Qiagen has appear the US barrage of QuantiFERON-TB Gold Plus (QFT-Plus), the fourth bearing of its arch claret analysis for tuberculosis (TB) infection. QFT-Plus kits will be accessible on October 9, 2017 for analytic use afterward US Food and Drug Administration approval in June.
QFT-Plus advances the science of TB testing with avant-garde antigens that admeasurement the cell-mediated allowed acknowledgment to tuberculosis infection from both CD4 and CD8 T beef – accouterment a broader appraisal of TB infection. CD8 T beef accept been apparent to comedy an important role in Mycobacterium tuberculosis immunity.
QFT-Plus builds on the foundation of QuantiFERON-TB Gold (QFT), the third bearing of Qiagen’s world-leading interferon gamma absolution appraisal (IGRA). The new QFT-Plus analysis includes the afterward new features: Optimized CD8 T corpuscle responses — Facilitates analysis on accommodating accident stratification of abeyant TB infections developing into alive disease. Published affirmation underlines the approaching abeyant of CD8 T beef for appropriate alive from abeyant TB, acute contempo vs. old infections, audition TB in assertive populations such as HIV co-infection and adolescent children, as able-bodied as assessing one’s acknowledgment to TB treatment. No added analysis is optimized for both CD4 and CD8 T corpuscle responses.
Expanded claret accumulating options — Accumulating and carriage adaptability that enables barter to booty ascendancy of the TB testing workflow with several claret accumulating options. QFT-Plus offers a new accepted single-tube claret accumulating advantage that allows beyond aggregate labs or accidentally calm claret samples to be candy up to 53 hours afterwards venipuncture for adjustable carriage to the lab. The absolute “assay in accumulating tube” architecture for actual dispatch of the claret sample continues to accommodate a absolute draw advantage with the identical carriage times as the antecedent QuantiFERON 3rd bearing assay.
High acuteness and specificity — QFT-Plus has a specificity of >97% and a acuteness of >94%, bearing added authentic after-effects than the century-old tuberculin bark analysis (TST).
“QuantiFERON-TB Gold Plus sets a new criterion in TB testing with the accession of specific CD8 T corpuscle aesthetic antigens. Abounding clinicians accept already accomplished the patient-centered aspects of a distinct appointment to get a aftereffect and accurateness of class testing over the tuberculin bark test. The proprietary CD4 /CD8 T corpuscle technology of QFT-Plus has the abeyant to accommodate important insights for high-risk patients such as contacts apparent to alive TB or HIV-positive bodies while advancement aerial specificity,” said Dr. Masae Kawamura, Senior Director, TB Medical and Scientific Affairs, at Qiagen. “In the United States, analysis accurateness has never been added important as the country aggressively fights to end tuberculosis through contempo policy-driven amplification of targeted testing and antitoxin treatment. It is currently estimated that 93% of the TB ache in the US comes from the 13 million-person backlog of abeyant TB infection.”
The US addition of QFT-Plus follows acceptance in added than 75 countries beyond Europe, the Middle East, Africa, Asia and Latin America, area about two actor of the new tests accept already been used. Added than ten peer-reviewed publications to date accept accurate the achievement of QFT-Plus, and studies underway in 22 countries absorb added than 30,000 patients. QFT-Plus is the alone IGRA analysis on the alleyway to appraisal by the Apple Health Organization (WHO) for its all-around attack to eradicate TB.
Tuberculosis is a catching bacterial infection advance primarily by coughing of patients with the alive pulmonary anatomy of the disease. In 2015, WHO estimates, there were 10.4 actor new cases of alive TB common and 1.8 actor deaths from TB. In abeyant tuberculosis infection (LTBI), the bacillus infects a being but produces no affection unless it progresses to the alive disease. On a all-around basis, about one out of three bodies are estimated to accept abeyant TB infection, and about 5-10% of those individuals, if untreated, will advance to alive tuberculosis at some point. Screening of high-risk individuals and analysis for LTBI comedy an important role in tuberculosis ascendancy efforts in the US and abounding European countries, as able-bodied as in added developed and arising markets about the world.
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