Introduction Sexually Transmitted Infections (STIs) are increasing worldwide. Innovative approaches are required to eliminate barriers to STIs testing such as home-based self-sampling for patients that are difficult to reach or for whose that refuse to go for clinical collection. Aim of this study was to evaluate the performance of a new Home–based Self Vaginal FLOQSwab^TM (HBSVF - COPAN Italia, Brescia) in combination with a commercially available real-time PCR assay, Anyplex II STI-7 (Seegene, Seoul, Korea) which detects seven major pathogens in a single reaction (Chlamydia trachomatis - CT, Neisseria gonorrhoeae - NG, Trichomonas vaginalis - TV, Mycoplasma hominis - MH, Mycoplasma genitalium - MG, Ureaplasma urealyticum - UU, and Ureaplasma parvum - UP).

Methods A total of 78 asymptomatic donors, employees of a private industry (aged 18 to 45 years) were voluntarily enrolled to STIs screening. The subjects answered to a standardise anonymized questionnaire regarding the easy of use of self vaginal collection. The new HBSV swab was collected in a domestic context by following the detailed “how to use it” instructions. After collection, the HBSV swabs were shipped at room temperature to the laboratory in Pievesestina and processed within five weeks. The threshold cycle value (Ct) of a human genomic target (internal control, IC) and Ct of pathogens (CT, NG, TV, MH, MG, UU, UP) were taken as parameters to assess respectively, the efficiency of self-sampling and presence of any inhibitor effects, the stability of nucleic acids on dry swabs.

Results no failure results have been observed, the IC of all samples were amplified (average Ct 30). The real time PCR assay was able to identified 2/78 CT, 4/78 UU, 40/78 UP, 6/78 MH, 1/78 TV positive patients. No MG and NG positive patients have been detected. Women reported self-collection with HBSV easy and comfortable (100%).

Conclusion the new HBSV device showed excellent recovery and stability of nucleic acid of STI pathogens up to 5 weeks at room temperature. The HBSV is suitable for screening of STIs with real-time PCR assay.