| 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 trachomatis, TMA (Alternate Target), Urogenital
Test Code15031
CPT Codes
87491
Preferred Specimen
1 vaginal, endocervical or urethral swab collected in an APTIMA® Vaginal Swab Specimen Collection kit or Multi-Test collection kit, or Unisex swab specimen collection kit
2 mL urine with no preservative transferred into an APTIMA® urine collection kit
1 mL PreservCyt® (ThinPrep®) transferred into APTIMA® Specimen Transfer tube (green label) or APTIMA® Vaginal Swab Specimen Collection kit or Multi-Test collection kit Collection tube (orange label)
2 mL urine with no preservative transferred into an APTIMA® urine collection kit
1 mL PreservCyt® (ThinPrep®) transferred into APTIMA® Specimen Transfer tube (green label) or APTIMA® Vaginal Swab Specimen Collection kit or Multi-Test collection kit Collection tube (orange label)
Patient Preparation
For urine, patient should not have urinated within 1 hour prior to collection
Other Acceptable Specimens
Vaginal swab in APTIMA® vaginal collection kit or Multi-Test collection kit
Instructions
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
Swabs: Swab MUST be submitted in APTIMA® Vaginal Swab Specimen Collection kit or Multi-Test collection kit, or Unisex Swab Specimen Collection tube. Follow instructions in the APTIMA® Swab Specimen Collection Kits for Vaginal, Endocervical and Urethral Swab Specimens package insert. In females, to ensure collection of an adequate specimen, columnar epithelial cells lining the endocervix should be obtained. To that effect, excess mucus should be removed prior to sampling by using the white shaft cleaning swab which is discarded after use.
Collection Container: APTIMA®Vaginal Swab Specimen Collection kit or Multi-Test collection kit, or Unisex Swab Specimen Collection Kit.
Urine: Urine MUST be submitted in APTIMA® Urine Specimen Collection tube within 24 hours of collection. The patient should not have urinated for at least one hour prior to specimen collection. Direct patient to provide a first-catch urine (approximately 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity. Female patients should not cleanse the labial area prior to providing the specimen. Thus, a urine sample collected from a female for Chlamydia/GC TMA cannot be collected at the same voiding event as that urine which would be intended for bacterial culture. Remove the cap of the APTIMA® Urine Specimen Collection tube and transfer 2 mL of urine into the urine specimen transport tube using the disposable pipette provided. The correct volume of urine has been added when the fluid level is between the black lines within the clear pane on the urine specimen transport tube label.
Collection Container: APTIMA® Urine Specimen Collection Kit. PreservCyt® (ThinPrep®): Transfer 1 mL of PreservCyt® (ThinPrep® solution into APTIMA® Specimen Transfer tube (green label) or APTIMA® Vaginal Swab Specimen Collection kit or Multi-Test collection kit Collection tube (orange label).
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
Swabs: Swab MUST be submitted in APTIMA® Vaginal Swab Specimen Collection kit or Multi-Test collection kit, or Unisex Swab Specimen Collection tube. Follow instructions in the APTIMA® Swab Specimen Collection Kits for Vaginal, Endocervical and Urethral Swab Specimens package insert. In females, to ensure collection of an adequate specimen, columnar epithelial cells lining the endocervix should be obtained. To that effect, excess mucus should be removed prior to sampling by using the white shaft cleaning swab which is discarded after use.
Collection Container: APTIMA®Vaginal Swab Specimen Collection kit or Multi-Test collection kit, or Unisex Swab Specimen Collection Kit.
Urine: Urine MUST be submitted in APTIMA® Urine Specimen Collection tube within 24 hours of collection. The patient should not have urinated for at least one hour prior to specimen collection. Direct patient to provide a first-catch urine (approximately 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity. Female patients should not cleanse the labial area prior to providing the specimen. Thus, a urine sample collected from a female for Chlamydia/GC TMA cannot be collected at the same voiding event as that urine which would be intended for bacterial culture. Remove the cap of the APTIMA® Urine Specimen Collection tube and transfer 2 mL of urine into the urine specimen transport tube using the disposable pipette provided. The correct volume of urine has been added when the fluid level is between the black lines within the clear pane on the urine specimen transport tube label.
Collection Container: APTIMA® Urine Specimen Collection Kit. PreservCyt® (ThinPrep®): Transfer 1 mL of PreservCyt® (ThinPrep® solution into APTIMA® Specimen Transfer tube (green label) or APTIMA® Vaginal Swab Specimen Collection kit or Multi-Test collection kit Collection tube (orange label).
Transport Temperature
Room temperature
Specimen Stability
Endocervical, urethral and vaginal swabs
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 1 year
Urine
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year
PreservCyt® solution specimen in APTIMA®
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 1 year
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 1 year
Urine
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year
PreservCyt® solution specimen in APTIMA®
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 1 year
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Transport tubes with 2 swabs • Non-APTIMA® transport tubes and swabs • Transport tubes containing white cleaning swabs • Over or under-filled APTIMA® urine tubes
Methodology
Dual Kinetic Assay (DKA) • Target Capture • Transcription-Mediated Amplification (TMA)
Setup Schedule
A.M. Sets up 1 day a week.
Clinical Significance
Several methods are available for the detection of C. trachomatis in clinical specimens, including giemsa staining of tissue, fluorescent antibody staining, culture, and nucleic acid detection. Although culture is very specific, it lacks sensitivity, so recommendations have been put forth to include multiple tests in assisting with a diagnosis of infection, including tests such as the CT/NG APTIMA® TMA Assay.
