Gema Fernández1, Elisa Martró2, Victoria González3, Verónica Saludes2, Elisabet Bascuñana4, Clara Marcó4, Belén Rivaya4, Evelin López5, Pep Coll6, Lurdes Matas2, Vicente Ausina7. 1. Servicio de Microbiología, Hospital Universitari Germans Trias i Pujol, Departamento de Genética y Microbiología, Universidad Autónoma de Barcelona, Badalona, Spain. Electronic address: gemafrivas@gmail.com. 2. Servicio de Microbiología, Hospital Universitari Germans Trias i Pujol, Departamento de Genética y Microbiología, Universidad Autónoma de Barcelona, Badalona, Spain; CIBER de Epidemiología y Salud Pública (CIBERESP) , Madrid, Spain. 3. CIBER de Epidemiología y Salud Pública (CIBERESP) , Madrid, Spain; Centre d'Estudis Epidemiològics sobre les ITS/sida de Catalunya, Agència de Salut Pública de Catalunya (ASPC), Generalitat de Catalunya, Badalona, Spain. 4. Servicio de Microbiología, Hospital Universitari Germans Trias i Pujol, Departamento de Genética y Microbiología, Universidad Autónoma de Barcelona, Badalona, Spain. 5. Centre d'Estudis Epidemiològics sobre les ITS/sida de Catalunya, Agència de Salut Pública de Catalunya (ASPC), Generalitat de Catalunya, Badalona, Spain. 6. IrsiCaixa Hospital Universitari Germans Trias i Pujol, Badalona, Spain; BCN Checkpoint, Barcelona, Spain. 7. Servicio de Microbiología, Hospital Universitari Germans Trias i Pujol, Departamento de Genética y Microbiología, Universidad Autónoma de Barcelona, Badalona, Spain; CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain.
Abstract
INTRODUCTION: Sexually transmitted infections (STI) are currently on the increase worldwide. New molecular tools have been developed in the past few years in order to improve their diagnosis. An evaluation was carried out using a new commercially available real-time PCR assay, Anyplex™ II STI-7 (Seegene, Seoul, Korea), which detects seven major pathogens in a single reaction - Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum, and Ureaplasma parvum - and compared with conventional methods performed in our laboratory. MATERIALS AND METHODS: Two different populations were included, and 267 specimens from different sites of infection (urines, endocervical swabs, rectal swabs, vaginal swabs, urethral swabs and one inguinal adenopathy) were processed for both methods. RESULTS: The parameters of clinical performance were calculated for C. trachomatis, N. gonorrhoeae, and T. vaginalis, and the assay achieved sensitivities (SE) from 93.94% to 100%, and specificities (SP) from 96.55% to 100%, with negative predictive values (NPV) from 93.33% to 98.85%, and positive predictive values (PPV) from 96.88% to 100%, with a very good agreement (kappa index from 0.88 to 1). CONCLUSIONS: Anyplex™ II STI-7 is a good tool for the reliable diagnosis of STI. Its ease of use and processing allows it to be incorporated into the day to day laboratory work.
INTRODUCTION: Sexually transmitted infections (STI) are currently on the increase worldwide. New molecular tools have been developed in the past few years in order to improve their diagnosis. An evaluation was carried out using a new commercially available real-time PCR assay, Anyplex™ II STI-7 (Seegene, Seoul, Korea), which detects seven major pathogens in a single reaction - Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum, and Ureaplasma parvum - and compared with conventional methods performed in our laboratory. MATERIALS AND METHODS: Two different populations were included, and 267 specimens from different sites of infection (urines, endocervical swabs, rectal swabs, vaginal swabs, urethral swabs and one inguinal adenopathy) were processed for both methods. RESULTS: The parameters of clinical performance were calculated for C. trachomatis, N. gonorrhoeae, and T. vaginalis, and the assay achieved sensitivities (SE) from 93.94% to 100%, and specificities (SP) from 96.55% to 100%, with negative predictive values (NPV) from 93.33% to 98.85%, and positive predictive values (PPV) from 96.88% to 100%, with a very good agreement (kappa index from 0.88 to 1). CONCLUSIONS: Anyplex™ II STI-7 is a good tool for the reliable diagnosis of STI. Its ease of use and processing allows it to be incorporated into the day to day laboratory work.
Authors: Giorgia Caruso; Anna Giammanco; Roberta Virruso; Teresa Fasciana Journal: Int J Environ Res Public Health Date: 2021-01-25 Impact factor: 3.390