Test Overview
Test Methodology

Aptima Combo 2 target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC).

Test Usage

Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in male or female urogenital specimens.

Reference Range *

Negative

Test Limitations

Adequate specimen collection is important. Mucoid specimens may cause inhibition of the assay. Some feminine sprays, powders, spermicidal agents, and lubricants may interfere with the assay and should not be used prior to specimen collection. A negative result does not exclude the possibility of infection. Predictive value of test will vary depending on disease prevalence. Nucleic acids may persist for up to 4 weeks following appropriate antimicrobial therapy.

Test Details
Days Set Up
Tuesday-Friday and Sunday
Analytic Time

Tuesday-Friday and Sunday TAT 1 day
Specimens received on Friday or Sunday afternoon TAT 2 days

Soft Order Code
CHLGC
MiChart Code
Chlamydia trachomatis-Neisseria gonorrhoeae RNA (Swab)
Synonyms
  • Chlamydia trachomatis RNA Amplification
  • CT RNA Amplification
  • GC RNA Amplification
  • GC
  • Neisseria gonorrhoeae RNA Amplification
  • GCI
  • PCRGC
  • PCRCHL
  • NEISSERIA GONORRHOEAE DNA
  • CHLAMYDIA TRACHOMATIS DNA
  • CHL
  • CHLI
Laboratory
Microbiology
Section
Microbiology
Specimen Requirements
Collection

VAGINAL: Use the APTIMA Vaginal Swab Collection Kit. 1. Partially peel open the swab package. Remove the swab. 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 Collection Kit. 2. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line. 3. Carefully insert the swab into the vagina about 2 inches (5 cm) past the introitus and gently rotate the swab for 10 to 30 seconds. Make sure the swab touches the walls of the vagina so that moisture is absorbed by the swab and then withdraw the swab without touching the skin. 4. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new APTIMA Vaginal Swab Collection Kit 5. Immediately place the swab into the transport tube so that the score line is at the top of the tube. 6. Carefully break the swab shaft against the side of the tube at the score line and discard the top portion of the swab shaft, using care to avoid splashing of contents. 7. Recap the swab transport media tube tightly and label with two identifiers. Store and transport at room temperature or refrigerated (up to 30 days). See http://www.pathology.med.umich.edu/handbook/Tables/Aptima_Vaginal_Swab… for collection procedure guide.

ENDOCERVICAL: Use the APTIMA Unisex Swab Collection Kit. 1. Remove excess mucus from the cervical os and surrounding mucosa using the large, white shaft cleaning swab. Discard this swab. 2. Insert the small blue shaft collection swab into the endocervical canal. Gently rotate the swab clockwise for 10 to 30 seconds. 3. Withdraw the swab carefully, avoiding any contact with the vaginal mucosa. 4. Remove the cap from the swab specimen transport tube and immediately place the swab into the transport tube. 5. Carefully break the swab shaft against the side of the tube at the score line and discard the top portion of the swab shaft, using care to avoid splashing of contents. 6. Recap the swab specimen transport tube tightly and label with two identifiers. Store and transport at room temperature or refrigerated (up to 30 days). See http://www.pathology.med.umich.edu/handbook/Tables/Aptima_Unisex_Swab.p… for collection procedure guide.

MALE URETHRAL: Use the APTIMA Unisex Swab Collection Kit. 1. The patient should not have urinated for at least 1 hour prior to sample collection. 2. Insert the small blue shaft collection swab (NOT the larger white shaft cleaning swab) 2-4 cm into the urethra. Gently rotate the swab clockwise for 2-3 seconds. 3. Withdraw the swab carefully. 4. Remove the cap from the swab specimen transport tube and immediately place the swab into the transport tube. 5. Carefully break the swab shaft against the side of the tube at the score line and discard the top portion of the swab shaft, using care to avoid splashing of contents. 6. Recap the swab specimen transport tube tightly and label with two identifiers. Store and transport at room temperature or refrigerated (up to 30 days). See http://www.pathology.med.umich.edu/handbook/Tables/Aptima_Unisex_Swab.p… for collection procedure guide.

Rejection Criteria
The following specimens are unacceptable: white shaft cleaning swabs, wooden swabs, or Calgiswabs, BD Eswabs, BD ProbeTec transport, M4-RT transport.
Contraindications
This assay should not be used for the evaluation of suspected sexual abuse or other medico-legal investigations where chain of custody is required. MLabs does not offer chain of custody testing.
Normal Volume
1 swab
Minimum Volume
1 swab
Additional Information

A combined assay for simultaneous detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) is used. Individual CT and NG test options are not available. If either CT or NG is requested, both assays will be performed, reported, and billed.

Billing
CPT Code
87491, 87591
Fee Code
32301, 32302
LOINC
64017-7
NY State Approved
No