Assessment of HPV DNA test value in management women with cytological findings of ASC-US, CIN1 and CIN2.

The aim of this retrospective study was to answer the following questions: 1) is HPV DNA test for high-risk types able to predict lesion behaviour in women with cytological abnormalities lower than CIN3 (ASC-US, CIN1 and CIN2); 2) how to predict the histological diagnosis CIN3, and 3) is its use in diagnostic management in these patients justified or not? The study included 345 women (11 ASC-US, 312 CIN1 and 22 CIN2) that underwent conventional diagnostic management (repeat cytology and colposcopy with or without histology) and HPV testing for high-risk HPV types by PCR method. The value of HPVDNA test in predicting lesion regression/persistence was assessed in 275 subjects without histology. In 70 subjects, diagnostic accuracy (sensitivity, specificity, and positive and negative predictive value) of repeat cytology and HPV DNA test in predicting severe intraepithelial lesion (CIN3) was determined on the basis of colposcopy guided biopsy. The prevalence of persistent lesions was significantly higher in the group of HPV positive than in the group of HPV negative subjects (37.7% vs. 16.4%; p < 0.001). Positive HPV test was associated with a 3.1-fold risk of lesion persistence [OR (95% CI) = 3.095 (1.65-5.82)]. However, on screening to predict the outcome of cytologically diagnosed cervical lesion with sensitivity of 39.7% and positive predictive value of 37.7% showed that a positive test could not be considered a reliable indicator of lesion persistence. In contrast, the specificity of 82.5% and negative predictive value of 83.6% suggested that a negative test result could be taken as a good indicator of lesion regression. In comparison with repeat cytology, HPV test showed higher sensitivity (69.2% vs. 61.5%) but significantly lower specificity (63.2% vs. 93.0%) and positive predictive value (30.0% vs. 66.7%), and comparable negative predictive value (90.0% vs. 91.4%) in predicting histologically verified CIN3. In one patient with a histological diagnosis of squamous cell carcinoma with minimal invasion, repeat cytology indicated CIN3, whereas HPV test was negative. Due to authors experience in women with cytological abnormalities lower than CIN3, HPV testing is not a method to reliably predict lesion behaviour (regression, persistence) or presence of CIN3. HPV testing is of limited value in daily routine and should not be widely used until it is definitely demonstrated to be superior to conventional methods in improving the sensitivity, specificity and positive predictive value of CIN3 and invasive carcinoma detection.