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

By LabMedica 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

Multiplex Genetic Analyzer

MassARRAY Dx Analyzer (Europe only)

3-Part Differential Hematology Analyzer
Swelab Alfa Plus Sampler

New

Clostridium Difficile Toxin A+B Combo Card Test

CerTest Clostridium Difficile Toxin A+B

New

Chlamydia Trachomatis Test

Aptima Chlamydia Trachomatis Assay

DIASOURCE (A Biovendor Company)

Latest COVID-19 News

Channels

Clinical Chemistry

view channel

New Clinical Chemistry Analyzer Designed to Meet Growing Demands of Modern Labs

A new clinical chemistry analyzer is designed to provide outstanding performance and maximum efficiency, without compromising affordability, to meet the growing demands of modern laboratories.... Read more

Image: The new research involved using digital PCR as a reference method to standardize test results between laboratories (Photo courtesy of Adobe Stock)

New Reference Measurement Procedure Standardizes Nucleic Acid Amplification Test Results

Nucleic acid amplification tests (NAATs) play a key role in diagnosing a wide range of infectious diseases. These tests are generally known for their high sensitivity and specificity, and they can be developed... Read more

Image: A pen-like tool collects molecules from the skin that can be screened for opioids (Photo courtesy of William Clarke/Johns Hopkins)

Pen-Like Tool Quickly and Non-Invasively Detects Opioids from Skin

Opioid drugs such as fentanyl, morphine, and oxycodone are the primary substances associated with overdose cases in the United States. Standard drug screening procedures typically involve collecting blood,... Read more

Image: The spectroscopy and AI-powered urine-based test detects 10 cancers (Photo courtesy of 123RF)

Simple Urine Test Could Detect Multiple Cancers at Early Stage

When disease is present, the human body releases tiny molecules known as volatile organic compounds (VOCs). Now, a spectroscopy and artificial intelligence (AI)-powered urine-based test uses scent-based... Read more

Molecular Diagnostics

view channel

Image: The Lyme IgM ImmunoBlot test kit has received FDA clearance (Courtesy of ID-FISH Technology)

Newly-Cleared Technology a Game Changer for Diagnosis of Lyme Disease

Lyme disease is one of the fastest-growing infectious diseases, with approximately 476,000 cases diagnosed annually in the United States. The symptoms of Lyme disease, such as fever, headache, fatigue,... Read more

Image: The sensitive liquid biopsy test that uses RNA instead of DNA for detecting cancer (Courtesy of Adobe Stock)

Innovative Liquid Biopsy Test Uses RNA to Detect Early-Stage Cancer

Detecting and diagnosing cancer, particularly in its early stages, remains a significant challenge. Liquid biopsies offer a promising non-invasive alternative to traditional biopsies, which require removing... Read more

Image: Combining rapid diagnostic tests with conventional serology proves to be a useful strategy for diagnosing Chagas disease (Courtesy of Adobe Stock)

Rapid Tests for Chagas Disease Improves Diagnostic Access

Chagas disease, caused by the parasite Trypanosoma cruzi, affects between six and seven million people across the Americas. It is primarily transmitted by insect vectors and remains largely underdiagnosed,... Read more

Image: The plasma biomarker p-tau217, obtained through a blood test, can predict the clinical progression of Alzheimer’s (Courtesy of Adobe Stock)

Simple Blood Test to Predict Alzheimer’s Clinical Progression in Earliest Stages

Alzheimer’s disease is difficult to diagnose in its early stages, often when symptoms are not yet evident, making it challenging to predict the rate of cognitive decline or progression to more advanced... Read more

Hematology

view channel

Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Image: The FINDER multifunctional testing platform can run multiple types of tests and deliver rapid results for near-patient use (Photo courtesy of Baebies)

First Point-of-Care Heparin Monitoring Test Provides Results in Under 15 Minutes

Heparin dosing requires careful management to avoid both bleeding and clotting complications. In high-risk situations like extracorporeal membrane oxygenation (ECMO), mortality rates can reach about 50%,... Read more

Image: The 3-parameter CCRS model was devised specifically for patients diagnosed with clonal cytopenia (Photo courtesy of 123RF)

