Comparison of the Cobas 4800 HPV Test and the Seeplex HPV4A ACE with the Hybrid Capture 2 Test

Background: It is well-known that persistent cervical infections with high-risk human papillomavirus (HPV) are related to the development of high-grade cervical intraepithelial neoplasia and invasive cervical cancer and that infection with HPV 16 and HPV 18 accounts for approximately 70% of all cases of invasive cervical cancer. Methods: We performed 3 HPV molecular tests―the Cobas 4800 HPV test, the Seeplex HPV4A ACE, and the hybrid capture 2 (HC2) test―in 146 cervical swab samples to compare between these three tests. Results: There was a concordance rate of 82.8% between the results of the Cobas 4800 HPV and the HC2 test and a concordance rate of 84.9% between the results of the Seeplex HPV4A ACE and the HC2 test. Between the Cobas 4800 HPV test and the Seeplex HPV4A ACE, there was a concordance rate of 89.6% in the detection of high-risk HPV between the results and a concordance rate of 98.7% in the detection of HPV 16 or 18. When an abnormal Pap test was defined as ≥low grade squamous intraepithelial lesion (LSIL), the sensitivity of the Cobas 4800 HPV test, the Seeplex HPV4A ACE and the HC2 test were 71.1%, 80.0%, and 88.9%, respectively, while their specificities were 76.4%, 74.5%, and 67.9%, respectively. Conclusions: The results of this study suggest that the Cobas 4800 HPV test and the Seeplex HPV4A ACE may be as effective as the HC2 test in detecting HR HPV and that the concordance between the results of the Cobas 4800 HPV test and the Seeplex HDV4A ACE may be higher in the detection of HPV 16 and HPV18 than concerning high-risk HPV.

[1]  J. C. Palomares,et al.  Comparison of the Cobas 4800 Human Papillomavirus test against a combination of the Amplicor Human Papillomavirus and the Linear Array tests for detection of HPV types 16 and 18 in cervical samples. , 2012, Journal of virological methods.

[2]  K. So,et al.  Comparison of the Seeplex HPV4A ACE and the Cervista HPV assays for the detection of HPV in hybrid capture 2 positive media , 2012, Journal of gynecologic oncology.

[3]  M. Sideri,et al.  Analytical comparison of the cobas HPV Test with Hybrid Capture 2 for the detection of high-risk HPV genotypes. , 2012, The Journal of molecular diagnostics : JMD.

[4]  Kanti Pabbaraju,et al.  Comparison of the Hybrid Capture 2 and cobas 4800 Tests for Detection of High-Risk Human Papillomavirus in Specimens Collected in PreservCyt Medium , 2011, Journal of Clinical Microbiology.

[5]  M. Schiffman,et al.  Comparison of the cobas Human Papillomavirus (HPV) Test with the Hybrid Capture 2 and Linear Array HPV DNA Tests , 2011, Journal of Clinical Microbiology.

[6]  Thomas C Wright,et al.  Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening of women aged 25 years and older: a subanalysis of the ATHENA study. , 2011, The Lancet. Oncology.

[7]  S. Wacholder,et al.  Human papillomavirus testing in the prevention of cervical cancer. , 2011, Journal of the National Cancer Institute.

[8]  Xia Wang,et al.  Prevalence and genotype distribution of human papillomavirus in women with cervical cancer or high‐grade precancerous lesions in Chengdu, western China , 2011, International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics.

[9]  J. Dillner,et al.  Chapter 9: Clinical applications of HPV testing: a summary of meta-analyses. , 2006, Vaccine.

[10]  J. Berkhof,et al.  HPV testing in cervical screening. , 2006, Best practice & research. Clinical obstetrics & gynaecology.

[11]  U Menon,et al.  Management of women who test positive for high-risk types of human papillomavirus: the HART study , 2003, The Lancet.

[12]  Eileen M. Burd,et al.  Human Papillomavirus and Cervical Cancer , 1988, The Lancet.

[13]  Shalini L Kulasingam,et al.  Evaluation of human papillomavirus testing in primary screening for cervical abnormalities: comparison of sensitivity, specificity, and frequency of referral. , 2002, JAMA.

[14]  H. Adami,et al.  International incidence rates of invasive cervical cancer before cytological screening , 1997 .

[15]  L. Gustafsson,et al.  International incidence rates of invasive cervical cancer before cytological screening. , 1997, International journal of cancer.