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
INTEGRA BIOSCIENCES AG

Download Mobile App




FDA Clears Diagnostic Assay for Group B Strep

By LabMedica International staff writers
Posted on 10 Aug 2018
Print article
Image: The NeuMoDx GBS assay is run on the 288 molecular system (Photo courtesy of NeuMoDx Molecular).
Image: The NeuMoDx GBS assay is run on the 288 molecular system (Photo courtesy of NeuMoDx Molecular).
Group B Streptococcus (GBS) is a Gram-positive bacterium found in 10% to 35% of healthy adults and is a commonly found bacterium within the human body. A person who carries GBS and does not present symptoms of GBS disease is said to be “colonized” with GBS.

GBS colonization is not considered contagious, however, under certain circumstances, GBS can invade the body and cause serious infection; this is referred to as Group B Streptococcal disease. It is a leading cause of life-threatening bacterial infection in newborns who acquire the disease during birth by vertical (mother-to-baby) transmission. Approximately 2,000 cases of newborn infections occur per year, with estimates of a mortality rate of 0.27 per 1,000 live births.

The US Food and Drug Administration (FDA, Silver Springs, MD, USA) have granted 510(k) clearance to a high-throughput molecular diagnostics platform and Group B Strep assay from NeuMoDx Molecular (Ann Arbor, MI, USA). The 288 Molecular System is an automated sample-to-answer diagnostics platform that runs up to 288 patient samples in continuous random-access mode. The time to first results is approximately one hour, according to the firm, with a walkaway window of more than six hours, and NeuMoDx intends the system to be used in central laboratories of hospitals and clinical reference laboratories.

Testing for GBS colonization is usually performed in the third trimester of pregnancy to prevent complications of transmission to a newborn during labor and delivery. The NeuMoDx GBS Assay is a qualitative polymerase chain reaction (PCR)-based diagnostic test to detect an 88 base-pair region of the pcsB gene and incorporates sample lysis, automated DNA extraction, and real-time PCR. The firm said the assay showed a sensitivity of 97% and specificity of 96% compared to culture in a multicenter clinical performance study.

The revolutionary dry format reagents require no refrigeration and are extremely robust with an on-board stability of greater than 60 days, and ambient temperature storage shelf life of greater than one year. Additionally, the unitized format of the dry reagents significantly increases operating efficiency while minimizing the waste associated with systems requiring manual reconstitution and/or use of bulk format lyophilized reagents.

Related Links:
US Food and Drug Administration
NeuMoDx Molecular

Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
HLX
POCT Fluorescent Immunoassay Analyzer
FIA Go
Gold Member
Real-time PCR System
GentierX3 Series

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: The study showed the blood-based cancer screening test detects 83% of people with colorectal cancer with specificity of 90% (Photo courtesy of Guardant Health)

Blood Test Shows 83% Accuracy for Detecting Colorectal Cancer

Colorectal cancer is the second biggest cause of cancer deaths among adults in the U.S., with forecasts suggesting 53,010 people might die from it in 2024. While fewer older adults are dying from this... Read more

Hematology

view channel
Image: The Gazelle Hb Variant Test (Photo courtesy of Hemex Health)

First Affordable and Rapid Test for Beta Thalassemia Demonstrates 99% Diagnostic Accuracy

Hemoglobin disorders rank as some of the most prevalent monogenic diseases globally. Among various hemoglobin disorders, beta thalassemia, a hereditary blood disorder, affects about 1.5% of the world's... Read more

Industry

view channel
Image: These new assays are being developed for use on the recently introduced DxI 9000 Immunoassay Analyzer (Photo courtesy of Beckman Coulter)

Beckman Coulter and Fujirebio Expand Partnership on Neurodegenerative Disease Diagnostics

Beckman Coulter Diagnostics (Brea, CA, USA) and Fujirebio Diagnostics (Tokyo, Japan) have expanded their partnership focused on the development, manufacturing and clinical adoption of neurodegenerative... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.