scope:

This document is written for laboratory and nonlaboratory personnel responsible for the collection, transport, and analysis of urine specimens. The guideline addresses macroscopic evaluation, chemical analysis, and microscopic examination of urine. A systematic outline for collecting, transporting, and storing specimens is included. The necessary materials and equipment used in the process are considered.

The focus of this guideline relates to urine collection and performance of the traditional, routine chemical and microscopic urinalysis. Unlike the previous edition, 24-hour urine collections are excluded, as are reference laboratory preanalytic requirements for specialized tests and detailed discussion of specific urine particle analyzer technologies.

Algorithmic approaches to evaluation of urine samples with respect to potential screening by reagent strip, with subsequent performance (or nonperformance) of culture, is beyond the scope of this guideline. See CLSI document EP12¹ for information on test comparisons for sensitivity, specificity, and predictive values in a clinical context.