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Effect of specimen order on Chlamydia trachomatis and Neisseria gonorrhoeae
test performance and adequacy of papanicolaou smear.
J Pediatr Adolesc Gynecol 2006; 19:23-30.
Ghanem KG, Koumans EH, Johnson RE, Sawyer MK, Papp JR, Unger ER, Black
CM, Markowitz LE.
Abstract
STUDY OBJECTIVE: To evaluate the effect of specimen collection order on the
performance of diagnostic tests for Chlamydia trachomatis (CT) and Neisseria
gonorrhoeae (GC), and the specimen adequacy of ThinPrep Papanicolaou (Pap)
smears. DESIGN: Prospective cohort study. SETTING: Public adolescent clinic.
POPULATION: 313 women. INTERVENTIONS: The order of five cervical testing
specimens was randomized for (1) ligase chain reaction (LCR) and (2) polymerase
chain reaction (PCR) for both CT and GC; (3) transcription-mediated amplification
(TMA) for CT; (4) culture for CT; and (5) cytology and LCR for GC and CT
performed on ThinPrep Pap specimens. For CT and GC, a reference standard
was based on three different tests performed on separate specimens. Generalized
estimating equations were used to account for repeated measures. MAIN OUTCOME
MEASURE: Sensitivity and specificity of diagnostic tests. RESULTS: The proportion
of inadequate Pap smears was independent of specimen order. As a group, nucleic
acid amplification test (NAAT) sensitivity and specificity for GC and CT
were similar in the first two (early) and last three (late) swabs. Although
point estimates for sensitivity were higher in the early swabs compared to
the late swabs for GC LCR (13% difference), GC PCR (13%), and CT TMA (10%),
these differences were not statistically significant. Their clinical significance
warrants further investigation. CONCLUSIONS: In clinical settings where both
Pap smears and STI testing are performed in adolescents, clinical considerations
can influence the order of specimen collection, since neither Pap specimen
adequacy nor test performance of NAAT for CT and GC were significantly associated
with swab order.