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Trichomonas vaginalis by PCR

Trichomoniasis, Trich, TV, Vaginosis, Vaginitis, STI, NAA, NAAT

Test Codes

EPIC: LAB7076, Beaker: ITVG

Department

Molecular Pathology

Specimen Collection Criteria

Collect: One of the following specimen types:

1. Vaginal/Endocervical Swab in one of the following:
   • Cobas PCR Media Swab Sample Kit
   • Universal Transport media (UVT)
2. Urine:
   • Cobas PCR Urine Sample Kit
   • Unpreserved, first catch urine in a sterile container. (Minimum: 8.0 mL)

Physician Office/Draw Specimen Preparation

• Swabs and urine collected in Cobas PCR media can be stored and transported at room temperature (20-26°C or 68-78.8°F).
• Unpreserved urine samples must be refrigerated (2-8°C or 36-46°F).

Preparation for Courier Transport

Transport: Swabs and urine collected in Cobas PCR media can be stored and transported at room temperature (20-26°C or 68-78.8°F). Unpreserved/neat urine samples must be refrigerated (2-8°C or 36-46°F).

Rejection Criteria

• Unlabeled specimens
• Frozen specimens
• Specimens submitted in transport media other than those listed above.
• Orders added on to unpreserved urine >24 hours after collection.

Storage

Specimen Stability for Testing:

Cobas PCR Media Swab Sample Kit - Vaginal/Endocervical Swabs
Room Temperature (20-26°C or 68-78.8°F): 12 months
Refrigerated (2-8°C or 36-46°F): 12 months
Frozen (-20°C/-4°F or below): Unacceptable

Universal Transport Media (UVT) - Vaginal/Endocervical Swabs
Room Temperature (20-26°C or 68-78.8°F): 4 hours
Refrigerated (2-8°C or 36-46°F): 7 days
Frozen (-20°C/-4°F or below): Unacceptable

Cobas PCR Urine Sample Kit

Room Temperature (20-26°C or 68-78.8°F): 12 months
Refrigerated (2-8°C or 36-46°F): 2 months
Frozen (-20°C/-4°F or below): Unacceptable

Urine (Unpreserved/Neat)
Room Temperature (20-26°C or 68-78.8°F): Unacceptable
Refrigerated (2-8°C or 36-46°F): 24 hours
Frozen (-20°C/-4°F or below): Unacceptable

Specimen Storage in Department Prior to Disposal:

UVT or UTM Transport Medium: Refrigerated (2-8°C or 36-46°F): 7 days
Cobas PCR Swab or Urine Collection: Room Temperature (20-26°C or 68-78.8°F): 7 days
Unpreserved/neat urine: Refrigerated (2-8°C or 36-46°F): 7 days

Laboratory

Royal Oak Molecular Pathology Laboratory

Performed

Monday – Saturday.
Results available within 24-48 hours of receipt in the laboratory (excluding holidays and weekends).

Reference Range

Trichomonas vaginalis not detected.

Test Methodology

Nucleic acid amplification testing was performed using the FDA-cleared Cobas TV/MG test (Roche Molecular Systems, Inc.) on the Cobas 6800 System.

Interpretation

A "not detected" negative result does not rule out Trichomonas vaginalis infection. Trichomonas tenax, a normal commensal of the oral cavity, may give a false positive test result and should be considered for individuals engaging in oral-genital sex.

Clinical Utility

This assay provides a highly sensitive and specific test for the diagnosis of Trichomonas vaginalis infection from female genitourinary specimens and female/male urine specimens.

Clinical Disease

Trichomonas vaginalis is a protozoan that resides in the female lower genital tract and in the urethra and prostate of males. Symptoms in females can include itching, burning, redness, or soreness of the genitals, unusual odor, discomfort with urination, or a thin clear, white, yellow, or green discharge. In men, trichomoniasis may cause non-gonococcal urethritis (NGU). Symptoms in males can include itching or burning inside the penis, burning after ejaculation or urination, or penile discharge.

Epidemiology

The protozoan Trichomonas vaginalis is responsible for trichomoniasis, which is a common sexually transmitted infection that can infect both men and women. There are 7.4 million cases of trichomoniasis annually in the United States. Trichomoniasis infections can be symptomatic or asymptomatic.

Incubation Period

The incubation period ranges from 5-28 days.

CPT Codes

87661

Contacts

Last Updated

11/8/2023