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N. gonorrhoeae (GC) & Chlamydia trachomatis (CT) Amplified Assay (8000100011 )
Test Mnemonic:

V NCAA

Specimen Requirements:
Test Included:

Female- endocervical or vaginal collection.

Male- urethral sample.

Both- urine first catch (first void) samples, throat swab, or rectal swab.

Collection:

Swabs- Follow the instructions found with the Aptima collection kit for endocervical/vaginal/male urethral specimens.

Urine- Patient should not have urinated at least 1 hour prior to collection. Patient is instructed to collect a first-catch urine (approximately 20-30 mL of the intial urine stream) in a urine collection container free from preservatives. Collection of larger volumes of urine may reduce test sensistivity. Female patients should not cleanse the labial area prior to providing the specimen.

Liquid Pap (ThinPrep) collection devices may also be submitted for this test.

Container:

Urine- sterile container.

Liquid Pap collection tubes (ThinPrep).

Aptima collection tubes.

Minimum Volume:

Urine- 2 mL aliquot from a 20 - 30 mL collection 

Storage/Transport:

Refrigerated or room temperature (2 - 30° C)

Do not allow contact with other patients' samples in order to avoid any cross contamination.

Stability:

Urine specimens (2 - 30° C) that are not tranferred into a Aptima Urine Specimen Transport Tube must be received in the laboratory within 24 hours of collection.

Aptima Transport Tubes- 30 days refrigerated/room temperature.

Liquid Pap (ThinPrep) containers- 30 days if refrigerated/room temperature

Causes for Rejection:

Specimens must meet criteri set forth in the Laboratory Services Labeling and Requests for Testing policy.

Failure to use Aptima collection kit,

Specimens from non-approved sources.

Urine in tube with preservatives with the exception of the Aptima Urine Specimen Transport tube.

Reference Range:

Negative

Turnaround Time:

Test is performed in batch, once per day, five days per week.

Methodology:

Nucleic acid amplification by transcription- mediated amplification, target capture and dual kinetic assay.

Performed:

Clinical Microbiology

Synonyms:

CT Test; CT Assay; CT Probe Test; Chlamydia Test; GC Test; GC Assay; GC Probe Test, Gonorrhoeae Test

Clinical Indication:

Suspected infection with Chlamydia trachomatis and/or N. gonorrhoeae in urine first catch (first void), throat, rectal, endocervical, urethral, and vaginal specimens.

CPT 4 Code:

87491, 87591

Note:

This test is not recommended for medico-legal purposes. Collect C. trachomatis and GC cultures in case of suspected sexual abuse.

Collection kits specific for the Aptima system must be used unless Liquid Pap sample or urine are collected. No other transport system is acceptable. One transport may be submitted for both Chlamydia trachomatis and Neisseria gonorrhoeae testing. 

When ordering tests for which Medicare or Medicaid reimbursement will be sought, physicians should only order tests that are medically necessary for the diagnosis or treatment of the patient. Components of the organ or disease panels may be ordered individually. The diagnostic information must substantiate all tests ordered and must be in the form of an ICD-10 code or its verbal equivalent.
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