Validation of the 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx) for the Detection of Shiga Toxin Gene (stx1 and/or stx2) in Additional Matrixes: AOAC Performance Tested MethodSM 071903.

BACKGROUND: The 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx) method is based on gene amplification by the use of real-time loop-mediated isothermal amplification when used with the 3M Molecular Detection System for the rapid and specific detection of Shiga toxin gene (stx1 and/or stx2) from Shiga toxin-producing enterohemorrhagic Escherichia coli (STEC) in enriched foods. OBJECTIVE: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) method was evaluated as a Level 2 method modification to add new matrixes to the certified claim: 25 g fresh raw ground beef (approximately 75% lean), 375 g raw beef trim (approximately 75% lean), 375 g fresh raw ground pork (approximately 70% lean), 375 g fresh raw poultry parts, and 25 g sprouts. METHODS: Matrix studies were conducted to assess the method's performance compared to the US Department of Agriculture Food Safety and Inspection Service Microbiology Laboratory Guidebook, 5C.00 for meat and poultry, and to the US Food and Drug Administration Bacteriological Analytical Manual, Ch. 4A for sprouts, using an unpaired study design. RESULTS: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) method demonstrated no significant differences between presumptive and confirmed results or between candidate and reference method results for any of the matrices tested. CONCLUSION AND HIGHLIGHTS: The data collected in these studies demonstrate that the 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) is a reliable method for the rapid and specific detection of STEC in fresh raw ground beef (approximately 75% lean), fresh raw beef trim (approximately 75% lean), fresh raw ground pork (approximately 70% lean), fresh raw poultry parts, and sprouts.

Validation of the 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) for the Detection of Shiga Toxin Gene (stx1 and/or stx2) and Intimin Gene (eae): AOAC Performance Tested MethodSM 071902.

BACKGROUND: The 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) method is based on gene amplification by the use of real-time loop-mediated isothermal amplification when used with the 3M Molecular Detection System for the rapid and specific detection of Shiga toxin gene (stx1 and/or stx2) and intimin gene (eae) from Shiga toxin-producing enterohemorrhagic Escherichia coli (STEC) in enriched foods. OBJECTIVE: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) method was evaluated as a Level 2 method modification to add new matrixes to the certified claim: 25 g fresh raw ground beef (approximately 75% lean), 375 g fresh raw ground pork (approximately 70% lean), 375 g fresh raw poultry parts, and 25 g sprouts. METHODS: Matrix studies were conducted to assess the method's performance compared to the U. S. Department of Agriculture Food Safety and Inspection Service Microbiology Laboratory Guidebook, 5C.00 for meat and poultry, and to the U. S. Food and Drug Administration Bacteriological Analytical Manual, Ch. 4A for sprouts, using an unpaired study design. RESULTS: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) method demonstrated no significant differences between presumptive and confirmed results or between candidate and reference method results for any of the matrixes tested. CONCLUSION AND HIGHLIGHTS: The data collected in these studies demonstrate that the 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) is a reliable method for the rapid and specific detection of STEC in fresh raw ground beef (approximately 75% lean), fresh raw ground pork (approximately 70% lean), fresh raw poultry parts, and sprouts.

Validation of the 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) for the Detection of Shiga Toxin Gene (stx and eae) in Fresh Raw Beef Trim, Fresh Raw Ground Beef and Fresh Spinach: AOAC Performance Tested MethodSM 071902.

BACKGROUND: The 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) method is based on gene amplification using real time loop-mediated isothermal amplification with the 3M Molecular Detection System for the rapid and specific detection of Shiga toxin gene (stx1 and/or stx2) and intimin gene (eae) from Shiga toxin-producing enterohemorrhagic Escherichia coli (STEC) in enriched foods. OBJECTIVE: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) method was evaluated for AOAC®  Performance Tested MethodsSM certification. METHODS: Matrix studies, inclusivity/exclusivity, robustness, product stability, and lot-to-lot variability testing were conducted to assess the method's performance. RESULTS: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) demonstrated equivalent results to the US Department of Agriculture-Food Safety and Inspection Service Microbiology Laboratory Guidebook 5C.00 for fresh raw beef trim and fresh raw ground beef, and to the US Food and Drug Administration Bacteriological Analytical Manual Chapter 4A for fresh spinach. The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) detected 50 of 50 E. coli strains with stx1 and/or stx2 genes, and the eae gene, and detected zero of 40 strains from the exclusivity panel. Robustness testing indicated that small variations in critical test parameters did not adversely affect the assay's performance. Product consistency and stability testing demonstrated no differences between the lots evaluated. CONCLUSION: The data collected demonstrates that the 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) is a reliable method for the rapid and specific detection of STEC in raw beef trim, raw ground beef, and spinach. HIGHLIGHTS: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) method is suitable for the rapid and specific detection of STECs in raw beef trim, raw ground beef, and spinach.

