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Optical techniques

Abstract Background Measurement of radiant energy (light) is used throughout the clinical laboratory to measure analytes, including proteins, metals, enzymes, antigens, and antibodies. Content This chapter describes the range of optical techniques used in clinical laboratory analysis. The techniques and instrumentation used for these measurements range from simple visualization by the naked eye to complex analysis with semiconductor-based lasers matched to solid-state, charge-coupled detectors (CCDs). With…

Principles of basic techniques and laboratory safety

Abstract Background To appropriately interpret clinical laboratory test results and adequately validate assays, the basic principles and techniques of analytical chemistry need to be understood. These techniques should be used by laboratory professionals in a safe testing environment. Content Factors that affect the analytical process and operation of the clinical laboratory are described in this chapter. The concepts of solute and solution, and the international system…

Laboratory stewardship and test utilization

Abstract Laboratory tests substantially impact clinical care, but their overuse, misuse, or underuse can cause patient harm and dissatisfaction, suboptimal patient care, and increased costs. Traditionally, the first consideration of pathology and laboratory medicine has been centered on optimizing the analytic phase of testing, which, of course, is critical for producing reliable and meaningful test results. Subsequently, it has become clear that specimen acquisition, transport and…

Machine learning and big data in laboratory medicine

Abstract Background The large number of test results generated by clinical laboratories has led to challenges in data management and analytics. Because of the potential diagnostic value of examining these results in aggregate, it is important to utilize emerging tools for the analysis of high-dimensional data. Machine learning uses a variety of computational algorithms to analyze complex datasets and make robust predictions. Content This chapter discusses…

Laboratory support of pharmaceutical, in vitro diagnostics, and epidemiologic studies

Abstract Background Biomarkers are used in the clinical laboratory for routine patient care, and in the pharmaceutical industry during drug development, and in establishing safety and efficacy of a candidate drug. Biomarkers are also used in clinical and epidemiologic research to gain a better insight into pathophysiology, to identify predictors of disease, and to refine treatment strategies. The in vitro diagnostic (IVD) industry develops most of…

Biobanking

Abstract Background Biobanks may be established for nonresearch purposes, such as diagnostic, therapeutic, treatment, forensic, transplantation, and transfusion, or for research purposes as part of epidemiologic studies and clinical trials. Biobank planning is essential for biospecimen integrity in support of such research, but also for the establishment, governance, management, operation, access, use, sustainability, and discontinuation of biobanks. Content We focus on best practices procedures for collection,…

Evidence-based laboratory medicine

Abstract Background Evidence-based laboratory medicine (EBLM) is an approach to medical practice that integrates the best available research evidence about laboratory investigations with the clinical expertise of clinicians, to improve the health and health care outcomes of individual patients. Practicing EBLM enables laboratory professionals to translate test results to clinically relevant information that helps clinicians in delivering effective and cost-effective patient care. Content This chapter provides…

Establishment and use of reference intervals

Abstract Background One of the most important elements of a laboratory test result is the reference interval, a set of values against which physicians compare their patients’ test results, facilitating interpretation. It is extremely important, therefore that the laboratory community devotes sufficient resources to ensure the reference limits they provide are well-founded. Most frequently, these reference limits represent values for healthy, adult patients, but other sets…

Biological variation and analytical performance specifications

Abstract Background There are many sources of variation in numerical results generated by examinations performed in laboratory medicine. Some measurands have biological variations over the span of life and others have predictable cyclical or seasonal variations. Most measurands in an individual display random variation around homeostatic set points and this is termed within-subject biological variation. The homeostatic set points vary between individuals and the variation between…

Standardization and harmonization of analytical examination results

Abstract Background The purpose of a clinical laboratory test is to provide information on the pathophysiologic condition of an individual patient to assist with diagnosis, to guide or monitor therapy, or to assess risk for a disease. Results for the same measurand must be equivalent when measured using different measurement procedures (MPs) to avoid medical errors when using clinical decision values to interpret those results. Standardization…

Quality control of the analytical examination process

Abstract Quality control (QC), also called internal QC, monitors a measurement procedure to verify that results for patient samples meet performance specifications appropriate for patient care or that an error condition exists that must be corrected. QC samples are measured at intervals along with patient samples. Recovery of the expected target values for the QC samples allows the laboratory to verify that a measurement procedure is…

Preanalytical variation and pre-examination processes

Abstract Background The preanalytical phase has long been recognized as a source of substantial variability in laboratory medicine. Laboratory errors, mostly due to some defect in the preanalytical phase, may lead to diagnostic errors. Understanding preanalytical variation and reducing errors in the pre-examination phase of the testing process are therefore important for improved safety and quality of laboratory services delivered to patients. Content There are numerous…

Specimen collection and processing

Abstract Background Proper specimen collection and processing are critical to avoiding common preanalytical errors and ensuring accurate test results. Specific steps, recommendations, and procedures are designed to protect both the patient and the individual collecting the specimen. Content This chapter addresses in detail the issues related to specimen collection. The most common types of specimens collected are discussed with the collection method(s) outlined, and some caveats…

Governance, risk, and quality management in the medical laboratory

Abstract The aspirational goal of diagnostic pathology laboratories is to always provide the right result for the right test on the right patient at the right time and with the right support. To deliver this outcome systematically, reliably, and safely for the patient, has required the long-term development of an organizational culture and framework by the international laboratory medicine community. Background Quality management (QM) is a…

Statistical methodologies in laboratory medicine: Analytical and Clinical Evaluation of Laboratory Tests

Abstract Background The careful selection and evaluation of laboratory tests are key steps in the process of implementing new measurement procedures in the laboratory for clinical use. Method evaluation in the clinical laboratory is complex and in most countries is a regulated process guided by various professional recommendations and quality standards on best laboratory practice. Content This chapter deals with the statistical aspects of both analytical…

Laboratory medicine

Abstract Background Laboratory medicine is a complex field that measures biomarkers and microorganisms in bodily specimens or tissues to diagnose and manage diseases. It encompasses multiple disciplines including clinical chemistry, hematology and coagulation, clinical microbiology, clinical immunology, molecular diagnostics, and transfusion medicine. Laboratory medicine is driven by technology that helps define the boundaries among its disciplines. Although laboratory medicine specialists are diverse in terms of their…

Electron Microscopy and Other Techniques

Introduction This chapter will focus primarily on the role of transmission electron microscopy (TEM) in the assessment of liver ultrastructure and disease. It also describes, in brief, the principles and uses of other methodologies. The special conditions required for tissue processing in each of these techniques ( Table 17.1 ) should be carefully planned for in advance of obtaining specimens. Use of newer ‘molecular fixatives’ (in…

The Liver in Organ Transplantation

Introduction The pathologist is often asked to examine liver biopsies obtained to evaluate liver dysfunction in transplant patients, including recipients of liver, renal and bone marrow grafts. For liver transplantation, liver biopsy remains the diagnostic ‘gold standard’ when jaundice and allograft dysfunction develop, because biochemical tests do not adequately discriminate between rejection and other conditions that may develop in the allograft. Moreover, even when serum liver…

The Liver in Systemic Disease and Pregnancy

Introduction Liver biopsies are often obtained to evaluate abnormalities of liver function tests in patients with known or suspected systemic disease and in the investigation of pyrexia of unknown origin. In the latter, liver biopsy provides diagnostic information in approximately 15%–30% of cases. The hepatic changes associated with systemic diseases vary from obvious granulomas or steatosis (discussed in Ch. 7 ) to more subtle findings, such…