New Pathogenic E.coli O104:H4 Test Kit for Pall GeneDisc® System

Pall Corporation's GeneDisc® System is helping German authorities screen for a deadly strain of E.coli that has sickened nearly 3000 people and disrupted that nation's food industry. Pall's GeneDisc technology is being used by Germany's national reference laboratory to expedite testing of food samples for the toxic strain of the pathogen known as E.coli O104:H4 (STEC).

'We are using Pall's GeneDisc test kit for investigative screening of potential E.coli O104:H4 samples as well as for confirmation of presumptive positive samples. The GeneDisc system has proven highly effective in rapidly identifying STEC and helping us manage this public health crisis,' said Dr. Lothar Beutin of Germany's Federal Institute for Risk Assessment (BfR).

2700 cases of serious illness, including 25 fatalities, have been reported in 12 countries to date as a result of the outbreak. Dr. Beutin has studied the use of Pall GeneDisc technology in identifying STECs associated with human illness.

The Pall GeneDisc System is a rapid, simple and reliable testing solution for the detection of multiple food-borne contaminants. Based on real-time Polymerase Chain Reaction (qPCR) technology, the system features an exceptionally robust platform utilizing ready-to-use consumables. The system and test procedure yields consistent results and virtually eliminates operator error. Data on the presence or absence of multiple pathogens are produced in as little as one hour after enrichment, as opposed to the days required by traditional methods.

'The Pall GeneDisc System is an ideal tool for reference laboratories and food manufacturers needing fast and specific detection of potential health risks,' said Jonathan Pratt, President Pall Food & Beverage.

The Pall GeneDisc System recently became the first technology to receive multiparametric validation from the AOAC Research Institute for the detection of non-O157 STEC in meat. The system enables producers to test simultaneously for the pathogenic E.coli O157 and four of the top six non-O157 STECs targeted by the U.S. Department of Agriculture. GeneDisc is also validated for Salmonella and E.coli O157:H7 testing. The Pathogenic E.coli O104:H4 test kit is the newest commercial assay in the GeneDisc product line.

The effectiveness of the GeneDisc platform in identifying STECs associated with hemorrhagic colitis and hemolytic uremic syndrome - the two catastrophic illnesses presenting in the German E.coli outbreak - was reported in the International Journal of Food Microbiology in April 2010. The study conducted jointly by Health Canada, the French Food Safety Agency (ANSES), and the German Federal Institute for Risk Assessment (BfR) stated: 'In conclusion, this report demonstrates that the GeneDisc array can be used for the fast and simultaneous detection of several serotypes and virulence factors of STEC. Simultaneous detection of these markers provides data suitable for molecular risk assessment of the potential virulence of STEC isolates.' [Marie Bugarel, et. al. Volume 142 (2010), page 318-329]