Development, implementation, and impact of acceptability criteria for serologic tests for infectious diseases.

Journal Article (Journal Article)

Serologic testing is essential for the diagnosis of some infectious diseases and yet is fraught with potential pitfalls. All parts of the diagnostic process must be optimized to ensure that serologic tests perform adequately. Recognizing that a lack of clinical data and correctly timed, paired sera frequently led to uninterpretable serology results at our laboratory, we developed and implemented simple acceptability criteria for serologic tests. We assessed the impact of these criteria by comparing submissions and results for the year before and the year after implementation of the criteria. The number of serologic tests performed declined by 25% after implementation of the acceptability criteria, despite an increase in requests for serologic tests. Inappropriate testing of acute-phase sera alone fell from 49 to 0% (P < 0.001) for the tests monitored. Appropriate submission of paired sera rose from 9 to 19% (P = 0.006). The proportion of results classified as interpretable rose from 52 to 100% (P < 0.001). We recommend that acceptability criteria be developed and applied to samples submitted to clinical microbiology laboratories for serologic testing.

Full Text

Duke Authors

Cited Authors

  • Crump, JA; Corder, JR; Henshaw, NG; Reller, LB

Published Date

  • February 2004

Published In

Volume / Issue

  • 42 / 2

Start / End Page

  • 881 - 883

PubMed ID

  • 14766879

Pubmed Central ID

  • PMC344489

International Standard Serial Number (ISSN)

  • 0095-1137

Digital Object Identifier (DOI)

  • 10.1128/JCM.42.2.881-883.2004


  • eng

Conference Location

  • United States