scope:

This report is intended for use by all constituent groups of NCCLS-clinical laboratory professionals, manufacturers, and governmental agencies-as a basis for arriving at a consensus for the need for different evaluation studies that are designed to meet different purposes.

NCCLS evaluation protocols are not intended to be so comprehensive as to provide the sole data on product testing and qualification on the part of manufacturers of in vitro diagnostic devices. There are many other studies that a manufacturer will perform during the research and development phases and during the manufacturing validation phase that are unique to the design of the test kit or test system and the manufacturing processes themselves. These special studies go beyond the scope of NCCLS evaluation protocols. However, it is appropriate that manufacturers use these recommendations as a means of generating performance data for the final product in a form to which the laboratory can relate.

Purpose

It is recognized that laboratories may have different needs and purposes for conducting evaluation studies; they may have different resources to apply to an evaluation study; and there may be different performance requirements.

This report creates a framework that relates the scope and design of an evaluation study to the purpose of the study. The framework also integrates this hierarchy of evaluation studies with the amount of performance information that may be known prior to the study. (This is discussed in greater detail in Section 2, Scope.)

Finally, this report incorporates the fundamentals of a defined path of workflow^{1- 3} for an evaluation study as described in Section 4. Please refer to the most recent edition of NCCLS document HS1-A Quality System Model for Health Care for additional information. All evaluation studies, regardless of purpose and scope have certain key elements or steps in common. Key issues that have been sources of confusion are discussed in more detail in the appropriate steps in the overall process for an evaluation study.