Evaluation of a solution chemiluminescent hybridization assay for identification of human papillomavirus from paraffin-embedded tissues

Aims To evaluate the use of the Digene Hybrid Capture^TM system, a chemiluminescent hybridization assay for the analysis of low and intermediate/high risk human papillomavirus (HPV) DNA, on paraffin-embedded tissues and to investigate possible reasons for reaction failure. Methods Fifty cervical biopsies were tested by an in situ hybridization (ISH) method using probes for HPV 6/11. 16/18, 31/33/51 and by the Digene Hybrid Capture^TM system. Results The ISH was able to detect HPV in 23 out of the 50 biopsies. Eight samples were positive with the HPV 6/11 probe, 4 with the 16/18 probe. 6 with the 31/33/51 probe and 5 had mixed infections. With the Hybrid Capture^TM system, having taken the mixed infections into account. 40 samples gave concordant results, while total and partial discordances were observed in 6 and 4 samples respectively. The relative sensitivity of the new assay was 91.6% and specificity 84.2% for low risk HPVs; and 80% and 94.3% respectively for intermediate/high risk HPVs. Agreement rates on HPV positivity for either low risk or intermediate/high risk types were 86% and 94% respectively in comparison with ISH results. Conclusion The Hybrid Capture^TM system is simple, reliable in use and suitable for routine discrimination of HPVs in tissue sections from paraffin-embedded blocks. It might thus be of clinical value in the diagnosis and prognosis of HPV infection.