Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis and Neisseria gonorrhoeae. High-risk HPV test is used for types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68, without differentiation of the individual types. This assay aids in the diagnosis of sexually-transmitted HPV infection and in the triage of patients with an ASCUS Pap test result. When the high-risk HPV result is positive, the specimen is tested specifically for types 16 and 18.
Failure to obtain adequate ectocervical, endocervical, or vaginal cell population is suboptimal for evaluation. Excessive use of lubricating jelly on the vaginal speculum will interfere with cytologic examination and may lead to unsatisfactory Pap results.
The use of the liquid-based cytology specimen for multiple tests may limit the volume available for Pap reprocessing or HPV testing. A negative result does not exclude the possibility of an HPV infection since very low levels of infection or sampling error may produce a false-negative result.
Testing for Chlamydia trachomatis and Neisseria gonorrhoeae requires special procedures to be used in the processing of the cytology specimen; therefore testing for these organisms cannot be added on after the specimen has been submitted. The liquid-based cytology specimen must be processed for Chlamydia trachomatis and Neisseria gonorrhoeae testing.
Any time a transport device used for molecular testing is processed, the chance of cross-specimen contamination increases. Aptima® transports can be placed directly on the analyzer limiting the possibility of cross-specimen contamination.
American Society for Colposcopy and Cervical Pathology. HPV Genotyping Clinical Update. Hagerstown, Md: ASCCP; 2009:1-3.
Centers for Disease Control and Prevention. Screening Tests to Detect Chlamydia trachomatis and Neisseria gonorrhoeae Infections -- 2002. MMWR Recomm Rep. 2002; 51(RR-15), 1-38. PubMed 12418541
Hutchinson ML, Cassin CM, Ball HG 3rd. The efficacy of an automated preparation device for cervical cytology. Am J Clin Pathol. 1991; 96(3):300-305. PubMed 1877527
Hutchinson ML, Isenstein LM, Goodman A, et al. Homogeneous sampling accounts for the increased diagnostic accuracy using the ThinPrep® Processor. Am J Clin Pathol. 1994; 101(2):215-219. PubMed 8116578
Joseph MG, Cragg F, Wright VC, et al. Cytohistological correlates in a colposcopic clinic: A 1-year prospective study. Diagn Cytopathol. 1991; 7(5):477-481. PubMed 1954825
Wilbur DC, Cibas ES, Merritt S, et al. ThinPrep® Processor: Clinical trials demonstrate an increased detection rate of abnormal cervical cytologic specimens. Am J Clin Pathol. 1994; 101(2):209-214. PubMed 8116577