Chlamydia/Gonococcus/Mycoplasma genitalium, NAA, Swab

Clinical Use

Order Test

Use

Detect Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium

Special Instructions

Not provided.

Limitations

The test is limited in its ability to detect infections only caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium. It cannot detect other sexually transmitted infections or pathogens not included in this assay. Incorrect specimen collection, handling, or transport may lead to false results. The presence of interfering substances or inadequate specimen volume can also affect the accuracy of the test. The test should not be used as the sole criterion for treatment decisions; clinical correlation with patient history and other diagnostic information is necessary.

Test Details

Methodology

PCR-based (qPCR)

Biomarkers

Chlamydia trachomatis

Microorganism

Chlamydia trachomatis, NAA

Other • Binary (Detected / Not Detected)

Mycoplasma genitalium

Microorganism

Mycoplasma genitalium NAA

Other • Binary (Detected / Not Detected)

Neisseria gonorrhoeae

Microorganism

Neisseria gonorrhoeae, NAA

Other • Binary (Detected / Not Detected)

LOINC Codes

Order Codes

21613-5 - C trach DNA Spec Ql NAA+probe
32705-6 - N gonorrhoea DNA Vag Ql NAA+probe
69935-5 - M genitalium DNA Spec Ql NAA+probe

Result Turnaround Time

3-4 days

Specimen

Vaginal 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

Vaginal swab: Collect vaginal fluid sample using the 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. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap.

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, including specimens received frozen, 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; Aptima® swab transport >30 days from collection; Aptima® swab specimen without a swab; cleaning swab (white-shaft swab) in Aptima® swab transport; any non-Aptima® swab submitted in Aptima® transport device; transport device with multiple swabs; bloody or grossly mucoid specimens; bacterial swabs; specimen in ProbeTec™ UPT transport; ProbeTec™ Q-swabs