PrEP Use Only: Chlamydia/Gonococcus, Urine or Urogenital Swab, NAA

CPT: 87491; 87591
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Synonyms

  • Pre-exposure prophylaxis screening for Ct/GC, Urine or Urogenital (Aptima®) Swab Source

Special Instructions

PrEP use only; this test is to be used for urine or swab specimens only, collected in Aptima® Urine Transport (urine) or Aptima® Multitest (Aptima Orange) or Aptima® Unisex Swab kits. For rectal and pharyngeal swabs, order PrEP Use Only: Chlamydia/Gonococcus, Rectal Swab, NAA [188725] and PrEP Use Only: Chlamydia/Gonococcus, Pharyngeal Swab, NAA [188710], respectively.


Expected Turnaround Time

2 - 3 days


Related Documents


Specimen Requirements


Specimen

Endocervical, vaginal or male urethral swab; or first-void urine (patient should not have urinated for one hour prior to specimen collection)


Volume

One swab (endocervical, vaginal or urethral) or 2 mL of a 20 mL to 30 mL urine collection


Minimum Volume

One swab (endocervical, vaginal or urethral) or 2 mL of a 15 mL urine collection


Container

Aptima® swab (Multitest or Unisex) or Aptima® urine specimen transport


Collection

Option 1: Aptima® Endocervical, Male Urethral, or Vaginal Swab

Endocervical swab: Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white-shaft swab in the package with red printing). Discard this swab. Insert the specimen collection swab (blue-shaft swab in the package with green printing) into the endocervical canal. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling. Withdraw the swab carefully; avoid contact with the vaginal mucosa. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube. Carefully break the swab shaft at the scoreline; use care to avoid splashing of the contents. Recap the swab specimen transport tube tightly.

Male urethral swab: The patient should not have urinated for at least one hour prior to specimen collection. Insert the specimen collection swab (blue-shaft swab in the package with the green printing) 2 to 4 cm into the urethra. Gently rotate the swab clockwise for two to three seconds in the urethra to ensure adequate sampling. Withdraw the swab carefully. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the specimen transport tube. Carefully break the swab shaft at the scoreline; use care to avoid splashing of contents. Recap the swab specimen transport tube tightly.

Vaginal swab: Care provider specimen: Collect vaginal fluid sample using the Gen-Probe® Aptima® vaginal swab kit by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap. Patient self-collection: Partially open the package of the Aptima® vaginal swab kit. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima® swab specimen collection kit. Remove the swab. Carefully insert the swab into the vagina about two inches past the introitus and gently rotate the swab for 10 to 30 seconds, making sure the swab touches the walls of the vagina so that moisture is absorbed by the swab. Withdraw the swab without touching the skin. Immediately place the swab into the transport tube, and carefully break the swab shaft against the side of the tube. Tightly screw on the cap.

Option 2: Urine Specimen: The patient should not have urinated for at least one 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. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity; lesser volumes may not adequately rinse organisms into the specimen. Female patients should not cleanse the labial area prior to providing the specimen. Add urine to the Aptima® urine collection device. The final volume must be between the two black lines on the device (about 2 mL).


Storage Instructions

Maintain specimen at room temperature or refrigerate (2°C to 30°C)


Causes for Rejection

Specimen with incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions; specimen leaked in transit; specimen in expired transport or incorrect transport device; specimens with inappropriate source for test requested; specimen with fixative or additives; Aptima® urine transport >30 days from collection; Aptima® urine transport with incorrect specimen volume; <15 mL urine submitted in sterile container; receipt of urine in sterile container >72 hours from collection; Aptima® swab transport >60 days from collection; Aptima® swab specimens with incorrect specimen volume; Aptima® swab specimen without a swab; cleaning swab (white-shaft swab) in Aptima® swab transport; any non-Gen-Probe® swab submitted in Aptima® transport device; wooden-shafted swab in transport device; transport device with multiple swabs; female urethral swab; bloody or grossly mucoid specimens; bacterial swabs; specimen in ProbeTec™ UPT transport; ProbeTec™ Q-swabs; BD ProbeTec™ ET male urethral swab; swab specimen in universal transport media or viral transport media; SurePath™ vial


Test Details


Use

This test is for PrEP use only. Testing includes detection of Chlamydia trachomatis or Neisseria gonorrhoeae in urine or swab specimens.


Limitations

Note: Specimens cannot be collected and used for Chlamydia/Gonococcus and routine chemistry or urine culture, Chlamydia/Gonococcus NAA requires the use of a first-catch (the initial stream of urine that will wash organisms out of the urethra of men or women). Routine chemistry and bacterial or fungal culture require use of the clean catch midstream collection technique.


Methodology

Nucleic acid amplification (NAA)


LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
188780 PrEP: Ct/GC, NAA 188078 Chlamydia trachomatis, NAA 43304-5
188780 PrEP: Ct/GC, NAA 188086 Neisseria gonorrhoeae, NAA 43305-2
188780 PrEP: Ct/GC, NAA 019054 PDF N/A

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