FDA Grand Rounds: Detection of transmissible spongiform encephalopathy (TSE) agents in biological products using protein aggregation assays, presented by Luisa Gregori, PhD (CBER)

FDA Grand Rounds

Detection of transmissible spongiform encephalopathy (TSE) agents in biological products using protein aggregation assays

Thursday, February 13, 2020

12:00 p.m. - 1:00 p.m. EST

 

Register here for webcast (public attendees and FDA staff)

CE Credit Available

Presented by: 

Luisa Gregori, PhD

Chemist and Principal Investigator

Lab of Bacterial & Transmissible Spongiform Encephalopathy Agents, Division of Emerging and Transfusion Transmitted Diseases (DETTD), CBER

 

About the Presentation:

Transmissible spongiform encephalopathies (“TSEs” or “prion diseases”) are rare, fatal illnesses that are transmitted by contaminated biologics such as tissues and blood products, surgical instruments and certain drugs (hormones) derived from human pituitary glands. Of particular interest to the CBER Lab of Bacterial & Transmissible Spongiform Encephalopathy Agents LBTSEA) is Creutzfeldt-Jakob disease (vCJD), a human TSE transmitted by blood transfusions and plasma products.

All TSEs have long asymptomatic incubation periods. During this phase, the host appears healthy and can donate infected blood or tissues without detection. Although vCJD is very rare, its impact is devastating as there is no vaccine or cure. New, rapid tests for TSE diseases are needed to improve the safety of blood and tissue donations and to possibly screen those biologicals that are at risk of being contaminated with the TSE agent.

In this presentation, the speaker will describe the results detecting vCJD agent in blood of macaques experimentally infected with the vCJD agent, using an in vitro test called “protein misfolding cyclic amplification” (PMCA). The macaque blood panels cab be used to help assay developers validate candidate blood screening tests. An alternative in vitro method, “real-time quaking-induced conversion” (RT-QuIC), used to detect TSE agent in biological materials other than blood will also be discussed. 

From this FDA Chemist, you’ll learn: 

• How to identify various TSE diseases by name 
• The basic principles of protein misfolding cyclic amplification assay
• The basic principles of real-time quaking-induced conversion assay