Clinica chimica acta; international journal of clinical chemistry
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Creatine kinase MB (CK-MB), and cardiac troponin I (cTnI) are important biomarkers for the diagnosis and rule-out of acute myocardial infarction (AMI) of patients who presented to the emergency department (ED) with chest pain. With new rapid ED assessment protocols, there is increasing pressure to produce results with a short turnaround time (TAT), and point-of-care (POC) testing is one alternative for providing fast results. ⋯ The RAMP cardiac marker assays are alternatives to other FDA-cleared central laboratory and POC testing devices.
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[corrected] Data on within- and between-subject biological variation are available for around 250 analytes commonly used in medical laboratories. ⋯ The biological variation is a pillar for managing quality in laboratory medicine.
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Quality specifications, the level of performance required to facilitate clinical decision-making, not only have a central role in quality management in the laboratory but are also essential for assuring the interpretation and utilization of laboratory data by physicians. Consensus has been reached on the hierarchy of criteria for quality specifications. However, the information on quality specifications that should be communicated to clinicians, and the way in which this information should be given, is still widely debated. ⋯ A proposal has been made to improve the way laboratory results are communicated to clinicians, with practical information derived from quality specifications. By providing clinicians with information on quality characteristics and the degree of uncertainty, a more objective interpretation of laboratory data may be possible, and data may be more appropriately utilized for diagnosis and monitoring.
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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.