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Neisseria gonorrhoeae RNA, TMA, Urogenital
Test Code11362X
CPT Codes
87591
Preferred Specimen
1 vaginal swab in Aptima® Transport Tube or
1 endocervical or urethral swab in Aptima® Transport Tube or
2 mL urine in Aptima® Transport Tube or
1 mL liquid cytology (PreservCyt®) Preservative (ThinPrep®) in Aptima® Transfer Tube or
0.5 mL SurePath™ Preservative Fluid in Aptima® Transfer Tube
1 endocervical or urethral swab in Aptima® Transport Tube or
2 mL urine in Aptima® Transport Tube or
1 mL liquid cytology (PreservCyt®) Preservative (ThinPrep®) in Aptima® Transfer Tube or
0.5 mL SurePath™ Preservative Fluid in Aptima® Transfer Tube
Patient Preparation
Urine: Patient should not have urinated within one hour prior to collection. Female patients should not cleanse the labial area prior to providing the specimen.
Minimum Volume
1 vaginal swab in Aptima® Transport • 1 endocervical or urethral swab in Aptima® Transport • 2 mL urine in Aptima® Transport • 1 mL PreservCyt® (ThinPrep®) in Aptima® Transfer Tube • 0.5 mL SurePath™ fluid in Aptima® Transfer Tube
Instructions
Vaginal Swab: Follow instructions in the APTIMA® Vaginal Swab Collection or 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 N. gonorrhoea, 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 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® ThinPrep solution before performance of liquid based cytology testing.
PreservCyt® ThinPrep: Transfer 1 mL PreservCyt® ThinPrep 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 N. gonorrhoea, 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 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® ThinPrep solution before performance of liquid based cytology testing.
PreservCyt® ThinPrep: Transfer 1 mL PreservCyt® ThinPrep 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
PreservCyt(R) (ThinPrep®) in Aptima® Transport Tube
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 1 year
Liquid cytology (Preservcyt® Preservative (ThinPrep®)
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year
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: 1 year
Swabs in Aptima® Transport
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 1 year
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 1 year
Liquid cytology (Preservcyt® Preservative (ThinPrep®)
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year
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: 1 year
Swabs in Aptima® Transport
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 1 year
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Transport tubes with 2 swabs • Transport tubes with Non-Aptima® swabs • Swab transport tubes with no swab • Specimens in broken containers • Swab submitted in viral transport media • Urine samples where the fluid level is not between the black fill lines • PreservCyt® ThinPrep® material previously processed for cytology • PreservCyt® ThinPrep® with excess mucus
Methodology
Transcription-Mediated Amplification (TMA)
Setup Schedule
A.M.
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.
