2. Method validation for the detection of Giardia in animal feces and water using ELISA

University Of Pennsylvania, Philadelphia PA

Investigators

Abstract

PROJECT SUMMARY/ABSTRACT The specific aim of comparing the Luminex® xTAG GGP® multiplex, real-time PCR assay and the TechLab? Giardia Vet Chek? ELISA is to determine which method is a better candidate for the multiple matrices that may be submitted to the laboratory for a foodborne illness investigation. By determining which method can be used for feces, water, food, and milk for the accurate detection of Giardia intestinalis (lamblia), the response to a foodborne illness can be enhanced compared to the current laboratory method of centrifugation, and staining and reading slides. Molecular and immunoassays increase the number of samples being tested during a single run/preparation and require less technician time. These methods improve organism detection and turnaround time. After the results of the comparison are analyzed, the assay that shows the best or better correlation to the stained microscopic technique will be selected to move on to a future Phase 2 validation project for use at our PADLS New Bolton Center Laboratory. The long-term objective is to have the assay available for FDA Vet-LIRN and FERN investigations and routine diagnostic submissions. The current test (microscopic examination) does not work well with all sample matrices, in dependent on a certain level of detectable cysts being present in the sample, requires a skilled microscopist, and is labor intensive. It is not a good option in surge capacity situations, so a better method of detection is necessary. Located 40 miles from Philadelphia and less than 150 miles from both New York City and Washington, DC, the PADLS New Bolton Center Laboratory is close to several major metropolitan areas and provides veterinary diagnostic support to agricultural interests, animal owners, and other agencies and stakeholders in surrounding states. This contact with a large portion of the Eastern United States makes the PADLS New Bolton Center Laboratory an ideal FDA Vet-LIRN partner for enhanced regional surveillance and emergency response capabilities.