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Clinical Chemistry 43: 608-614, 1997;
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(Clinical Chemistry. 1997;43:608-614.)
© 1997 American Association for Clinical Chemistry, Inc.

Articles

A pragmatic approach to estimating total analytical error of immunoassays

William A. Sadlera, Murray H. Smith1, Lynda M. Murray and John G. Turner

Department of Nuclear Medicine, Christchurch Hospital, Private Bag, Christchurch, New Zealand.
1 Department of Mathematics & Statistics, University of Canterbury, Christchurch, New Zealand.
a Author for correspondence. Fax 64 3 364 0869.

Several groups have recently commented on the need for more realistic information on analytical performance of laboratory tests. The term "total analytical error" is sometimes used in this context. However, differing opinions have been expressed on how best to obtain estimates of clinical assay error, as it would be perceived by clinicians. We suggest a pragmatic definition of total analytical error for immunoassays and describe our attempts to estimate it by simple designs in the internal quality-control process. We use results over 29 months from a total serum thyroxine RIA. The most important error sources were those related to calibration materials and operator effects, errors not usually captured by short-term or snapshot experiments.


Key Words: indexing terms: quality control • thyroxine RIA






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Copyright © 1997 by the American Association for Clinical Chemistry.