Comparison of the PANArray HPV Genotyping Chip Test with the Cobas 4800 HPV and Hybrid Capture 2 Tests for Detection of HPV in ASCUS Women

ABSTRACT

PURPOSE: This study aimed to evaluate the performance of the PANArray human papilloma virus (HPV) test, a PCR-based DNA microarray assay, in detecting HPV from patient samples and its concordance with the cobas 4800 HPV and Hybrid Capture 2 (HC2) tests. MATERIALS AND METHODS: The PANArray HPV, cobas 4800 HPV, and HC2 tests were performed on 504 cervical swab samples from patients with atypical cells of undetermined significance at five hospitals. The samples that were interpreted as ‘HPV-other’ type positive in the PANArray HPV test were confirmed by direct sequencing. RESULTS: The concordance rates were 80.8% between the cobas 4800 HPV and PANArray HPV tests [κ=0.59, 95% confidence interval (CI) 0.52–0.66] and 80.2% (κ=0.6, 95% CI 0.55–0.68) between the HC2 and PANArray HPV tests. Among the 62 patients negative on PANArray HPV (defined as the absence of high risk HPV), but positive on both cobas 4800 HPV and HC2 tests, 42 (67.7%) tested positive for ‘HPV-other’ types on the PANArray HPV test, and 31 (50.0%) had gray zone results [relative light unit/control (RLU/CO), 1.4–9.25] in the HC2 test. Of the patients deemed positive by the PANArray HPV test, 43 tested positive for high-risk (HR) HPV in cobas 4800 HPV and HC 2 tests. Among them, 58.2% showed HR HPV, including HPV 16, by direct sequencing, of which 25% had gray results. CONCLUSION: Results classified as ‘HPV-other’ type by the PANArray HPV test, or gray zone results by HC2 (RLU/CO ratio level 1–10) should be carefully interpreted using comprehensive clinical information.