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

DIASORIN MOLECULAR

DiaSorin Molecular LLC manufactures and distributes innovative molecular diagnostic products on the versatile LIAISON... read more Featured Products: More products

Download Mobile App




Events

09 Apr 2024 - 12 Apr 2024
15 Apr 2024 - 17 Apr 2024
23 Apr 2024 - 26 Apr 2024

Direct Test Includes Eight Circulating Influenza Viruses

By LabMedica International staff writers
Posted on 14 Jan 2015
Print article
The Simplexa Flu A/B & RSV Direct kit
The Simplexa Flu A/B & RSV Direct kit (Photo courtesy of Diasorin Molecular)
Seasonal influenza epidemics occur primarily during the winter in temperate climates and year round in tropical climates and according to the experts, flu activity most commonly peaks in the United States between December and February.

A test kit with the eight additional influenza strains is now available directly and internationally. The test can report results in about an hour through a proprietary process that eliminates nucleic acid extraction, a time consuming technique typically employed by molecular tests.

The US Food and Drug Administration (FDA; Silver Springs, MD, USA) has granted 510(k) clearance to the test kit which is classified as Clinical Laboratory Improvement Amendments (CLIA) moderate complexity. The additional eight strains for which FDA cleared analytical reactivity are: H7N9, H3N2 (both the Minnesota and Indiana strains) as well as H1N1 (2011), H3N2 (the Ohio and Texas strains) and influenza B (Brisbane and Wisconsin strains). Of particular concern are the novel avian influenza A strain H7N9, which can cause death in as many as one third of infected patients, and the H3N2v, which infects humans more easily than other swine influenza virus.

The Simplexa Flu A/B & RSV Direct kit (Focus Diagnostics; Cypress, CA, USA) used with the 3M Integrated Cycler is a real-time polymerase chain reaction (RT-PCR) molecular test for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors.

Michelle Tabb, PhD, vice president of research and development for Focus Diagnostics, said, “Timely diagnosis is critical to effective management of infectious diseases like influenza. By providing fast, reliable results in about an hour, our Simplexa platform helps physicians quickly diagnose and treat patients. These changes to our Simplexa test reflect our vision to develop high quality molecular tests that deliver critical insights to improve outcomes and empower better health.”

Related Links:

US Food and Drug Administration 
Focus Diagnostics 


Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
HLX
POCT Fluorescent Immunoassay Analyzer
FIA Go
New
Gold Member
Magnetic Bead Separation Modules
MAG and HEATMAG
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get complete 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

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.