Test name: Chlamydia/Gonorrhea
Specimen: Thin Prep Pap Test Vial, Aptima Urine Specimen Collection Kit for Urine, or an Aptima Unisex Specimen Collection Kit for Endocervical Swab Specimens.
CPT Codes: 87491 and 87591
Collection: Clinician-collected endocervical, gynecological specimen collected in the PreservCyt Solution, or a first catch urine specimens. 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.
Urine Specimens: The patient should not have urinated for at least 1 hour prior to specimen collection. Direct patient to provide a first-catch urine (approximately 20 to 30 mL of the initial urine stream) into a urine collection cup free of any preservatives. Female patients should not cleanse the labial area prior to providing the specimen. Remove the cap and transfer 2 mL of urine into the urine specimen transport tube, within 24 hours of collection, using the disposable pipette provided. The correct volume of urine has been added when the fluid level is between the black fill lines on the urine specimen transport tube label. Urine samples that are still in the primary collection container must be transported to the lab within 24 hours of collection. Must be tested within 30 days of collection.
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, Aptima Transport Urine Tube with insufficient volume, or specimen older than 21 days from collection.
Limitations, Causes for Unsatisfactory Results: Sample collected near menstrual cycle, with excessive lubricant, or collection of larger volumes of urine may result in rRNA target dilution that may reduce test sensitivity.
Test Methodology: Nucleic acid amplification (NAA) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae.
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
Buimer, M., G. J. J. Van Doornum, S. Ching, P. G. H. Peerbooms, P. K. Plier, D. Ram, and H. H. Lee. 1996. Detection of Chlamydia trachomatis and Neisseria gonorrhoeae by Ligase chain reaction-based assays with clinical specimens from various sites: implications for diagnostic testing and screening. J. Clin. Microbiol. 34:2395-2400.