Genital Mycoplasma Profile, NAA, Urine

CPT: 87798(x3)
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Test Details

Test Includes

Mycoplasma genitalium; Mycoplasma hominis; Ureaplasma spp

Use

Detect 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

First-void urine in Aptima® urine transport

Volume

2 mL of a 20 to 30 mL urine collection

Container

Aptima® urine transport

Patient Preparation

The patient should not have urinated for at least one hour prior to specimen collection.

Collection

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 20-30 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

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 >30 days from collection; Aptima® urine transport with incorrect specimen volume; specimen in ProbeTec® UPT transport; ProbeTec® Q-swabs; urine in sterile container

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
180040 Genital Mycoplasmas NAA, Urine 180024 Mycoplasma genitalium NAA 69935-5
180040 Genital Mycoplasmas NAA, Urine 180037 Mycoplasma hominis NAA 68546-1
180040 Genital Mycoplasmas NAA, Urine 180038 Ureaplasma spp NAA 68547-9
180040 Genital Mycoplasmas NAA, Urine 180044 Comment: N/A

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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