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Neisseria gonorrhoeae RNA, TMA, UROGENITAL : 11362
Test CodeGCRNA2 or 11362
CPT Codes
87591
Transport Container
Vaginal swab: Follow instructions in the Multitest Collection Kit (orange label).
Endocervical or urethral swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit (white label).
In females, to ensure collection of cells infected with C. trachomatis, columnar epithelial cells lining the endocervix should be obtained. Excess mucus should be removed prior to sampling.
Urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Aptima® Specimen Transport Tube within 24 hours of collection and before being assayed. Use the tube provided in the Urine Specimen Collection Kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube label.
Labs performing cytology: Aliquot PreservCyt® solution before performance of liquid-based cytology testing.
PreservCyt®: Transfer 1 mL PreservCyt® solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Vaginal Collection or Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label).
SurePath™: SurePath™ fluid must be transferred to Aptima® tube within 4 days of collection. Transfer 0.5 mL SurePath™ solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Vaginal Collection or Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label)
Endocervical or urethral swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit (white label).
In females, to ensure collection of cells infected with C. trachomatis, columnar epithelial cells lining the endocervix should be obtained. Excess mucus should be removed prior to sampling.
Urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Aptima® Specimen Transport Tube within 24 hours of collection and before being assayed. Use the tube provided in the Urine Specimen Collection Kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube label.
Labs performing cytology: Aliquot PreservCyt® solution before performance of liquid-based cytology testing.
PreservCyt®: Transfer 1 mL PreservCyt® solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Vaginal Collection or Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label).
SurePath™: SurePath™ fluid must be transferred to Aptima® tube within 4 days of collection. Transfer 0.5 mL SurePath™ solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Vaginal Collection or Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label)
Transport Temperature
Room temperature.
Specimen Stability
(ThinPrep) in APTIMA(R) Transport Tube
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 1 year
Liquid cytology Preservative (ThinPrep®)
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 12 months
SurePath™ Preservative Fluid
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable
Urine in Aptima® Transport Medium
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 12 months
Swabs in Aptima® Transport
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 12 months
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 1 year
Liquid cytology Preservative (ThinPrep®)
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 12 months
SurePath™ Preservative Fluid
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable
Urine in Aptima® Transport Medium
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 12 months
Swabs in Aptima® Transport
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 12 months
Methodology
Transcription-Mediated Amplification (TMA)
Setup Schedule
Monday - Saturday
Report Available
1-3 days
Limitations
Note: Results from the APTIMA® Combo 2 Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician.
The APTIMA® Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications.
The APTIMA® Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications.
Reference Range
NOT DETECTED
Clinical Significance
Neisseria gonorrhoeae (gonococci) is the causative agent of gonorrhea. In men, this disease generally results in anterior urethritis accompanied by purulent exudate. In women, the disease is most often found in the cervix, but the vagina and uterus may also be infected.
Performing Laboratory
med fusion
