A success stroy
NAT in Blood Screening
The diagnostic window
Significant reduction of the diagnostic window by NAT testing.
It takes a while until the human immune system starts its reaction against a new invader. During this time a virus is spreading within the blood without being detectable by the serological tests that are applied. As this blood has proven to be infectious in blood transfusion, it became a major driver to reduce the window period (diagnostic window) in which the virus is invisible for testing by the introduction of NAT testing.
The diagnostic window
Impact of introduction of mandatory HCV NAT testing in 1999.
When NAT testing became mandatory for blood screening (first in Germany in 1999), it indeed showed the hoped for effect on the rate of transfusion transmitted infections (TTI). The prime example has become the risk of an HCV transmission, which dropped from a residual risk of 1 : 5,000 down to 1 : 80,000,000 ever since.
Routine testing sice 1997
International implementation of NAT testing.
The intensive research in the mid 1990th at the German Red Cross finally resulted in the introduction of routine NAT testing in blood screening in 1997. Building on the success of these tests the technology soon started spreading over the world complementing the serological tests in all major laboratories.
Company Background & History
1996
Set-up of PCR group at GRC
The German Red Cross in Frankfurt establishes a dedicated PCR group to develop PCR tests for blood screening.
1997
First PCR test in routine
The GRC introduces the first PCR test for routine NAT screening of HCV.
1997 – 2004
Various new PCR tests
In a short sequence the GRC developes and introduces various in-house PCR assays for the routine blood screening.
2005
Foundation of GFE
Three GRC organisations establish the GFE to bring NAT testing to the full IVD level. (Prof. Dr. med. W. Kurt Roth appointed as CEO)
2009
Certification of company and products
ISO 13485, ISO 9001 and IVD-Guideline 98/79/EG certification
2010
Launch of autoX-System
GFE introduces the autoX-System for the routine NAT blood screening.
2012
New production site
The GFE moves the kit production into a new production site in Frankfurt Griesheim.
2013
Registration of manual assays
GFE registers the confirmatory kits for the manual use with third party extraction.
2014
Triple target HIV-1 test
GFE introduces the proprietary HIV-1 triple target test to increase blood safety.
2014
Release of new WNV PCR Kit
GFE redesigned its WNV PCR Kit and releases the new version into the market.
2016
First preview of PoET
A fist preview of the new PoET-Instrument design study shown at the ISBT in Dubai.
2018
Dr. Reiner Babiel appointed new CEO
Change of general managment after retirement of Prof. Dr. med. W. Kurt Roth.