Head-to-head multicenter comparison of DNA probe and nucleic acid amplification tests for Chlamydia trachomatis infection in women performed with an improved reference standard

J Clin Microbiol. 2002 Oct;40(10):3757-63. doi: 10.1128/JCM.40.10.3757-3763.2002.


Few evaluations of tests for Chlamydia trachomatis have compared nucleic acid amplification tests (NAATs) with diagnostic tests other than those by culture. In a five-city study of 3,551 women, we compared the results of commercial ligase chain reaction (LCR) and PCR tests performed on cervical swabs and urine with the results of PACE 2 tests performed on cervical swabs, using independent reference standards that included both cervical swabs and urethral swab-urine specimens. Using cervical culture as a standard, the sensitivities of PACE 2, LCR, and PCR tests with cervical specimens were 78.1, 96.9, and 89.9%, respectively, and the specificities were 99.3, 97.5, and 98.2%, respectively. Using either cervical swab or urine LCR-positive tests as the standard decreased sensitivities to 60.8% for PACE 2 and to 75.8 and 74.9% for PCR with cervical swabs and urine, respectively. Specificities increased to 99.7% for PACE 2 and to 99.7 and 99.4% for PCR with cervical swabs and urine, respectively. Sensitivities with a cervical swab-urine PCR standard were 61.9% for PACE 2 and 85.5 and 80.8% for LCR with cervical swabs and urine, respectively. Specificities were 99.6% for PACE 2 and 99.0 and 98.9% for LCR with cervical swabs and urine, respectively. Cervical swab versus urine differences were significant only for PCR specificities (P = 0.034). Overall, LCR sensitivity exceeded that of PCR, and sensitivities obtained with cervical swabs exceeded those obtained with urine specimens by small amounts. These data have substantiated, using a large multicenter sample and a patient standard, that LCR and PCR tests performed on endocervical swabs and urine are superior to PACE 2 tests for screening C. trachomatis infections in women. In our study, NAATs improved the detection of infected women by 17 to 38% compared to PACE 2.

Publication types

  • Comparative Study
  • Evaluation Study
  • Multicenter Study
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Cervix Uteri / parasitology
  • Chlamydia Infections / diagnosis*
  • Chlamydia Infections / parasitology
  • Chlamydia trachomatis / genetics
  • Chlamydia trachomatis / isolation & purification*
  • DNA Probes
  • DNA, Protozoan / analysis
  • Diagnostic Techniques and Procedures*
  • Female
  • Gene Amplification
  • Humans
  • Ligase Chain Reaction / methods
  • Nucleic Acid Amplification Techniques / methods
  • Polymerase Chain Reaction / methods
  • Reference Standards
  • Sexually Transmitted Diseases / parasitology
  • Urine / parasitology


  • DNA Probes
  • DNA, Protozoan