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1 Coris Bioconcept, Science Park Crealys, Rue Jean Sonet 4a, 5032 Gembloux, BELGIUM

Development and Evaluation of a New Rapid Gravity-Driven Test for Detection of Legionella pneumophila Antigen in Urine. www.corisbio.com. Poster C-169. L. Denorme, L. Avrain, S. Degallaix, V. Labrune, T. Laurent, O. Lefèvre, P. Mertens and T. Leclipteux.

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1 Coris Bioconcept, Science Park Crealys, Rue Jean Sonet 4a, 5032 Gembloux, BELGIUM

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  1. Development and Evaluation of a New Rapid Gravity-Driven Test for Detection of Legionella pneumophila Antigen in Urine www.corisbio.com Poster C-169 L. Denorme, L. Avrain, S. Degallaix, V. Labrune, T. Laurent, O. Lefèvre, P. Mertens and T. Leclipteux 1Coris Bioconcept, Science Park Crealys, Rue Jean Sonet 4a, 5032 Gembloux, BELGIUM Materials and Procedure Introduction We have developped a new Legionella antigen detection test based on colloidal gold-labelled antibodies directed against L. pn. serogroup 1. This is a rapid Gravity-Driven sandwich-type membrane assay (GDT) which is a ready-to-use test that does not require dilution of urine with a reaction buffer. Freshly collected urine is simply deposited on the top of the device and result is obtained after 5 to 15 minutes, appearing as a purple line in case of a positive test. A build-in control is used as migration control. Legionnaires' disease includes pneumonia and is the major clinical manifestation of Legionella infection. L. pneumophila is responsible for approximately 90% of infections, and of these, over 80% are due to the single serogroup 1. The disease is transmitted via aspiration of aerolized water containing the bacteria, and there is no evidence for direct person-to-person transmission. The mortality rate of untreated patients is as high as 25%. Antigen detection in urine has proved to be sensitive and is thus widely used for detection of Legionella infection. Results Evaluation 1 Results Evaluation 2 -Samples: 10 positive urine samples -Rapid tests: the new GDTLegionella antigen detection test compared to a market leader rapid immunochromatographic test (Test N) -Samples: reference strains -Rapid tests: the new GDTLegionella antigen detection test compared to a market leader rapid immunochromatographic test (Test N) Detectability: 104 to 105 CFU/ml for both tests on L. pneumophila serogroup1 Specificity on selected strains: Both tests showed similar sensitivities for detection of L. pneumophila antigen in urine. Conclusion The Coris' GDTLegionella antigen detection test in urine shows very good sensitivity and specificity. The test is rapid, very simple to use, and is appropriate for the detection of L.pn. infection due to its very high specificity. GDTLegionella antigen detection test is highly specific for L. pneumophila serogroup1 and shows similar analytical sensitivity as the other rapid test. Acknowledgments • This work is granted by : • The European Commission : GRACE Program - contract n° LSHM-CT-2005-518226 • The Région Wallonne : DGTRE contract n° : 327151 www.grace-lrti.org

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