Prospective clinical study comparing DNA flow cytometry and HPV typing as predictive tests for persistence and progression of CINI/II

A cohort of 70 consecutive women at a university hospital colposcopy clinic with untreated CIN I and CIN II (CIN VII) confirmed by cytology and histol ogy was followed for 1 year in the setting of a prospective trial. In the l esions, the presence of DNA from HPV types was examined by restriction frag ment length polymorphism (RFLP) analysis. Aneuploid cell lines were demonst rated by aneuploid histograms generated by high-resolution DNA flow cytomet ry. HPV type 16 infection and the existence of aneuploid cell lines proved to be significant risk factors for CIN VII lesions to persist or progress t o CIN III in the 1-year follow-up period in the same cohort of patients. Th e relative risks and 95% confidence intervals (CI) were 1,81 (1.44-2.76) fo r aneuploid cell lines and 1,74 (1.10-2.76) for HPV type 16 infection in CI N VII lesions. As a predictive diagnostic test for CIN I/II lesions to pers ist or progress, the specificity and positive predictive value (PPV) for an euploid histograms were 100% (CI, 73.5-100%) and 100% (CI, 86,8-100%), resp ectively. The low sensitivity of 27.3% (CI, 14.9-42.8%) restricted the clin ical application of the test, leaving 32 of 44 women with persisting or pro gressing CINI/II with diploid histograms. HPV type 16 positivity by FRLP ha d a PPV of 68.4% (CI, 43.5-87.4%) as a prognostic test. Six of 19 HPV 16 in fected women showed complete remission of their CIN lesion. A combination o f the two tests did not provide any additional information. (C) 2001 Wiley- Liss, Inc.