Trichomonas amplified probe

Alphabetical Test listing

Trichomonas amplified probe-8940

10/06/2020

Due to the validation of new instrumentation, this test is currently not available.  The suggested alternative test is the Trichomonas vaginalis, NAA, (13423/LAB13423) which is acceptable for both male and female sources

 

  
Trichomonas amplified probe
  
8940
  
LAB8940
  
TRI
  

Trichomonas vaginalis is the most common curable sexually transmitted disease (STD) agent in the U.S. It causes vaginitis, 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.

The assay may be used to test the following specimens from symptomatic or asymptomatic women; clinician-collected endocervical or vaginal swabs and female urines.

  

Urine:

  • Patient should not have urinated for at least 1hour prior to specimen collection
  • Female patients should not cleanse labial area prior to providing the specimen
  
Vaginal or endocervical swab
  

Aptima Unisex swab specimen collection kit

Endocervical swab collections

Aptima Multitest swab specimen collection kit

Vaginal swab collections

 

 

 

  

Endocervical swab specimens:

Use Aptima Unisex swab specimen collection kit. Specimen will be rejected if collected with Aptima Vaginal Swab Specimen Collection Kit.

  1. Remove excess mucus from cervical os and surrounding mucosa using cleaning swab (white-shafted swab in package with red printing). Discard the white swab.
  2. Insert specimen collection swab (blue-shafted swab in package with green printing) into endocervical canal.
  3. Gently rotate swab clockwise for 10 to 30 seconds in endocervical canal to ensure adequate sampling.
  4. Withdraw swab carefully; avoid any contact with vaginal mucosa.
  5. Remove cap from swab specimen transport tube and immediately place specimen collection swab into specimen transport tube.
  6. Carefully break swab shaft at scoreline and discard the top portion of the swab shaft; use care to avoid splashing contents.
  7. Re-cap swab specimen transport tube tightly.

 Vaginal swab specimens:

Use Aptima Multitest swab specimen collection kit. Specimen will be rejected if collected with Aptima Unisex Swab Specimen Collection Kit.

  1. 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. 
  2. 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. 
  3. 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.
  4. 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 Vaginal swab Specimen Collection Kit.
  5. Immediately place the swab into the transport tube so that the score line is at the top of the tube.
  6. Carefully break the swab shaft at the score line against the side of the tube.
  7. Immediately discard the top portion of the swab shaft.
  8. Tightly screw the cap onto the tube.

 

  

Do not group multiple tubes together in one bag due to the risk of DNA cross-contamination and rejection of all specimens if there is leakage.

  

Aptima Multitest swab specimen collection kit

Aptima Unisex specimen collection kit

 

 

  
Urine (female only)
  
  

 Female Urine Specimens:

  • Patient should not have urinated for at least 1hr prior to specimen collection.
  • Female patients should not cleanse labial area prior to providing the specimen.

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.

  
  1. Remove cap from urine specimen transport tube and transfer 2 mL of 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 urine specimen transport tube label.
  2. If refrigerated, urine may be transferred to the transport tube at the collection site within 24 hr.
  3. Re-cap urine specimen transport tube tightly.

Do not group multiple tubes together in one bag due to the risk of DNA cross-contamination and rejection of all specimens if there is leakage.

  
  

Swab:

Ambient - 60 days
Refrigerated - 60 days

Urine:

Ambient - 30 days                                                 

Refrigerated - 30 days

 

 

  
  • Vaginal Cuff
  • No swab, white swab or two swabs in Aptima swab transport tube
  • Swab not from Aptima Unisex swab collection kit
  • Pink-shafted swab for endocervical source
  • Blue-shafted swab for vaginal source
  • Urine transport tube not filled to “Fill Area” (above or below-rejected)
  • Urine not in Aptima transport tube
    • Client may transfer urine to Transport tube within 24 hr. of collection.
    • Due to nucleic acid cross-contamination issues, this must be done at the client site and will not be done at Allina Labs. 
  • M4 or M5 media
  • Frozen
  • Catheterized urine
  • Male urethral
  • Male urine
  
  • To ensure proper endocervical sampling, excess mucus should be removed.
  • Urine and vaginal swab specimen sampling is not designed to replace cervical exams and endocervical specimen 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 with APTIMA Trichomonas vaginalis Assay since nucleic acid may persist following appropriate antimicrobial therapy.
  • Results from the APTIMA Trichomonas vaginalis Assay 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 rRNA. T. tenax is a commensal of the oral cavity, and P. hominis is a commensal of the large intestine.
  
AHL - Microbiology: M
  
Mo - Fr
  
1 - 3 days
  

Target capture with transcription-mediated amplification

  

Negative

  

Aptima Trichomonas Overall Assay Performance

Specimen type

Sensitivity

Specificity

Endocervical swab

100%

99.4%

Vaginal swab

100%

99.0%

Female urine

95.2%

98.9%

 

Trichomonas vaginalis probe vs Patient infected status (symptomatic)

Specimen type

Sensitivity

Specificity

Female endocervical swab

100%

99.1%

Female vaginal

100%

99.1%

Female urine

95.2%

98.9%

Overall

98.4%

99.1%

 

Trichomonas vaginalis Probe vs Patient Infected Status (asymptomatic)

Specimen Type

Sensitivity (%)

Specificity (%)

Female endocervical swab

100

99.7

Female vaginal

100

98.9

Female urine

95.5

99.0

Overall

98.5

99.7

  
87661
  
No
  
11/21/2012
  
03/10/2020
  
02/25/2020