New Scoring System Predicts Risk of Developing Cancer from Common Blood Disorder

Clonal cytopenia of undetermined significance (CCUS) is a blood disorder commonly found in older adults, characterized by mutations in blood cells and a low blood count, but without any obvious cause or... Read more

Image: The technology has the unique ability to detect challenging RhD variants that are typically excluded by other commercial tests (Photo courtesy of BillionToOne)

Non-Invasive Prenatal Test for Fetal RhD Status Demonstrates 100% Accuracy

In the United States, approximately 15% of pregnant individuals are RhD-negative. However, in about 40% of these cases, the fetus is also RhD-negative, making the administration of RhoGAM unnecessary.... Read more

Immunology

view channel

Image: How the predictive test works (Photo courtesy of QMUL)

World’s First Clinical Test Predicts Best Rheumatoid Arthritis Treatment

Rheumatoid arthritis (RA) is a chronic condition affecting 1 in 100 people in the UK today, causing the immune system to attack its joints. Unlike osteoarthritis, which is caused by wear and tear, RA can... Read more

Image: A simple blood test could replace surgical biopsies for early detecion of heart transplant rejection (Photo courtesy of Shutterstock)

Blood Test Detects Organ Rejection in Heart Transplant Patients

Following a heart transplant, patients are required to undergo surgical biopsies so that physicians can assess the possibility of organ rejection. Rejection happens when the recipient’s immune system identifies... Read more

Image: Schematic overview of the deep learning-based circulating exosome analysis for lung cancer detection (Photo courtesy of Chuan Xu, Cheng Jiang)

Liquid Biopsy Approach to Transform Diagnosis, Monitoring and Treatment of Lung Cancer

Lung cancer continues to be a major contributor to cancer-related deaths globally, with its biological complexity and diverse regulatory processes making diagnosis and treatment particularly difficult.... Read more

Image: The new tool shines a light on elusive genomic patterns (Photo courtesy of Adobe Stock)

Computational Tool Exposes Hidden Cancer DNA Changes Influencing Treatment Resistance

Structural changes in tumor DNA are among the most damaging genetic alterations in cancer, yet they often go undetected, particularly when tissue samples are degraded or of low quality. These hidden genomic... Read more

Microbiology

view channel

Image: Using viral load tests can help predict mpox severity when skin lesions first appear (Photo courtesy of Laiman Kana Ariga/Nagoya University)

Viral Load Tests Can Help Predict Mpox Severity

Mpox is a viral infection that causes flu-like symptoms and a characteristic rash, which evolves significantly over time and varies between patients. The disease spreads mainly through direct contact with... Read more

Image: Gut microbiota dysbiosis has been linked to the onset and progression of gestational diabetes (Photo courtesy of 123RF)

Gut Microbiota Analysis Enables Early and Non-Invasive Detection of Gestational Diabetes

Gestational diabetes mellitus is a common metabolic disorder marked by abnormal glucose metabolism during pregnancy, typically emerging in the mid to late stages. It significantly heightens the risk of... Read more

Image: The new handheld TB testing device significantly improves disease detection in HIV patients (Photo courtesy of Vincent Postle/Tulane University)

Credit Card-Sized Test Boosts TB Detection in HIV Hotspots

Current tuberculosis (TB) tests face major limitations when it comes to accurately diagnosing the infection in individuals living with HIV. HIV, a frequent co-infection with TB, complicates detection by... Read more

Fecal Metabolite Profiling Predicts Mortality in Critically Ill Patients

Critically ill patients in medical intensive care units (MICUs) often suffer from conditions such as acute respiratory distress syndrome (ARDS) or sepsis, which are linked to reduced diversity of gut microbiota... Read more

Pathology

view channel

Image: The AI-based tool quantifies tumor-infiltrating lymphocytes in tissue samples with greater consistency and accuracy (Courtesy of Adobe Stock)

AI Tool Enhances Interpretation of Tissue Samples by Pathologists

Malignant melanoma, a form of skin cancer, is diagnosed by pathologists based on tissue samples. A crucial aspect of this process is estimating the presence of tumor-infiltrating lymphocytes (TILs), immune... Read more

Image: A tool uses artificial intelligence and high-resolution imaging to track senescent cells (Courtesy of Adobe Stock)

