A POLYMERASE CHAIN REACTION-ENZYME-LINKED IMMUNOSORBENT-ASSAY METHOD FOR DETECTING HUMAN PAPILLOMAVIRUS IN CERVICAL CARCINOMAS AND HIGH-GRADE CERVICAL-CANCER PRECURSORS

Objective: To develop and evaluate a novel polymerase chain reaction ( PCR)-enzyme-linked immunosorbent assay (ELISA)-based method for detect ing high-oncogenic-risk human papillomaviruses (HPV). Methods: An HPV assay based on PCR amplification of a region of the E6 open reading fr ame and ELISA detection of PCR products that specifically identify hig h-oncogenic-risk HPV types (eg, types 16, 18, 31, 33, 35, 39, 45, 56, 58, and 65) was developed. Dacron swabs were used to obtain samples fr om the cervices of 371 women referred for colposcopy. The swabs were a nalyzed using the PCR-ELISA method. The results of HPV DNA testing wer e then compared with the results of a repeat Papanicolaou smear and ce rvical biopsy obtained at the same visit. Results: The sensitivity of the PCR-ELISA HPV test for detecting invasive cervical cancer or high- grade squamous intraepithelial lesions (SIL) was 90%. High-oncogenic-r isk HPVs were detected in six of seven women with biopsy-confirmed inv asive cervical cancer, 74 of 81 women with biopsy-confirmed high-grade SIL, 58 of 128 women with biopsy-confirmed low-grade SIL, and 46 of 1 55 women with no evidence of cervical disease by colposcopy and cervic al biopsy. When used in conjunction with a repeat Papanicolaou test, 9 7% of the women with invasive cervical carcinoma and high-grade SIL le sions were identified. Conclusion: The PCR-ELISA-based HPV detection p rovides the potential for an automated, rapid, and sensitive test for cervical cancer and high-grade cervical lesions.