| 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, TMA (Alternate Target), Urogenital
Test Code15033
CPT Codes
87591
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)
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)
Patient Preparation
For urine, the patient should not have urinated for at least one hour prior to specimen collection
Other Acceptable Specimens
Vaginal swab in APTIMA® Combo 2 assay vaginal swab
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
Swab
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 1 year
APTIMA® 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
APTIMA® 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 underfilled APTIMA® urine tubes
Methodology
Dual Kinetic Assay (DKA) • Target Capture • Transcription-Mediated Amplification (TMA)
Setup Schedule
A.M. Sets up 1 day a week.
Report Available
Reports in 2 days.
Clinical Significance
Several methods are available for the detection of N. gonorrhoeae in clinical specimens. These methods include: Observation of gram-negative intracellular diplococci in gram-stained smears of urethral discharges from men and of endocervical secretions from women; Growth of N. gonorrhoeae from the urethra (men) or endocervix on selective culture media followed by demonstration of typical colonial morphology; and/or detection of N. gonorrhoeae with non-culture laboratory tests. A definitive diagnosis of gonorrhoea requires: Isolation of N. gonorrhoeae from the sites of exposure by culture; demonstration of typical colonial morphology, a positive oxidase test, and typical gram-negative morphology; And finally, a confirmation by specific identification methods. These confirmation methods may include acid production from carbohydrates, rapid enzyme tests, serologic assays, and tests for specific nucleic acids, such as is performed by the CT/NG APTIMA® TMA Assay.
