Abstract
The clinical hemostasis laboratory is a complex testing arena which employs numerous
coagulation assays and spans several different test methodologies. Adding further
complexity, these test results are expressed in a wide variety of unique units (concentration,
activity, time, percentage, and ratio). Unfortunately, many of these reference values
are derived from a local plasma pool or manufacturer's standards, as there are few
established international standards. These three main issues complicate the validation
and performance of the coagulation testing. Before an assay can be introduced into
clinical use, both analytical and clinical performance parameters must be validated
or verified using the standard validation procedures of the laboratory. This article
summarizes the initial evaluation and validation processes of the coagulation laboratory,
which sometimes can be difficult concepts to implement. A standardized validation
protocol is described in this article and, if used, will help to objectively evaluate
the assay performance and determine if it meets acceptable laboratory criteria.
Keywords
hemostasis assay - coagulation assay - test validation - specificity - sensitivity
- accuracy - precision
