Human papillomavirus testing in primary cervical screening and the cut-off level for hybrid capture 2 tests: systematic review

Testing for E6/E7 mRNA in cells infected with high-risk (HR) human papillomavirus (HPV) might improve the specificity of HPV testing for the identification of cervical precancerous lesions. Here we compared the RNA-based Aptima HPV (AHPV) assay (Hologic) and the DNA-based Hybrid Capture 2 (HC2) HPV test (Qiagen) to liquid-based cytology (LBC) for women undergoing routine cervical screening. A total of 10,040 women, 30 to 60 years of age, were invited to participate in the study, 9,451 of whom were included in the analysis. Specimens were tested centrally by LBC, the AHPV test, and the HC2 test, and women who tested positive on any test were referred for colposcopy. Genotyping was performed on all HR-HPV-positive samples. Test characteristics were calculated based on histological review. As a result, we identified 90 women with cervical intraepithelial neoplasia grade 2+ (CIN2+), including 43 women with CIN3+. Sensitivity differences between the AHPV test and the HC2 test in detecting CIN2+ ( P = 0.180) or CIN3+ ( P = 0.0625) lesions were statistically nonsignificant. Of three CIN3 cases that were missed with the AHPV test, two cases presented lesion-free cones and one had a non-HR HPV67 infection. The specificity (<CIN2) and positive predictive value (CIN2+) of the AHPV test were significantly higher (both P < 0.001) than those of the HC2 test. The overall agreement between the tests was substantial (κ = 0.77). Finally, we present results for several possible triage strategies, based on the primary screening test being either the AHPV test or the HC2 test. In summary, the AHPV assay is both specific and sensitive for the detection of high-grade precancerous lesions and may be used in primary cervical cancer screening for women ≥30 years of age.

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

American Journal of Clinical Pathology ◽

10.1309/0dggqbdqamjcjbxb ◽

2004 ◽

Vol 122 (6) ◽

pp. 894-901 ◽

Cited By ~ 60

Author(s):

Ming Guo ◽

Lulin Hu ◽

Mithra Baliga ◽

Zhi He ◽

Michael D. Hughson

Keyword(s):

Human Papillomavirus ◽

Cervical Intraepithelial Neoplasia ◽

Predictive Value ◽

Intraepithelial Neoplasia ◽

High Grade ◽

Hybrid Capture ◽

Human Papillomavirus Testing ◽

Hybrid Capture 2

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A Comparison of the Roche Cobas HPV Test With the Hybrid Capture 2 Test for the Detection of High-Risk Human Papillomavirus Genotypes

Archives of Pathology & Laboratory Medicine ◽

10.5858/arpa.2015-0027-oa ◽

2016 ◽

Vol 140 (2) ◽

pp. 153-157 ◽

Cited By ~ 19

Author(s):

Angelique W. Levi ◽

Jane I. Bernstein ◽

Pei Hui ◽

Kara Duch ◽

Kevin Schofield ◽

...

Keyword(s):

Human Papillomavirus ◽

High Risk ◽

Linear Array ◽

The United States ◽

Hybrid Capture ◽

Human Papillomavirus Testing ◽

Significant Difference ◽

Hybrid Capture 2 ◽

Papillomavirus Dna ◽

Roche Cobas

Context All Food and Drug Administration–approved methods in the United States for human papillomavirus testing including the Hybrid Capture 2 human papillomavirus assay and the Roche cobas human papillomavirus test are approved for cytology specimens collected into ThinPrep media but not for specimens collected into SurePath solution. Objective To compare the performance of the Roche cobas and Hybrid Capture 2 tests for the detection of high-risk human papillomavirus using both ThinPrep and SurePath preparations as part of a validation study. Design One thousand three hundred seventy-one liquid-based cytology samples, including 1122 SurePath and 249 ThinPrep specimens, were tested for high-risk human papillomavirus DNA using the Roche cobas human papillomavirus test and the Hybrid Capture 2 human papillomavirus assay. For cases with discrepant results, confirmatory testing was performed using Linear Array human papillomavirus testing. Results One hundred and fifty-six (11.38%) and 184 (13.42%) of the 1371 specimens tested positive for high-risk human papillomavirus DNA using the Hybrid Capture 2 human papillomavirus assay and Roche cobas human papillomavirus assay, respectively. In addition, 1289 (94.0%) of 1371 specimens demonstrated concordant high-risk human papillomavirus results with a κ value of 0.72 (95% confidence interval, 065–0.78). There was no statistically significant difference in the percentage of positive high-risk human papillomavirus results between the 2 liquid-based preparations with either assay. Discordant results between the 2 assays were noted in 82 of 1371 cases (6%). Twenty-seven of 82 cases (32.9%) were Hybrid Capture 2 positive/Roche cobas negative and 55 of 82 cases (67.1%) were Roche cobas positive/Hybrid Capture 2 negative. Two of 20 Hybrid Capture 2–positive/Roche cobas–negative cases (10%) and 26 of 37 Roche cobas–positive/Hybrid Capture 2–negative cases (70%) tested positive for high-risk human papillomavirus by Linear Array. Conclusions Both assays showed good agreement and excellent specificity with either ThinPrep or SurePath preparations. The number of discordant results was relatively small. The performance of both assays was similar for ThinPrep specimens, but the Roche cobas test demonstrated higher sensitivity with SurePath specimens.

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