Validation of the 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx) for the Detection of Shiga Toxin Gene (stx1 and/or stx2) in Fresh Raw Ground Beef and Fresh Spinach: AOAC Performance Tested MethodSM 071903.

BACKGROUND: The 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx) method is based on gene amplification by the use of real time loop-mediated isothermal amplification when used with the 3M Molecular Detection System for the rapid and specific detection of Shiga toxin gene (stx1 and/or stx2) from Shiga toxin-producing Escherichia coli (STEC) in enriched foods. The stx assay does not differentiate between stx1 and stx2 but detects the presence of stx1 and/or stx2. OBJECTIVE: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) method was evaluated for AOAC®  Performance Tested MethodsSM certification. METHODS: Matrix studies, inclusivity/exclusivity, robustness testing, product stability, and lot-to-lot variability testing were conducted to assess the method's performance. RESULTS: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) demonstrated equivalent results to the United States Department of Agriculture/Food Safety and Inspection Service Microbiology Laboratory Guidebook Chapter 5C.00 reference method for fresh raw ground beef, and the U.S. Food and Drug Administration Bacteriological Analytical Manual Chapter 4A reference method for fresh spinach. The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) detected all STEC E. coli strains (E. coli strains with stx1 and/or stx2 genes) and did not detect any of the 45 strains from the exclusivity panel. Robustness testing indicated that small variations in critical test parameters did not adversely affect the assay's performance. Product consistency and stability testing demonstrated no differences between the lots evaluated. CONCLUSION: The data collected in these studies demonstrate that the 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) is a reliable method for the rapid and specific detection of Shiga toxin-producing E. coli in raw ground beef and spinach. HIGHLIGHTS: The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx) method is suitable for the rapid and specific detection of Shiga toxin-producing E. coli in fresh raw ground beef, and spinach.

High-Expenditure Disease in the EU-28: Does Drug Spend Correspond to Clinical and Economic Burden in Oncology, Autoimmune Disease and Diabetes?

BACKGROUND: Drug costs are increasing in Europe, and there is a heightened need to reduce pressure on healthcare systems. In 2017, oncology, autoimmune disease, and diabetes featured as the three highest therapy areas for drug spend in the EU-28. However, the absolute 1-year drug spend growth for diabetes did not feature within the ten fastest growing therapy areas. OBJECTIVE: This study explores the association between drug spend and disease burden in oncology, autoimmune disease, and diabetes in the EU-28. METHODS: Oncology, autoimmune disease and diabetes therapeutic areas were investigated using four methodologies. Historical and forecasted drug spend was analysed using the IQVIA MIDAS® drug sales database. Clinical and economic burden was estimated from targeted literature reviews. Trend analyses compared changes in drug spend with clinical burden using the Global Burden of Disease tool as the epidemiological reference. Cost per quality-adjusted life-years (QALYs) from UK health technology assessments were compared to interpret the health economic value. RESULTS: Oncology had the highest historical drug spend and growth compared with autoimmune disease and diabetes. Total drug spend and growth in oncology is forecasted to exceed diabetes by twofold. Increasing oncology drug spend historically did not correspond with reductions in mortality and morbidity. Diabetes had the lowest drug spend and greatest QALY/€1000 spent benefit. CONCLUSION: This study indicates that drug spend may not correlate to clinical burden across diseases. Future research could stimulate debate on whether more equitable drug funding may improve disease management.

Influence of social support on asthma self-management in adolescents.

OBJECTIVE: Adolescents with asthma are influenced by peers and family. The objective was to better understand family social support and test its association with medication adherence, asthma control, and Emergency Department (ED) use. METHODS: This study is a cross-sectional secondary data analysis from a randomized controlled trial with urban adolescents from three U.S. cities. Participants (12-20 years old) with asthma completed the Perceived Family Support Scale (PFS) and Horne's Medication Adherence Report Scale (MARS). Data from both tools were classified into 2 categories- high and low (< 25th percentile) perceived family support and high (total score >10) and low medication adherence, respectively. Chi-square statistic and logistic regression were used for analysis. RESULTS: Of the 371 participants, the majority were young (96% ≤ 17 years), African American or Bi-racial (85%), and Medicaid-insured (72%); over one-third had maternal family history of asthma. Among those on a controller medication (n = 270), only 37% reported its use ≥8 days over 2 weeks. Asthma control was poor with 50% categorized "not well controlled," 34% "very poorly controlled." Participants responded positively to most social support items. One item, providing and receiving social support to and from family members, was less often positively reported. Low medication adherence was significantly associated with lower perceived social support (p = 0.018). CONCLUSION: This study underscores the importance of family social support in understanding the extent of adolescents' self-management, particularly medication adherence.

