Comparison of high-risk human papillomavirus detection by aptima and hybrid capture 2 tests in cervical cytology specimens

Abstract

Objectives: The Aptima HPV assay (AHPV) is a qualitative test for detecting mRNA expressions of viral oncogenes. It is the fourth US FDA-approved hrHPV test. The performance of AHPV was compared to Hybrid Capture 2 (HC2) test for the detection of high-risk Human Papillomavirus (HPV) in cervical samples. Methods: A total of 1300 cervical ThinPrep PreservCyt specimens were tested with both AHPV and HC2 tests, and the positive percent agreement was determined. HPV results were correlated with cytological findings of all samples and cervical biopsy, if available. Results: AHPV and HC2 were positive in 101 (7.8%) and 145 (11.2%) samples, respectively. The overall agreement between the results of the two tests was 94%, with a kappa value of 0.66, indicating a significantly difference between two tests (McNemar test, p<0.001). Of the 1300 women, 1246 (95.8%) had normal cytology, 23 (1.8%) had ASC-US, 31 (2.4%) had abnormal cytology >ASC-US. The AHPV test detected less positive than HC2 test in normal (5.6% vs 8.6%), ASC-US (39.1% vs 56.5%) and LSIL (67.9% vs 82.1%) samples. However, in high-grade lesions (two cases), AHPV detected 100% positive, whereas HC2 detected only 50% positive. Of 150 women had cervical biopsy, both tests had same detection rate of 67% (4 of 6) in CIN2 samples. Conclusions: The AHPV test is as sensitive as HC2 test but it may be more specific for detection of significant cervical disease. Due to the small number of HGCIN cases, larger study is warrant to further analyze the performance of both tests.