A system for the detection and typing of human papillomavirus of the lower genital tract: in situ hybridization screening and polymerase chain reaction confirmation.

We developed a simplified and non-isotopic in situ hybridization procedure for the detection of Human Papillomavirus (HPV) in routine Papanicolaou cervical smears. The assay involves one oligonucleotide (malignant probe) which recognizes high risk HPV 16 and 18, and another which detects HPV 6 and 11 (benign probe). We adapted the system to fulfill the requirements of gynecologists and cytologists, assimilating their protocols and simplifying the in situ hybridization assay. When we compared the detection levels reached by the in situ hybridization versus a ladder PCR assay in 156 clinical samples, original designed for this work, the kappa coefficient between both methods is 0.945, indicating a strong agreement between the ISH and the PCR assays.