| Neisseria gonorrhoeae (GC) Amplified Assay (8000100613) | |
|---|---|
| Test Mnemonic: | |
| Specimen Requirements: | Female - endocervical or vaginal collection. Male - urethral sample. Both - urine first catch (first void), throat, rectal samples. |
| Collection: | Aptima® transport tubes- Follow the directions in the Aptima® collection kit. 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 initial urine stream) in a urine collection container free of any preservatives. Collection of larger volumes of urine may reduce test sensitivity. Female patients should not cleanse the labial area prior to providing the specimen. Liquid Pap (Thin Prep®) collection devices may also be submitted for this test. |
| Container: | Urine samples - sterile cup or tube; Aptima® collection tubes; Liquid Pap containers (ThinPrep) |
| 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. |
| Specimen Preparation: | Urine- Transfer 2 mL urine first catch (first void) into the Aptima®Urine Specimen Transport tube using the disposable pipette provided in the kit. The correct volume of urine has been added when the fluid level is between the black fill lines on the urine specimen transport tube label. |
| Stability: | Urine samples (2 - 30°C) that are not transferred 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 (Thin Prep®) containers - 30 days if refrigerated/room temperature. |
| Causes for Rejection: | Failure to use Aptima® collection kit, samples from non-approved sources. Urine in tube with preservatives, specimen container unlabeled or labeled incorrectly, no date and time of collection on the requisition form, insufficient quantity of urine for test requirements. |
| Reference Range: | Negative |
| Turnaround Time: | Test is performed daily, Monday through Friday |
| Methodology: | Nucleic acid amplification by transcription-mediated amplification (TMA), target capture, and Dual Kinetic Assay (DKA) technologies |
| Performed: | Clinical Microbiology |
| Synonyms: | GC Probe; GC Amplified Assay; GC Test |
| Clinical Indication: | Suspected infection with N. gonorrhoeae in urine first catch (first void), throat, rectal, endocervical, urethral, and vaginal specimens. |
| Patient Preparation : | Female - endocervical or vaginal collection; male - urethral sample; Both - urine first catch (first void), throat, rectal samples |
| CPT 4 Code: | 87591 |
| Note: | This test is not recommended for medico-legal purposes. Collect C. trachomatis and GC cultures in cases 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. Aptima transport for male and female collection kits are available through Materials Management.
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| 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. | |