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
INTEGRA BIOSCIENCES AG

Download Mobile App




Events

02 Jun 2025 - 04 Jun 2025
11 Jun 2025 - 13 Jun 2025

Labeling for RVP Diagnostic Test Updated

By LabMedica International staff writers
Posted on 16 Jul 2009
Labeling updates for a respiratory viral panel (RVP) diagnostic test will include data about the performance of the test in humans infected with the pandemic strain of influenza A virus, the 2009 influenza A(H1N1).

The xTAG RVP labeling has been updated to include information from two new studies demonstrating that xTAG RVP can be an effective aid in the detection of 2009 Influenza A(HIN1) virus, but cannot identify the hemagglutinin gene of the 2009 Influenza A(H1N1) virus in clinical specimens.

xTAG RVP can simultaneously detect 12 respiratory viruses and subtypes, including influenza A with subtyping at the DNA/RNA level. More...
The viral panel was designed to detect the matrix gene that is shared across several influenza A strains, including 2009 influenza A(H1N1) virus. In contrast, it does not detect the hemagglutinin gene of the 2009 Influenza A(H1N1) virus strain whereas it does detect the hemagglutinin gene of seasonal strains of H1N1 and H3N2. This design enables xTAG RVP to provide 3 types of results for patients infected with influenza A: 1) influenza A-H1; 2) influenza A-H3; 3) influenza A-unsubtypeable.

Luminex Corporation (Austin, TX, USA), announced that the U.S. Food and Drug Administration (FDA; Silver Spring, MD, USA) has cleared labeling updates for the company's xTAG RVP to include data about the performance of the xTAG RVP test in humans as demonstrated by the two separate studies.

"The studies now referenced in the xTAG RVP package insert demonstrate that the test can help determine if a patient is carrying a typical, seasonal respiratory virus or an unsubtypeable flu A virus," said Patrick J. Balthrop, president CEO of Luminex. "The xTAG RVP test can be a critical first line of defense in virus surveillance and in separating patients with more common respiratory infections from novel cases."

The xTAG RVP package insert has been updated to reference two recent publications of studies led by Dr. Christine Ginocchio at North Shore-LIJ Health System Laboratories (New York, NY, USA). One study demonstrated that all 1,108 influenza flu A unsubtypeable samples tested by the x TAG RVP were confirmed to be the 2009 Influenza A(H1N1) virus. The confirmation was carried out with the U.S. Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA) rRT-PCR assay for the 2009 Influenza A(H1N1) virus. This study is slated to appear in the Journal of Clinical Virology, (July 2009, in press).

The validation of the x TAG RVP test was carried out during the 2009 Influenza A/H1N1 outbreak in New York (NY, USA). Ninety-nine of the 101 unsubtypeable specimens tested with the CDC assay were identified as positive for the 2009 influenza A(H1N1) virus. This study appeared ahead of print in the July 2009 edition of the Journal of Clinical Microbiology.

Luminex Corporation develops, manufactures, and markets biological testing technologies with applications throughout the diagnostic and life sciences.

Related Links:

Luminex Corporation
U.S. Food and Drug Administration
North Shore-LIJ Health System Laboratories
U.S. Centers for Disease Control and Prevention



Gold Member
Serological Pipet Controller
PIPETBOY GENIUS
Gold Member
Flocked Fiber Swabs
Puritan® Patented HydraFlock®
New
Plasmodium Test
Plasmodium DNA Real Time PCR Kit
New
Hemoglobin Stool Test
CerTest FOB 50 + 200 One Step Combo Card Test
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

Molecular Diagnostics

view channel
Image: New biomarkers could someday make it easy to spot Parkinson’s disease in a patient’s blood sample (Photo courtesy of Shutterstock)

Unique Blood-Based Genetic Signature Can Diagnose Parkinson’s Disease

Parkinson's disease is primarily recognized for its impact on the central nervous system. Recent scientific progress has shifted focus to understanding the involvement of the immune system in the onset... 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: Custom hardware and software for the real-time detection of immune cell biophysical signatures in NICU (Photo courtesy of Pediatric Research, DOI:10.1038/s41390-025-03952-y)

First-Of-Its-Kind Device Profiles Newborns' Immune Function Using Single Blood Drop

Premature infants are highly susceptible to severe and life-threatening conditions, such as sepsis and necrotizing enterocolitis (NEC). Newborn sepsis, which is a bloodstream infection occurring in the... Read more

Pathology

view channel
Image: The new tool is designed for accurate detection of structural variations in clinical samples (Photo courtesy of Karen Arnott/EMBL-EBI and Isabel Romero Calvo/EMBL)

ML Algorithm Accurately Identifies Cancer-Specific Structural in Long-Read DNA Sequencing Data

Long-read sequencing technologies are designed to analyze long, continuous stretches of DNA, offering significant potential to enhance researchers' abilities to detect complex genetic changes in cancer genomes.... Read more

Technology

view channel
Image: Concept of biosensor integrated into hygiene pads enabling direct semi-quantitative analysis of biomarkers in unprocessed menstruation blood (Photo courtesy of Dosnon, L et al. DOI: 10.1002/advs.202505170)

First Ever Technology Recognizes Disease Biomarkers Directly in Menstrual Blood in Sanitary Towels

Over 1.8 billion people menstruate worldwide, yet menstrual blood has been largely overlooked in medical practice. This blood contains hundreds of proteins, many of which correlate with their concentration... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.