Chlamydia/Gonococcus/Mycoplasma genitalium (with Reflex to Macrolide Resistance), NAA, Urine

First-void urine in APTIMA® urine transport

2 mL aliquot of a 20-to-30 mL urine collection

2 mL aliquot of a 20-to-30 mL urine collection

Aptima® urine transport

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® urine collection device. The final volume must be between the two black lines on the device (about 2 mL).

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

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

Specimen with incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions; specimens received after prolonged delay (usually greater than 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 greater than 30 days from collection; Aptima® urine transport with incorrect specimen volume; specimen in ProbeTec™ UPT transport; ProbeTec™ Q-swabs; urine in sterile container

This test detects the presence of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium via nucleic acid amplification (NAA). If M. genitalium is detected, a reflex test for the presence of mutations conferring macrolide resistance will be performed.

A negative result does not preclude a possible infection. Test results may be affected by improper specimen collection or target levels below the assay limit of detection (LoD). Results from this testing should be interpreted in conjunction with other clinical and laboratory data available to the clinician. Reliable results are dependent on adequate specimen collection, transport, storage and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results.

The macrolide resistance reflex 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.

Nucleic acid amplification (NAA)

Getman D, Jiang A, O'Donnell M, Cohen S. Mycoplasma genitalium prevalence, coinfection and macrolide antibiotic resistance frequency in a multicenter clinical study cohort in the United States. J Clin Microbiol. 2016 Sep;54(9):2278-2283. PubMed 27307460

Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187. PubMed 34292926