Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


In Brief: HIV-1 antigen blood screening

This article was originally published in The Gray Sheet

Executive Summary

HIV-1 antigen blood screening: Benefits of testing blood donors for HIV-1 antigens would not outweigh the potential costs, FDA's Blood Products Advisory Committee concludes June 23 in Bethesda, Maryland. The 9 to 6 vote reflects the belief by the majority of panel members that blood banks should not conduct HIV antigen screening of donors. Panel members noted that, although antigen screening could detect a few HIV-infected donors that currently are missed, the test is significantly more expensive than existing HIV antibody screening tests. Panelists also raised concern that individuals who think they may be infected with HIV would donate blood in order to receive the antigen screening test. The panel also voted 8 to 6, with one abstention, that FDA should not approve donor screening claims for HIV antigen test kits...

You may also be interested in...

Decision Time For MSD/AZ, Lilly, Kite EU Fast-Track Hopes

Three accelerated assessment requests will either be granted or rejected this week at the European Medicines Agency.

Singapore And Malaysia Test Joint Evaluation Of Generics

A new work sharing pilot has been launched to evaluate jointly generic drugs intended for launch in Singapore and Malaysia.

Australia Looking Into In-Vitro Self-Test Deregulation

In-vitro self-tests for influenza and sexually transmitted diseases as well as direct-to-consumer genetic tests are on the agenda for deregulation in Australia. 



Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts