A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
Neisseria gonorrhoeae RNA, TMA, UROGENITAL : 11362
Test CodeGCRNA2 or 11362
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
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 Tub
Instructions
Vaginal Swab: Follow instructions in the Aptima® 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. gonorrhoeae, 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 ThinPrep® PreservCyt® solution before performance of liquid-based cytology testing.
ThinPrep PreservCyt: Transfer 1 mL ThinPrep PreservCyt solution into Aptima Specimen Transfer Tube (green label) or Aptima Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Tube (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 Multitest Collection Kit Collection Tube (orange label) or Unisex Swab Specimen Collection Tube (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. gonorrhoeae, 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 ThinPrep® PreservCyt® solution before performance of liquid-based cytology testing.
ThinPrep PreservCyt: Transfer 1 mL ThinPrep PreservCyt solution into Aptima Specimen Transfer Tube (green label) or Aptima Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Tube (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 Multitest Collection Kit Collection Tube (orange label) or Unisex Swab Specimen Collection Tube (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
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
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