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P5.092 Evaluation of a Laboratory Developed Test For the Detection of Trichomonas Vaginalis Using a Modification of the Abbott M 2000 Realtime System
  1. J A Williams1,
  2. L Eddleman1,
  3. A LeMonte1,
  4. B Van Der Pol1,2
  1. 1Indiana University School of Medicine, Indianapolis, IN, United States
  2. 2Indiana University School of Public Health, Bloomington, IN, United States

Abstract

Background Assays for the detection of Trichomonas vaginalis (TV) are available on certain commercial platforms. The objective of this study was to assess the performance characteristics of a new laboratory developed test (LDT) for the detection of TV from urine, and swab samples, when tested on the Abbott m2000 platform; a platform widely used for the detection of C. trachomatis (CT) and N. gonorrhoeae (NG).

Methods Residual swab samples that had been previously eluted into CT transport medium and urine were placed into Abbott transport tubes. Testing for CT/NG was performed on the m2000 platform per package insert; the remaining residual extracted DNA was used for TV testing on the m2000 platform. TV specific primers, probe, and thermal cycling conditions were optimised in our laboratory. Residual DNA from each sample was manually transferred to an amplification plate containing master mix. Real-time PCR was performed on the m2000 platform in open mode with the TV LDT results being compared to an LDT for TV that has been validated and used in our laboratory for more than a decade. Assay agreement was assessed using Kappa statistics.

Results A total of 49 urine specimens, 50 vaginal and 33 endocervical swabs were evaluated. Positive percent agreement was 92.0 for urine, and 100%, for both of the swab specimen types compared to the routine assay. Negative percent agreement between the two assays was 100% for all three specimen types. Kappa scores between the two assays were 0.918, 1.000, and 1.000 for urine, vaginal, and endocervical swabs, respectively.

Conclusions The TV LDT assay, performed on the Abbott m2000 platform, has excellent agreement with a molecular assay for TV being used in our laboratory. Advantages to using the m2000 for TV testing include automation and the use of residual DNA from the CT/NG assay for TV detection.

  • Laboratory developed test
  • Real-time PCR
  • Trichomonas vaginalis

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