Troponin-T: improved diagnostic assessment of myocardial damage in childhood

Troponin-T (cTnT) as a marker of myocardial damage is well established in adults, but not yet in children. cTnT was measured in 85 children (aged 1 day-204 months, mean 46 months). Twenty-five children were non-surgical patients, with possible myocardial damage suspected on clinical grounds. The other 60 patients had cardiac surgery leading to a defined myocardial damage. In these children, troponin-T (cTnT), creatine kinase activity (CK), creatine kinase-MB activity (CK-MB), and creatine kinase-MB-Mass (CK-MB-Mass) were measured preoperatively and 3-4 times during the first 55 postoperative h. Except in four children with probable preoperative myocardial damage, all troponin-T values were in the normal range (< 0.1 microg/l). All children with intracardiac surgery showed a postoperative increase in troponin-T. Children with extracardiac surgery of the great vessels showed no postoperative increase of troponin-T. For the assessment of myocardial damage, troponin-T was more specific and more sensitive than the other markers tested, troponin-T might significantly improve the diagnostic assessment of myocardial damage in children.     

Comparison of clinical diagnostic tests in hydrogel extended wear

In order to formulate a biosocial conception of tobacco dependence essential for fundamental grounding of smoking prevention, the authors examined 1106 subjects with smoking habits, smoking dependence and nonsmokers. A combination of internal and external factors is determined underlying the onset and maintenance of tobacco dependence. Risk factors responsible for consolidation of tobacco addiction are listed.     

Whole blood cytokine assays--a new generation of diagnostic tests for tuberculosis?

We describe a patient with Sj?gren's syndrome who died from undiagnosed adrenocortical failure. A positive test for adrenocortical antibody, performed pre-terminally, suggested the underlying diagnosis, which was subsequently confirmed at post-mortem. This case highlights the rare association of Sj?gren's syndrome with occult adrenocortical failure. Perhaps a greater awareness of this association and more frequent serological screening are necessary to prevent a fatal outcome.     

Statistical applications for in vitro diagnostic tests and other medical device clinical trials

Some statistical methods applied to in vitro diagnostic tests for the three primary indications (screening, diagnosis, and monitoring) are discussed. Various examples with practical statistical applications are presented, including test for k by k ordered categorical matched-pair data for screening of cervical cancer, receiver operating characteristic (ROC) curve for diagnosis or screening, and the Cox time-to-event model to estimate relative risk of first cancer progression by monitoring carcinoembryonic (CEA) levels for stage IV breast cancer patients.     

Methods of investigation in clinical cardiology. X. Studies on the evaluation of diagnostic tests in cardiology

Diagnosis is a complex cognitive process which is characterised by uncertainty. This uncertainty can be managed through specific knowledge in conjunction with probability theory. Studies evaluating diagnostic tests are the best way of building this knowledge. Studies evaluating diagnostic tests have two essential components: the gold standard and the new test. Both components, gold standard and test, are independent measurement process that can be influenced by diverse sources of variability. The comparison between diagnostic and test is essentially a hierarchical procedure. Diagnostic tests are evaluated by their sensitivity, specificity compared to a definitive gold standard. The predictive values and the likelihood ratio test are also used. Sensitivity (the proportion of true positives) and specificity (the proportion of true negatives) are values obtained from a sample and thereby can be considered as the conditional agreement between gold standard and the new test. Kappa coefficients for sensitivity and specificity are useful tools for adjusting both indices. Sensitivity and specificity are non-poblational values, they are estimates of the true values of the study population and can be affected by random error and systematic errors (bias). Confidence intervals are useful for giving an indication of the precision of the point estimates of sensitivity and specificity. A suitable sound design is required to avoiding a biased estimate of sensitivity, likelihood ratio, and predictive values. Finally a list of potential biases is given with methods for minimising these.     

