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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 # |
Chlamydia/N. gonorrhoeae and T. vaginalis RNA, Qualitative TMA
Test CodeCPT Codes
87491, 87591, 87661
Includes
Trichomonas vaginalis RNA, Qualitative, TMA
Preferred Specimen
2 mL Female or Male urine in collected in an Aptima® transport 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
Other Acceptable Specimens
Instructions
Vaginal swab: Follow instructions in the Aptima® Vaginal Swab Collection or Multitest Collection Kit (orange label).
Endocervical swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit (white label). In females, to ensure collection of cells infected with N. gonorrhoeae/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 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.
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.
For a complete list of assay limitations we recommend that you review the manufacturers package insert, https://www.hologic.com/package-inserts/diagnostic-products/aptima-combo-2-assay-ctng
Transport Temperature
Specimen Stability
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 6 months
Urine
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 6 months
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Methodology
Transcription-Mediated Amplification (TMA)
Setup Schedule
Reference Range
C. trachomatis RNA, TMA, Urogenital | Not detected |
N. gonorrhoeae RNA, TMA, Urogenital | Not detected |
T. vaginalis RNA, QL, TMA | Not detected |
Clinical Significance