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
LGC Clinical Diagnostics

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




Multiplex PCR Test Detects Common Viral and Bacterial Causes of Respiratory or Sore Throat Infections in 15 Minutes

By LabMedica International staff writers
Posted on 15 Jul 2024

The COVID-19 pandemic has created the need for healthcare professionals to employ diagnostic tests as close as possible to the patient and provide rapid actionable results. More...

An increasing number of tests are conducted outside hospital labs directly in Emergency Departments (ED) or at the Point of Care (POC). This market is especially active in the U.S. Now, a fast and innovative syndromic testing solution perfectly matches these new medical needs.

bioMérieux’s (Marcy-l’Étoile, France) BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini has obtained U.S. Food and Drug Administration (FDA) Special 510(k) clearance and CLIA-waiver (Clinical Laboratory Improvement Amendments). Designed for use on the BIOFIRE® SPOTFIRE® system, the BIOFIRE® SPOTFIRE® R/ST Panel Mini is a unique multiplex PCR test that detects five of the most common viral and bacterial causes of respiratory or sore throat infections in around 15 minutes. Samples can be taken from a nasopharyngeal swab when a respiratory tract infection is suspected or from a throat swab when pharyngitis is suspected. When implementing decentralized testing, CLIA-waiver is vital as it allows for the use of this system and panels by non-lab professionals in POC settings where patients require care such as urgent care, physician offices, local pharmacies, student health clinics, or emergency departments.

The BIOFIRE® SPOTFIRE® system is a unique POC platform that delivers fast results and offers flexibility with the capability to run either a large multiplex respiratory test with up to 15 pathogens with the BIOFIRE® SPOTFIRE® R/ST Panel, already FDA-cleared and CLIA-waived, or a small multiplex respiratory test with five pathogens with the BIOFIRE® SPOTFIRE® R/ST Panel Mini. This flexibility enables clinicians to select the appropriate test for their patients. The BIOFIRE® SPOTFIRE® R/ST Panel Mini has become the fourth panel of the BIOFIRE® SPOTFIRE® range to achieve FDA clearance and CLIA waiver. bioMérieux will make the new BIOFIRE® SPOTFIRE® R/ST Panel Mini available in the third quarter of 2024 in the U.S. bioMérieux intends to commercialize the BIOFIRE® SPOTFIRE® R/ST Panel Mini along with the larger multiplex BIOFIRE® SPOTFIRE® R/ST Panel to further expand its presence in the North American outpatient market.

“The medical community continues to bring enhanced technology closer to patients, allowing clinicians to have more information to make real-time decisions,” said Dr Charles K. Cooper, Executive Vice-President and Chief Medical Officer. “Regarding strep throat, Group A Streptococcus accounts for approximately 20% of sore throat cases and has historically been diagnosed via antigen tests. Including it on this PCR panel with common viral causes of strep throat, including rhinovirus, represents a step forward in healthcare, ultimately increasing diagnostic yield and removing the need to reflex to culture in most patients.”

“With our BIOFIRE® SPOTFIRE® R/ST Panel Mini, we bring a fast, highly sensitive, and targeted panel to test for 4 of the most common respiratory viruses (including influenzas) and Streptococcus A, from one throat swab, all at the same time,” added Jennifer Zinn, Executive Vice President, Clinical Operations. “Our offer meets the current needs of the growing decentralized, POC market bringing syndromic testing to the frontline of patient care. With this innovation, clinicians now can confidently tell their patients quickly what is making them sick and get them on the right treatment pathway, limiting the overuse of antibiotics.”


Gold Member
Veterinary Hematology Analyzer
Exigo H400
Verification Panels for Assay Development & QC
Seroconversion Panels
New
Myocardial Infarction Test
Quidel Triage Cardio3 Panel
New
Compound Management Solution
comPOUND
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

Clinical Chemistry

view channel
Image: The POC device rapidly predicts neonatal respiratory disease at birth in the NICU (Photo courtesy of SIME Diagnostics)

AI-Powered Lung Maturity Test Identifies Newborns at Higher Risk of Respiratory Distress

Each year, approximately 300,000 babies in the United States are born between 32 and 36 weeks' gestation, according to national health data. This group is at an elevated risk for respiratory distress,... Read more

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: The cancer stem cell test can accurately choose more effective treatments (Photo courtesy of University of Cincinnati)

Stem Cell Test Predicts Treatment Outcome for Patients with Platinum-Resistant Ovarian Cancer

Epithelial ovarian cancer frequently responds to chemotherapy initially, but eventually, the tumor develops resistance to the therapy, leading to regrowth. This resistance is partially due to the activation... Read more

Pathology

view channel
Image: A biomarker discovery pipeline has shown promise as a noninvasive method of diagnosing CRC (Photo courtesy of NCI Center for Cancer Research)

Machine Learning Tool Enables Noninvasive Diagnosis and Monitoring of Colorectal Cancer

Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United States when considering both genders. Colonoscopy remains the gold standard for CRC diagnosis, but it is invasive,... Read more

Technology

view channel
Image: Scanning electron microscopy images showing 3D micro-printed Limacon-shaped whispering-gallery-mode microcavities with different amounts of deformation (Photo courtesy of A. Ping Zhang/PolyU)

Tiny Microlaser Sensors with Supercharged Biosensing Ability to Enable Early Disease Diagnosis

Optical whispering-gallery-mode microlaser sensors function by trapping light within tiny microcavities. When target molecules bind to the cavity, they induce subtle changes in the laser’s frequency, allowing... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.