Test Details
Methodology
Nucleic acid amplification (NAA)
Result 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.
Test Includes
Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium with possible reflex to Mycoplasma genitalium, NAA, Urine with Reflex to Macrolide Resistance Testing
Use
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.
Special Instructions
If reflex test is performed, additional charges/CPT code(s) may apply.
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 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.
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. 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
Specimen Requirements
Specimen
First-void urine in APTIMA® urine transport
Volume
2 mL aliquot of a 20-to-30 mL urine collection
Minimum Volume
2 mL aliquot of a 20-to-30 mL urine collection
Container
Aptima® urine transport
Collection Instructions
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).
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) |
Storage Instructions
Maintain specimen at room temperature or refrigerate (2°C to 30°C).
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 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
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 180123 | Ct Ng Mgen w/Rflx, NAA, Urine | 180050 | Chlamydia trachomatis, NAA | 42931-6 | ||
| 180123 | Ct Ng Mgen w/Rflx, NAA, Urine | 180052 | Neisseria gonorrhoeae, NAA | 60256-5 | ||
| 180123 | Ct Ng Mgen w/Rflx, NAA, Urine | 180086 | Mycoplasma genitalium NAA | 100703-8 | ||
| Order Code | 180123 | |||||
| Order Code Name | Ct Ng Mgen w/Rflx, NAA, Urine | |||||
| Order Loinc | ||||||
| Result Code | 180050 | |||||
| Result Code Name | Chlamydia trachomatis, NAA | |||||
| UofM | ||||||
| Result LOINC | 42931-6 | |||||
| Order Code | 180123 | |||||
| Order Code Name | Ct Ng Mgen w/Rflx, NAA, Urine | |||||
| Order Loinc | ||||||
| Result Code | 180052 | |||||
| Result Code Name | Neisseria gonorrhoeae, NAA | |||||
| UofM | ||||||
| Result LOINC | 60256-5 | |||||
| Order Code | 180123 | |||||
| Order Code Name | Ct Ng Mgen w/Rflx, NAA, Urine | |||||
| Order Loinc | ||||||
| Result Code | 180086 | |||||
| Result Code Name | Mycoplasma genitalium NAA | |||||
| UofM | ||||||
| Result LOINC | 100703-8 |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 180088 | M gen Macrolide Resistance | 180088 | M gen Macrolide Resistance | Pending | |
| Reflex 1 | ||||||
| Order Code | 180088 | |||||
| Order Name | M gen Macrolide Resistance | |||||
| Result Code | 180088 | |||||
| Result Name | M gen Macrolide Resistance | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||