Beyond the twelve-lead electrocardiogram: diagnostic tests in the evaluation for suspected acute myocardial infarction in the emergency department, part I

On a daily basis the emergency physician is faced with the difficult task of determining whether or not a patient with acute chest pain is sustaining an acute myocardial infarction. In most cases, this is not a straightforward decision. Although observation units are being used more often for chest pain evaluations, many emergency physicians currently admit such patients to an intensive care setting. Because fewer than one-third of emergency department chest pain patients actually suffer an acute myocardial infarction, expensive resources are, in retrospect, used unnecessarily. Conversely, patients who are infarcting, and are inadvertently discharged home from the emergency department, have a worse prognosis than those admitted. This two-part series reviews the newer modalities available that may help the emergency physician arrive at a more accurate diagnosis. The current article, Part I, examines the use of myocardial imaging, computer assisted diagnostic protocols, and newer uses of the electrocardiogram. Part II reviews the use of biochemical assays of cardiac proteins and the Chest Pain Observation Unit.     

Analytical and clinical evaluation of an electrochemiluminescence immunoassay for the determination of CA 125

The CA 125 II assay on the Elecsys(R) 2010 analyzer was evaluated in an international multicenter trial. Imprecision studies yielded within-run CVs of 0.8-3.3% and between-day CVs of 2.4-10.9%; CVs for total imprecision in the manufacturer's laboratory were 2.4-7.8%. The linear range of the assay extended to at least 4500 kilounits/L (three decades). Interference from triglycerides (10.3 mmol/L), bilirubin (850 micromol/L), hemoglobin (1.1 mmol/L), anticoagulants (plasma), and several widely used drugs was undetectable. Method comparisons with five other CA 125 II assays showed good correlation but differences in standardization. A 95th percentile cutoff value of 35 kilounits/L was calculated from values measured in 593 apparently healthy (pre- and postmenopausal) women. In 95% of patients with benign gynecological diseases CA 125 was 190 kilounits/L. A comparison of CA 125 values obtained with the Elecsys test and with other common CA 125 tests in monitored patients being treated for ovarian cancer showed identical patterns. In conclusion, the Elecsys CA 125 II assay is linear over a broad range, yields precise and accurate results, is free from interferences, and compares well with other assays.     

Limited clinical diagnostic specificity of technetium-99m stannous pyrophosphate myocardial imaging in acute myocardial infarction

To test the sensitivity and specificity of technetium-99m stannous pyrophosphate myocardial imaging in the diagnosis of acute myocardial infarction, myocardial scintigrams were performed in 115 patients. Positive scintigrams were found in all 48 patients with acute myocardial infarction; uptake was localized in 29 patients with transmural infarction and diffuse in 2 patients with transmural infarction and in the remaining 17 patients with subendocardial myocardial infarction. Positive scintigrams were also found in 31 of 67 patients without clinical evidence of acute myocardial infarction. Diffusely positive scintigrams were found in 3 of 3 patients with unstable angina pectoris, 7 of 30 patients with stable angina pectoris, 4 of 13 patients who had undergone aortocoronary bypass surgery, 4 of 4 patients with congestive cardiomyopathy and 1 patient studied 1 day after direct current cardioversion. Localized uptake of 99mTc-pyrophosphate was found in 9 of 10 patients with left ventricular aneurysm and in 3 of 13 patients after aortocoronary bypass surgery. All four patients with atypical chest pain and two patients with pericarditis had normal scintigrams. Our data confirm the previously reported sensitivity of 99mTc-pyrophosphate imaging in detection of acute myocardial infarction but indicate that positive scintigrams are not specific for this entity.     

