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.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
INTEGRA BIOSCIENCES AG

Download Mobile App





Snibe Diagnostic’s Maglumi 2019-nCoV IgM/IgG Test Granted FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 21 Sep 2020
Snibe Diagnostic (Shenzhen, China) has received Emergency Use Authorization from the US Food and Drug Administration for its SARS-CoV-2 antibody test.

Snibe’s Maglumi 2019-nCoV IgM/IgG test comprises a capture chemiluminescence immunoassay for immunoglobulin M antibodies against SARS-CoV-2 and an indirect chemiluminescence immunoassay for immunoglobulin G antibodies against the virus. More...
The test uses human serum and serum in separating gel tube samples and runs on the company's Maglumi 2000 series fully automated chemiluminescence immunoassay analyzer. The test can be used by any lab certified to perform moderate- or high-complexity tests, according to the FDA.

Snibe had received CE marking for the Maglumi 2019-nCoV IgM/IgG test in February. In August, the company also received CE marking for its fully automated quantitative serology test for detecting IgG antibodies against SARS-CoV-2S-RBD, the receptor-binding domain of the S protein.

Related Links:
Snibe Diagnostic


Platinum Member
Fully Automatic ACLIA Analyzer
MAGLUMI X8
Gold Member
SARS-CoV-2 Reactive & Non-Reactive Controls
Qnostics SARS-CoV-2 Typing
Japanese Encephalitis Test
Japanese Encephalitis Virus Real Time PCR Kit
Electrolyte Analyzer
BKE-B
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Molecular Diagnostics

view channel
Image: The researchers Manel Pérez Pons y Carlos Rodriguez Muñoz at the IRBLleida laboratory (Photo courtesy of IRBLleida)

New Blood RNA Markers Help Advance Precision Medicine for Respiratory Patients

Risk stratification in hospitalized respiratory disease, particularly among older adults with COVID-19, remains challenging despite rich clinical datasets. Blood-based non-coding RNA biomarkers are promising,... Read more

Microbiology

view channel
Image: The “broth” used to monitor red blood cell depletion in whole blood spiked with one colony-forming-unit of E. coli bacteria, each incubated at different orbital shaking speeds—left to right: 0 RPM, 65 RPM, 120 RPM and 200 RPM—after four hours of incubation. This culturing raises a bacteria-rich, plasma-like layer of bacteria to the top of the vials, while clusters of stuck blood cells known as a Rouleaux formation sink to the bottom. (Image Credit: Pak Kin Wong)

New Diagnostic Workflow Identifies Bloodstream Pathogens and Antibiotic Response in Hours

Sepsis is a life-threatening complication of infection that affects more than 1.5 million patients annually in the United States and contributes to roughly one in three in-hospital deaths.... Read more

Pathology

view channel
Image: Researchers evaluated AI models that quantify tumor-infiltrating lymphocytes (TIL) on routine breast tissue slides, where higher TIL levels reflect stronger antitumor response and improved breast cancer outcomes (Image Credit: Shutterstock)

AI Matches Pathologists in Predicting Breast Cancer Prognosis from Immune Cells

Breast cancer is the most common cancer in Australian women, with more than 20,000 cases each year. Prognosis can be informed by counting tumor-infiltrating lymphocytes (TILs) on routine pathology slides,... Read more
Copyright © 2000-2026 Globetech Media. All rights reserved.