title: Diagnostic performance of the Roche AMPLICOR PCR in detecting Neisseria gonorrhoeae in genitourinary specimens from female sex workers in Cotonou, Benin.
abstract: The objective of this study was to evaluate the diagnostic performance of the Roche multiplex AMPLICOR Chlamydia trachomatis/Neisseria gonorrhoeae PCR test for the detection of Neisseria gonorrhoeae infection in female urine specimens and wet and dry endocervical swabs. Endocervical swabs and urine specimens were collected from 342 female sex workers from Cotonou, Benin, and were tested using the AMPLICOR C. trachomatis/N. gonorrhoeae test (Roche Diagnostic Systems, Inc., Branchburg, N.J.) with internal control detection. Endocervical swabs were also cultured on Thayer-Martin medium. A series of alternate standards that included a combination of all the tests but not the test being evaluated was used to assess the performance of the test with each type of specimen. The sensitivity, specificity, and positive and negative predictive values for the urine were 53.8, 98.9, 93.5, and 87.5%, respectively. Corresponding figures for the wet swab were 91.5, 100, 100, and 97.4%, respectively. Those for the dry swab were 96.3, 96.2, 88.5, and 98.8%, respectively. Based on this study, the AMPLICOR PCR assay showed a low sensitivity for detection of N. gonorrhoeae infection in urine specimens, whereas the test was found to be highly sensitive and specific with endocervical specimens.
authors.affiliation: Epidemiology Research Group, Hôpital du Saint-Sacrement du CHA and Université Laval, Québec, Canada.
authors.forename: L
authors.initials: L
authors.lastname: Mukenge-Tshibaka
authors.forename: M
authors.initials: M
authors.lastname: Alary
authors.forename: F
authors.initials: F
authors.lastname: Bernier
authors.forename: E
authors.initials: E
authors.lastname: van Dyck
authors.forename: C M
authors.initials: CM
authors.lastname: Lowndes
authors.forename: A
authors.initials: A
authors.lastname: Guédou
authors.forename: S
authors.initials: S
authors.lastname: Anagonou
authors.forename: J R
authors.initials: JR
authors.lastname: Joly
mesh_terms: D001541:Benin / Q000453:epidemiology; D002584:Cervix Uteri / Q000382:microbiology*; D005260:Female; D006069:Gonorrhea / Q000175:diagnosis* / Q000453:epidemiology / Q000382:microbiology; D006801:Humans; D009344:Neisseria gonorrhoeae / Q000235:genetics / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction / Q000379:methods*; D011237:Predictive Value of Tests; D015995:Prevalence; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D011477:Sex Work; D013048:Specimen Handling; D014556:Urine / Q000382:microbiology*
chemical_list: D011933:Reagent Kits, Diagnostic