The construct validity and responsiveness of the EQ-5D-5L, AQL-5D and a bespoke TTO in acute asthmatics.

PURPOSE: Measuring quality of life in acute asthmatics is challenging, especially when asthma attacks can occur sporadically. Several questionnaires can be used to measure quality of life in this patient group; however, psychometric testing is limited on questionnaires that can be used to estimate Quality Adjusted Life years. The objective of this study is to assess the construct validity (convergent and discriminative validity) and responsiveness of the EuroQol-5-Dimensions 5-Level (EQ-5D-5L), Asthma Quality of Life Utility Index-5 Dimensions (AQL-5D) and Time Trade-Off (TTO) in acute asthma patients. METHODS: Data from a prospective cohort study were used to test the validity and responsiveness of the EQ-5D-5L, AQL-5D and TTO in asthma patients who were recruited from UK accident & emergency departments or hospital wards. The spearman's rank correlation coefficient, the Kruskal-Wallis test statistic and the standardized response mean were used to test for convergent validity, discriminative validity and responsiveness, respectively. RESULTS: One hundred and twenty-one participants were included in the available case analysis. The EQ-5D-5L and AQL-5D showed moderate to strong correlations for convergent validity at baseline, week 4 and week 8. The AQL-5D and TTO showed moderate correlations at week 4 and week 8. No statistical significance was observed for discriminative validity at baseline. Both the EQ-5D-5L and the AQL-5D also showed that they were sensitive to change for the recovery responses. CONCLUSIONS: The EQ-5D-5L and AQL-5D showed stronger construct validity and responsiveness compared to the TTO. Therefore, both the EQ-5D-5L and AQL-5D should be considered for use in future economic evaluations.

Estimating loss in quality of life associated with asthma-related crisis events (ESQUARE): a cohort, observational study.

BACKGROUND: Evidence of quality of life implications of asthma attacks are limited, particularly when measured on a utility scale, which enables calculating Quality-Adjusted Life-Years (QALYs) and comparisons with other health conditions and services. Therefore, this study sought to estimate the utility loss associated with an asthma-related crisis event (accident and emergency (A&E) attendance or hospital admission). METHODS: Participants were recruited in a cohort study from A&E and hospital admissions at three UK hospitals. They completed the EuroQol-5 Dimensions 5-Level (EQ-5D-5 L), Asthma Quality of Life Questionnaire (AQLQ), Time trade-off (TTO), and peak flow and symptom diary over 8 weeks, where three different methods (EQ-5D-5 L, AQLQ, and TTO), were used to estimate utilities. The mean difference between two time points were estimated using the Wilcoxon signed rank test. RESULTS: From baseline to week 8, mean increases (95% CI) were estimated to be 0.086 (0.019-0.153), 0.154 (0.112-0.196) and 0.132 (0.063-0.201) for EQ-5D-5 L, AQL-5D (preference-based measure derived from AQLQ), and TTO respectively over 8 weeks (p < 0.01). CONCLUSION: Asthma crisis events are estimated to be associated with a mean utility loss of between 0.086 and 0.132. The utility decrement can be used to assign values to asthma-related crisis events, which can enhance economic evaluations. TRIAL REGISTRATION: NCT02771678 . Registered 13 May 2016.

Biomarkers in adult asthma: a systematic review of 8-isoprostane in exhaled breath condensate.

OBJECTIVES: We aimed to assess the evidence for the use of 8-isoprostane in exhaled breath condensate (EBC) as a biomarker in adult asthma. DESIGN: A systematic review and meta-analysis of EBC 8-isoprostane. METHODS: We searched a number of online databases (including PubMed, Embase and Scopus) in January 2016. We included studies of adult non-smokers with EBC collection and asthma diagnosis conducted according to recognised guidelines. We aimed to pool data using random effects meta-analysis and assess heterogeneity using I 2. RESULTS: We included twenty studies, the findings from which were inconsistent. Seven studies (n = 329) reported 8-isoprostane levels in asthma to be significantly higher than that of control groups, whilst six studies (n = 403) did not. Only four studies were appropriate for inclusion in a random effects meta-analysis of mean difference. This found a statistically significant between-groups difference of 22 pg ml-1. Confidence in the result is limited by the small number of studies and by substantial statistical heterogeneity (I 2 = 94). CONCLUSION: The clinical value of EBC 8-isoprostane as a quantitative assessment of oxidative stress in asthma remains unclear due to variability in results and methodological heterogeneity. It is essential to develop a robust and standardised methodology if the use of EBC 8-isoprostane in asthma is to be properly evaluated.