Prediction value with a novel and accurate tissue-based human papillomavirus detection method in low-grade squamous intraepithelial lesions

Abstract

Background: The progression rate from CIN1 to CIN3 is 9.0% and that for invasive cancer is 1.0%. The large majority of CIN1 lesions regress spontaneously, and the treatment of CIN1 is still controversial. Aims: The aim of this study is to investigate the responsible HPV genotype in the low-grade SILs, then to predict the presence of high-grade SILs, and determine whether further treatment is needed. Methods: We use the methods of manual microdissection with FFPE tissue specimens and the E6/E7 uniplex polymerase chain reaction (PCR) to detect HPV in the lesions. Results: The HPV test was performed on 72 biopsy tissue specimens, and 55 (76.4%, 55/72) of them were HPV positive. Nine (16.4%, 9/55) of them escalated to CIN2 after LEEP or cervical conization, and 46 (83.6%, 46/55) were still CIN1. There were 17 (23.6%, 17/72) cases with HPV-negative results in cervical biopsy tissues. HPV test of cervical biopsy diagnosed with CIN1 has a positive predictive value of 16.4% in the presence of CIN2 or higher lesions, a negative predictive value of 94.1%, a specificity of 25.8%, and a sensitivity of 90.0%. HPV test of cervical biopsy tissues for the prediction of HPV infection in LEEP or cone surgery tissues had a positive predictive value of 80.0%, a negative predictive value of 82.3%, a specificity of 56.0%, and a sensitivity of 93.6%. Conclusions: It is the first time that we have detected HPV genotype in the low-grade SILs by the methods of manual microdissection with FFPE tissue specimens and the E6/E7 uniplex PCR. Patients with cervical biopsy tissue diagnosed with CIN1 and with a negative or only low-risk HPV type result can be considered for follow-up. Conversely, in cases of cervical biopsy tissue diagnosed with CIN1 positive for high-risk HPV, surgery or a close follow-up program can be selected.