AI-Assisted Technique Tracks Cells Damaged from Injury, Aging and Disease

Senescent cells, which stop growing and reproducing due to injury, aging, or disease, play a critical role in wound repair and aging-related diseases like cancer and heart disease. These cells, however,... Read more

Novel Fluorescent Probe Shows Potential in Precision Cancer Diagnostics and Fluorescence-Guided Surgery

Hepatocellular carcinoma (HCC), a common type of liver cancer, is difficult to diagnose early and accurately due to the limitations of current diagnostic methods. Glycans, carbohydrate structures present... Read more

Image: Cellular work has found mutation in gene that leads to disease progression in myelodysplastic syndromes (Photo courtesy of University of Birmingham)

New Lab Model to Help Find Treatments for Aggressive Blood Cancer

Myelodysplastic syndrome (MDS) is a type of blood cancer that often progresses into Acute Myeloid Leukemia (AML), a highly aggressive form of cancer that is difficult to diagnose and treat.... Read more

Technology

view channel

Image: The prototype at-home test kit for the new diagnostic includes a 3D printed scaffold (Courtesy of Kamyar Behrouzi/UC Berkeley)

Low-Cost Biosensing Technology Detects Disease Biomarkers in Minutes

Rapid at-home tests for diseases like COVID-19 have become increasingly popular for their convenience, but they come with a major drawback: they are less sensitive than the tests performed in medical settings.... Read more

Image: A simplified breakdown of the inputs, process and outputs that make up the system. (©2025 Tsunoda et al. CC-BY-ND)

AI Tool Could Help Identify Specific Gut Bacterial Targets for Treatment of Diseases

The human body hosts trillions of bacteria, particularly in the gut, which have a significant role in digestion and various other aspects of health. These gut bacteria produce a variety of metabolites... Read more

Image: The electrochemical sensors consist of DNA adhered to an inexpensive gold leaf electrode (Photo courtesy of MIT)

Inexpensive DNA Coated Electrode Paves Way for Disposable Diagnostics

Many people around the world still lack access to affordable, easy-to-use diagnostics for diseases like cancer, HIV, and influenza. Conventional sensors, while accurate, often rely on expensive equipment... Read more

Image: The actual chip of human leukemia bone marrow where chambers and channels were filled with food dyes (Photo courtesy of Weiqiang Chen/NYU Tandon Applied Micro-Bioengineering Laboratory)

New Miniature Device to Transform Testing of Blood Cancer Treatments

Chimeric antigen receptor (CAR) T cell therapy has emerged as a groundbreaking treatment for blood cancers like leukemia, offering hope to patients when other treatments fail. However, despite its promise,... Read more

Industry

view channel

Image: The acquisition will add Akoya’s cutting-edge spatial biology capabilities to Quanterix’s portfolio (Courtesy of Akoya Biosciences)

Quanterix Completes Acquisition of Akoya Biosciences

Quanterix Corporation (Billerica, MA, USA) has completed its previously announced acquisition of Akoya Biosciences (Marlborough, MA, USA), paving the way for the creation of the first integrated solution... Read more

Lunit and Microsoft Collaborate to Advance AI-Driven Cancer Diagnosis

Lunit (Seoul, South Korea) and Microsoft (Redmond, WA, USA) have entered into a collaboration to accelerate the delivery of artificial intelligence (AI)-powered healthcare solutions. In conjunction with... Read more

Image: The AMP’s best practice recommendations are for clinical laboratories developing and performing HRD testing (Photo courtesy of 123RF)

AMP Releases Best Practice Recommendations to Guide Clinical Laboratories Offering HRD Testing

Homologous recombination deficiency (HRD) testing identifies tumors that are unable to effectively repair DNA damage through the homologous recombination repair pathway. This deficiency is often linked... Read more

Image: Illumina’s acquisition of SomaLogic aims to strengthen its presence in the proteomics market (Photo courtesy of Illumina)

Illumina Acquires SomaLogic to Accelerate Proteomics Business

Illumina, Inc. (San Diego, CA, USA) has entered into a definitive agreement to acquire SomaLogic (Boulder, CO, USA), a leader in data-driven proteomics technology, and other specified assets for USD 350... Read more