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.

Snibe Diagnostic’s Maglumi SARS-CoV-2 Neutralizing Antibody Assay Receives CE Mark

By HospiMedica International staff writers
Posted on 12 Jan 2021

Illustration

Snibe Diagnostic (Shenzhen, China) has received CE marking for its Maglumi SARS-CoV-2 Neutralizing Antibody Assay.

The fully automated test can detect neutralizing antibodies against SARS-CoV-2 within 20 minutes when used with the company’s Maglumi analyzers. Designed for highly sensitive and specific detection of SARS-CoV-2 neutralizing antibodies, the assay aims to address the urgent need for assessing immunity during the COVID-19 pandemic. It can be used to determine the immune status of COVID-19 patients and individuals who have been vaccinated against the virus. By evaluating immunity in individuals and the community, the test can provide “immunity certification” for those returning to the society.

The new assay shows a high agreement rate with the gold standard Virus Neutralization Test (VNT/PRNT), indicating that it could be a useful tool for assessment of the immunity to SARS-CoV-2 infection. The Maglumi SARS-CoV-2 Neutralizing Antibody Assay could also serve as an important tool for assessment of the efficacy of COVID-19 vaccines.

Related Links:
Snibe Diagnostic

Visit expo >

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)

Antipsychotic TDM Assays
Saladax Antipsychotic Assays

New

Surgical System

Stealth AXiS

New

Desk Aneroid Sphyg

Diagnostix 750D+

Latest COVID-19 News

Channels

Artificial Intelligence

view channel

Machine Learning Approach Enhances Liver Cancer Risk Stratification

Hepatocellular carcinoma, the most common form of primary liver cancer, is often detected late despite targeted surveillance programs. Current screening guidelines emphasize patients with known cirrhosis,... Read more

Image: connected devices offer new possibilities in the early detection of abnormalities or changes in brain health (Photo courtesy of 123RF)

New AI Approach Monitors Brain Health Using Passive Wearable Data

Brain health spans cognitive and emotional functions and can fluctuate even in adults without diagnosed disease. Detecting early changes remains difficult in routine care and burdens specialty services... Read more

$Image: Study procedure flow chart. After patients with BSI were identified from microbiology databases, 27 patients\' characteristics were extracted from electronic health records. After the dimension of those variables was reduced with Uniform Manifold Approximation and Projection (UMAP), k-means++ was used to identify clusters. Three clinically distinct clusters were identified. Among those clusters, patients were divided into solid organ transplant (SOT) and non-SOT groups. Clinical characteristics and outcomes were evaluated (Masayuki Nigo et al., American Journal of Transplantation (2026). DOI: 10.1016/j.ajt.2025.10.019)$

AI Tool Maps Early Risk Patterns in Bloodstream Infections

Bloodstream infections can deteriorate rapidly and carry high mortality, especially in immunocompromised patients. Clinicians need reliable early risk stratification to prioritize monitoring and organ support.... Read more

AI Model Identifies Rare Endocrine Disorder from Hand Images

Acromegaly is a rare, intractable disease that typically begins in middle age and causes enlargement of the hands and feet, changes in facial appearance, and abnormal bone and organ growth.... Read more

Critical Care

view channel

Automated IV Labeling Solution Improves Infusion Safety and Efficiency

Medication administration in high-acuity settings is often complicated by multiple concurrent infusions, making accurate line identification essential. In a 10-hospital intensive care unit study, 60% of... Read more

First-Of-Its-Kind AI Tool Detects Pulmonary Hypertension from Standard ECGs

Pulmonary hypertension is a progressive, life‑threatening disease that is frequently missed early because symptoms such as dyspnea are nonspecific and diagnostic delays can exceed two years.... Read more

Routine Blood Pressure Readings May Identify Risk of Future Cognitive Decline

Hypertension is a major contributor to vascular aging and dementia, yet routine clinical workflows rarely flag neurocognitive risk early. Identifying patients at risk before symptoms appear could support... Read more

Image: SIBIONICS presented its GS3 system at ATTD 2026, highlighting AI integration in routine diabetes management (photo courtesy of SIBIONICS)

AI Turns Glucose Data Into Actionable Insights for Diabetes Care

As continuous glucose monitoring becomes routine in diabetes care, the challenge is shifting from collecting numbers to interpreting them in ways that drive clinical decisions and patient behavior.... Read more

Surgical Techniques

view channel

Continuous Monitoring with Wearables Enhances Postoperative Patient Safety

Postoperative hypoxemia on general surgical wards is common and often missed by intermittent vital sign checks. Undetected low oxygen levels can delay recovery and raise the risk of complications that... Read more

Image: Figure shows biofabrication of scaffold-free customizable modular shapes for tissue engineering (photo courtesy of Stanford University Department of Cardiothoracic Surgery)

New Approach Enables Customized Muscle Tissue Without Biomaterial Scaffolds

Volumetric muscle loss is a traumatic loss of skeletal muscle that often leads to permanent functional impairment and limited reconstructive options. Current experimental strategies struggle to deliver... Read more

