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Journal of Clinical Microbiology, February 1998, p. 375-381, Vol. 36, No. 2
Division of AIDS,
Received 2 June 1997/Returned for modification 12 August
1997/Accepted 30 October 1997
When a new diagnostic test is potentially more sensitive than the
reference test used to classify persons as infected or uninfected, a
substantial number of specimens from infected persons may be reference-test negative but new-test positive. Discrepant analysis involves the performance of one or more additional tests with these
specimens, reclassification as infected those persons for whom the
new-test-positive results are confirmed, and recalculation of the
estimates of new-test sensitivity and specificity by using the revised
classification. This approach has been criticized because of the bias
introduced by the selective use of confirmation testing. Under
conditions appropriate for evaluating a nucleic acid amplification
(NAA) test for Chlamydia trachomatis infection with cell
culture as the reference test, we compared the bias in estimates based
on the discrepant-analysis classification of persons as infected or
uninfected with that in estimates based on the culture classification.
We concluded that the bias in estimates of NAA-test specificity based
on discrepant analysis is small and generally less than that in
estimates based on culture. However, the accuracy of
discrepant-analysis-based estimates of NAA-test sensitivity depends
critically on whether culture specificity is equal to or is slightly
less than 100%, and it is affected by competing biases that are not
fully taken into account by discrepant analysis.
0095-1137/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.
Evaluation of Bias in Diagnostic-Test Sensitivity
and Specificity Estimates Computed by Discrepant Analysis
*
Corresponding author. Mailing address: Centers for
Disease Control and Prevention, 1600 Clifton Road, N.E. (MS-A12),
Atlanta, GA 30333. Phone: (404) 639-4460. Fax: (404) 639-4664. E-mail: tag1{at}cdc.gov.
Journal of Clinical Microbiology, February 1998, p. 375-381, Vol. 36, No. 2
0095-1137/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.
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