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

bioMérieux

Designs, develops, manufactures and markets in vitro diagnostics systems used in clinical and industrial applications read more Featured Products: More products

Download Mobile App




Unique Multiplex PCR Test Detects 15 Most Common Respiratory Pathogens in 15 Minutes

By LabMedica International staff writers
Posted on 25 Sep 2023

Patients frequently go to their healthcare providers with signs of respiratory or throat infections. More...

The current standard for diagnosis involves taking a swab sample and sending it to a lab for culture-based analysis. This process often takes several days to complete, during which healthcare providers might prescribe antibiotics that may not necessarily be effective. Now, a unique multiplex PCR test is capable of detecting 15 of the most common bacteria, viruses, and viral subtypes responsible for respiratory or throat infections in approximately 15 minutes. The test can be conducted using either a nasopharyngeal or a throat swab, depending on whether the patient shows symptoms of a respiratory infection or sore throat.

For doctors, it's currently a challenge to determine whether symptoms like cough, cold, or sore throat are caused by bacterial or viral infections, as only bacterial infections are treatable with antibiotics. The BIOFIRE® SPOTFIRE® R/ST Panel from bioMérieux (Marcy-l’Étoile, France) quickly detects viruses and bacteria to guide the treatment of children and adults with respiratory infection. The test, which takes only 15 minutes, uses PCR (polymerase chain reaction) technology to quickly detect the genetic material of the viruses and bacteria causing these infections.

bioMérieux has now submitted the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel to U.S. Food and Drug Administration (FDA) for a dual 510(k) clearance and CLIA1-waiver. The panel is already CE-marked (IVDD2) to address the European market. This is the third panel submitted for FDA review to be used on the BIOFIRE® SPOTFIRE® System with two other FDA-cleared and CLIA-waived panels already available for use on this system. The BIOFIRE® SPOTFIRE® Respiratory Panel and BIOFIRE® SPOTFIRE® Respiratory Panel Mini detect 15 and 5 of the most common respiratory pathogens, respectively. The BIOFIRE® SPOTFIRE® solution allows bioMérieux to take its syndromic testing technology outside of the traditional clinical laboratories to point-of-care settings, allowing healthcare professionals to deliver results to their patients during their visit.

“This new panel enhances the clinicians’ ability to focus patient care by choosing one of these two important tests to identify the most relevant pathogens using a single pouch,” said Mark Miller, Executive Vice-President, Chief Medical Officer, bioMérieux. “There is a great need for rapid and reliable diagnostic solutions for common infections, particularly in this era of increasing antimicrobial resistance when we need to use antibiotics only when appropriate. Patients and families expect clear direction from physicians when managing respiratory and sore throat infections. Performing rapid syndromic testing closer to the patient has important medical value, giving clarity on treatment options, and providing peace of mind for patients and their loved ones.”

“We’re thrilled to submit the BIOFIRE® SPOTFIRE® R/ST Panel to the US FDA, and to demonstrate once again, our leadership in the field of syndromic diagnostics, and our intention to reach as many patients as possible where they are first seen!,” added Jennifer Zinn, Executive Vice President, Clinical Operations, bioMérieux. “In fact, throat infections are one of the most common causes of patient visits to medical centers. By offering practitioners a unique and innovative way of testing for the agents that cause most respiratory tract infections, including sore throat, using a single multiplex panel of 15 targets, we'll be helping them to save time and improve patient management.”

Related Links:
bioMérieux 


New
Gold Member
Hybrid Pipette
SWITCH
Collection and Transport System
PurSafe Plus®
New
Gold Member
Automated MALDI-TOF MS System
EXS 3000
Sperm Quality Analyis Kit
QwikCheck Beads Precision and Linearity Kit
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

Hematology

view channel
Image: New evidence shows viscoelastic testing can improve assessment of blood clotting during postpartum hemorrhage (Photo courtesy of 123RF)

Viscoelastic Testing Could Improve Treatment of Maternal Hemorrhage

Postpartum hemorrhage, severe bleeding after childbirth, remains one of the leading causes of maternal mortality worldwide, yet many of these deaths are preventable. Standard care can be hindered by delays... Read more

Immunology

view channel
Image: The CloneSeq-SV approach can allow researchers to study how cells within high-grade serous ovarian cancer change over time (Photo courtesy of MSK)

Blood Test Tracks Treatment Resistance in High-Grade Serous Ovarian Cancer

High-grade serous ovarian cancer (HGSOC) is often diagnosed at an advanced stage because it spreads microscopically throughout the abdomen, and although initial surgery and chemotherapy can work, most... Read more

Industry

view channel
Image: The collaboration aims to improve access to Hb variant testing with the Gazelle POC diagnostic platform (Photo courtesy of Hemex Health)

Terumo BCT and Hemex Health Collaborate to Improve Access to Testing for Hemoglobin Disorders

Millions of people worldwide living with sickle cell disease and other hemoglobin disorders experience delayed diagnosis and limited access to effective care, particularly in regions where testing is scarce.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.