Introduction
Cervical cancer ranked the fourth for both incidence and mortality of gynecological cancers globally in 2020 [1]. In China, there were approximately 110,000 newly diagnosed cases and 60,000 deaths reported in 2020 [1]. Prevention and treatment of cervical cancer is still a serious problem in the world. In fact, cervical intraepithelial neoplasia (CIN) progresses slowly to cervical cancer, it provides gynecologists with chances to detect and treat CIN or cervical cancer under appropriate screening approaches [2, 3].
Currently, the high-risk human papillomavirus (hrHPV) testing and cervical cytology either alone or in combination (co-testing) are recommended as primary cervical screening strategies [4, 5]. HPV-based testing alone has been proven efficacious worldwide, it demonstrated a superior sensitivity over cytology but with a lower specificity [6, 7]. Most HPV infections are transient and can be eliminated by hosts within 1-2 years especially in young women [8]. Thus, positive HPV testing results may cause over-referral colposcopy and patients’ psychological burden [9]. On the contrary, cytology alone has a relatively low sensitivity owing to sampling quality, technic, and intra/inter-observer errors during cytological morphological assessment [10]. Sensitivities of atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesion (LSIL) were 34%-96% and 18%-89% for detecting CIN2+ [11]. Moreover, when transferring to colposcopy and biopsy, patients with cervical transformation zone (TZ) type III, often postmenopausal women, cannot be assessed comprehensively due to the unseen cervical squamocolumnar junction (SCJ). Thus, endocervical curettage (ECC) is applied [12]. Therefore, incorporation of additional screening methods is necessary.
TruScreen (TS) is a non-invasive diagnostic method for CIN with immediate and automatically generated results [13]. Briefly, it detects and analyzes cervical tissues through optoelectronic signals emitted from the tip of the device. Up to date, TS has been studied in several studies in different population worldwide [13-19]. According to a meta-analysis, the pooled sensitivity, specificity and area under curve (AUC) of TS were 76%, 69%, 0.7859 respectively, the author thus concluded that TS had a moderately good diagnostic accuracy [20].
Since the coronavirus disease 2019 (COVID-19) has been declared a global pandemic in January 2020 [21], challenges for cervical screening emerged and still exists now during COVID -19 post-pandemic. Gynecologists are seeking for a better method to decrease cervical specimen contact during screening session, meanwhile reducing colposcopy and biopsy. The non-invasiveness and immediacy of reports make TS a suitable choice for this purpose.
Our objective is to evaluate efficacy of TS detecting ASC and LSIL patients and explore any feasibility of TS as one of the cervical cancer screening methods in China.