Comparison of the AMPLICOR human papillomavirus (HPV) Test and the Hybrid Capture 2 Assay for detection of high-risk HPV

Yun, Yeo Min; Kim, Soo Nyung; Cha, Yun Jeong; Park, Soo Kyung; Lee, Sun Joo; Joo, Sung Hong; Sohn, In Sook; Lee, Ji Young; Kwon, Han Sung; Song, Eun Young

Abstract

OBJECTIVE
The purpose of this study was to determine the efficacy of the AMPLICOR HPV test in comparison with the Hybrid Capture 2 (HC2) test in detecting HR HPV.
METHODS
One hundred and fifty-three consecutive women attending the Colposcopy Clinic were included and cervical scrape specimens were tested for the presence of 13 HR HPV genotypes by both AMPLICOR HPV test and HC2 assay.
RESULTS
The prevalence of HR HPV was 53/153 (34.6%) and 52/153 (34.0%) by AMPLICOR HPV test and HC2 assay, respectively. When discordant results were observed between AMPLICOR HPV test and HC2 assay, we used the HPV genotyping DNA chip and DNA sequence analysis, as reference standards. Concordant results were obtained for 128 (83.7%) of the 153 samples (Cohen's kappa=0.63, p<0.001). The genotyping showed that no HR HPV was detected in the 10 AMPLICOR negative HC2 positive samples, while HR HPV genotype was found in 3/13 (23.1%) AMPLICOR positive HC2 negative samples. The detection rates of HR HPV with AMPLICOR HPV test and HC2 assay were 38.7% and 48.4%, respectively, in CIN1; 95.0% and 100%, respectively, in CIN3/cancer. HPV positivity of AMPLICOR HPV test and HC2 assay increased linearly with the increasing grade of cytology or histology (p<0.001). In detecting high grade (CIN2+) lesions, sensitivities were 90.9% (CI, 75.9~97.0%), 95.5% (CI, 81.9~99.0%), respectively, for AMPLICOR HPV test and HC2 assay (p=1.00). The specificities of AMPLICOR HPV test and HC2 assay were 72.7% (CI, 64.3~79.8%) and 69.3% (CI, 60.7~76.7%), respectively (p=0.75).
CONCLUSIONS
AMPLICOR HPV test is comparable to HC2 assay for detection of HR HPV, with similar sensitivity and specificity in detecting CIN2+ lesions. AMPLICOR HPV test can be considered clinically useful for detection of HR HPV. However, more data are clearly needed on the performance of AMPLICOR HPV test as a screening tool.