[Diagnostic value of TruScreen in cervical lesions screening]

To investigate the diagnostic value of TruScreen (TS) as a novel option for cervical lesions screening.

A total of 218 cases were selected between 2013 December and 2014 November from outpatients of the Department of Gynecology, PLA General Hospital. Using histopathology as the gold standard for diagnosis, the diagnostic efficacy of TS was compared with that of high-risk human papillomavirus (Hr-HPV) test.

(1) In 218 patients, there were 193 Hr-HPV positive cases accounting for 88.5%, 94 TS positive cases accounting for 43.1%. According to the histopathology, there were 112 cases of cervical intraepithelial neoplasia (CIN)1+, 71 cases of CIN2+, accounting for 51.4% and 32.6%, respectively. (2) The sensitivity of Hr-HPV was 98.2% and specificity was 21.7%. The sensitivity of TS was 51.8% and specificity 66.0%. (3) Sensitivity of TS for triaging cases of atypical squamous cells of undetermined signification (ASC-US) was 43.9%, specificity 65.7%, diagnostic accordance rate 53.9%. Those indexes for triaging cases of equivalent or more than atypical squamous cells-cannot exclude high-grade squamous intraepithelial lesion (ASC-H) were 56.3%, 66.2% and 61.3%. With regard to Hr-HPV test, those indexes for triaging cases of equivalent or more than ASC-H were 97.2%, 32.4% and 64.8%.

Hr-HPV test shows higher sensitivity while TruScreen shows higher specificity for cervical lesions screening. More studies with larger sample size are still needed to evaluate which method is a better triage tool.