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.