Techniques to improve physicians' use of diagnostic tests: a new conceptual framework

OBJECTIVES: To review the published literature on interventions aimed at improving physicians' testing practices and propose methodologic standards for these studies and to review selected studies using the PRECEDE framework, a behavioral model that helps categorize interventions based on which behavioral factors are being affected. DATA SOURCES: MEDLINE, EMBASE, and HEALTHStar databases were searched for the years 1966 to January 1, 1998, for English-language articles pertaining to diagnostic testing behavior; bibliographies were scanned to identify articles of potential interest; and researchers in health services, health behavior, and behavior modification were contacted for proprietary and other unpublished articles. STUDY SELECTION: A total of 102 articles were identified that described the results of interventions aimed at changing physicians' testing practices. We included the 49 studies that compared diagnostic testing practices in intervention and control groups. DATA EXTRACTION: Two investigators independently reviewed each article in a blinded fashion using a standard data collection form to obtain a methodologic score and to abstract the key elements of each intervention. DATA SYNTHESIS: On a 38-point methodologic criteria scale, the mean +/- SD score was 13+/-4.4. The desired behavior change was reported in the intervention group in 37 (76%) of 49 studies. Twenty-four (86%) of 28 interventions targeted at many behavioral factors were successful, while 13 (62%) of 21 studies aimed at a single behavioral factor were successful (P=.12). CONCLUSIONS: A majority of interventions to improve physicians' testing practices reported in the literature claimed success, with interventions based on multiple behavioral factors trending toward being more successful. While methodologic flaws hamper drawing strong conclusions from this literature, application of a behavioral framework appears to be useful in explaining interventions that are successful and can facilitate interpretation of intervention results.     

Meta-analysis of screening and diagnostic tests.

Screening and diagnostic tests are common in the fields of psychology, medicine, and education. Often there are several competing tests, and decisions must be made about the relative accuracy of those tests. This article describes a general measure that can be used for both continuous and dichotomous outcome measures. It is the standardized distance between the means of the 2 populations. For continuous measures, it is the effect size measure. For dichotomous measures, it is proportional to the logarithm of the odds of the sensitivity plus the logarithm of the odds of the specificity. The measure is easily computed for both kinds of outcomes. Properties of this measure are discussed, and examples are given. The use of this measure to compare the average performance of different tests is described. (PsycINFO Database Record (c) 2011 APA, all rights reserved)     

Quantitative information of specific diagnostic tests

BACKGROUND: The 1997 A.S.P.E.N. Research Workshop was held at the annual meeting in San Francisco, on January 26, 1997. The workshop focused on advances in clinical and basic research involving the interface between nutrient and luminal gastroenterology. METHODS: Presentations on the genetic regulation of gastrointestinal development, the molecular biology of small intestinal adaptation, the effect of nutrition support on intestinal mucosal mass, the relationship between nutrition and gastrointestinal motility, nutrient absorption, and gastrointestinal tract substrate metabolism were made by the preeminent leaders in the field. RESULTS: The investigators presented an insightful analysis of each topic by reviewing data from their own laboratories and the published literature. CONCLUSIONS: This workshop underscored the important interactions between nutrition and luminal gastroenterology at the basic science, metabolic/physiologic, and clinical levels. The integration of presentations from the different disciplines provided a unique interaction of information and ideas to advance our understanding of nutrition and gastrointestinal tract.     

Analytical and clinical performance characteristics of Tandem-MP Ostase, a new immunoassay for serum bone alkaline phosphatase

