Chlamydia/Gonococcus/Genital Mycoplasma Profile, NAA, Swab

CPT: 87491; 87591; 87798(x3)
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Test Details

Test Includes

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

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

Methodology

Nucleic acid amplification (NAA)

Specimen Requirements

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

Collection

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.

Storage Instructions

Maintain specimen at room temperature or refrigerate (2°C to 30°C). Stable at room temperature or refrigerated for 30 days.

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

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
180093 Ct, Ng, Mycoplasmas NAA, Swab 180077 Mycoplasma genitalium NAA 69935-5
180093 Ct, Ng, Mycoplasmas NAA, Swab 180022 Mycoplasma hominis NAA 68546-1
180093 Ct, Ng, Mycoplasmas NAA, Swab 180023 Ureaplasma spp NAA 68547-9
180093 Ct, Ng, Mycoplasmas NAA, Swab 180044 Comment: N/A
180093 Ct, Ng, Mycoplasmas NAA, Swab 180097 Chlamydia trachomatis, NAA 43304-5
180093 Ct, Ng, Mycoplasmas NAA, Swab 180104 Neisseria gonorrhoeae, NAA 43305-2

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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2017, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf