Trichomonas amplified probe
Trichomonas amplified probe-8940
Diagnosis of Trichomonas vaginalis infection in male or female patients.
Trichomonas vaginalis is the most common curable sexually transmitted disease (STD) agent in the U.S. It causes vaginitis, urethritis, pelvic inflammatory disease, preterm births, low-birth-weight infants, and increased risk of HIV transmission.
Due to the high prevalence of T. vaginalis in all female age groups, it is suggested that both symptomatic and asymptomatic women who are screened for Chlamydia trachomatis and Neisseria gonorrhoeae should also be screened for T. vaginalis.
- To ensure proper endocervical sampling, excess mucus should be removed.
- Urine and vaginal swab specimen sampling is not designed to replace cervical exams for diagnosis of female urogenital infections. Patients may have cervicitis, urethritis, urinary tract infections, or vaginal infections due to other causes or concurrent infections with other agents.
- Performance with other specimen types has not been evaluated.
- Therapeutic failure or success cannot be determined since nucleic acid may persist following appropriate antimicrobial therapy.
- Results should be interpreted in conjunction with other clinical data available to the clinician.
- Performance of the vaginal swab specimen has not been evaluated in pregnant women or women less than 14 years of age.
- A negative result does not preclude a possible infection because the presence of Trichomonas tenax or Pentatrichomonas hominis in a specimen may affect the ability to detect T. vaginalis. T. tenax is a commensal of the oral cavity, and P. hominis is a commensal of the large intestine.
Urine collections:
- Patient should not have urinated for at least 1 hour prior to specimen collection
- Female patients should not cleanse labial area prior to providing the specimen
Aptima Multitest swab specimen collection kit
or
Xpert Swab Specimen Collection Kit (Allina Only, Workday # 418585)
Vaginal swab specimens:
- Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new collection kit.
- Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line.
- Carefully insert the swab into the vagina about 2 inches past the introitus and gently rotate the swab for 10 to 30 seconds. Make sure the swab touches the walls of the vagina so that moisture is absorbed by the swab and then withdraw the swab without touching the skin.
- While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Multitest Swab Specimen Collection Kit.
- Immediately place the swab into the transport tube so that the score line is at the top of the tube.
- Carefully break the swab shaft at the score line against the side of the tube.
- Immediately discard the top portion of the swab shaft.
- Tightly screw the cap onto the tube.
Note: Large white swab in Xpert Swab kit is for clearing excessive mucus or discharge if present prior to collecting specimen with the smaller scored swab.
Aptima Multitest swab specimen collection kit
or
Xpert Swab Specimen Collection Kit
Direct patient to provide first-catch urine (approximately 20 to 30 mL of initial urine stream) into urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity.
Urine should preferably be transferred to urine specimen transport at the bedside to reduce risk of molecular cross contamination. If poured off in the lab change gloves before and after opening urine.
- Label urine transport with patient information.
- Remove cap from urine specimen transport tube and transfer urine into urine specimen transport tube using disposable pipette provided. The correct volume of urine has been added when fluid level is between black fill lines on transport tube.
- Screw cap on tightly to prevent leaking.
Aptima Urine specimen collection kit
or
Xpert Urine Specimen Collection Kit (Allina Only, Workday # 418586)
Swab:
Ambient - 60 days
Refrigerated - 60 days
Urine:
Ambient - 30 days
Refrigerated - 30 days
- Improper label (unlabeled or mislabeled)
- Time delay between time of collection and receipt of specimen
- Improper transport container
- Improper transport temperature
- Interfering substances
- Blue Swab in Multitest Specimen Collection transport media
- Catheterized urine
- Urine transport tube not filled “Fill Area” (above or below-rejected)
- M4 or M5 media
- Sources other than vaginal or urine (eye, rectal, throat specimens, etc.)
- Leaking container
Nucleic Acid Amplification Test (NAAT)
Negative (Not Detected)
|
Aptima Trichomonas Female Assay Performance |
||
|
Specimen Type |
Sensitivity |
Specificity |
|
Vaginal Swab Asymptomatic |
100% |
98.9% |
|
Urine Asymptomatic |
95.5% |
99.0% |
|
Overall Asymptomatic |
98.4% |
99.7% |
|
Vaginal Swab Symptomatic |
100% |
99.1% |
|
Urine Symptomatic |
95.2% |
98.9% |
|
Symptomatic Overall |
98.4% |
99.1% |
|
Aptima Trichomonas Male Urine Assay Performance |
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|
|
Sensitivity |
Specificity |
|
Symptomatic |
100% |
99.7% |
|
Asymptomatic |
100% |
99.9% |
|
Overall |
100% |
99.8% |