Laboratory medicine tests

Solberg HE. Statistical treatment of reference values in laboratory medicine Testing the goodness-of-fit of an observed distribution to the Gaussian distribution. Scand J Clin Lab Invest 1986 46 (Suppl. 184) 125-32. 

Molecular research advances have created useful techniques that are complementary to routine testing within many sections of clinical laboratory medicine... 

Most of these requirements are explicit or implicit within ISO 43-l 1997-Develop-ment and operation of proficiency testing schemes and in the Standards for EQA Schemes in Laboratory Medicine, issued by CPA (UK) [3]. It is appropriate for participants to ensure that the schemes to which they belong, or are considering membership, comply with these basic requirements. 

The concept of measurement traceability provides probably the most important strategy to achieve standardisation in laboratory medicine aimed at comparable measurement results regardless of the method, the measurement procedure (test kit) and of the laboratory where the analyses are carried out. 

Bruns, D. E. Lo, Y. M. D. Wittwer, C. Molecular Testing in Laboratory Medicine Selections from Clinical Chemistry, 1998—2001, with Annotations and Updates. AACC Press Washington, DC, 2002. 

Can-Test Inc., Vancouver Lynn Johnston Laboratories Ltd, Montreal Mann Testing Inc., Toronto Metropolitan Police Forensic Science Laboratory, London Poisons Unit, Guy s Hospital, London Racecourse Security Services Laboratory, Newmarket The Laboratory of the Government Chemist, London The Medicines Testing Laboratory, PSGB, Edinburgh. 

Presented at the EURACHEM/EQUALM Workshop Proficiency Testing in Analytical Chemistry, Microbiology and Laboratory Medicine , 24-26 September 2000, Boras, Sweden... 

Marshall DA, O Brien BJ. Economic evaluation of diagnostic tests. In Price CP and Christenson RH, eds. Evidence-based laboratory medicine from principles to outcomes. Washington DC AACC Press, 2003 159-86. 

The boundaries between clinical chemistry and other areas of laboratory medicine are not always distinct. In many institutions, clinical chemists initiate and direct activities, such as laboratory informatics and POCT. In some areas of the world, the term clinical chemistry has long been used to include laboratory areas such as hemostasis, thrombosis testing, immunology testing, and parts of hematology that in the United States are not considered to be part of classical clinical chemistry. 

Clinical Chemistry, Laboratory Medicine, and Evidence-Based Laboratory Medicine In this chapter, we review the new influences on clinical chemistry and laboratory medicine from the fields of cfinical epidemiology and evidence-based medicine (EBM). Cfinical epidemiologists have developed study designs to quantify the diagnostic accuracy of the tests developed in laboratory medicine, and study methods to evaluate the effect and value of laboratory testing in healthcare. Practitioners of EBM focus on use of the best available evidence from such well-designed studies in the care of individual patients. EBM rephrases problems in the clinical care of patients as structured clinical questions, looks for the available evidence, evaluates the quality of cfinical studies, evaluates the clinical implications of the results, and provides tools to help clinicians optimally use those results in the care of individual patients. 

The identification of a clinical goal provides the foundation of the service provided by the healthcare professional. In the area of laboratory medicine, as described later in this chapter, the goal can be expressed in terms of answering a clinical question appropriate laboratory investigations help to answer the question." Knowledge of the characteristics of these investigations is needed to decide which test to use, when to use it, and how to interpret the results. 

The stream of new tests in laboratory medicine requires frequent decisions about whether or not to implement them. Economic evaluations can help in making these decisions. The finite resources for healthcare require use of an objective means of determining how resources are allocated and how the efficiency and effectiveness of service delivery can be improved. 

Figure 13-7 Level of evidence for recommendations in NACB guideline for testing in diabetes. (From Bruns DE, OosterhuisWP in Price CP, Christenson RH, eds Ev/dence-Bosed Laboratory Medicine from principles to outcomes. AACC Press, 2003.)...

It is hopefully clear from the foregoing discussion that the principles of evidence-based laboratory medicine can underpin the way in which laboratory medicine is practiced, from the discovery of a new diagnostic test through to its application in routine patient care. The principles provide the logic on which aU of the elements of practice are founded. The tools of evidence-based laboratory medicine provide the means of delivering the highest quality of service in meeting the needs of patients and the healthcare professionals who serve them. The application of evidence-based practice is far more complex in the case of laboratory medicine than in the major area in which such principles have previously been applied, namely the pharmaceutical intervention. 

Christenson RH, Duh S-H, Price CP. Identifying the question the laboratory s role in testing provisional assumptions aimed at improving patient outcomes. In Price CP and Christenson RH (editors). Evidence-Based Laboratory Medicine from principles to outcomes. AACC Press, Washington, 2003 21-37. 

Lumbreras-Lacarra B, Ramos-Rinc6n JM, Hernandez-Aguado I. Methodology in diagnostic laboratory test research in Clinical Chemistry and Clinical Chemistry and Laboratory Medicine. Clin Chem 2004 50 530-6. 

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