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Trichomonas vaginalis Detection in Female Specimens with cobas® TV/MG for use on the cobas® 6800/8800 Systems

Authors :
Carolin Bier
Michael Steidle
Peter Gohl
Elizabeth M. Marlowe
Rodney Arcenas
Source :
European Journal of Microbiology & Immunology, European Journal of Microbiology & Immunology, Vol 9, Iss 2, Pp 42-45 (2019)
Publication Year :
2019
Publisher :
Akadémiai Kiadó, 2019.

Abstract

Trichomoniasis, a common curable sexually transmitted infection caused by the protozoan Trichomonas vaginalis (TV), is usually asymptomatic. However, symptomatic women may experience vaginal discharge and/or vulvar irritation. This study evaluated cobas® TV/ Mycoplasma genitalium (MG) (Conformité Européene marking for in vitro diagnostic medical devices [CE-IVD]) against other nucleic acid amplification tests (NAATs) for detecting TV in female urogenital specimens. Matched de-identified specimens from 412 females were collected. cobas® TV/MG results were compared against a composite reference (CR) of 3 different NAATs for TV (Aptima TV, modified S-DiaMGTV™, and a laboratory-developed test). The overall TV prevalence rate was 6.2%, based on cobas® TV/MG results. Relative to the CR, cobas® TV/MG sensitivity/specificity for the specimen types were endocervical swabs (ES) 100%/99.2%, vaginal swabs (VS) 100%/99.7%, urine (U) 100%/99.7%, and cervical specimens in PreservCyt® solution (PC) 100%/99.5%. There was no significant statistical difference between clinician-collected and self-collected VS (p = 0.28). Correlation of cobas® TV/MG vs. Aptima TV demonstrated the following positive, negative, and overall percent agreements, respectively: ES 69.0%, 98.7%, and 96.6%; VS 88.9%, 99.5%, and 98.8%; U 100%, 100%, and 100%; and PC 95.5%, 99.0%, and 98.8%. Detection of TV with cobas® TV/MG for use on the cobas® 6800/8800 systems demonstrated excellent performance in female urogenital specimens (overall sensitivity/specificity of 100%≥99.2%).

Details

Language :
English
ISSN :
20628633 and 2062509X
Volume :
9
Issue :
2
Database :
OpenAIRE
Journal :
European Journal of Microbiology & Immunology
Accession number :
edsair.doi.dedup.....a30f22cf0b4c603717c325fdc6b601bf