Nucleic Acid Technology (NAT)

The specific detection of viral nucleic acids 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, NAT testing became a major technique to reduce the window period (diagnostic window) in which the virus is invisible for 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 1990-ies 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


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.


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 develops and introduces various in-house PCR assays for the routine blood screening.


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.


Certification of company and products

ISO 13485, ISO 9001 and IVD-Guideline 98/79/EG certification


Launch of autoX-System

GFE introduces the autoX-System for the routine NAT blood screening.


New production site

The GFE establishes the kit production on a new production site in Frankfurt Griesheim.


Registration of manual assays

GFE registers the confirmatory kits for the manual use with third party extraction.


Triple target HIV-1 test

GFE introduces the proprietary HIV-1 triple target test to increase blood safety.


Release of new WNV PCR Kit

GFE redesigned its WNV PCR Kit and releases the new version into the market.


First preview of PoET

A fist preview of the new PoET-Instrument design study shown at the ISBT in Dubai.


Dr. Reiner Babiel appointed new CEO

Change of general managment after retirement of Prof. Dr. med. W. Kurt Roth.

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