Handheld Robotic System Expands Options for Total Knee Surgery

Orthopedic teams vary in their adoption of robotics, with some surgeons favoring intraoperative decision-making and a manual instrument feel, while others rely on preoperative, computed tomography–based... Read more

VR Experience Reduces Patient Anxiety Before Kidney Stone Procedure

Many patients experience anxiety and limited comprehension when preparing for invasive or device-assisted care. Complex consent materials can leave people uncertain about risks, benefits, and what to expect... Read more

Patient Care

view channel

Wearable Sleep Data Predict Adherence to Pulmonary Rehabilitation

Chronic obstructive pulmonary disease (COPD) is a long-term lung disorder that makes breathing difficult and often disturbs sleep, reducing energy for daily activities. Limited engagement in pulmonary... Read more

Image: The revolutionary automatic IV-Line flushing device set for launch in the EU and US in 2026 (Photo courtesy of Droplet IV)

Revolutionary Automatic IV-Line Flushing Device to Enhance Infusion Care

More than 80% of in-hospital patients receive intravenous (IV) therapy. Every dose of IV medicine delivered in a small volume (<250 mL) infusion bag should be followed by subsequent flushing to ensure... Read more

Image: A screengrab from the VR training module that shows invisible contamination on portable medical equipment (Photo courtesy of Mass General Brigham)

VR Training Tool Combats Contamination of Portable Medical Equipment

Healthcare-associated infections (HAIs) impact one in every 31 patients, cause nearly 100,000 deaths each year, and cost USD 28.4 billion in direct medical expenses. Notably, up to 75% of these infections... Read more

Image: The portable biosensor platform uses printed electrochemical sensors for the rapid, selective detection of Staphylococcus aureus (Photo courtesy of AIMPLAS)

Portable Biosensor Platform to Reduce Hospital-Acquired Infections

Approximately 4 million patients in the European Union acquire healthcare-associated infections (HAIs) or nosocomial infections each year, with around 37,000 deaths directly resulting from these infections,... Read more

Health IT

view channel

mage: The EHR–driven tool could help doctors intervene earlier to protect transplanted kidneys (Photo courtesy of 123RF)

EMR-Based Tool Predicts Graft Failure After Kidney Transplant

Kidney transplantation offers patients with end-stage kidney disease longer survival and better quality of life than dialysis, yet graft failure remains a major challenge. Although a successful transplant... Read more

Image: A wearable sweat sensor based on the core–shell nanoparticle technology (Photo courtesy of Caltech)

Printable Molecule-Selective Nanoparticles Enable Mass Production of Wearable Biosensors

The future of medicine is likely to focus on the personalization of healthcare—understanding exactly what an individual requires and delivering the appropriate combination of nutrients, metabolites, and... Read more

Image: Smartwatches could provide more affordable and accessible cardiac monitoring (Photo courtesy of 123RF)

Smartwatches Could Detect Congestive Heart Failure

Diagnosing congestive heart failure (CHF) typically requires expensive and time-consuming imaging techniques like echocardiography, also known as cardiac ultrasound. Previously, detecting CHF by analyzing... Read more

Image: Schematic diagram of a wireless, skin-contact system that simultaneously measures biosignals and delivers drugs (Photo courtesy of DGIST)

Versatile Smart Patch Combines Health Monitoring and Drug Delivery

As the global population ages, the need for personalized healthcare is becoming increasingly important. This shift has fueled a growing interest in wearable medical devices that can provide real-time health... Read more

Point of Care

view channel

Image: The Nevisense uses a non-invasive procedure that combines EIS technology with AI to provide in-depth skin analysis (photo courtesy of SciBase)

AI-Enabled Platform Supports Clinical Decision-Making in Melanoma Detection

Visual examination remains the foundation of dermatologic assessment for suspicious skin lesions, and many dermatologists are confident using clinical and dermoscopic techniques. However, studies show... Read more

Business

view channel

GE HealthCare Leads Major European Initiative to Advance Cardio-Oncology Care

Cardiovascular complications are increasingly recognized among people undergoing or recovering from cancer treatment, driven by pre‑existing disease and the cardiotoxic effects of chemotherapy, radiotherapy,... Read more

Medtronic and GE HealthCare Broaden Alliance Across Monitoring and Care Solutions

Medtronic announced a multiyear renewal and significant expansion of its global strategic alliance with GE HealthCare across Patient Care Solutions. Building on more than three decades of collaboration,... Read more

Image: NeuWave’s microwave ablation system is used in percutaneous tumor ablation procedures (photo courtesy of NeuWave Medical)

Quantum Surgical Acquires NeuWave from Johnson & Johnson

Quantum Surgical announced that it has acquired NeuWave Medical from Johnson & Johnson. NeuWave’s microwave ablation system is used in percutaneous tumor ablation procedures, and the acquisition supports... Read more

Image: Medtronic’s intent to acquire CathWorks follows a 2022 strategic partnership with a co-promotion agreement for the FFRangio System (Photo courtesy of CathWorks)

Medtronic to Acquire Coronary Artery Medtech Company CathWorks

Medtronic plc (Galway, Ireland) has announced that it will exercise its option to acquire CathWorks (Kfar Saba, Israel), a privately held medical device company, which aims to transform how coronary artery... Read more