title: Use of self-collected vaginal specimens for detection of Chlamydia trachomatis infection.
abstract: OBJECTIVE
  To evaluate the efficacy of a self-collected vaginal introital specimen, obtained by women using only an instruction booklet as a guide, for the detection of Chlamydia trachomatis using polymerase chain reaction (PCR).
  
  
  METHODS
  Comparison analysis in an Urban hospital clinic, using a convenience sample of 101 women undergoing screening or treatment for C trachomatis infection. Subjects were given an illustrated instruction booklet and were asked to collect a single specimen from the vaginal introitus using the Amplicor collection kit. Cervical and introital specimens then were obtained by clinicians. The presence of C trachomatis in patient-collected versus clinician-collected samples was determined by PCR. Discordant specimens were retested by PCR, using primer pairs to the C trachomatis major outer membrane protein gene, and were screened for the presence of PCR assay inhibitors.
  
  
  RESULTS
  Ninety-nine subjects completed the self-collection. Sixty-two percent were adolescents and 17% spoke English as their second language. Forty-three percent had never used tampons, and 36% had never looked at their own genitals. Twenty-eight cervical specimens (28%), 32 clinician-collected introital specimens (32%), and 33 self-collected introital specimens (33%) were positive for C trachomatis infection. All clinician-collected introital specimens that were positive for C trachomatis and all cervical specimens that were positive for C trachomatis were positive on self-test. Compared with clinician-collected introital specimens, self-collected specimens had a sensitivity of 100% and a specificity of 98.5%. Compared with cervical specimens, self-collected specimens had a sensitivity of 100% and a specificity of 93.4%. After discrepant analysis, self-test had a sensitivity of 100% and a specificity of 94.6% for detection of C trachomatis cervical infection.
  
  
  CONCLUSIONS
  Self-collection of introital samples is both sensitive and specific in screening for C trachomatis.
authors.affiliation: Department of Obstetrics and Gynecology, Cornell University Medical College, New York, New York, USA. mpolanec@mail.med.cornell.edu
authors.forename: M
authors.initials: M
authors.lastname: Polaneczky
authors.forename: C
authors.initials: C
authors.lastname: Quigley
authors.forename: L
authors.initials: L
authors.lastname: Pollock
authors.forename: D
authors.initials: D
authors.lastname: Dulko
authors.forename: S S
authors.initials: SS
authors.lastname: Witkin
mesh_terms: D000328:Adult; D002690:Chlamydia Infections / Q000175:diagnosis* / Q000382:microbiology; D002692:Chlamydia trachomatis / Q000302:isolation & purification; D005260:Female; D006801:Humans; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods; D014621:Vagina