HC2 Test Research Articles

The Predictive Value of p16 INK4a and Hybrid Capture 2 Human Papillomavirus Testing for High-Grade Cervical Intraepithelial Neoplasia

We performed p16(INK4a) immunocytochemical analysis and Hybrid Capture 2 (HC2; Digene, Gaithersburg, MD) high-risk HPV testing on 210 abnormal SurePath (TriPath Imaging, Burlington, NC) Papanicolaou specimens diagnosed as low-grade squamous intraepithelial lesion (LSIL) or high grade squamous intraepithelial lesion (HSIL). The results were compared with 121 follow-up biopsy specimens. p16(INK4a) was positive in 57.9% of women with LSIL compared with 97.1% of women with HSIL. In contrast, HC2 testing was positive in 85.0% of women with LSIL and 86.4% of women with HSIL. The differences in the positive rates for16(INK4a) between LSIL and HSIL was significant (P < .001), whereas, for HC2, it was not (P = .264). In patients who had cervical biopsies following a cytologic diagnosis of LSIL, the positive predictive value (PPV) of p16(INK4a) for a biopsy of cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3; 33.3%) was significantly higher than the PPV of HC2 results (21.2%) (P < .001). Using liquid-based cytology specimens, p16(INK4a) immunocytochemical analysis has a higher PPV than reflex HC2 HPV testing for identifying CIN2/3 among patients with LSIL and might be useful for selecting patients with LSIL for colposcopy.

The Predictive Value of p16INK4aand Hybrid Capture 2 Human Papillomavirus Testing for High-Grade Cervical Intraepithelial Neoplasia

We performed p16 INK4a immunocytochemical analysis and Hybrid Capture 2 (HC2, Digene, Gaithersburg, MD) high-risk HPV testing on 210 abnormal SurePath (TriPath Imaging, Burlington, NC) Papanicolaou specimens diagnosed as low-grade squamous intraepithelial lesion (LSIL) or high-grade squamous intraepithelial lesion (HSIL). The results were compared with 121 follow-up biopsy specimens. p16 INK4a was positive in 57.9% of women with LSIL compared with 97.1% of women with HSIL. In contrast, HC2 testing was positive in 85.0% of women with LSIL and 86.4% of women with HSIL. The differences in the positive rates for16 INK4a between LSIL and HSIL was significant (P < .001), whereas for HC2 it was not (P = .264). In patients who had cervical biopsies following a cytologic diagnosis of LSIL, the positive predictive value (PPV) of p16 INK4a for a biopsy of cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3; 33%) was significantly higher than the PPV of HC2 results (21%) (P < .001). Using liquid-based cytology specimens, p16 INK4a immunocytochemical analysis has a higher PPV than reflex HC2 HPV testing for identifying CIN2/3 among patients with LSIL and might be useful for selecting patients with LSIL for

The efficacy of reprocessing unsatisfactory cervicovaginal ThinPrep specimens with and without glacial acetic acid: effect on Hybrid Capture II human papillomavirus testing and clinical follow-up.

We sought to determine the efficacy of remaking initially unsatisfactory cervicovaginal ThinPrep (Cytyc, Boxborough, MA) specimens with and without the addition of glacial acetic acid (GAA) and the effect on human papilloma virus (HPV) Hybrid Capture II (HC2; Digene, Gaithersburg, MD) testing. A total of 583 initially unsatisfactory ThinPrep slide preparations were identified, and remakes were made with the residual in the PreservCyt (Cytyc) vials with (n = 455) or without (n = 128) GAA. Clinical follow-up information was obtained. The addition of GAA resulted in a 56.5% reduction in unsatisfactory cases, compared with a 26.6% reduction without GAA. Neoplasia and atypia were detected in the reprocessed specimens. The addition of GAA resulted in false-positive HC2 test results in 10 of 10 cases. Neutralization of the specimen may reverse this effect. Reprocessing unsatisfactory ThinPrep specimens with GAA can substantially reduce the overall unsatisfactory rate and result in the detection of significant lesions. However, the addition of GAA can result in false-positive results on HC2 HPV tests.