COMPARISON OF 2 TESTS FOR DETECTING CARCINOGENIC HPV IN WOMEN WITH PAPANICOLAOU SMEAR REPORTS OF ASCIS AND LSIL

BACKGROUND. The detection of cancer-associated types of human papillom avirus (HPV) in cervical specimens predicts the presence and future de velopment of cervical intraepithelial neoplasia (CIN). The purposes of this study were (1) to determine the efficacy of a second-generation assay by hybrid capture (HC II) to detect carcinogenic HPV from residu al cervical cells of a liquid-based cervical cytologic specimen, and ( 2) to compare the performance of this second-generation test with the first-generation hybrid capture (HCT) HPV test of material from direct cervical sampling to detect CIN in women with atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepit helial lesion (LSIL) Papanicolaou (Pap) smear reports. METHODS. Women with a recent Pap smear report of ASCUS or LSIL had a sampling of the cervix using either an Ayre's spatula and cytobrush or an Accellon dev ice sampling for liquid-based cytologic system HC II HPV testing, foll owed by a Dacron swab sampling of the cervix for standard HCT HPV test ing of the paired specimens. All women received colposcopy examination s including cervical biopsy and endocervical curettage, when indicated , to determine criterion standards for comparison. RESULTS. Paired swa bs and liquid-based cervical specimens from 242 women were available f ar testing by standard HCT and the newer HC II HPV DNA assays. The sen sitivity, specificity, and positive and negative predictive values for detecting CIN grade 2 or 3 (CIN 2/3) were 61.9%, 57.0%, 12.0%, and 94 .0%, respectively, for the HCT test, and 90.5%, 29.4%, 10.9%, and 97.0 %, respectively, for the liquid-based cytology HC II assay. When only women with an initial ASCUS Pap smear report were considered, the HC I I test results were 88.9%, 40.3%, 9.1%, and 98.2%, respectively. Concl usions. Testing for lower genital tract carcinogenic HPV DNA using a c ervical cytology liquid transport media residual sample is clinically feasible. The new HC II microplate HPV test achieved a greater test se nsitivity for detecting carcinogenic HPV and correspondingly of CIN 2/ 3 compared with the currently available first-generation HC HPV test. Use of a liquid-based cervical cytology system combined with intermedi ate triage by HC II testing of residual cells for carcinogenic HPV alo ne may help to efficiently identify CIN 2/3 in women who have a prior screening Pap smear report of ASCUS.