Chlamydia/Gonococcus/Mycoplasma genitalium, NAA, Urine

Clinical Use

Order Test

Use

Detect Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium

Special Instructions

Not provided.

Limitations

The test may have reduced sensitivity if the urine volume exceeds the specified amount or if the specimen is not properly rinsed into the collection container. Specimens with a fixative or those collected in an improper transport medium may be rejected. False negatives may occur due to inadequate sample collection or transport error.

Test Details

Methodology

PCR-based (Nucleic acid amplification (NAA))

Biomarkers

3 components

Chlamydia trachomatis NAA • Nucleic acid amplification (NAA)Neisseria gonorrhoeae NAA • Nucleic acid amplification (NAA)Mycoplasma genitalium NAA • Nucleic acid amplification (NAA)

LOINC Codes

Result Codes

88226-6 - M genitalium DNA Ur 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

Minimum Volume

Not provided

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® 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