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

PROJECT SUMMARY/ABSTRACTThe specific aim of comparing the Luminex® xTAG GGP® multiplex, real-time PCR assay and theTechLab? Giardia Vet Chek? ELISA is to determine which method is a better candidate for the multiplematrices that may be submitted to the laboratory for a foodborne illness investigation. By determiningwhich method can be used for feces, water, food, and milk for the accurate detection of Giardiaintestinalis (lamblia), the response to a foodborne illness can be enhanced compared to the currentlaboratory method of centrifugation, and staining and reading slides. Molecular and immunoassaysincrease the number of samples being tested during a single run/preparation and require less techniciantime. 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 tothe stained microscopic technique will be selected to move on to a future Phase 2 validation project foruse at our PADLS New Bolton Center Laboratory. The long-term objective is to have the assay availablefor 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 levelof detectable cysts being present in the sample, requires a skilled microscopist, and is labor intensive. Itis 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 providesveterinary diagnostic support to agricultural interests, animal owners, and other agencies andstakeholders in surrounding states. This contact with a large portion of the Eastern United States makesthe PADLS New Bolton Center Laboratory an ideal FDA Vet-LIRN partner for enhanced regionalsurveillance and emergency response capabilities.