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Test Code LAB53211 Trichomonas Vaginalis

Important Note

Not approved for patients <14 years of age. For those patients, use AOMC test code LAB921. Please note AOMC collection instructions are different: Vaginal or Endocervical swab collected using the Xpert Swab Collection kit. Urine specimens are collected in a sterile cup.

Test Performed By

Cayuga Medical Center, Main Laboratory

Container Name

Aptima Swab

PAP Vial

Urine

Day(s) and Time(s) Test Performed

Monday through Friday, days

Source

Vaginal, Endocervical, Urine (male & female)

Specimen Collection Instructions

To ensure proper samping, excess muscus should first be removed. 

 

Submit only 1 of the following specimens:

 

Specimen Type: Endocervix/Cervix

Supplies: Aptima Unisex Swab Collection Kit

 

Collection Instructions:

1. Specimens must be collected using the Aptima Unisex Swab Collection Kit.

2. Use cleaning swab (white shaft) to remove excess mucus from endocervix/cervix.

3. Discard the cleaning swab.

4. Insert second swab (blue shaft) 1 to 1.5 cm into endocervical canal and rotate swab gently for 30 seconds. Avoid touching vaginal wall when removing swab.

5. Place blue swab into transport tube provided in collection kit.

6. Snap off blue swab at score line so it fits into closed tube.

7. Cap tube securely, and label tube with patient's entire name and collection date and time.

  

Specimen Type: Vaginal

Supplies: Aptima Multitest Swab Collection Kit

 

Collection Instructions:

1. Specimens must be collected using the Aptima Multitest Swab Collection Kit.

2. Insert swab (pink shaft) about 5 cm past introitus and rotate gently for 30 seconds.

3. Place pink swab into transport tube provided in collection kit.

4. Snap off pink swab at score line so it fits into closed tube.

5. Cap tube securely, and label tube with patient's entire name and collection date and time.

 

 Specimen Type: Urine (Male and Female)

Supplies: Aptima Urine Transport Tube

 

When collecting urine for Trichomonas AND urinalysis/culture please collect the Trichomonas urine first before any surface urethral cleaning is done. Collect a second clean catch urine specimen for the urinalysis/culture.

 

Collection Instructions:

1. Patient should not have urinated for at least 1 hour prior to specimen collection.

2. Patient should collect first portion of random voided urine (first part of stream) into a sterile, plastic, preservative-free container.

3. Within 24 hours of collection, 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 fill lines on the urine transport tube.

4. Place the labels on the transport tube so the black fill lines are still visible for volume confirmation.

  

Specimen Type: ThinPrep Specimen (Endocervix/Cervix)

Supplies: Aptima Specimen Transfer Kit

 

Collection Instructions:

1. Collect ThinPrep sample as per normal collection process.

 

Temperature and Specimen Stability

Aptima Swab - 60 days room temp or refrigerated, 24 months frozen

 

PAP Vial - 30 days room temp or refrigerated

 

Aptima Thin Prep Vial - 14 days room temp, 30 days refrigerated, 24 months frozen

 

Urine - unpreserved 24 hours room temp or refrigerated

 

Aptima Urine Vial - 30 days room temp or refrigerated, 24 months frozen

 

CPT Codes

87661

Methodology

Nucleic Acid Amplification 

Clinical and Interpretive

Trichomonas vaginalis (T. vaginalis) is the most common curable sexually transmitted disease (STI) agent in the United States, with an estimated 6.9 million new cases occurring annually.

 

T. vaginalis infections in women cause vaginitis, urethritis, and cervicitis. Discharge and small hemorrhagic lesions may be present in the genitourinary tract. Complications can include premature labor, low-birth-weight offspring, premature rupture of membranes, and post-abortion or post-hysterectomy infection. An association with pelvic inflammatory disease, tubal infertility, and cervical cancer with previous episodes of trichomoniasis has been reported. Symptomatic women with trichomoniasis usually report of vaginal discharge, vulvovaginal soreness, and/or irritation. Dysuria is also common. However, it has been estimated that 10 to 50% of T. vaginalis infections in women are asymptomatic, and in men the proportion may even be higher.

 

Reported symptoms of trichomonas urogenital tract infection in men include penile discharge, pain during urination and intercourse, and groin and testes pain. Prevalence of trichomonas infection in males ranges from 0.49% in a low-risk asymptomatic population to 6% in populations at high risk for infection.

 

Detection of T. vaginalis with traditional culture methods is technically challenging and requires up to 7 days. Immediate inoculation into the media is preferred, and proper incubation conditions are required in addition to frequent microscopic examinations of the media to successfully culture the protozoa. The sensitivity of culture has been estimated to range from 38% to 82% when compared to molecular methods due to problems visualizing low numbers of the organisms or the motility of the protozoa.

 

T. vaginalis may also be detected using “wet-mount” preparation by mixing vaginal secretions with saline on a slide and examining the slide under a microscope. However, the wet-mount method is only 35% to 80% sensitive compared with culture. The sensitivity of the wet-mount method is highly dependent on the experience of lab personnel.

 

Molecular methods, such as the APTIMA Trichomonas vaginalis Assay, offer the highest sensitivity and specificity for detection of trichomoniasis. The APTIMA test utilizes target capture, transcription-mediated amplification (TMA), and hybridization protection assay (HPA) technologies for detection of Trichomonas vaginalis ribosomal RNA (rRNA). A positive result is considered indicative of current or recent Trichomonas vaginalis infection (trichomoniasis).