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
PURITAN MEDICAL

QIAGEN

Qiagen is a provider of sample and assay technologies for molecular diagnostics and applied testing, including comple... read more Featured Products: More products

Download Mobile App




FDA Approves Fourth-Generation Blood Test

By LabMedica International staff writers
Posted on 10 Jul 2017
The US Food and Drug Administration (FDA) has approved a next-gen assay for latent tuberculosis (TB) infection that combines breakthrough CD4/CD8 design for comprehensive immune response detection with flexible blood collection workflow.

The FDA approved test QuantiFERON-TB Gold Plus (QFT-Plus) is QIAGEN’s (Germantown, MD, USA, and Hilden, Germany) fourth-generation blood test for detecting latent-TB infection. More...
QFT-Plus builds on the foundation of QuantiFERON-TB Gold (QFT), the third-generation version of Qiagen’s leading interferon gamma release assay (IGRA). QFT is well proven, with a vast body of clinical evidence, as a cost-effective and efficient tool for TB infection testing. Availability in the US is planned to begin later this year (2017).

“We are pleased by the timely FDA approval for QuantiFERON-TB Gold Plus and that we can now bring a range of very attractive clinical and workflow benefits to customers,” said Thierry Bernard, senior VP and head of QIAGEN’s Molecular Diagnostics Business Area, “Tuberculosis is a global disease that is having an impact in the United States as well, where up to 13 million people are infected and nearly 10,000 people are currently suffering with active disease.”

With the addition of proprietary CD8+ technology, QFT-Plus represents a key milestone in the development of diagnostic tests for latent-TB infection. For the first time, a test has the potential to offer the ability to capture a much broader picture of an individual's immune response to TB infection. This technological advancement is critical to improving the understanding of how the immune system reacts to TB infection, and is expected to set a new standard for future disease management.

Among the new features of QFT-Plus is workflow flexibility that allows for even more efficient implementation, especially in large-scale TB screening programs. These include a standard single-tube blood collection option that allows blood samples to be processed up to 53 hours after venipuncture without affecting the accuracy of the test. This adds to the existing, unique "assay in collection tube" design allowing for immediate stimulation of the blood sample.

Another new feature includes advances to support research into the risk-stratification of latent-TB infections developing into active disease based on the first-time incorporation of CD8+ T cell response data, which provides valuable new information by measuring a broader range of immune response. Published scientific evidence underlines the future potential of CD8+ T cells in distinguishing active from latent TB, discerning recent vs. old infections, detecting TB in certain risk populations (such as HIV co-infection and young children), as well as assessing response to TB treatment.

QFT-Plus is set to be released in the US amid new recommendations that are broadening the use of IGRAs. In December 2016, a task force supported by the American Thoracic Society (ATS), US Centers for Disease Control and Prevention (CDC), and Infectious Diseases Society of America published new evidence-based guidelines recommending the use of IGRA tests in wider groups of people at risk for TB infection. This followed recommendations by the US Preventive Services Task Force (USPSTF) in September 2016 that primary care physicians should screen adult patients in groups at high risk for latent TB infection. Both referred to QFT as an FDA-approved IGRA at the time, preferable in certain patient groups to the century-old tuberculin skin test (TST).

Nine independent peer-reviewed publications to date have supported the performance of QFT-Plus, and additional studies underway in 22 countries involve more than 30,000 patients. QFT-Plus is the only IGRA TB test on the pathway to evaluation by the World Health Organization (WHO) as part of its global campaign to eradicate the disease.


Gold Member
Flocked Fiber Swabs
Puritan® Patented HydraFlock®
Serological Pipet Controller
PIPETBOY GENIUS
New
PlGF Test
Quidel Triage PlGF Test
New
Hand-Held Immunofluorescence Analyzer
WS-Si1500
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








DIASOURCE (A Biovendor Company)

Channels

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: An “evolutionary” approach to treating metastatic breast cancer could allow therapy choices to be adapted as patients’ cancer changes (Photo courtesy of 123RF)

Evolutionary Clinical Trial to Identify Novel Biomarker-Driven Therapies for Metastatic Breast Cancer

Metastatic breast cancer, which occurs when cancer spreads from the breast to other parts of the body, is one of the most difficult cancers to treat. Nearly 90% of patients with metastatic cancer will... Read more

Pathology

view channel
Image: A real-time trial has shown that AI could speed cancer care (Photo courtesy of Campanella, et al., Nature Medicine)

AI Accurately Predicts Genetic Mutations from Routine Pathology Slides for Faster Cancer Care

Current cancer treatment decisions are often guided by genetic testing, which can be expensive, time-consuming, and not always available at leading hospitals. For patients with lung adenocarcinoma, a critical... Read more

Technology

view channel
Image: Researchers Dr. Lee Eun Sook and Dr. Lee Jinhyung examine the imprinting equipment used for nanodisk synthesis (Photo courtesy of KRISS)

Multifunctional Nanomaterial Simultaneously Performs Cancer Diagnosis, Treatment, and Immune Activation

Cancer treatments, including surgery, radiation therapy, and chemotherapy, have significant limitations. These treatments not only target cancerous areas but also damage healthy tissues, causing side effects... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.