Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (GC) (Aptima® Combo 2 Assay) -IVD

TEST:   CPT: 87491 (CT), 87591(GC)

ThinPrep

Unisex Swab in female

Unisex Swab in male

Urine collection male or female

Storage Instructions

Causes for Rejection

Limitations

Methodology

CDC INFO

Expected Turnaround Time 1-4 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the report is sent to the ordering provider.  Additional time should be allowed for confirmatory, or reflex tests. 

Additional Documentation

SPECIMEN COLLECTION GUIDE

Specimen Requirements

Specimen

Vaginal, endocervical, or male urethral swab, first-void urine (patient should not have urinated for one hour prior to specimen collection), or cervical cells in liquid cytology vial.

Collection

Click on the images for a color guide

ThinPrep:  follow the standard collection methods for ThinPrep Cytology collection.

Multitest Vaginal Swab: 

Care provider specimen: Collect vaginal fluid sample using the Gen-Probe® Aptima® Vaginal Swab Kit by contacting the swab to the lower third of the vaginal wall, rotating the swab for 10 to 30 seconds to absorb the 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. 

Patient self-collection instructions: Partially open the package. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima® Vaginal Swab Specimen Collection Kit. Remove the swab. Carefully insert the swab into the vagina about 2" past the introitus and gently rotate the swab for 10 to 30 seconds, making sure the swab touches the walls of the vagina so that moisture is absorbed by the swab. Withdraw the swab without touching the skin. 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.

Endocervical swab: 

Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white shaft swab in the package with red printing). Discard this swab. Insert the specimen collection swab (blue shaft swab in the package with green printing) into the endocervical canal. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling. Withdraw the swab carefully; avoid contact with the vaginal mucosa. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube. Carefully break the swab shaft at the scoreline using care to avoid splashing of the contents. Recap the swab specimen transport tube tightly.

Male urethral swab: The patient should not have urinated for at least one hour prior to specimen collection. Insert the specimen collection swab (blue shaft swab in the package with the green printing) 2 to 4 cm into the urethra. Gently rotate the swab clockwise for two to three seconds in the urethra to ensure adequate sampling. Withdraw the swab carefully. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the specimen transport tube. Carefully break the swab shaft at the scoreline using care to avoid splashing of contents. Recap the swab specimen transport tube tightly.

Urine specimen: The patient should not have urinated for at least one hour prior to specimen collection. Direct patient to provide a first-catch urine (approximately 20 mL to 30 mL of the initial urine stream) into a urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity; lesser volumes may not adequately rinse organisms into the specimen. Female patients should not cleanse the labial area prior to providing the specimen. Add urine to the Aptima® COMBO 2 urine collection device. The final volume must be between the two black lines on the device (about 2 mL).

Store and transport specimens at room temperature (15 to 30°C). DO NOT freeze.

Specimen with incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions; specimens received after prolonged delay from time of pickup (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 >30 days from collection; Aptima® urine transport with incorrect specimen volume; <15 mL urine submitted in sterile container; receipt of urine in sterile container >24 hours from collection; Aptima® swab transport >30 days from collection; Aptima® swab specimens with incorrect specimen volume; Aptima® swab specimen without a swab; cleaning swab (white-shaft swab) in Aptima® swab transport; any non−Gen-Probe® swab submitted in Aptima® transport device; wooden-shaft swab in transport device; transport device with multiple swabs; female urethral swab; bloody or grossly mucoid specimens; bacterial swabs; specimen in ProbeTec™ UPT transport; ProbeTec™ Q-swabs; UTM-RT

Test Details

Use

Diagnosis of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis infections

The performance of the Aptima Combo 2 Assay has not been evaluated in adolescents less than 14 years of age.

The Aptima Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications. For those patients for whom a false positive result may have adverse psycho-social impact, the CDC recommends retesting.

See Product insert for full list of limitations.

Nucleic acid amplification (NAAT)

CDC Treatment resources:

NAAT tests are recommended by the CDC for detection.  
 
Chlamydia: Repeat infection with chlamydia is common. Women whose sex partners have not been appropriately treated are at high risk for re-infection. Having multiple chlamydial infections increases a woman’s risk of serious reproductive health complications, including pelvic inflammatory disease and ectopic pregnancy. Women and men with chlamydia should be retested about three months after treatment of an initial infection, regardless of whether they believe that their sex partners were successfully treated.
For Chlamydia, the CDC recommends that the woman and partner be treated with azithromycin, or doxycycline (97% and 98% cure rate respectively).  
Gonorrhea: Only one regimen, dual treatment with ceftriaxone and azithromycin, is recommended for treatment of gonorrhea in the United States.  This treats resistant strains as well.  "Following the spread of gonococcal fluoroquinolone resistance, the cephalosporin antibiotics have been the foundation of recommended treatment for gonorrhea." -CDC
 
CDC (https://www.cdc.gov/std/gisp) and state health departments can provide the most current information on gonococcal susceptibility.
Speciation of strains is not recommended  and is not necessarily an accurate representation of resistance.
If the patient is negative for Chlamydia and Gonorrhea, but still presents with similar symptoms, especially urethritis,  the patient could instead be infected with mycoplasma genitalium.  1-g single dose of azithromycin is the recommended treatment, but more information can be found on DC website. CDC: https://www.cdc.gov/std/tg2015/emerging.htm
Unisex Swab

Multitest Swab in female