Clinica chimica acta; international journal of clinical chemistry
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The Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) mandate universal requirements for all U.S. clinical laboratory-testing sites. The intent of CLIA'88 is to ensure quality testing through a combination of minimum quality practices that incorporate total quality management concepts. These regulations do not contain established, objective indicators or measures to assess quality. However, there is an implicit assumption that compliance with traditionally accepted good laboratory practices--following manufacturers' directions, routinely analysing quality control materials, applying quality assurance principles, employing and assessing competent testing personnel, and participating in external quality assessment or proficiency testing (PT)--will result in improved test quality. ⋯ The results from these subjective indicators are more difficult to interpret but also seem to show improved quality in US clinical laboratories eleven years post-CLIA'88.
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This study determines the analytical characteristics of the i-STAT cardiac troponin I assay (cTnI; i-STAT, Princeton, NJ), a 10-min POC assay, designed to be performed at the bedside. ⋯ The i-STAT cTnI assay is a sensitive and precise monitor of cTnI, poised for point-of-care/near bedside clinical utilization for triage, diagnostics and risk management of acute coronary syndrome patients.
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A consensus document developed by a joint committee of the European Society of Cardiology and the American College of Cardiology redefines myocardial infarction (MI) using an increase of troponin I or T as compared to a reference control population (i.e., troponin T (TnT) of 0.01 microg/l). A clinical problem arises when an arbitrary cut-off point is selected for determination of MI (i.e., TnT> or =0.1 microg/l), as minor elevations of troponin are associated with increased cardiovascular risk in selected patients with acute coronary syndromes. ⋯ Using an MI cut-off concentration for TnT from a "non-ACS reference" improves risk stratification, but fails to detect a positive TnT in 11.7% of subjects with an acute coronary syndrome.
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Neurological diseases are often associated with cerebrovascular dysfunction and changes in blood-brain barrier (BBB) function. This is important for two seemingly conflicting reasons. On the one hand, a leaky BBB may lead to brain disease by allowing extravasation of cells and molecules normally segregated in the periphery, while on the other hand an intact BBB may hamper drug delivery to the ailing brain. ⋯ Other markers of brain-to-blood barriers have been recently discovered by a proteomic approach. These proteins are virtually absent in normal blood, appear in serum from patients with cerebral lesions, and can be easily detected. We will present clinical and laboratory evidence supporting the use of these markers as modern neurodiagnostic tools.
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Review
Systematic reviews in laboratory medicine: principles, processes and practical considerations.
Systematic reviews and meta-analyses are generally accepted to represent the highest level of evidence, and are a cornerstone in practising evidence-based medicine. So far, these efforts have been largely confined to the evaluation of the efficacy and effectiveness of therapeutic and preventive interventions. Systematic reviews in laboratory medicine are scarce and many of them do not meet essential quality criteria [Clin. Chem. Lab. Med. 38 (2000) 577]. Most of these problems are related to the poor design and heterogeneity of primary research, and that there are no agreed methods or quality standards for making systematic reviews in laboratory medicine. ⋯ Systematic reviews of diagnostic interventions support clinical and policy decisions, the development of practice guidelines, clinical audit, technology assessment, economic evaluations, education and training, and identify gaps in our knowledge for future research. Systematic reviewing of laboratory data is expected to result in better, bigger and more reliable primary studies, which hopefully will support the diffusion of new diagnostic technologies with scientifically proven efficacy and effectiveness in the future.