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A developmental validation was performed to demonstrate reliability, reproducibility and robustness of the ANDE System with the FlexPlex assay, including an integrated Expert System, across a number of laboratories and buccal sample variations. Previously, the related DNAscan™/ANDE 4C Rapid DNA System using the PowerPlex®16 assay and integrated Expert System Software received NDIS approval in March 2016. The enhanced ANDE instrument, referred to as ANDE 6C, and the accompanying 6-dye, 27-locus STR assay, referred to as FlexPlex, have been developed to be compatible with all widely used global loci, including the expanded set of the CODIS core 20 loci.Six forensic and research laboratories participated in the FlexPlex Rapid DNA developmental validation experiments, testing a total of 2045 swabs, including those obtained from 1387 unique individuals. The goal of this extensive and comprehensive validation was to thoroughly evaluate and document the ANDE System and its internal Expert System to reliably genotype reference buccal swab samples in a manner compliant with the FBI’s Quality Assurance Standards and the NDIS Operational Procedures.The ANDE System, including automated Expert System analysis, generated reproducible and concordant results for buccal swabs when testing various instruments at different laboratories by a number of different operators. When testing a number of non-human DNAs, including oral bacteria, the ANDE System and FlexPlex assay demonstrated limited cross-reactivity. Potential PCR inhibitors were evaluated as part of the validation and no inhibition was detected. Reproducible and concordant profiles were generated from buccal swab samples collected with a limit of detection appropriate for buccal swab collections from arrestees. The precision and resolution of the System met industry standards for detection of microvariants and single base resolution.The integrated Expert System appropriately demonstrated the ability to correctly pass or fail profiles for CODIS upload without human review. During this comprehensive developmental validation, the ANDE System successfully interpreted over 2000 samples tested with over 99.99% concordant alleles. The data package described herein led to the ANDE System with the FlexPlex assay receiving NDIS approval in June 2018. 相似文献
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《The Journal of arthroplasty》2020,35(8):2200-2203
BackgroundRecently, a revised definition of the minor criteria scoring system for diagnosing periprosthetic joint infection (PJI) was developed by the second International Consensus Meeting on musculoskeletal infection. The new system combines preoperative and intraoperative findings, reportedly achieving high sensitivity and specificity. We aimed to validate the modified scoring system at a high-volume center.MethodsWe retrospectively reviewed patients who underwent a revision total hip or knee arthroplasty at our institution from May 2015 to August 2018. Serum C-reactive protein, synovial white blood cell count and polymorphonuclear percentage, leukocyte esterase test, alpha-defensin, microbiological and histologic results, and documented existence of sinus tract and intraoperative purulence were available for all patients. Cases with at least 1 major criterion were considered as infected. Using the new minor criteria, a score of ≥6 reflects PJI, while a score <3 can be considered as noninfected. Sensitivity, specificity, mean accuracy (ACC), positive predictive value (PPV), and negative predictive value (NPV) were analyzed.ResultsA total of 345 cases were included. A cutoff score of ≥6 points had the following diagnostic performance: area under the curve (AUC) = 0.90; ACC = 0.88; sensitivity = 0.96; specificity = 0.84; PPV = 0.70; NPV = 0.98. Diagnostic performance was better for the hip (AUC = 0.92; ACC = 0.90; sensitivity = 0.96; specificity = 0.86; PPV = 0.81; NPV = 0.98) than the knee (AUC = 0.89; ACC = 0.85; sensitivity = 0.95; specificity = 0.83; PPV = 0.59; NPV = 0.98).ConclusionThe modified scoring system proposed by the 2018 International Consensus Meeting in diagnosing PJI showed high sensitivity and a good performance, especially as rule-out diagnostic criteria. The cutoff level seems to be different between the hip and knee. Further validation studies considering the acknowledged limitations are recommended. 相似文献
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《Revue neurologique》2022,178(8):817-825
Current screening batteries for assessing neuropsychological function are not specific for Amyotrophic Lateral Sclerosis (ALS) and are considered as limited tools due to the physical disabilities associated with ALS. The Edinburgh Cognitive and Behavioural ALS screen (ECAS) was developed to detect the specific cognitive and behavioral changes that may occur among ALS patients. This study presents the ECAS developed for Arabic-speaking ALS patients (ECAS-AR) for use by healthcare professionals. ECAS was translated and modified to refined variety of Arabic language. Eighty-five ALS patients were included. Normative data were collected from 200 healthy controls (among them 97 were matched). Subjects were administered the ECAS-AR and two conventional cognitive screening batteries, Frontal Assessment Battery (FAB) and Mini-Mental State Examination (MMSE). ECAS-AR discriminated well between healthy controls and ALS patients. Significant differences were noted in language, executive functions, memory, and visuospatial domains between the two groups. The most prevalent deficit occurred in language and executive functions in ALS-specific functions. Whereas memory was more readily impaired in the lower and middle education groups concerning ALS non-specific functions. Verbal fluency tended to be preserved. Positive correlations were found between ECAS-AR and the standard cognitive tests supporting its full validity. The ECAS-AR version proposed will provide rapid, efficient and sensitive tools for healthcare professional to determine the cognitive-behavioural profile in Arabic-speaking ALS patients. 相似文献
