New CDC-Developed Diagnostic Lab Test for Flu Approved

New CDC-Developed Diagnostic Lab Test for Flu Approved

ArticlePress release
Health & Wellness
Diseases & Conditions
Contributed byLester Fahrner, MDApr 02, 2020

New CDC-Developed Diagnostic Lab Test for Flu Approved

CDC′s new laboratory test kit for influenza

A laboratory diagnostic kit to diagnose human infections with seasonal influenza viruses and novel influenza A viruses with pandemic potential has been authorized for use by Food and Drug Administration. The in–vitro, or IVD, kit was developed by the Centers for Disease Control and Prevention.

“As the spread of the H1N1 pandemic slowed last year, we conducted an end–to–end review of our nation’s medical countermeasure enterprise, which showed a clear need for better diagnostic tests,” said Dr. Nicole Lurie, assistant secretary for preparedness and response in the U.S. Department of Health and Human Services. “In helping public health officials quickly identify seasonal flu as well as the flu viruses that could become pandemic, this kit can make a real difference in protecting health and saving lives in the United States and around the world.”

The CDC test kit will be given at no cost to qualified international public health laboratories to improve global laboratory capacity for detecting influenza virus infections in human respiratory tract specimens.

The CDC Human Influenza Virus Real–Time RT–PCR Diagnostic Panel utilizes a three–module design. The modules incorporate and streamline previous versions of CDC′s two separate FDA–cleared diagnostic test kits.

The first module is used to identify and distinguish between infection with influenza A and B viruses. The second module can further classify influenza A viruses by subtype, such as H1N1, H3N2 or 2009 H1N1. And the last module specifically detects highly pathogenic avian influenza A (H5N1) virus infection in human respiratory tract specimens, in support of ongoing global preparedness efforts against a possible H5N1 bird flu pandemic.

The modular design makes the kit more efficient for use by diagnostic laboratories, and eliminates waste by allowing users the flexibility to order components separately, according to the laboratory′s needs. “This will lead to more efficient testing, with cost savings for the federal government and for state and local public health agencies,” stated Nancy Cox, P.H.D., director of CDC Influenza Division and director of the World Health Organization Collaborating Center for Surveillance, Epidemiology and Control of Influenza.

The test kit is used with specimens collected from a patient’s upper or lower respiratory tract. Upper respiratory specimens are easily obtainable in an outpatient or inpatient setting, and lower respiratory specimens are typically obtained from severely ill patients with lower respiratory disease (e.g., severe pneumonia) in a hospital setting. The test kit is the only IVD for influenza that is FDA cleared for use with lower respiratory tract specimens. Several studies have shown that among hospitalized patients with severe lower respiratory disease, including critically ill patients requiring mechanical ventilation in the intensive care unit, testing lower–respiratory tract specimens can help detect influenza virus infections that can be missed by only testing upper respiratory tract samples.

###

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Was this article helpful

On the Article

Lester Fahrner, MD picture
Approved by

Lester Fahrner, MD

Chief Medical Officer, DoveMed Team

0 Comments

Please log in to post a comment.

Related Articles

Test Your Knowledge

Asked by users

Related Centers

Loading

Related Specialties

Loading card

Related Physicians

Related Procedures

Related Resources

Join DoveHubs

and connect with fellow professionals

Related Directories

Who we are

At DoveMed, our utmost priority is your well-being. We are an online medical resource dedicated to providing you with accurate and up-to-date information on a wide range of medical topics. But we're more than just an information hub - we genuinely care about your health journey. That's why we offer a variety of products tailored for both healthcare consumers and professionals, because we believe in empowering everyone involved in the care process.
Our mission is to create a user-friendly healthcare technology portal that helps you make better decisions about your overall health and well-being. We understand that navigating the complexities of healthcare can be overwhelming, so we strive to be a reliable and compassionate companion on your path to wellness.
As an impartial and trusted online resource, we connect healthcare seekers, physicians, and hospitals in a marketplace that promotes a higher quality, easy-to-use healthcare experience. You can trust that our content is unbiased and impartial, as it is trusted by physicians, researchers, and university professors around the globe. Importantly, we are not influenced or owned by any pharmaceutical, medical, or media companies. At DoveMed, we are a group of passionate individuals who deeply care about improving health and wellness for people everywhere. Your well-being is at the heart of everything we do.

© 2023 DoveMed. All rights reserved. It is not the intention of DoveMed to provide specific medical advice. DoveMed urges its users to consult a qualified healthcare professional for diagnosis and answers to their personal medical questions. Always call 911 (or your local emergency number) if you have a medical emergency!