Chlamydia/Gonococcus/Genital Mycoplasma Profile, NAA, Urine

Casandra

Casandra Test Code LC31973Version 1 (DRAFT)

Performing Lab

Lab LabcorpLab Test ID 180051CPT Codes 87491, 87563, 87591, 87798

Chlamydia/Gonococcus/Genital Mycoplasma Profile, NAA, Urine

Clinical Use

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

Not provided.

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.

Test Details

Methodology

PCR-based (NAA)

Biomarkers

5 components

Chlamydia trachomatis NAA • NAANeisseria gonorrhoeae NAA • NAAMycoplasma genitalium NAA • NAAMycoplasma hominis NAA • NAA+1 more

LOINC Codes

Order Codes

91134-7 - STI Pnl Spec NAA+probe

Result Codes

88226-6 - M genitalium DNA Ur Ql NAA+probe
68546-1 - M hominis DNA Spec Ql NAA+probe
68547-9 - Ureaplasma DNA Spec Ql NAA+probe
42931-6 - C trach rRNA Ur Ql NAA+probe
60256-5 - N gonorrhoea rRNA Ur Ql NAA+probe

Result Turnaround Time

3-4 days

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