1 Clinical Pathology, Institute of Regional Health Research, Det Sundhedsvidenskabelige Fakultet, SDU2 Center Lillebaelt, Institute of Regional Health Research, Det Sundhedsvidenskabelige Fakultet, SDU3 Pathology, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU4 unknown5 Clinical Pathology, Institute of Regional Health Research, Det Sundhedsvidenskabelige Fakultet, SDU6 Pathology, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU
BACKGROUND: The objective of the current study was to investigate the clinical performance of detecting high-grade lesions with the CINtec PLUS p16INK4a/Ki-67 dual stain and the APTIMA human papillomavirus (HPV) Assay in a cohort of women with low-grade squamous intraepithelial lesion (LSIL) cytology. The authors also assessed the reproducibility of the evaluation of immunocytochemical staining. METHODS: The 2 tests were performed on liquid-based residual material from 469 women with LSILs. The samples had at least 5 years of follow-up and the gold standard used was high-grade cervical intraepithelial neoplasia (CIN2+/CIN3+) proven on histology. RESULTS: Approximately 69% of all the women included in the study had a positive test for HPV mRNA and 56% was positive for the dual stain. The 2 tests demonstrated high sensitivities. When examining the specificities, the APTIMA HPV Assay performed with significantly lower values than the CINtec PLUS test. For patients with CIN2+, the APTIMA HPV Assay had a specificity of 36.1% versus 51.3% for the CINtec PLUS test, and for women with CIN3+, the specificity was 33.8% versus 48.2%, respectively. The difference was even more pronounced when analyzing women aged <30 years separately. The kappa values between the 3 observers in scoring the dual stain ranged from 0.43 to 0.49 and improved in a second evaluation round to values ranging from 0.50 to 0.66. CONCLUSIONS: The CINtec PLUS p16INK4a/Ki-67 dual-staining test in LSIL cytology samples demonstrated high sensitivity that was similar to that of the APTIMA HPV Assay in the detection of underlying high-grade disease but with enhanced specificity, especially among women aged <30 years. The kappa value for the evaluation of the CINtec PLUS dual-staining test was moderate but could be improved through training. Cancer (Cancer Cytopathol) 2013. (c) 2012 American Cancer Society.
Cancer Cytopathol, 2013, Vol 121, Issue 3, p. 136-145
APTIMA human papillomavirus (HPV) assay CINtec PLUS test dual immunocytochemical stain low-grade squamous intraepithelial lesion (LSIL) triage CERVICAL-CANCER FOLLOW-UP ABNORMAL SMEARS HPV DNA WOMEN P16(INK4A) TRIAGE NEOPLASIA ASCUS PERFORMANCE