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  • Chlamydia trachomatis and Neisseria gonorrhoeae NAA (Nucleic Acid Amplification and Detection)

Chlamydia trachomatis and Neisseria gonorrhoeae NAA (Nucleic Acid Amplification and Detection)

Due to a nationwide shortage of collection/transport devices, McLendon Clinical Laboratories has limited availability of molecular testing for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) [Test: LAB 5814].

Female urine and Male urethral swabs are currently NOT an acceptable option. Urine (Males only) and Swabs (vaginal, throat or rectal) are still acceptable given the appropriate Hologic Aptima transport collection devices are used. Consider prioritizing CT/NG testing to symptomatic individuals and asymptomatic persons in groups at higher risk for complications (i.e. pregnant women, immunocompromised) who can benefit the most from screening. If testing is not available, empiric therapy for both pathogens is generally recommended as per CDC STD Treatment Guidelines at https://www.cdc.gov/std/tg2015/tg-2015-print.pdf for symptomatic sexually active patients or sexual contacts to a known case of CT/NG, irrespective of symptoms.

Urine (Males ONLY)


Specimen Type

Test ID LAB5814
EPIC Order
CHLAMYDIA/GONORRHOEAE NAA
CPT Code(s) 87491, 87591
Group/Individual Test Group
Laboratory Molecular Microbiology
Tube Station 82
Specimen Routine:
Urine(First stream) (2-30mL) - MALES ONLY
Endocervical swab
Urethral swab (Males only) not currently accepted due to a national shortage of collection devices.
Vaginal swab
Rectal swab
Throat swab
Ocular swab

See Comments for additional specimen information
Availability Routine: Monday through Friday
Turnaround Time 3 days
Comments

Assay performed using the FDA-approved Hologic Panther Aptima Combo2 test.

1. First stream urine samples are stable at room temperature for up to 24 hours, including transportation time. Urine specimens must be first-stream, with no urination within the last hour. Patient collection volumes for urine must be no less than 2mL, and no more than 30mL AT COLLECTION. Higher collection volumes of urine will result in decreased sensitivity, and will not be accepted. Specimens must not be poured-off to obtain a 30mL volume. Clean catch and catheterized urines are not acceptable.

A negative urine result for a female patient who is clinically suspected of having a gonococcal infection does not rule-out the presence of Neisseria gonorrhoeae in the urogenital tract. Further, a negative urine result for N. gonorrhoeae from a female has a lower negative predictive value than does an endocervical swab result. Testing of endocervical or vaginal specimens is recommended for female patients who are clinically suspected of having a gonococcal infection.  Urine from females not currently accepted.

2. Swabs should be held and transported at room temperature.  Use ONLY the Hologic APTIMA collection kit for swab samples.  NOTE: The Hologic swabs are NOT acceptable for culture of any type.

3. Test of Cure C. trachomatis NAAT testing can be ordered using the combination test as indicated above, but write in the comment line “CHLAMYDIA TOC ONLY”. In general, practitioners should consider testing for BOTH chlamydia and gonorrhea with each specimen as the risk factors, signs and symptoms are not distinguishable. Note that test of cure for chlamydia is only recommended by the CDC for pregnant women. Testing should be performed 3 weeks after the completion of therapy, or the results may be falsely positive.
4.   If you suspect therapeutic failure for gonorrhea, please contact the Microbiology Lab at 984-974-1830 to arrange antimicrobial susceptibility testing to be performed by the CDC.


Test sensitivity and specificity data are available here.

Reviewed by christopher parker on October 13, 2020

Note: Reference ranges provided on this web site are for guidance only, and may not reflect the most recent changes. Refer to laboratory reports for current reference data.

UNC Hospitals
McLendon Clinical Laboratories
101 Manning Drive
Chapel Hill, NC 27514