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Mycoplasma genitalium, NAA, Urine With Reflex to Macrolide Resistance Testing
CPT:
87563
Special Instructions
If reflex testing is performed, additional charges/CPT code(s) may apply.
Expected Turnaround Time
3 - 4 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
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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CPT Statement/Profile Statement
The LOINC® codes are copyright © 1994-2021, 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