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Chlamydia/Gonococcus/Mycoplasma genitalium, NAA, Urine

CPT: 87491; 87563; 87591
87491; 87591; 87798
87491; 87563; 87591
Updated on 01/29/2020
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Expected Turnaround Time

3 - 4 days


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Specimen Requirements


Specimen

First-void urine in Aptima® urine transport


Volume

2 mL aliquot of a 20 to 30 mL urine collection


Container

Aptima® urine transport


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 mL to 30 mL of the initial urine stream) into a urine collection container 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).

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

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)

Temperature

Period

Room temperature

30 days (stability provided by manufacturer or literature reference)

Refrigerated

30 days (stability provided by manufacturer or literature reference)


Patient Preparation

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


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


Test Details


Use

Detect Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium


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)


LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
180049 Ct Ng M genitalium NAA, Urine 180024 Mycoplasma genitalium NAA 88226-6
180049 Ct Ng M genitalium NAA, Urine 180050 Chlamydia trachomatis, NAA 42931-6
180049 Ct Ng M genitalium NAA, Urine 180052 Neisseria gonorrhoeae, NAA 60256-5

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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2020, 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