The performance characteristics of the Tandem-MP Ostase assay, a new microplate immunoassay for bone-specific alkaline phosphatase (bone ALP; EC 3.1.3.1) in human sera, are described. Bone ALP is bound to streptavidin-coated microwells by a single biotinylated anti-bone ALP monoclonal antibody. Antigen is detected by the addition of p-nitrophenyl phosphate. The assay is performed at room temperature in <90 min. Imprecision was 2.3-6.1% with a detection limit of 0.6 microg/L. Method comparison of bone ALP measurements with the Tandem-MP Ostase assay and the mass-based Tandem-R Ostase assay (n = 285) indicated regression statistics of Tandem-MP Ostase = 1.03 Tandem-R Ostase + 0.22 microg/L, S(y/x) = 4.0 microg/L, r = 0.97. Serum bone ALP values in apparently healthy men and in pre- and postmenopausal women were also similar between the two Ostase assay formats. Liver ALP reactivity determined using the slope and heat inactivation methods was similar in both Ostase assays. Liver ALP reactivity ranged from 3 microg/L (heat inactivation) to 6 microg/L (slope method) per 100 U/L of liver ALP activity, whereas bone ALP reactivity was 37 microg/L per 100 U/L of bone ALP activity, indicating a liver ALP relative reactivity of 8.1-16.2%. Similar results were obtained with the Alkphase-B bone ALP immunoassay. The Tandem-MP Ostase bone ALP assay demonstrated increased concentrations of serum bone ALP in conditions where bone metabolism is increased and showed a rapid, temporal decrease in serum bone ALP in Paget disease patients on bisphosphonate therapy. In conclusion, the Tandem-MP Ostase assay for serum bone ALP is a rapid, simple, robust nonisotopic alternative to the Tandem-R Ostase immunoradiometric assay that provides an accurate and sensitive assessment of bone turnover.     

Reliability of diagnostic tests for contact allergy to mydriatic eyedrops

AIM: To perform a clinical trial of selegiline in 25 patients with chronic fatigue syndrome (CFS) where patients were told they would receive placebo or active agent at different times during the 6-week trial. We chose selegiline, a specific monoamine oxidase (MAO) B receptor inhibitor, because a prior trial of lowdose phenelzine, a nonspecific MAO inhibitor, showed a small but significant therapeutic effect. METHODS: Questionnaires comprised of 19 tests of mood, fatigue, functional status and symptom severity were collected at the start and end of the trial as well as 2 weeks after its start. The trial was done in three 2-week blocks: in the first, 2 placebo pills were given per day; in the next, one 5-mg tablet of agent and one placebo were given per day, and in the last, a 5-mg tablet of agent was given twice a day. The plan was to compare the changes in the 19 tests during the placebo phase to those found in the active treatment phase in 19 patients completing the trial. FINDINGS: Significant improvement in 3 variables-tension/anxiety, vigor and sexual relations-was found. A significant pattern of improvement compared to worsening was found for the 19 self-report vehicles during active treatment as compared with placebo treatment. Evidence for an antidepressant effect of the drug was not found. CONCLUSIONS: Selegiline has a small but significant therapeutic effect in CFS which appears independent of an antidepressant effect.     

Screening tests for new teat dips

Increased use of after-milking teat dips has resulted in the appearance of many new teat dips and a need for methods of evaluation of efficacy. A method was developed for determining the ability of a disinfectant to kill bacteria on the teat ends. Results from several known efficacious products indicated an approximate 95% reduction in bacterial flora. Additional data are presented on some experimental products. This method will provide a measure of effectiveness of a producton teat-skin disinfection. The effect of some changes in the testing procedure on bacterial reduction is demonstrated: 1) Increased times between inoculation and dipping and between dipping and swabbing tended to decrease recoveries on control teats. 2) Saline dips on controls teats provided increased recoveries of test organisms.     

Analytical electron microscopy studies of radiation damage

Analytical electron microscopy (AEM) has provided structural, crystallographic, and compositional characterization to aid in the understanding of radiation damage processes, especially in multiphase materials. The range of AEM techniques is based on the use of as many of the signals produced by the interaction of an electron beam with a specimen as possible. This paper briefly discusses the origins, capabilities, and current developments of AEM, including the spatial resolution of the various techniques. Several important applications of AEM in radiation damage studies, including radiation-induced segregation and phase instability in austenitic stainless steels, will be reviewed. From the comparison of phase equilibria under irradiation to that under thermal aging, principles for alloy development in non-nuclear applications will be discussed. This paper is based on a presentation made in the symposium “Irradiation-Enhanced Materials Science and Engineering” presented as part of the ASM INTERNATIONAL 75th Anniversary celebration at the 1988 World Materials Congress in Chicago, IL, September 25-29, 1988, under the auspices of the Nuclear Materials Committee of TMS-AIME and ASM-MSD.