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Evaluation of nucleic acid amplification tests as reference tests
for Chlamydia trachomatis infections in asymptomatic men.
Journal of Clinical Microbiology 2000;38(12):4382-4386.
Johnson RE, Green TA, Schachter J, Jones RB, Hook III, EW, Black CM, Martin
DH, St. Louis ME, Stamm WE.
Abstract
Urine ligase chain reaction (LCR) and PCR tests and urethral swab culture were
compared for their abilities to detect Chlamydia trachomatis infection in
3,639 asymptomatic men by using one-, two-, and three-test reference standards.
Frozen urine at four of five participating centers was also tested by a transcription-mediated
amplification assay which was used as a reference test. LCR increased the
yield of positive results by 27% and PCR increased the yield of positive
results by 26% over the yield of positive results by culture (n = 295). LCR
and PCR sensitivities were similar, ranging from 80.4 to 93.5%, depending
on the reference standard. Culture sensitivity was substantially less. A
multiple-test standard yielded LCR, PCR, and culture specificities of 99.6%,
with or without discrepant analysis. Test performance varied among centers
partly due to different interpretations of the testing protocols. The study
confirms that urine LCR and PCR for the detection of C. trachomatis have
substantially improved sensitivities over that of urethral swab culture for
testing of asymptomatic men, enabling screening of this important target
group. These tests, perhaps in combination, are also candidate reference
tests for the conduct of test evaluation studies.