LAUSR

WORKSHOP W1 DIAGNOSIS, EPIDEMIOLOGY W1.1 | Evaluation of Curian HpSA fluorometric assay. A novel, rapid immunoassay for the detection of Helicobacter pylori antigens in human stool I. Saracino1; M. Pavoni1; G. Fiorini1; L. Saccomanno1; D. Bibbs2; D. Vaira1 1University of Bologna, Bologna, Italy; 2Meridian Bioscience, Cincinnati, OH, United States Stool antigen has become a widely acceptable method for detection of H. pylori. This noninvasive method provides an alternative to the more invasive techniques of biopsy. The recent Maastricht V1 Consensus Report recommends the use of the stool antigen tests as an aid in the detection of Helicobacter pylori disease in the primary care setting. The purpose of this study was to evaluate the sensitivity and specificity of a novel, rapid immunoassay compared to the gold standard method of detection. Curian HpSA Fluorometric (RUO), is an innovative immunoassay that utilizes fluorescent technology to detect Helicobacter pylori antigens in stool specimens. The test uses monoclonal antiHelicobacter pylori antibodies for both capture and detection. For clear interpretation, the Curian Analyzer (reader) is used to report results. Methods: The Curian HpSA Fluorometric (RUO) assay was compared using 95 prospective positive stools and 53 retrospective negative stools characterized by UBT, Histology and Culture. Results: The sensitivity was 94.73% and specificity was 98.11% compared to the gold standard for diagnosis of Helicobacter pylori infection. Overall correlation was 95.95%. Conclusions: The Curian HpSA Fluorometric (RUO) assay performance demonstrated comparable sensitivity and specificity compared to the gold standard. The 20 minute, rapid, qualitative assay provides the end user with accurate interpretation of results without subjective review. Curian HpSA Fluorometric is a 20 minute rapid test for the accurate, noninvasive detection of Helicobacter pylori in human stool specimens. G. Fiorini: None. I. Saracino: None. M. Pavoni: None. L. Saccomanno: None. D. Vaira: None. D. Bibbs: A. Employment (full or parttime); Significant; Meridian Bioscience. W1.2 | PCR vs culture in the detection of Helicobacter pylori and its antimicrobial resistance A. Miqueleiz1; P. Martinez-Martinez2; H. López-Tello2; A. López-Sierra2; A. Ortega-Pradera2; C. Ramos del Moral2; C. Alba1; V. B. Valdez1; T. Alarcón1,2 1Hospital Univ. de La Princesa, Madrid, Spain; 2Universidad Autonoma de Madrid, Madrid, Spain Aim: The aim of this study was to compare PCR and culture in a routine laboratory for the detection of H. pylori and the detection of antimicrobial resistance. Methods: All the specimens received in a routine laboratory were included. A total of 616 patients were studied in a 2years period (20162017). Gastric biopsy was obtained and cultured for H. pylori detection following standard methodology. Etest for determine the MIC of 5 antimicrobial agents were carried out following EUCAST recommendations. DNAs was extracted from the biopsy using EasyMag (bioMerieux) and a commercially available PCR was performed to detect H. pylori and the clarithromycin and levofloxacin resistance (GenoType®HelicoDR, HainLifeScience). The time required to inform the results was recorded. Results: 234 specimens (38%) were H. pylori positive simultaneously by PCR and culture, whilst 308 (50%) were H. pylori negative by both methods. Culture was negative in 72 PCRpositive specimens (11.7%). PCR was negative in 2 culturepositive specimens (0.32%). The relationship between the results of resistance by PCR and culture were also studied. PCR was performed in a maximum of 9 days whilst culture may require 14days to 29days (including Etest). Conclusion: In conclusion, PCR was able to detect more positive results than culture and it required less days to obtain the results, but the Etest was able to detect resistance to all antibiotics, whilst PCR detect only clarithromycin and levofloxacin resistance. T. Alarcón: None. A. Miqueleiz: None. P. MartinezMartinez: None. H. LópezTello: None. A. LópezSierra: None. A. OrtegaPradera: None. C. Ramos del Moral: None. C. Alba: None. V.B. Valdez: None. Susceptible by Etest Resistent by Etest Total ClarithromycinPCR Mutation 21 (15.4%) 115 (84.5%) 136 No mutation 84 (98.8%) 1 (1.1%) 85 LevofloxacinPCR Mutation 0 (0%) 15 (100%) 15 No mutation 197 (100%) 0 (0%) 197