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Journal of Clinical Microbiology, June 2004, p. 2470-2475, Vol. 42, No. 6
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.6.2470-2475.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Human Papillomavirus Testing with the Hybrid Capture 2 Assay and PCR as Screening Tools

S.-M. Kulmala,1 S. Syrjänen,1* I. Shabalova,2,3 N. Petrovichev,2 V. Kozachenko,2 J. Podistov,2 O. Ivanchenko,4 S. Zakharenko,5 R. Nerovjna,6 L. Kljukina,7 M. Branovskaja,8 V. Grunberga,9 A. Juschenko,9 P. Tosi,10 R. Santopietro,10 K. Syrjänen,11 and the NIS Cohort Study Group{dagger}

Department of Oral Pathology, Institute of Dentistry, and MediCity Research Laboratory, University of Turku, Turku, Finland,1 N. N. Blokhin Cancer Research Centre of Russian Academy of Medical Sciences,2 Russian Academy of Post-Graduate Medical Education, Moscow,3 Novgorod Clinical Regional Hospital, Centralised Cytology Laboratory,4 Novgorod Municipal Dermatovenereological Dispensary, Department of Gynaecology,5 Novgorod Female Consultative Outpatient Hospital, Department of Gynaecology, Novgorod, Russia,6 Research Institute of Oncology and Medical Radiology, Republican Centre of Clinical Cytology,7 Minsk State Medical Institute, Department of Gynaecology and Obstetrics, Minsk, Belarus,8 Latvian Cancer Centre, Department of Gynaecology, & Laboratory of Cytology, Riga, Latvia,9 Department of Pathology, University of Siena, Siena,10 Unit of Cytopathology, Laboratory of Epidemiology and Biostatistics, National Institute of Health, Rome, Italy,11

Received 17 November 2003/ Returned for modification 10 January 2004/ Accepted 20 February 2004

The recognition of high-risk human papillomaviruses (HPVs) as etiological agents of cervical cancer has increased the demands to use testing for HPV for the detection of abnormal cervical smears and for cervical cancer screening. The present study compared the performance of the Hybrid Capture 2 (HC2) assay with that of PCR for the detection of significant cervical lesions in 1,511 women with different risks for HPV infections in three New Independent States of the former Soviet Union. The results showed that the level of agreement between the HC2 assay and PCR was substantial, with a kappa (Cohen) value of 0.669 (95% confidence interval [CI], 0.629 to 0.709). Of the 228 samples with discrepant results, 92 were positive by the HC2 assay but negative by PCR, whereas 136 samples were PCR positive but HC2 assay negative. The positive predictive values (PPVs) of the HC2 assay and PCR in detecting high-grade intraepithelial lesions (HSILs) were 4.5% (95% CI, 3.5 to 5.5%) and 3.6% (95% CI, 2.7 to 4.5%), respectively, and the negative predictive values (NPVs) were 99.6% (95% CI, 99.3 to 99.9%) and 99.3% (95% CI, 98.9 to 99.7%), respectively. The sensitivities of the HC2 assay and PCR for the detection of HSILs were 85.2 and 74.0%, respectively, and the specificities were 67.2 and 64.1%, respectively. In receiver operating characteristic (ROC) analysis, the performance of the HC2 assay for the detection of HSILs was excellent (P = 0.0001); the area under the ROC analysis curve was 0.858 (95% CI, 0.811 to 0.905), and the optimal balance between sensitivity (86.5%) and specificity (80%) was obtained with an HC2 assay cutoff level of 15.6 relative light units/positive control. Use of this cutoff would increase the specificity of the HC2 assay to 80.0% without compromising sensitivity. In conclusion, the results of PCR and the HC2 assay were concordant for 85% of samples, resulting in substantial reproducibility. Both tests had low PPVs, equal specificities, and equal (almost 100%) NPVs for the detection of HSILs; but the sensitivity of the HC2 assay was slightly better.

* Corresponding author. Mailing address: Department of Oral Pathology, Institute of Dentistry, Faculty of Medicine, Lemminkäisenkatu 2, 205020 Turku, Finland. Phone: 358-2-3338349. Fax: 358-2-3338399. E-mail: stina.syrjanen{at}utu.fi.

{dagger} Contributing members of the NIS Cohort Study Group are listed in Acknowledgments.

Journal of Clinical Microbiology, June 2004, p. 2470-2475, Vol. 42, No. 6
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.6.2470-2475.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.



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