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
Sign In
Advertise with Us
LGC Clinical Diagnostics

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
Print article
Image: Snibe Maglumi 2000 Immunology Analyzer (Photo courtesy of Snibe Diagnostic)
Image: Snibe Maglumi 2000 Immunology Analyzer (Photo courtesy of Snibe Diagnostic)
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. 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
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
HLX
Anti-Cyclic Citrullinated Peptide Test
GPP-100 Anti-CCP Kit
Gold Member
SARS-CoV-2 Test
One Step SARS-CoV-2 Nucleic Acid Detection Kit (P761H)

Print article

Channels

Clinical Chemistry

view channel
Image: Reaching speeds up to 6,000 RPM, this centrifuge forms the basis for a new type of inexpensive, POC biomedical test (Photo courtesy of Duke University)

POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection

Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics.... Read more

Molecular Diagnostics

view channel
Image: MOF materials efficiently enrich cfDNA and cfRNA in blood through simple operational process (Photo courtesy of Science China Press)

Blood Circulating Nucleic Acid Enrichment Technique Enables Non-Invasive Liver Cancer Diagnosis

The ability to diagnose diseases early can significantly enhance the effectiveness of clinical treatments and improve survival rates. One promising approach for non-invasive early diagnosis is the use... Read more

Hematology

view channel
Image: The low-cost portable device rapidly identifies chemotherapy patients at risk of sepsis (Photo courtesy of 52North Health)

POC Finger-Prick Blood Test Determines Risk of Neutropenic Sepsis in Patients Undergoing Chemotherapy

Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections,... Read more

Pathology

view channel
Image: The OvaCis Rapid Test discriminates benign from malignant epithelial ovarian cysts (Photo courtesy of INEX)

Intra-Operative POC Device Distinguishes Between Benign and Malignant Ovarian Cysts within 15 Minutes

Ovarian cysts represent a significant health issue for women globally, with up to 10% experiencing this condition at some point in their lives. These cysts form when fluid collects within a thin membrane... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.