High Risk (HR) Human Papilloma Virus (HPV) Tests for HPV detection differ in sensitivity and specificity. In this study we evaluated the sensitivity and specificity of Qiagen HC2 HR HPV Test® (Qiagen) and Roche Cobas 4800 HPV Test® (Roche Diagnostics) in consecutive cervical samples collected from a referral population with a high prevalence of disease, using CIN2+ histology as clinical outcome. High Risk (HR) Human Papilloma Virus (HPV) Tests for HPV detection differ in sensitivity and specificity. In this study we evaluated the sensitivity and specificity of Qiagen HC2 HR HPV Test® (Qiagen) and Roche Cobas 4800 HPV Test® (Roche Diagnostics) in consecutive cervical samples collected from a referral population with a high prevalence of disease, using CIN2+ histology as clinical outcome.
10213 consecutive cervical samples were assayed for HR-HPV for any reason in Laboratory Medicine Division of IEO: 5140 from January 2012 to June 2013 with HC2 and 5073 from July 2013 to December 2014 with Cobas HPV Test. These two assays differ in terms of target genes and testing methods: HC2 is a signal amplification detection system based on chemiluminescence that detects 13 HR-HPV, while Cobas HPV test is a fully automated real-time PCR assay that detects the same 13 HR genotypes of HC2 plus HPV 66, and allows, in case of positive results, to differentiate HPV 16 and 18 from the other HR HPV genotypes.
Overall in the three years under consideration we found 223 CIN2+: in the first period we diagnosed 144 CIN2+, of which 24 were24 HC2 negative (16.4%); in the second period we diagnosed 79 CIN2+ of which 13 were Cobas HPV negative (16.5%). In our population no statistically significant difference in terms of sensitivity and specificity of HC2 and Cobas was found.
The analysis of the performance of HC2 and Cobas HPV testing in the detection of CIN2+ lesions in a referral population showed comparable performance of the two test.The difference in sensitivity and specificity of a test should be considered when choosing the HPV test to use in routine: in our experience we did not find significant changes in sensitivity and specificity between HC2 and Cobas 4800 in CIN2+ detection.