scope:

The number of specific immunochemical tests, and modifications thereof, is already large and is increasing rapidly. Therefore, this document addresses testing only in a general manner; examples are given as appropriate. It is anticipated that many current and future tests will have characteristics and problems not addressed in this document. The basic concepts of sensitivity and specificity, from both a laboratory and clinical standpoint, will remain important in regard to future tests.

This document addresses several issues to which particular attention should be paid, including the following:

• Determination of purity and structure of antigens used as immunogens or as detection molecules in assays;

• Antibody specificity and quantification (titer or other measurement);

• The use of enhancing and amplifying agents; Interfering substances;

• Sensitivity and specificity criteria for test kits and procedures for assessing sensitivity and specificity;

• Patient preparation and sample collection and handling;

• Laboratory and clinical evaluation of test results;

• Specifications for reference materials;

• Storage conditions for samples and reference materials;

• Performance criteria for ensuring comparability of results among methods and laboratories; and

• Recommendations for product labeling and product literature, including limitations of the procedure(s).