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Genital Mycoplasma Profile, NAA, Swab

CPT 87563; 87798(x2)

Test Details

Methodology

Nucleic acid amplification (NAA)

Result Turnaround Time

3 - 4 days

Use

Detect Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma spp

Specimen Requirements

Test Includes

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 US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.

Specimen

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

Volume

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

Container

Aptima® unisex or vaginal swab

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; 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−Gen-Probe® 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

Collection Instructions

Vaginal swab: Collect vaginal fluid sample using the Gen-Probe® 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.

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)

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
180089 Genital Mycoplasmas NAA, Swab 91134-7 180077 Mycoplasma genitalium NAA 69935-5
180089 Genital Mycoplasmas NAA, Swab 91134-7 180022 Mycoplasma hominis NAA 68546-1
180089 Genital Mycoplasmas NAA, Swab 91134-7 180023 Ureaplasma spp NAA 68547-9
Order Code180089
Order Code NameGenital Mycoplasmas NAA, Swab
Order Loinc91134-7
Result Code180077
Result Code NameMycoplasma genitalium NAA
UofM
Result LOINC69935-5
Order Code180089
Order Code NameGenital Mycoplasmas NAA, Swab
Order Loinc91134-7
Result Code180022
Result Code NameMycoplasma hominis NAA
UofM
Result LOINC68546-1
Order Code180089
Order Code NameGenital Mycoplasmas NAA, Swab
Order Loinc91134-7
Result Code180023
Result Code NameUreaplasma spp NAA
UofM
Result LOINC68547-9