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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(1):23-30JP

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.

Authors+Show Affiliations

Johns Hopkins University School of Medicine, Bayview Medical Center, 4940 Eastern Avenue B3 North, Baltimore, MD 21224, USA. kghanem@jhmi.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Studies
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16472725

Citation

Ghanem, Khalil G., et al. "Effect of Specimen Order On Chlamydia Trachomatis and Neisseria Gonorrhoeae Test Performance and Adequacy of Papanicolaou Smear." Journal of Pediatric and Adolescent Gynecology, vol. 19, no. 1, 2006, pp. 23-30.
Ghanem KG, Koumans EH, Johnson RE, et al. Effect of specimen order on Chlamydia trachomatis and Neisseria gonorrhoeae test performance and adequacy of Papanicolaou smear. J Pediatr Adolesc Gynecol. 2006;19(1):23-30.
Ghanem, K. G., Koumans, E. H., Johnson, R. E., Sawyer, M. K., Papp, J. R., Unger, E. R., ... Markowitz, L. E. (2006). Effect of specimen order on Chlamydia trachomatis and Neisseria gonorrhoeae test performance and adequacy of Papanicolaou smear. Journal of Pediatric and Adolescent Gynecology, 19(1), pp. 23-30.
Ghanem KG, et al. Effect of Specimen Order On Chlamydia Trachomatis and Neisseria Gonorrhoeae Test Performance and Adequacy of Papanicolaou Smear. J Pediatr Adolesc Gynecol. 2006;19(1):23-30. PubMed PMID: 16472725.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of specimen order on Chlamydia trachomatis and Neisseria gonorrhoeae test performance and adequacy of Papanicolaou smear. AU - Ghanem,Khalil G, AU - Koumans,Emilia H, AU - Johnson,Robert E, AU - Sawyer,Mary K, AU - Papp,John R, AU - Unger,Elizabeth R, AU - Black,Carolyn M, AU - Markowitz,Lauri E, PY - 2006/2/14/pubmed PY - 2006/6/23/medline PY - 2006/2/14/entrez SP - 23 EP - 30 JF - Journal of pediatric and adolescent gynecology JO - J Pediatr Adolesc Gynecol VL - 19 IS - 1 N2 - 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. SN - 1083-3188 UR - https://www.unboundmedicine.com/medline/citation/16472725/Effect_of_specimen_order_on_Chlamydia_trachomatis_and_Neisseria_gonorrhoeae_test_performance_and_adequacy_of_Papanicolaou_smear_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1083-3188(05)00187-7 DB - PRIME DP - Unbound Medicine ER -