Nucleic Acid Technology (NAT)

The specific detection of viral nucleic acid by the Nobel-Price awarded Polymerase Chain Reaction (PCR) marks a break-through milestone in the in-vitro diagnostics.

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

HCV transmissions

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

Vox Sang. 2012; 102(1): 82-90

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.

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