Chlamydia/Gonococcus/Genital Mycoplasma Profile, NAA, Swab

CPT: 87491; 87563; 87591; 87798(x2)
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Test Includes

Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma spp


Expected Turnaround Time

3 - 4 days



Specimen Requirements


Specimen

Endocervical, vaginal, or male urethral swab in Aptima® swab transport


Volume

One Aptima® swab (endocervical, vaginal, or male urethral)


Container

Aptima® Multitest Swab Specimen Collection Kit or Aptima® Unisex Swab Specimen Collection Kit


Collection

Vaginal swab: Collect vaginal fluid sample using the Aptima® swab 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.

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.


Storage Instructions

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


Stability Requirements

Temperature

Period

Room temperature

30 days (stability provided by manufacturer or literature reference)

Refrigerated

30 days (stability provided by manufacturer or literature reference)


Causes for Rejection

Specimen with incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions, including specimens received frozen, 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; Aptima® swab transport >30 days from collection; Aptima® swab specimen without a swab; cleaning swab (white-shaft swab) in Aptima® swab transport; any non-Aptima® swab submitted in Aptima® transport device; transport device with multiple swabs; bloody or grossly mucoid specimens; bacterial swabs; specimen in ProbeTec™ UPT transport; ProbeTec™ Q-swabs


Test Details


Use

Detect Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma spp


Limitations

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary.


Methodology

Nucleic acid amplification (NAA)


LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
180093 Ct, Ng, Mycoplasmas NAA, Swab 91134-7 180077 Mycoplasma genitalium NAA 69935-5
180093 Ct, Ng, Mycoplasmas NAA, Swab 91134-7 180022 Mycoplasma hominis NAA 68546-1
180093 Ct, Ng, Mycoplasmas NAA, Swab 91134-7 180023 Ureaplasma spp NAA 68547-9
180093 Ct, Ng, Mycoplasmas NAA, Swab 91134-7 180097 Chlamydia trachomatis, NAA 45084-1
180093 Ct, Ng, Mycoplasmas NAA, Swab 91134-7 180104 Neisseria gonorrhoeae, NAA 32705-6

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