Genital Mycoplasma Profile, NAA, Swab

Casandra

Casandra Test Code LC68074Version 1 (DRAFT)

Performing Lab

Lab LabcorpLab Test ID 180089CPT Codes 87563, 87798

Genital Mycoplasma Profile, NAA, Swab

Clinical Use

Order Test

Use

Detect Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma spp

Special Instructions

The test requires the collection of an endocervical, vaginal, or male urethral swab using the Aptima® swab transport system. Proper collection technique is essential to ensure adequate sampling and accurate results.

Limitations

This test was developed by Labcorp, and its performance characteristics have been determined by the laboratory itself. It has not been cleared or approved by the Food and Drug Administration, which has deemed such clearance or approval as unnecessary. The test's efficacy is based on Labcorp's internal validation. Results may be affected by inadequate specimen collection, transport delays, or inappropriate transport conditions.

Test Details

Methodology

PCR-based (NAA)

Biomarkers

LOINC Codes

Order Codes

91134-7

Result Codes

69935-5
68546-1
68547-9
11502-2

Result Turnaround Time

3-4 days

Specimen

Other

Volume

One Aptima® swab

Minimum Volume

Not provided

Container

Aptima® unisex or vaginal swab

Collection Instructions

Vaginal swab: Collect vaginal fluid sample using the Gen-Probe® Aptima® swab by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Endocervical swab: Insert the specimen collection swab into the endocervical canal and gently rotate. Male urethral swab: Insert the swab into the urethra and rotate.

Patient Preparation

The patient should not have urinated for at least one hour prior to specimen collection (for male urethral swab).

Storage Instructions

Maintain specimen at room temperature or refrigerate (2°C to 30°C).

Causes for Rejection

Incorrect patient identification, unlabeled specimen, inappropriate specimen transport conditions, prolonged delay (usually >72 hours), specimen leaked, expired transport device, inappropriate source, fixative or additives, Aptima® urine transport, Aptima® swab transport >30 days, cleaning swab in transport, non−Gen-Probe® swab in transport, multiple swabs, bloody or mucoid specimens, bacterial swabs, specimen in ProbeTec™ transport or Q-swabs.