Chlamydia/Gonococcus, NAA With Reflex to Trichomonas vaginalis, NAA

CPT: 87491; 87591
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Expected Turnaround Time

2 - 4 days


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Specimen Requirements


Specimen

Vaginal, endocervical, or male urethral swab, first-void urine (patient should not have urinated for one hour prior to specimen collection), or cervical cells in liquid cytology vial.


Volume

One swab, 2 mL of a 20 mL to 30 mL urine collection, or entire liquid cytology vial


Minimum Volume

One swab, 2 mL of a 20 mL to 30 mL urine collection, or entire liquid cytology vial


Container

Gen-Probe® Aptima® swab or Aptima® urine specimen transport; ThinPrep® liquid cytology vial


Collection

Vaginal swab collection: 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, rotating the swab for 10 to 30 seconds to absorb the 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 instructions: Partially open the package. 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® Vaginal Swab Specimen Collection Kit. Remove the swab. Carefully insert the swab into the vagina about 2" 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.

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 using 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 using care to avoid splashing of contents. Recap the swab specimen transport tube tightly.

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 mL 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® COMBO 2 urine collection device. The final volume must be between the two black lines on the device (about 2 mL).


Storage Instructions

Room temperature


Causes for Rejection

Specimen with incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions; specimens received after prolonged delay (usually >72 hours); 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 >24 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-shaft 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; UTM-RT; SurePath™ vial


Test Details


Use

Diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae infection. If a positive result is obtained for either Chlamydia trachomatis or Neisseria gonorrhoeae, testing for Trichomonas vaginalis is performed.


Limitations

Note: Specimens cannot be collected and used for Chlamydia/Neisseria and routine chemistry or urine culture. Chlamydia/Neisseria requires 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
183198 Ct/Ng NAA rfx Tv NAA 64017-7 188106 Chlamydia by NAA 43304-5
183198 Ct/Ng NAA rfx Tv NAA 64017-7 188107 Gonococcus by NAA 43305-2
183198 Ct/Ng NAA rfx Tv NAA 64017-7 183199 Trich vag by NAA Rfx N/A
Reflex Table for Trich vag by NAA Rfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 183200 Trich vag by NAA 188053 Trich vag by NAA 46154-1
Reflex Table for Trich vag by NAA Rfx
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 183200 Trich vag by NAA 183201 Trich vag by NAA Tracking N/A

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