Chlamydia/Gonococcus/Genital Mycoplasma Profile, NAA, Swab

Clinical Use

Order Test

Use

Detect Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma spp

Special Instructions

Not provided.

Limitations

This test was developed by Labcorp and its performance characteristics were determined by the lab. It has not been cleared or approved by the FDA, as the FDA has determined that such clearance is not necessary. The presence of interfering substances or improper collection/storage may lead to inaccuracies in the test results. Samples received in incorrect conditions or inappropriate specimens will be rejected.

Test Details

Methodology

PCR-based (NAA)

Biomarkers

5 targets

Chlamydia trachomatisMycoplasma genitaliumMycoplasma hominisNeisseria gonorrhoeaeUreaplasma spp

LOINC Codes

Order Codes

91134-7 - STI Pnl Spec NAA+probe

Result Codes

69935-5 - M genitalium DNA Spec Ql NAA+probe
68546-1 - M hominis DNA Spec Ql NAA+probe
68547-9 - Ureaplasma DNA Spec Ql NAA+probe
21613-5 - C trach DNA Spec Ql NAA+probe
32705-6 - N gonorrhoea DNA Vag Ql NAA+probe

Result Turnaround Time

3-4 days

Specimen

Cervical Swab

Volume

One Aptima® swab

Minimum Volume

Not provided

Container

Aptima® Multitest Swab Specimen Collection Kit or Aptima® Unisex Swab Specimen Collection Kit

Collection Instructions

Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab. Insert the specimen collection swab into the endocervical canal and gently rotate clockwise for 10 to 30 seconds. Withdraw carefully without touching vaginal mucosa and place in transport tube. Break swab at scoreline and seal the tube tightly.

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 transport conditions; specimens received frozen; prolonged delay; specimen leaked in transit; expired transport; incorrect transport device; specimens with inappropriate source; specimen with fixative or additives; Aptima® urine transport; Aptima® swab transport >30 days from collection; Aptima® swab specimen without a swab; cleaning swab in transport; non-Aptima® swab in transport device; transport device with multiple swabs; bloody or grossly mucoid specimens; bacterial swabs; specimen in ProbeTec™ UPT transport.