Nonisotopic ELISA-based detection of human papillomavirus-amplified DNA.

The polymerase chain reaction is being increasingly used for human papillomavirus (HPV) detection in routine diagnostics and in research. Recently, a nonisotopic, enzyme-linked immunosorbent assay-based sandwich capture hybridization assay was introduced as a commercial kit. This hybrid capture system can be used directly on extracted DNA or on polymerase chain reaction products. The latter approach, the SHARP Signal System, uses the consensus primers MY09/MY11, MY11 being biotinylated at its 5' end. We applied the SHARP Signal System to 72 neutral-buffered, formaldehyde-fixed, cervical biopsy specimens to assess the sensitivity and specificity of the kit compared with an earlier established, highly sensitive HPV detection method, GP+/GP6+ and single-stranded conformation polymorphism (SSCP). With the MY09/MY11/SHARP Signal System, 38% of the cases proved positive and with GP5+/GP6+/SSCP, 35%. Correlation of the two methods was 94% for the negative and positive cases and 100% for low- and high-risk HPV. We concluded that the MY09/MY11/ SHARP Signal System is suitable for amplified HPV DNA detection in research and for clinical purposes.