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Molecular sensitivity threshold of wet mount and an immunochromatographic assay evaluated by quantitative real-time PCR for diagnosis of Trichomonas vaginalis infection in a low-risk population of childbearing women.
Infez Med. 2016 Jun 01; 24(2):112-6.IM

Abstract

Vaginal trichomoniasis is a sexually transmitted infection caused by Trichomonas vaginalis, a flagellated protozoan. Diagnosis of T. vaginalis infection is mainly performed by wet mount microscopy, with a sensitivity ranging from 38% to 82%, compared to culture, still considered the gold standard. Commercial immunochromatographic tests for monoclonal-antibody-based detection have been introduced as alternative methods for diagnosis of T. vaginalis infection and have been reported in some studies to be more sensitive than wet mount. Real-time PCR methods have been recently developed, with optimal sensitivity and specificity. The aim of this study was to evaluate whether there is a molecular sensitivity threshold for both wet mount and imunochromatographic assays. To this aim, a total of 1487 low-risk childbearing women (median age 32 years, interquartile range 27-37) were included in the study, and underwent vaginal swab for T. vaginalis detection by means of a quantitative real-time PCR assay, wet mount and an immunochromatographic test. Upon comparing the results, prevalence values observed were 1.3% for real-time PCR, 0.5% for microscopic examination, and 0.8% for the immunochromatographic test. Compared to real-time PCR, wet mount sensitivity was 40% (95% confidence interval 19.1% to 63.9%) and specificity was 100% (95% CI 99.7% to 100%). The sensitivity and specificity of the immunochromatographic assay were 57.9% (95% CI 33.5% to 79.8%) and 99.9% (95% CI 99.6% to 100%), respectively. Evaluation of the wet mount results and those of immunochromatographic assay detection in relation to the number of T. vaginalis DNA copies detected in vaginal samples showed that the lower identification threshold for both wet mount (chi-square 6.1; P = 0.016) and the immunochromatographic assay (chi-square 10.7; P = 0.002) was ≥100 copies of T. vaginalis DNA/5 mcl of eluted DNA.

Authors+Show Affiliations

Microbiology Section, Department of Experimental Medicine, University of Perugia, Santa Maria della Misericordia Hospital, Perugia, Italy.Microbiology Section, Department of Experimental Medicine, University of Perugia, Santa Maria della Misericordia Hospital, Perugia, Italy.Microbiology Section, Department of Experimental Medicine, University of Perugia, Santa Maria della Misericordia Hospital, Perugia, Italy.Microbiology Section, Department of Experimental Medicine, University of Perugia, Santa Maria della Misericordia Hospital, Perugia, Italy.Microbiology Section, Department of Experimental Medicine, University of Perugia, Santa Maria della Misericordia Hospital, Perugia, Italy.Microbiology Section, Department of Experimental Medicine, University of Perugia, Santa Maria della Misericordia Hospital, Perugia, Italy.Microbiology Section, Department of Experimental Medicine, University of Perugia, Santa Maria della Misericordia Hospital, Perugia, Italy.Microbiology Section, Department of Experimental Medicine, University of Perugia, Santa Maria della Misericordia Hospital, Perugia, Italy.

Pub Type(s)

Journal Article
Observational Study

Language

eng

PubMed ID

27367320

Citation

Leli, Christian, et al. "Molecular Sensitivity Threshold of Wet Mount and an Immunochromatographic Assay Evaluated By Quantitative Real-time PCR for Diagnosis of Trichomonas Vaginalis Infection in a Low-risk Population of Childbearing Women." Le Infezioni in Medicina, vol. 24, no. 2, 2016, pp. 112-6.
Leli C, Castronari R, Levorato L, et al. Molecular sensitivity threshold of wet mount and an immunochromatographic assay evaluated by quantitative real-time PCR for diagnosis of Trichomonas vaginalis infection in a low-risk population of childbearing women. Infez Med. 2016;24(2):112-6.
Leli, C., Castronari, R., Levorato, L., Luciano, E., Pistoni, E., Perito, S., Bozza, S., & Mencacci, A. (2016). Molecular sensitivity threshold of wet mount and an immunochromatographic assay evaluated by quantitative real-time PCR for diagnosis of Trichomonas vaginalis infection in a low-risk population of childbearing women. Le Infezioni in Medicina, 24(2), 112-6.
Leli C, et al. Molecular Sensitivity Threshold of Wet Mount and an Immunochromatographic Assay Evaluated By Quantitative Real-time PCR for Diagnosis of Trichomonas Vaginalis Infection in a Low-risk Population of Childbearing Women. Infez Med. 2016 Jun 1;24(2):112-6. PubMed PMID: 27367320.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Molecular sensitivity threshold of wet mount and an immunochromatographic assay evaluated by quantitative real-time PCR for diagnosis of Trichomonas vaginalis infection in a low-risk population of childbearing women. AU - Leli,Christian, AU - Castronari,Roberto, AU - Levorato,Lucia, AU - Luciano,Eugenio, AU - Pistoni,Eleonora, AU - Perito,Stefano, AU - Bozza,Silvia, AU - Mencacci,Antonella, PY - 2016/7/2/entrez PY - 2016/7/2/pubmed PY - 2017/11/29/medline SP - 112 EP - 6 JF - Le infezioni in medicina JO - Infez Med VL - 24 IS - 2 N2 - Vaginal trichomoniasis is a sexually transmitted infection caused by Trichomonas vaginalis, a flagellated protozoan. Diagnosis of T. vaginalis infection is mainly performed by wet mount microscopy, with a sensitivity ranging from 38% to 82%, compared to culture, still considered the gold standard. Commercial immunochromatographic tests for monoclonal-antibody-based detection have been introduced as alternative methods for diagnosis of T. vaginalis infection and have been reported in some studies to be more sensitive than wet mount. Real-time PCR methods have been recently developed, with optimal sensitivity and specificity. The aim of this study was to evaluate whether there is a molecular sensitivity threshold for both wet mount and imunochromatographic assays. To this aim, a total of 1487 low-risk childbearing women (median age 32 years, interquartile range 27-37) were included in the study, and underwent vaginal swab for T. vaginalis detection by means of a quantitative real-time PCR assay, wet mount and an immunochromatographic test. Upon comparing the results, prevalence values observed were 1.3% for real-time PCR, 0.5% for microscopic examination, and 0.8% for the immunochromatographic test. Compared to real-time PCR, wet mount sensitivity was 40% (95% confidence interval 19.1% to 63.9%) and specificity was 100% (95% CI 99.7% to 100%). The sensitivity and specificity of the immunochromatographic assay were 57.9% (95% CI 33.5% to 79.8%) and 99.9% (95% CI 99.6% to 100%), respectively. Evaluation of the wet mount results and those of immunochromatographic assay detection in relation to the number of T. vaginalis DNA copies detected in vaginal samples showed that the lower identification threshold for both wet mount (chi-square 6.1; P = 0.016) and the immunochromatographic assay (chi-square 10.7; P = 0.002) was ≥100 copies of T. vaginalis DNA/5 mcl of eluted DNA. SN - 1124-9390 UR - https://www.unboundmedicine.com/medline/citation/27367320/Molecular_sensitivity_threshold_of_wet_mount_and_an_immunochromatographic_assay_evaluated_by_quantitative_real_time_PCR_for_diagnosis_of_Trichomonas_vaginalis_infection_in_a_low_risk_population_of_childbearing_women_ L2 - https://www.infezmed.it/index.php/article?Anno=2016&numero=2&ArticoloDaVisualizzare=Vol_24_2_2016_112 DB - PRIME DP - Unbound Medicine ER -