HPV testing in liquid cytology specimens: comparison of analytic sensitivty and specificity for in situ hybridization and chemiluminescent nucleic acid testing.

OBJECTIVE: To compare the analytic sensitivity and specificity of Hybrid Capture 2 (HC2) (Digene Corporation, Gaithersburg, Maryland, U.S.A.) with in situ hybridization (ISH) in detecting high-risk types of HPV (HR-HPV).

STUDY DESIGN: Performance characteristics of ISH and HC2 were compared in 99 consecutive cervical cytology samples diagnosed as low grade squamous intraepithelial lesion and processed by either the ThinPrep (Cytyc Corporation, Boxborough, Massachusetts, U.S.A.) or SurePath (TriPath Imaging Systems, Research Triangle Park, North Carolina, U.S.A.) method at 2 geographically different centers. Polymerase chain reaction (PCR) was used as the gold standard.

RESULTS: Of the samples, 67% were positive for HR-HPV viral types by PCR. ISH had a sensitivity of 0.87 as compared to 0.95 (p = 0.11) for HC2. The specificity of ISH was significantly different from that of HC2 (0.57 vs. 0.13, respectively; p = 0.0004). The performance characteristics of ISH were not affected by the processing method or population tested.

CONCLUSION: The sensitivity of ISH is comparable to that of HC2, with significantly superior specificity, and is therefore an efficacious alternative to HC2 for triaging patients with abnormal cervical cytology results.