FDA Approves HIV Blood, Tissue Screen Test

The Food and Drug Administration recently approved the cobas TaqScreen MPX Test, the first nucleic acid test that screens for the presence of two divergent types of HIV in donated blood plasma and tissue.

"With the MPX test, blood donor testing laboratories will be able to use nucleic acid technology to screen for additional HIV strains, further assuring that donated blood and tissue are free from infection and providing better protection for patients," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.

Nucleic acid is the common name for the large chemical compounds that make up the genetic material in living cells. The new FDA-approved test detects nucleic acid from HIV-2 and from HIV-1 Group O. HIV-2 infections and HIV-1 Group O infections are predominantly found on the African continent. Some cases of infection with these two types of viruses have also been detected in the United States.

In addition to HIV-2 and HIV-1 Group O, the MPX test simultaneously detects nucleic acid from the most common form of HIV, HIV-1 Group M, as well as the Hepatitis C Virus and the Hepatitis B Virus.

The MPX test is designed for use with plasma specimens from human donors of whole blood and blood components, but not for testing donated source plasma. Donated source plasma is considered plasma intended for further manufacturing.

The test is also intended for screening tissue specimens obtained while the donor's heart is still beating; it is not intended for use on specimens from donors whose heart no longer functions.

The cobas TaqScreen MPX Test runs on the fully-automated cobas s 201 System. It is manufactured by Roche Molecular Systems Inc., Pleasanton, Calif.

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 - June 2022

    June 2022

    Featuring:

    • SAFETY CULTURE
      Corporate Safety Culture Is Workplace Culture
    • HEAT STRESS
      Keeping Workers Safe from Heat-Related Illnesses & Injuries
    • EMPLOYEE HEALTH SCREENING
      Should Employers Consider Oral Fluid Drug Testing?
    • PPE FOR WOMEN
      Addressing Physical Differences
    View This Issue