Abstracts of the Scientific Posters, 2013 AACC Annual Meeting ...

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Clinical Studies/Outcomes Tuesday, July 30, 9:30 am – 5:00 pm with existing ELISA method. Cut-off point differentiation (20 CU for BIO-FASH analyzer or ELISA Units for QUANTA-Lyser) between Positive/ Negative samples remain unchanged between both methods. Semi-Quant reportable numbers with respect to cut-off agreed well within the negative samples, but not well with positive samples. Overall, the automation and simplification of the assay makes it ideal for non specialized staff and high throughput. A-399 Clinical and Analytical Evaluation of the ARCHITECT HAVAB-G Assay D. T. Shaar 1 , P. Moreno 1 , S. Du 1 , J. Huang 1 , J. Yen 1 , D. Brotherton 1 , S. Worobec 1 , P. Schwebel 1 , W. Castellani 2 , M. Petruso 3 , M. E. Boyle 4 . 1 Abbott Diagnostics, Abbott Park, IL, 2 MS Hershey Medical Center, Hershey, PA, 3 Nationwide Laboratory Services, Fort Lauderdale, FL, 4 University of Colorado Hospital, Aurora, CO Objective: To evaluate the performance of the ARCHITECT ® HAVAB-G assay in a diagnostic population. Method: ARCHITECT HAVAB-G is a chemiluminescent microparticle immunoassay for the qualitative detection of IgG antibody to hepatitis A virus (IgG anti-HAV). A 5-day system reproducibility study was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP15-A2. For method comparison, ARCHITECT HAVAB-G results were compared to the final HAV IgG status, which was determined with AxSYM HAVAB 2.0 (total HAV assay) and ARCHITECT HAVAB-M (HAV IgM assay). Percent agreement of positive results (positive percent agreement or PPA) and percent agreement of negative results (negative percent agreement or NPA) were calculated for the following populations: a) individuals at increased risk of HAV infection and individuals with signs and symptoms of hepatitis infection, b) apparently healthy individuals, c) Hepatitis A vaccine recipients, and d) surplus pediatric specimens. Results: The ARCHITECT HAVAB-G assay demonstrated a %CV range of 4.3-4.9 for within-laboratory imprecision at clinically relevant analyte levels. In the method comparison study, the positive percent agreement (PPA) was as follows: individuals at increased risk of HAV infection and individuals with signs and symptoms of hepatitis infection 95.30% (385/404), apparently healthy individuals 98.69% (151/153), Hepatitis A vaccine recipients 100.00% (68/68), and surplus pediatric specimens 97.62% (82/84). The negative percent agreement (NPA) was as follows: individuals at increased risk of HAV infection and individuals with signs and symptoms of hepatitis infection 97.84% (363/371) apparently healthy individuals 99.18% (364/367), Hepatitis A vaccine recipients 100.00% (2/2), and surplus pediatric specimens 97.81% (223/228). Conclusion: The ARCHITECT HAVAB-G assay provides detection of IgG antibody to Hepatitis A virus. The presence of IgG anti-HAV implies a past HAV infection (recent or distant) or vaccination against HAV. Detectable levels above the assay cutoff imply immunity to HAV infection. A-400 Multimarker Logistic Regression Models Predict Sepsis Prior to Onset of Overt Clinical Symptoms J. M. Colón-Franco, D. A. Anderson, S. Litt, S. Srinivasa Gowda, T. W. Rice, A. P. Wheeler, W. D. Dupont, A. Woodworth. Vanderbilt University Medical Center, Nashville, TN Background: Sepsis is a life-threatening condition characterized by systemic inflammatory response syndrome (SIRS) along with a documented infection. Rapid diagnosis and early initiation of therapy significantly reduces mortality, but diagnosis during early stages of disease is difficult because many clinical conditions present with SIRS. No single biochemical or clinical marker can accurately identify early sepsis among patients with SIRS. Objective: To develop prediction models able to identify sepsis up to two days before overt clinical presentation of SIRS in Medical Intensive Care Unit (MICU) patients and to compare their diagnostic utilities to the only FDA approved sepsis biomarker, procalcitonin (PCT) Methods: This retrospective cohort study enrolled 201 MICU patients with SIRS who were identified by an electronic system that scans electronic medical records (EMRs) and alerts when patients meet ≥2 SIRS criteria (temperature >38°C or 90 beats/min, respiratory rate >20 breaths/min and white cell count >12x10 9 or
Tuesday, July 30, 9:30 am – 5:00 pm Clinical Studies/Outcomes A-404 Enhanced Liver Fibrosis (ELF) Panel as a Predictor of Liver Fibrosis in Chronic Hepatitis C Patients F. Fernandes 1 , A. Dellavance 2 , L. E. Andrade 2 , F. Campos 1 , G. H. Pereira 3 , C. Terra 1 , J. Pereira 3 , F. Figueiredo 1 , R. Perez 1 , M. L. Ferraz 2 . 