A laboratory developed test (LDT) for the detection of Trichomonas vaginalis (TV) was developed in our laboratory for use on the Abbott m2000 instrument. In this assay, the extraction of nucleic acids is automated on the m2000sp and performed using commercially available extraction reagents. Extracted DNA and master mix containing the TV specific primers and fluorescently labeled probe are added manually to a 96 well amplification plate. The loaded amplification plate is transferred to the m2000rt for real time PCR amplification. The amount of fluorescence generated after each amplification cycle is measured and allows for the generation of a delta cycle value (DC) for each specimen. Specimens with a positive DC value after 35 cycles of amplification are considered positive for TV, specimens where no DC value is generated are negative, and specimens with a negative DC value are considered equivocal. The performance characteristics for vaginal and endocervical swabs, male urethral swabs and urine were established in our laboratory. All other sample types are unacceptable. The limit of detection is 10-100 trichomonads per sample for both swabs and urine.
TV LDT disclaimer
The Nucleic Acid Amplification Test (NAAT) for the detection of Trichomonas vaginalis (Tv) was developed and its performance characteristics determined by the Indiana University School of Medicine Infectious Diseases Laboratory (IDL). The Tv NAAT has not been cleared or approved by the U.S. Food and Drug Administration but is used for clinical purposes and should not be regarded as investigational or for research. The IDL is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing and has established and verified the accuracy and precision of this test. Additional information about this test is available upon request.