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Journal of Clinical Microbiology, February 2004, p. 881-883, Vol. 42, No. 2
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.2.881-883.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Development, Implementation, and Impact of Acceptability Criteria for Serologic Tests for Infectious Diseases

John A. Crump,1 Jennifer R. Corder,1 Nancy G. Henshaw,1 and L. Barth Reller1,2,3*

Clinical Microbiology Laboratory, Duke University Medical Center,1 Departments of Pathology ,2 Medicine, Duke University School of Medicine, Durham, North Carolina 277103

Received 29 August 2002/ Returned for modification 7 November 2002/ Accepted 13 November 2003

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.


* Corresponding author. Mailing address: Clinical Microbiology Laboratory, Box 3938, Duke University Medical Center, Durham, NC 27710. Phone: (919) 684-6474. Fax: (919) 684-8519. E-mail: relle001{at}mc.duke.edu.


Journal of Clinical Microbiology, February 2004, p. 881-883, Vol. 42, No. 2
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.2.881-883.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.




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