Chlamydia/Gonorrhea, Trichomonas, High-Risk HPV, and Reflex HPV Genotype 16 18/45

Diagnostic Testing Medical

Test name: Chlamydia/Gonorrhea, Trichomonas, High-Risk HPV, and Reflex HPV Genotype 16 18/45

Specimen: Thin Prep Pap Test Vial and an Aptima Unisex Specimen Collection Kit for Endocervical Swab Specimen.

CPT Codes: 87491, 87591, 87661, 87624 and 87625

Collection: Clinician-collected endocervical and gynecological specimens collected in the PreservCyt Solution. Record the patient name and ID number on the specimen container, fully complete a specimen requisition, and forward to Arbor Diagnostics in a specimen bag.

Special Instructions and Considerations:

Swab Specimens: Remove any excess mucus using the cleaning swab (white shaft swab in the package with red printing). Discard this swab. The specimen collection swab (blue shaft swab in the package with the green printing) should be placed into the transport tube immediately after collection. Carefully break the swab shaft against the side of the tube at the score-line and discard the top portion of the swab shaft. Must be tested within 60 days.

PreservCyt Solution Liquid Pap specimens: Gynecological broom-type or endocervical brush/spatula collection devices should be used. Specimen should not be collected within 1 week of menstruation. Excessive lubricant may interfere with sample adequacy.  Must be processed within 30 days of collection.

Storage Instructions: Maintain at room temperature

Transport Instructions: Transport at room temperature

Causes for Rejection: Improperly labeled or expired vial, frozen specimen, Aptima Unisex tube containing anything other than the blue swab, or specimen older than 21 days from collection.

Limitations, Causes for Unsatisfactory Results:  Sample collected near menstrual cycle or with excessive lubricant

Test Methodology: Nucleic acid amplification (NAA) for the qualitative detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, 14 types of high-risk HPV (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) without differentiation of the individual type and reflex testing for HPV genotype 16 18/45

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Gaydos, C. A., T.C. Quinn, D. Willis, A. Weissfeld, E. W. Hook, D. H. Martin, D. V. Ferraro, and J. Schachter. 2003. Performance of the Aptima Combo 2 Assay for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in female urine and endocervical swab specimens. J. Clin. Microbiol. 41:304-309

Nye, M. B., J. R. Schwebke, and B. A. Body. 2009. Comparison of Aptima Trichomonas vaginalis transcription-mediated amplification to wet mount microscopy, culture, and polymerase chain reaction for diagnosis of trichomoniasis in men and women. Am. J. Obstet. Gynecol. 200:188.e1-188.e7.Manos MM, Kinney WK, Hurley B, et al. Identifying women with cervical neoplasia: Using human papillomavirus DNA testing for equivocal Papanicolaou results. JAMA. 1999 May 5; 281:1605-1610.PubMed 8116578

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