GC/Chlamydia Amplification, Urine




Test Mnemonic

UGCCT

CPT Codes

  • 87491 - QTY (1)
  • 87591 - QTY (1)

LOINC ®

44806-8

Aliases

  • GCCAMP; Neisseria gonorrhoeae/Chlamydia trachomatis Amplif;

Performing Laboratory

Cleveland Clinic Laboratories


Specimen Requirements

Volume Type Container Collect Temperature Transport Temperature Special Instructions
2 mLUrine, first-catchAPTIMA Urine specimen collection kit  Type: Urine, first-catch Container: APTIMA Urine specimen collection kit Notes: First-catch urine is the optimal specimen for screening asymptomatic men; urine may also be used for testing symptomatic patients of either sex. Patients providing urine specimens should not have urinated within one hour of collection. Transfer 2ml of urine into the APTIMA Urine specimen transport tube using a sterile, disposable pipette. The correct volume of urine has been added when the fluid level is between the black fill lines on the APTIMA Urine specimen transport tube. Do not overfill or underfill the APTIMA Urine transport tube. Ambient: Urine in APTIMA transport media: 30 days Frozen: Urine in APTIMA transport media: 12 months Refrigerated: Urine in APTIMA transport media: 30 days

Alternate Specimen Requirements

Volume Type Container Collect Temperature Transport Temperature Special Instructions
20 mLUrine, first-catchSterile container  Urine, first-catch Container: Sterile container (no preservatives) Notes: First-catch urine is the optimal specimen for screening asymptomatic men; urine may also be used for testing symptomatic patients of either sex. Patients providing urine specimens should not have urinated within one hour of collection. Unpreserved urine must be transported to the lab within 24 hours. Transport 2-30 C. Ambient: Unpreserved urine: 24 hours Refrigerator: Unpreserved urine: 24 hours Frozen: Unpreserved urine: Unacceptable

Stability

Environmental Condition Description
AmbientAmbient: Urine in APTIMA transport media: 30 days; Unpreserved urine (urine in primary container): 24 hours;
FrozenFrozen: Urine in APTIMA transport media: 12 months; Unpreserved urine (urine in primary container): Unacceptable;
RefrigeratedRefrigerated: Urine in APTIMA transport media: 30 days; Unpreserved urine (urine in primary container): 24 hours;

Days Performed

Mon - Fri

Turnaround Time

1 - 4 days

Methodology

Name Description
Target amplification nucleic acid probe, qualitative 

Reference Range

Special Info

Because the predictive value of a test correlates with disease prevalence, positive results in low-prevalence populations should be interpreted carefully with the understanding that the likelihood of a false positive may be higher than a true positive. False positive results due to nonviable organism may occur if repeat NAAT is performed within 3 weeks after treatment. Patients treated for chlamydia should be retested 3 months after treatment. A test-of-cure is not recommended for patients with uncomplicated urogenital or rectal gonorrhea. Culture to recover N. gonorrhoeae for susceptibility testing is suggested if treatment failure is suspected. Specimens being submitted for culture need collection with a non-Aptima kit (culturette for N. gonorrhoeae; swab in M4 or universal transport media device for C. trachomatis). There is currently no FDA clearance for use of amplification assays on specimens outside of the genitourinary tract or urine from female patients. Culture is required for testing specimens from the throat, eye, or rectal area if molecular testing validated for these sites is not available. Culture is preferred for testing extragenital sites from children and urethral or urine specimens from boys. Since NAAT is more sensitive, it may be run in conjunction with culture for purposes of treatment decision-making. NAAT is considered acceptable for testing vaginal secretions or urine from girls.

Clinical Info

Chlamydia trachomatis and Neisseria gonorrhoeae are bacteria that cause sexually transmitted diseases (STDs) known as chlamydia and gonorrhea. Sites of chlamydial and gonococcal infections include the urethra, cervix, rectum, and throat. In women, the entire reproductive tract may be involved leading to pelvic inflammatory disease (PID), chronic pelvic pain and infertility. Newborns exposed to C. trachomatis and N. gonorrhoeae during birth may develop a type of conjunctivitis known as ophthalmia neonatorum. Untreated gonococcal infections can progress to disseminated disease with bacteremia, arthritis and dermatitis. Individuals who have chlamydia or gonorrhea are at increased risk of acquiring HIV. Chlamydial and gonococcal infections are often asymptomatic. When symptoms do occur, those reported include dysuria, urethral or vaginal discharge, vaginal bleeding, and abdominal or testicular pain. In 2015, more than 1.5 million cases of chlamydia and nearly 400,000 cases of gonorrhea were reported to the CDC. Nucleic acid amplification tests (NAAT) are used for detection of genitourinary tract infections caused by C. trachomatis and N. gonorrhoeae. This assay detects nucleic acids of both types of bacteria in a single specimen, thus providing a convenient approach to dual detection. For asymptomatic women, the optimal specimen is a vaginal swab. For asymptomatic men, the optimal specimen is urine. In symptomatic women, a vaginal swab, cervical swab, or urine may be collected. In symptomatic men, a urethral swab or urine specimen may be submitted. Swab specimens must be collected using an Aptima Unisex or Vaginal swab collection kit.