About 3.2 million people in the United States are chronically infected with HCV and each year, about 17,000 people are newly infected.

FDA Approves Rapid Test for Antibodies to Hepatitis C Virus

The agency announced approval of The OraQuick HCV Rapid Antibody Test, the first rapid blood test for antibodies to the virus for individuals 15 and older.

The Food and Drug Administration has announced approval of the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals aged 15 years and older.

The OraQuick HCV Rapid Antibody Test is used to test individuals who are at risk for infection with HCV and people with signs or symptoms of hepatitis. HCV is transmitted through exposure to infected blood, which, for example, can occur during intravenous drug use. The virus can also be transferred from an infected mother to her child. Hepatitis C can lead to liver inflammation and dysfunction and, over time, to liver disease and liver cancer.

OraQuick is a test strip and does not require an instrument for diagnosis. It takes about 20 minutes to obtain results from the test.

"Approval of OraQuick means that more patients can be notified of their HCV infection faster so that they can consult with their physicians for appropriate health measures," said Jeffrey Shuren, M.D., J.D., director of FDA's Center for Devices and Radiological Health. "Getting faster treatment is an important public health step to control this dangerous disease."

OraQuick is not approved for HCV screening of the general population.

According to the Centers for Disease Control and Prevention, there are approximately 3.2 million people in the United States chronically infected with HCV and each year, about 17,000 people are newly infected. Chronic HCV infection is a leading reason for a liver transplants in the United States and HCV is associated with an estimated 12,000 deaths annually. Approximately 75 to 85 percent of people who become infected with the hepatitis C virus develop chronic infection.

OraQuick is manufactured by Bethlehem, Penn.-based OraSure Technologies Inc.

Download Center

  • Safety Metrics Guide

    Is your company leveraging its safety data and analytics to maintain a safe workplace? With so much data available, where do you start? This downloadable guide will give you insight on helpful key performance indicators (KPIs) you should track for your safety program.

  • Job Hazard Analysis Guide

    This guide includes details on how to conduct a thorough Job Hazard Analysis, and it's based directly on an OSHA publication for conducting JHAs. Learn how to identify potential hazards associated with each task of a job and set controls to mitigate hazard risks.

  • A Guide to Practicing “New Safety”

    Learn from safety professionals from around the world as they share their perspectives on various “new views” of safety, including Safety Differently, Safety-II, No Safety, Human and Organizational Performance (HOP), Resilience Engineering, and more in this helpful guide.

  • Lone Worker Safety Guide

    As organizations digitalize and remote operations become more commonplace, the number of lone workers is on the rise. These employees are at increased risk for unaddressed workplace accidents or emergencies. This guide was created to help employers better understand common lone worker risks and solutions for lone worker risk mitigation and incident prevention.

  • EHS Software Buyer's Guide

    Learn the keys to staying organized, staying sharp, and staying one step ahead on all things safety. This buyer’s guide is designed for you to use in your search for the safety management solution that best suits your company’s needs.

  • Vector Solutions

Featured Whitepaper

OH&S Digital Edition

  • OHS Magazine Digital Edition - July August 2022

    July / August 2022

    Featuring:

    • CONFINED SPACES
      Specific PPE is Needed for Entry and Exit
    • HAZARD COMMUNICATION
      Three Quick Steps to Better HazCom Training
    • GAS DETECTION
      Building a Chemical Emergency Toolkit
    • RESPIRATORY PROTECTION
      The Last Line of Defense
    View This Issue