Analytical Performance Characteristics of a New Transcription-Mediated Amplification Assay for Treponema pallidum

Author:

Getman Damon1ORCID,Lin Mike1,Barakat Nesreen1,Skvoretz Rhonda1,Godornes Charmie2,Swenson Paul3,Nenninger Ashley1,Golden Matthew R.32,Lukehart Sheila A.2

Affiliation:

1. Hologic, Inc., San Diego, California, USA

2. Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington School of Medicine, Seattle, Washington, USA

3. Public Health—Seattle and King County, Seattle, Washington, USA

Abstract

This study evaluated the performance characteristics of a new research-use-only transcription-mediated amplification (TMA) assay for the detection of rRNA from Treponema pallidum . Analytical sensitivity determined using dark-field microscopy-quantitated T. pallidum was 1.4 organisms/ml (95% confidence interval [CI], 0.7 to 6.33 organisms/ml).

Funder

Hologic

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

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