Laboratory medicine method evaluation

Marcovina SM, Albers JJ, Scanu AM, Kennedy H, GiacuUi F, Berg K, et al. Use of a reference material proposed by the International Federation of Clinical Chemistry and Laboratory Medicine to evaluate analytical methods for the determination of plasma lipoprotein (a). Clin Chem 2000 46 1956-67. 

In clinical laboratory medicine, this procedure has been applied to the evaluation of human myeloma proteins. However, the method is being replaced by immunofixation (IF) electrophoresis, particularly for the study of protein antigens and their spHt products, and for evaluation of human myeloma proteins (see later discussion of IF electrophoresis). 

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. 

Eraser CG, Peterson PH, Ricos C, Haeckel R. Quality specifications, Jn Evaluation Methods in Laboratory Medicine, R. Haeckel, Ed. Hew York, VCH Publishers, 1993, pp. 87-99. 

It is clear that Plot had travelled all over the county (as he had in Staffordshire and elsewhere in England) examining its marls, earths, minerals and waters, and he mentions many local scientifically minded worthies, such as Dr Lane of Banbury and his brother Mr Lane of Deddington, both physicians, who were experts on the properties of their local environments. And inevitably, Plot must have lectured on these subjects in the Museum, and no doubt boiled, sniffed, and tasted a wide variety of specimens brought into his laboratory. One method by which a skilled experimenter or doctor often evaluated the chemical content of a mineral or medicinal spring was to have a quantity poured over a red-hot shovel or piece of iron, and to carefully sniff the resulting steam, for in an age when few reliable chemical tests existed the operator s sense of smell and taste buds were frequently crucial. 

Mannhalter C, Koizar D, and Mitterbauer G (2000) Evaluation of RNA isolation methods and reference genes for RT-PCR analyses of rare target RNA. Clinical Chemistry and Laboratory Medicine 38 171-177. 

The US Food and Drug Administration (FDA) evaluates methods to be used in government regulatory laboratories for the determination and confirmation of drug residues in food derived from animal products. The FDA Center for Veterinary Medicine (CVM) oversees the validation (i.e., demonstration that the method is suitable for use) via a protocol known as a method trial. CVM ensures that the appropriate government laboratories have the tools needed to monitor the Nation s food supply. 

Assistant Professor of Biomedical Informatics, Director, Discovery Systems Laboratory Department of Biomedical Informatics Vanderbilt University School of Medicine Nashville, Tennessee Clinical Evaluation of Methods... 

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