whole-Genome Cancer Testing

European hospitals are increasingly using comprehensive tumor genomics to guide therapy, but routine whole genome sequencing (WGS) requires validated, regulation-compliant workflows. A newly CE-certified... Read more

National Rare Disease Registry Standardizes Genetic and Clinical Data for Coordinated Care

Rare diseases collectively impose a significant clinical burden despite their individual rarity, often involving multisystem presentations and prolonged diagnostic journeys. Limited specialist expertise... Read more

Industry

view channel

Collaboration Supports Global ADC Development with AI-Powered Tissue Analysis

Selecting patients for antibody-drug conjugates (ADCs) increasingly requires broader tissue context, as target expression alone may not fully explain therapeutic response. Laboratories and translational... Read more

Image: Professor David Brettle, Chief Scientific Officer at Leeds Teaching Hospitals NHS Trust with a pathology slide showing the TANGO technology (Photo courtesy of Leeds Teaching Hospitals NHS Trust)

Standardized Staining Technology Advances Digital Pathology Workflows

Digital pathology is increasingly used to streamline cancer diagnostics, yet staining variability can hinder slide interpretation and limit the reliability of artificial intelligence tools.... Read more

Global Testing Service Advances Leukemia MRD Monitoring

KMT2A rearrangements drive aggressive subsets of acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) and are associated with relapse and poor outcomes. As menin inhibitors enter clinical... Read more

Ultrasensitive MRD Assay Gains Medicare Coverage for Immunotherapy and Breast Cancer Monitoring

Patients with late-stage solid tumors and breast cancer often require repeated monitoring to assess recurrence risk and treatment response. Minimal residual disease (MRD) testing is intended to detect... Read more