Test Details

Mnemonic

GCRNA

Ordering Code

3091200

CPT-4 Code(s)

87591

Specimen Information

Collect

Variable specimen types
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Specimen Preparation

Specimen source required for testing.
Endocervical, vaginal or male urethral swab specimens in APTIMA Combo II transport medium.
First catch urine in APTIMA Combo II Urine Transport Tube. Liquid level must fall between the two black indicator lines. Minimum 2.0 mL urine in sterile, specimen cup.
Dedicated specimens are required. If Chlamydia and Neisseria are both ordered one sample may be sent. Specimens used in other assays will not be tested.

Aptima Combo II Urine Transport media is currently unavailable.
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Minimum Volume

Determined by specimen type
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Transport Temperature

Varies by specimen type, see stability
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Rejection Criteria

Specimens submitted with the white cleaning swab or with two swabs. Transport tubes without swabs. Swabs in gel, wooden swabs, dry swabs other than BD Dry Swab system. Swabs in bacterial transport medium (e.g., culturettes). Urine specimens where the liquid level in the urine transport tube does not fall between the two black indicator lines. Urine specimens in sterile containers that have exceeded the 24 hour stability. Specimens collected in liquid cytology containers or media will not be tested.
Specimens collected in Universal Transport Medium (UTM)
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Stability

Swab in APTIMA Combo II or Aptima Multitest transport medium, Urine in APTIMA Combo II urine transport tube:
Room temperature: 30 days
Refrigerated: 30 days
Frozen -20°C: 90 days

Urine in an IATA sterile screw-capped plastic container. (For increased stability, transfer urine sample to APTIMA Combo II Urine transport tube within 24 hours of collection.) If sending a primary urine, transfer urine to a sterile IATA-approved screw-topped plastic container:
Refrigerated: 24 hours
Room temperature: Unacceptable
Frozen -20°C: 4 days

Swab in M4 and M5 Viral Transport tube:
Refrigerated: 4 days
Room temp: 24 hours
Frozen -20°C: 4 days

Swab in Gen-Probe Pace 2 swab transport tubes:
Room temperature: 7 days
Refrigerated: 7 days
Frozen -20°C: Unacceptable

Swab in BD ProbeTec ET CT/GC Diluent, BD ProbeTec Dry Swab:
Room temperature: 4 days
Refrigerated: 4 days
Frozen -20°C: Unacceptable
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Methodology

Transcription Mediated Amplification (TMA). Positive specimens are retested using a different TMA assay (different target) before reporting.
The analytical sensitivity of the Neisseria gonorrhoeae assay is 362 organisms per swab or 250 organisms per milliliter of urine.
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Reference Range

Not detected
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Performing Laboratory

Warde Medical Laboratory
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