Chlamydia/Gonococcus/Genital Mycoplasma Profile, NAA, Urine
Use
This test is used to detect Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, Mycoplasma hominis, and Ureaplasma species. It is useful for diagnosing infections caused by these organisms in the urogenital tract. Detection of these pathogens can assist in timely treatment and management of sexually transmitted infections, reducing the risk of complications and further transmission.
Special Instructions
The patient should not have urinated for at least one hour prior to specimen collection. A first-catch urine sample is required, and it should be collected in an Aptima® urine transport device. The final urine volume must be between the two black lines on the device, approximately 2 mL. Larger urine volumes may lead to dilution and decreased sensitivity, while smaller volumes may be insufficient for testing.
Limitations
This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the US Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Results should be interpreted in the context of the clinical presentation and should not be used as the sole basis for diagnosis. Specimens with prolonged delay or improper storage may yield inaccurate results.
Methodology
PCR-based (NAA)
Biomarkers
LOINC Codes
- 91134-7
- 88226-6
- 68546-1
- 68547-9
- 42931-6
- 60256-5
Result Turnaround Time
3-4 days
Related Documents
For more information, please review the documents below
Specimen
Urine
Volume
2 mL aliquot of a 20 to 30 mL urine collection
Minimum Volume
Not provided
Container
Aptima® urine transport
Collection Instructions
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 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® Combo 2 urine collection device. The final volume must be between the two black lines on the device (about 2 mL).
Patient Preparation
The patient should not have urinated for at least one hour prior to specimen collection.
Storage Instructions
Maintain specimen at room temperature or refrigerate (2°C to 30°C).
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
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 30 days |
| Refrigerated | 30 days |