Comparison of the Hybrid Capture II Assay With the Human Papillomavirus DNA Chip Test for the Detection of High-Grade Cervical Lesions

Abstract

Cervical intraepithelial neoplasia (CIN) 2 is used as the threshold for treatment decisions. This study was conducted to evaluate the clinical efficacy of the Hybrid Capture II assay (HC2) and the human papillomavirus (HPV) DNA chip test (HDC) for detecting HPV in high-grade cervical lesions CIN2 or greater, including adenocarcinoma (CIN2+). Seven hundred forty-one women with abnormal cervical cytology were evaluated with the HC2, the HDC, and histological assessment of the cervix. The overall agreement of the 2 HPV tests was 88.8% (kappa value, 0.61). Of 615 high-risk HPV-positive specimens by the HC2, 571 (92.8%) were HDC-positive. Both tests were performed similarly on CIN2+ samples; the sensitivities of the HC2 and HDC as predictors of CIN2+ were 93.4 and 92.6%, respectively. In 83 cases of discrepancies between the HC2 and HDC, genotyping of 39 HC2-negative/HDC-positive cases revealed 13 HPV-53, 8 HPV-58, 7 HPV-16, 6 HPV-18, 2 HPV-68, 1 HPV-31, 1 HPV-45, and 1 HPV-66. In 515 patients with CIN2+, HPV-16 (45.0%) was the most common type; the next most common types were HPV-58 (20.8%), HPV-18 (16.1%), HPV-31 (6.6%), and HPV-33 (6.6%). Human papillomavirus types 16, 58, and 18 were more likely associated with CIN2+ (P < 0.05). In conclusion, the HDC is a reliable diagnostic tool for the detection of CIN2+. In addition, the HDC provides useful information regarding viral genotypes.

Prior High-Risk Human Papillomavirus Testing and Papanicolaou Test Results of 70 Invasive Cervical Carcinomas Diagnosed in 2012: Results of a Retrospective Multicenter Study

“…Our findings are consistent with most previous studies showing similar negative HPV testing rates in invasive cervical cancer. 5,[10][11][12] In our study, HPV À rates in patients with invasive cervical cancer seemed to increase with increased time before cancer diagnosis, and it is reasonable to attribute that trend to the smaller size of the lesion or the lower viral titers during earlier periods.…”

“…HC2 was the first FDA-approved HPV test, and studies from different countries, including the United Kingdom, Slovenia, China, and Korea, have demonstrated that HC2 is associated with negative results in cervical cytology specimens from patients with cervical cancer; HC2 À rates have varied from 5.0% to 25%. [14][15][16][17][18] The question is, whether those are true-negative or false-negative results. In a recent study, 3 of 31 patients 10 (9.7%) diagnosed with invasive cervical squamous cell carcinoma and tested within the prior 12 months for hrHPV by HC2 had negative HC2 results.…”

“…5 Other studies found a similar range of negative detection rates for hrHPV in cervical cytologic specimens from patients with cervical cancers. [10][11][12][13] Accurate estimates of the sensitivity of hrHPV testing for detection of invasive cervical cancer is important. Because some HPV infections are persistent for only a few years before invasive squamous cell carcinomas develop, a low sensitivity rate in hrHPV testing in detecting invasive cervical cancers would result in poor performance of screening programs that extend cotesting to 5 years.…”

Human Papillomavirus Laboratory Testing: the Changing Paradigm

“…The rate is actually probably slightly higher when the HPV test is performed not on the whole vial but on the cell-enriched fraction (128). Data from studies performed in several different countries using different molecular tests as comparators indicate that the HC2 test has a false-negative rate of about 5 to 12% in patients with cervical cancer (131,(138)(139)(140)(141)(142)(143)(144). Since the HC2 test does not contain an internal control, it is not possible to determine the adequacy of the specimen or the presence of potentially interfering substances.…”

The Role of High-Risk Human Papilloma Virus Testing in the Surveillance of Cervical Cancer After Treatment

“…13 Even though HPV infection is widely implicated in the pathogenesis of cervical cancer, only 91% of cervical carcinomas tested at the time of diagnosis were positive for hr-HPV. 14,15 The reasons for this are unclear, but Sundstrom et al 16 hypothesize that HPV 16 viral load may decrease in a significant subset of patients developing cervical carcinoma. In fact, even though viral infection may be present in the preceding years, it may be below the threshold detectable by current clinical testing.…”