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Mary C. Gawlicki MBA Margaret C. Reilly MPH Ana Popielnicki BA Kate Reilly MA 《Value in health》2006,9(3):199-204
INTRODUCTION: There are no measures of health-related absenteeism and presenteeism validated for use in the large and increasing US Spanish-speaking population. Before using a Spanish translation of an available English-language questionnaire, the linguistic validity of the Spanish version must be established to ensure its conceptual equivalence to the original and its cultural appropriateness. OBJECTIVE: The objective of this study was to evaluate the linguistic validity of the US Spanish version of the Work Productivity and Activity Impairment questionnaire, General Health Version (WPAI:GH). METHODS: A US Spanish translation of the US English WPAI:GH was created through a reiterative process of creating harmonized forward and back translations by independent translators. Spanish-speaking and English-speaking subjects residing in the US self-administered the WPAI:GH in their primary language and were subsequently debriefed by a bilingual (Spanish-English) interviewer. RESULTS: US Spanish subjects (N = 31) and English subjects (N = 35), stratified equally by educational level, with and without a high school degree participated in the study. The WPAI-GH item comprehension rate was 98.6% for Spanish and 99.6% for English. Response revision rates during debriefing were 1.6% for Spanish and 0.5% for English. Responses to hypothetical scenarios indicated that both language versions adequately differentiate sick time taken for health and non-health reasons and between absenteeism and presenteeism. CONCLUSION: Linguistic validity of the US Spanish translation of the WPAI:GH was established among a diverse US Spanish-speaking population, including those with minimal education. 相似文献
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Loa Clausen Kristian Rokkedal Jan H. Rosenvinge 《European eating disorders review》2009,17(6):462-467
The Eating Disorder Inventory, Version 2 (EDI‐2) is a questionnaire used clinically and in research all over the world. EDI‐2 is cross‐culturally valid, yet normative values may depend on culture. Norms and reliability of the Danish version have to date been lacking, and will be presented in this article, comparing patients (N = 575) and controls (N = 881). Also, internal reliability of scales is tested for both groups. Differences between norms of the Danish and the North American version of EDI were small but significant for all scales except asceticism (eating disorder patients) and ineffectiveness, interpersonal distrust and maturity fears (normal controls). For both groups the internal consistency was >0.70 for all subscales except asceticism. Although differences across the eating disorder diagnostic groups were dubious, the EDI‐2 is useful to screen for eating problems in the general population as well as to rate progress and outcome among eating disorder patients. Copyright © 2009 John Wiley & Sons, Ltd and Eating Disorders Association. 相似文献
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HASIM BOYACI NILAY ETILER CAN DUMAN ILKNUR BASYIGIT AYSE PALA 《Pediatrics international》2006,48(4):382-389
BACKGROUND: Environmental tobacco smoke (ETS) in the home continues to be a major health risk for children around the world. Measuring ETS is a central feature of clinical and epidemiological studies, with children's exposure often assessed through parental estimates. The authors examined the relationship between parent-reported estimates of children's exposure to ETS and children's urinary cotinine levels and evaluated the ETS exposure and its effect on respiratory health in children. METHODS: A total of 188 school children were included in the study. Parents were asked to complete a questionnaire about their smoking habits, their children's respiratory morbidity status and housing conditions. Urinary cotinine levels were measured in children. RESULTS: According to the responses, 72.3% of the children came from households with smokers, and 34.6% had daily exposure to ETS. When urine cotinine levels of >10 ng/mL were used as the yardstick of exposure, 76% of the children were identified as ETS exposed. No relation was detected between the symptoms of respiratory tract diseases and ETS exposure. To determine the amount of ETS exposure, the contribution of parental reports was low. CONCLUSION: To evaluate the level of ETS exposure of children, the parents' reports were not reliable. The addition of a biological measure results in a more informative estimate of ETS exposure in children. 相似文献
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Summary Bayesian analysis is given of a random effects binary probit model that allows for heteroscedasticity. Real and simulated examples illustrate the approach and show that ignoring heteroscedasticity when it exists may lead to biased estimates and poor prediction. The computation is carried out by an efficient Markov chain Monte Carlo sampling scheme that generates the parameters in blocks. We use the Bayes factor, cross‐validation of the predictive density, the deviance information criterion and Receiver Operating Characteristic (ROC) curves for model comparison. 相似文献