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.
Use
This test is used to detect the presence of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium rRNA in urine specimens. If M. genitalium is detected, additional testing for macrolide resistance determination 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.
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
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 >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
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 180107 | Ct/GC/Tv/Mg Rflx MacRes NAA Ur | 180050 | Chlamydia trachomatis, NAA | 42931-6 | ||
| 180107 | Ct/GC/Tv/Mg Rflx MacRes NAA Ur | 180052 | Neisseria gonorrhoeae, NAA | 60256-5 | ||
| 180107 | Ct/GC/Tv/Mg Rflx MacRes NAA Ur | 180072 | Trich vag by NAA | 70167-2 | ||
| 180107 | Ct/GC/Tv/Mg Rflx MacRes NAA Ur | 180086 | Mycoplasma genitalium NAA | 100703-8 | ||
| Order Code | 180107 | |||||
| Order Code Name | Ct/GC/Tv/Mg Rflx MacRes NAA Ur | |||||
| Order Loinc | ||||||
| Result Code | 180050 | |||||
| Result Code Name | Chlamydia trachomatis, NAA | |||||
| UofM | ||||||
| Result LOINC | 42931-6 | |||||
| Order Code | 180107 | |||||
| Order Code Name | Ct/GC/Tv/Mg Rflx MacRes NAA Ur | |||||
| Order Loinc | ||||||
| Result Code | 180052 | |||||
| Result Code Name | Neisseria gonorrhoeae, NAA | |||||
| UofM | ||||||
| Result LOINC | 60256-5 | |||||
| Order Code | 180107 | |||||
| Order Code Name | Ct/GC/Tv/Mg Rflx MacRes NAA Ur | |||||
| Order Loinc | ||||||
| Result Code | 180072 | |||||
| Result Code Name | Trich vag by NAA | |||||
| UofM | ||||||
| Result LOINC | 70167-2 | |||||
| Order Code | 180107 | |||||
| Order Code Name | Ct/GC/Tv/Mg Rflx MacRes NAA Ur | |||||
| 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 | |||||