Mycoplasma genitalium, NAA, Urine With Reflex to Macrolide Resistance Testing

CPT: 87563
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Special Instructions

If reflex testing is performed, additional charges/CPT code(s) may apply.


Expected Turnaround Time

3 - 4 days


Related Documents


Specimen Requirements


Specimen

First-void urine in Aptima® urine transport


Volume

2 mL of a 20-30 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 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).


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)


Causes for Rejection

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


Test Details


Use

The test is used to detect the presence of Mycoplasma genitalium in urine collections. If M. genitalium is detected, further testing for the presence of macrolide resistance will be performed.


Limitations

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 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.


Methodology

Nucleic acid amplification (NAA)


References

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):2278-2283.27307460
Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187.34292926

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
180084 M genitalium NAA, Urine w/Rflx 100703-8 180086 Mycoplasma genitalium NAA 100703-8
Reflex Table for Mycoplasma genitalium NAA
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 180088 M gen Macrolide Resistance 180088 M gen Macrolide Resistance Pending

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