1 Hospital Universitário Pedro Enesto - UERJ, Rio de Janeiro, Brazil, 2 Fleury Laboratory, São Paulo, Brazil, 3 Hospital Federal de Bonsucesso, Rio de Janeiro, Brazil A-403 The clinical Laboratory can demonstrate value by leveraging technology to reduce Hospital Acquired Infections (HAIs) D. L. Uettwiller-Geiger. John T. Mather Memorial Hospital, Port Jefferson, NY Background: Hospital acquired infections (HAIs) are a major cause of morbidity, mortality, increased length of stay and excessive healthcare costs. The federal Centers for Disease Control and Prevention (CDC) estimates that, each year there are 1.7 million HAIs, causing about 100,000 deaths annually. Objectives: To implement a rapid testing program to cost effectively detect Methicillin Resistant Staphylococcus Aureus (MRSA) and Clostridium difficile (C. difficile) in colonized and/or infected patients using new technologies. The availability of rapid testing on demand and in real time provides clinicians with key test results within one hour instead of days. An effective infection control program along with strong laboratory support will reduce the number of HAIs and the associated morbidity and mortality. Methods: A program for MRSA was implemented in March 2008 using rapid polymerase chain reaction (PCR) on the Cepheid GeneXpert® System. The system uses a single test cartridge delivering test results in less than an hour. In May 2010, the C. difficile program was implemented using the C. DIFF Quik Chek Complete from Alere, manufactured by TechLab Inc. The technology uses antibodies to identify and confirm the presence of toxigenic C. difficile by detecting toxins A and B in a single assay device and glutamate dehydrogenase (GDH) antigen, delivering test results in < 45 minutes. Results: Our testing strategy for MRSA focused on high risk populations of intensive care units, cardiac care unit, and Orthopedics. In 2007, before rapid PCR MRSA screening, the infection rate was .90/1000 discharges and five years after implementation of the rapid PCR MRSA screening program the infection rate in 2012 was .23/1000. Comparing MRSA infection rates from 2007 to 2012 there was a 76% reduction with a corresponding 76% reduction in associated infection costs. The five year PCR screening cost was $448,400. Based on the average cost of medical care for a MRSA infection of $35,000 dollars per infected patient, we decreased the cost of infection by $1,511,600 during the five year period and the length of stay for the critical care units decreased by 21%. In 2009, the C. difficile infection rate was .95/1000 and three years after implementation of the simultaneous testing the infection rate in 2012 was .34/1000. Comparing C. difficile infection rates from 2009 to 2012 there was a 63% reduction with a corresponding 63% reduction in associated infection costs. The three year C. difficile testing cost was $86,460. Based on the average cost of medical care for a C. difficile infection of $35,000 dollars per infected patient, we decreased the cost of infection by $1,453,540 during this three year period. Total cost avoidance/savings due to the decrease in MRSA and C. difficile infections was $2,965,140. Conclusions: Our Laboratory’s rapid testing programs for MRSA and C.difficile using new technologies demonstrate the Laboratory’s value by supporting our infection control measures and strategies that permit rapid identification and interventions that assure patient safety, improve bed management, decrease length of stay, and saves millions of dollars, while enhancing patient outcomes and significantly reducing hospital acquired infections. Relevance: Fibrosis is the most important issue in the assessment of chronic hepatitis C (CHC), with treatment and prognostic relevance. Liver biopsy remains the gold standard for staging fibrosis, despite its many drawbacks. In recent years much has been researched in the field of non-invasive serological markers of liver fibrosis. Among these one of the most promising is ELF panel which comprises hyaluronic acid (HA), tissue inhibitor of matrix metalloproteinases-1 (TIMP-1) and aminoterminal propeptide of procollagen type III (PIIINP). To date, there is scarce data on ELF performance as a non-invasive marker of fibrosis in patients with CHC. Objective: To evaluate the performance of ELF as a non-invasive marker of fibrosis in CHC patients. Material and Methods: A hundred and twenty patients with CHC that were consecutively submitted to liver biopsy were included. Exclusion criteria: human immunodeficiency virus and hepatitis B co-infection, daily alcohol intake of more than 40g, cholestasis, chronic kidney failure, right-sided heart failure, fibrogenic drugs use, less than six portal tracts or concomitant pathology in the liver biopsy. The blood sample was collected within an interval of at most 3 months from the biopsy. The serum was frozen at - 70° C in an interval no longer than 3 hours. PIIINP, HA, and TIMP-1 were measured in all patients by a CE-marked, random-access, automated clinical immunoassay system that uses magnetic particle separation technology with direct chemiluminescence (ADVIA Centaur®, Siemens Healthcare Diagnostics, Tarrytown, NY, USA). The ELF score was calculated using the algorithm: ELF = 2.278 + 0.851 ln(HA) + 0.751 ln(PIIINP) + 0.394 ln(TIMP-1). Cut-off points proposed by the manufacturer were applied: < 7.7 absent or mild fibrosis, ≥ 7.7 and < 9.8 moderate fibrosis and ≥ 9.8 severe fibrosis. Biopsies were reviewed by one experienced pathologist. The study was approved by the local Ethics Committee. Statistical analyses were performed using SPSS 17.0 (SPSS Inc., Chicago IL). Results: Thirty-four percent of the patients were men, mean age 53 (SD ± 11.3) years old. The distribution of fibrosis stages according to METAVIR was: stage 0 - 2%; stage 1 - 52%; stage 2 - 30%; stage 3 - 9% and stage 4 - 7% . According to ELF cut-off points we had: three (2%) patients with absent or mild fibrosis (F0-1), seventyfour (61%) with moderate fibrosis (F2-3) and forty-four (37%) with cirrhosis (F4). When compared to histological analysis ELF overestimated fibrosis in 76% of cases and underestimated in one case. The Spearman correlation coefficient of ELF with the histological staging was 0.57 (p
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