OVERVIEW

Purpose: In vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease.

SPECIMEN COLLECTION

Specimen Requirements: Submit one specimen per test requested. Specify the exact specimen source/origin (e.g., endocervical). Indicate a specific test number on the test request form.

Specimen Source: Endocervical, vaginal 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.

Minimum Volume: One swab (endocervical, vaginal or urethral), 2 mL of a 15 mL urine collection, or entire liquid cytology vial.

Collection Method:

• Gen-Probe® Aptima® Endocervical, Male Urethral, or Vaginal Swab
• Urine Specimen in a 15 mL urine collection tube
• Liquid-based Cytology Specimen

TEST DETAILS

Methodology: The Aptima Combo® 2 Assay is a 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) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease using the Panther System automated instrumentation as specified.

Compliance Category: FDA approved test.

Reference Interval: No Chlamydia trachomatis or Neisseria gonorrhoeae detected.

Limitations:

• This assay has been tested using only the following specimens:
  • Clinician-collected endocervical, vaginal, and male urethral swab specimens
  • Clinician-collected PreservCyt Solution liquid Pap specimens
  • Patient-collected vaginal swab specimens
  • Patient-collected female and male urine specimens
• Performance with specimens other than those collected with the following specimen collection kits has NOT been evaluated:
  • Aptima Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens
  • Aptima Urine Collection Kit for Male and Female Urine Specimens
  • Aptima Vaginal Swab Specimen Collection Kit
  • Aptima Specimen Transfer Kit (for use with gynecologic samples collected in PreservCyt Solution)
• Urine, vaginal swab, and PreservCyt Solution liquid Pap specimen sampling is not designed to replace cervical exams and endocervical specimens for diagnosis of female urogenital infections. Patients may have cervicitis, urethritis, urinary tract infections or vaginal infections due to other causes or concurrent infections with other agents.
• 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.
• Reliable results are dependent on adequate specimen collection. Because the transport system used for this assay does not permit microscopic assessment of specimen adequacy, training of clinicians in proper specimen collection techniques is necessary.
• Therapeutic failure or success cannot be determined with the Aptima Combo 2 Assay since nucleic acid may persist following appropriate antimicrobial therapy.
• Results from the Aptima Combo 2 Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician.

Sample Stability: 7 days at 37°C and 50°C, 14 days at room temperature, as well as refrigerated and frozen temperatures.

Turnaround Time: 98% < 72 hours, 50% < 24 hours

Directorship: Cheryl Hanau, MD; Garth Ehrlich, PhD, FAAAS, FAAM; Donald Hall Jr., PhD; Yinghua Qiu, PhD, DABCC

CPT Code: 87491; 87591

Review Date: 08/28/2023

SPECIMEN PROCESSING

Specimen Transport and Storage:

• Swab specimens: Transport and store the swab in the swab specimen transport tube at 2C to 30C until tested. Specimens must be assayed within 60 days of collection. Freeze at -20C to -70C for up to 12 months after collection.
• Urine specimens: Transfer the urine sample into the Aptima urine specimen transport tube within 24 hours of collection. Store at 2C to 30C and test within 30 days of collection. Freeze at -20C to -70C for up to 12 months after collection.
• PreservCyt Solution liquid Pap specimens: PreservCyt Solution liquid Pap specimens must be processed for cytology and/or transferred to an Aptima Specimen Transfer tube within 30 days of collection when stored at 2°C to 30°C. Once the PreservCyt Solution liquid Pap specimen is transferred to the Aptima Specimen Transfer tube, the specimen must be assayed within 30 days when stored at 2°C to 8°C or 14 days when stored at 15°C to 30°C. Freeze at -20°C to -70°C for up to 12 months after transfer.

Rejection Criteria:

• Inappropriate specimen condition:
  • Incorrect patient identification
  • Unlabeled specimen
  • Incorrect specimen volume
  • Without a swab, multiple swabs, cleaning swab (white-shaft swab), any non-Gen-Probe® swab
  • Bloody or grossly mucoid specimens
• Inappropriate specimen transport conditions:
  • Specimen leaked in transit
  • Specimen in expired transport or incorrect transport device
  • Inappropriate specimen source for test requested
• Specimen stability limits exceeded

 
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The information on these pages is provided for general information only and should not be used for diagnosis or treatment, or as a substitute for consultation with a physician or health care professional. If you have specific questions or concerns about your health, you should consult your health care professional.