Evaluation of a real-time optoelectronic method for the detection of cervical intraepithelial neoplasia and cervical cancer in patients with different transformation zone types

Abstract

We aimed to evaluate the diagnostic value of TruScreen, a real-time diagnostic technology, for cervical lesions in patients with different transformation zone (TZ) types. A total of 1908 women aged 34.0 ± 7.3 years who have received cytology, human papillomavirus (HPV) testing, TruScreen, and colposcopy were recruited. The clinical performances of these tests were evaluated for their detection of high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma in situ (AIS), or more severe lesions in patients with different TZ types. For the detection of HSIL, AIS, or more severe lesions, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of TruScreen were 65.08%, 64.76%,11.55%, and 96.33%, respectively, which were similar to cytology (all P values > 0.05). For the detection of HSIL + in patients with type 3 TZ, the sensitivity, specificity, PPV, and NPV of TruScreen were 72.29%, 67.59%, 13.86%, and 97.13%, respectively, which were significantly higher than the sensitivity (51.16%, P = 0.029), specificity (59.59%, P = 0.001), PPV (7.94%, P = 0.016), and NPV (94.71%, P = 0.049) in type 1 and type 2 TZs. TruScreen has detection accuracy comparable to cytology and performs even better in patients with type 3 TZ.