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. 1995 Mar;33(3):545–550. doi: 10.1128/jcm.33.3.545-550.1995

Accuracy and interlaboratory reliability of human papillomavirus DNA testing by hybrid capture.

M H Schiffman 1, N B Kiviat 1, R D Burk 1, K V Shah 1, R W Daniel 1, R Lewis 1, J Kuypers 1, M M Manos 1, D R Scott 1, M E Sherman 1
PMCID: PMC227988  PMID: 7751355

Abstract

Epidemiologists and clinicians wishing to introduce human papillomavirus (HPV) testing into cervical cancer prevention programs need standardized, reliable, and accurate HPV DNA tests that can detect the full spectrum of pathogenic HPV types. The Hybrid Capture System assay from Digene (hybrid capture assay) is a nonradioactive kit designed to detect 14 HPV types in two groups: a mix of 9 high-risk types associated with anogenital cancer (HPV types 16, 18, 31, 33, 35, 45, 51, 52, and 56) and another group of 5 low-risk types associated with condyloma acuminatum (HPV types 6, 11, 42, 43, and 44). The assay yields quantitative data meant to reflect viral concentration. In a study of 199 cervical specimens from women with concurrent Pap smears, we assessed the reliability of the new assay by comparing the hybrid capture assay results from three laboratories. We assessed the accuracy of the hybrid capture assay in comparison with a reference standard of HPV DNA content (multiple testing by several methods in two reference laboratories). We also compared the hybrid capture assay results with the concurrent cytologic diagnoses on the basis of an independent review of each smear by five pathologists. Pairwise interlaboratory agreement rates on HPV positivity for either high-risk or low-risk types ranged from 87 to 94%, and kappa values ranged from 0.61 to 0.83. Among specimens positive for high-risk types (the most important clinical outcome), the interlaboratory correlations of the quantitative data ranged from 0.60 to 0.90.(ABSTRACT TRUNCATED AT 250 WORDS)

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Selected References

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  1. Bauwens J. E., Clark A. M., Stamm W. E. Diagnosis of Chlamydia trachomatis endocervical infections by a commercial polymerase chain reaction assay. J Clin Microbiol. 1993 Nov;31(11):3023–3027. doi: 10.1128/jcm.31.11.3023-3027.1993. [DOI] [PMC free article] [PubMed] [Google Scholar]
  2. Bergeron C., Barrasso R., Beaudenon S., Flamant P., Croissant O., Orth G. Human papillomaviruses associated with cervical intraepithelial neoplasia. Great diversity and distinct distribution in low- and high-grade lesions. Am J Surg Pathol. 1992 Jul;16(7):641–649. doi: 10.1097/00000478-199207000-00002. [DOI] [PubMed] [Google Scholar]
  3. Brandsma J., Burk R. D., Lancaster W. D., Pfister H., Schiffman M. H. Inter-laboratory variation as an explanation for varying prevalence estimates of human papillomavirus infection. Int J Cancer. 1989 Feb 15;43(2):260–262. doi: 10.1002/ijc.2910430216. [DOI] [PubMed] [Google Scholar]
  4. Cuzick J., Terry G., Ho L., Hollingworth T., Anderson M. Human papillomavirus type 16 in cervical smears as predictor of high-grade cervical intraepithelial neoplasia [corrected]. Lancet. 1992 Apr 18;339(8799):959–960. doi: 10.1016/0140-6736(92)91532-d. [DOI] [PubMed] [Google Scholar]
  5. Franco E. L. The sexually transmitted disease model for cervical cancer: incoherent epidemiologic findings and the role of misclassification of human papillomavirus infection. Epidemiology. 1991 Mar;2(2):98–106. [PubMed] [Google Scholar]
  6. Fuchs P. G., Girardi F., Pfister H. Human papillomavirus DNA in normal, metaplastic, preneoplastic and neoplastic epithelia of the cervix uteri. Int J Cancer. 1988 Jan 15;41(1):41–45. doi: 10.1002/ijc.2910410109. [DOI] [PubMed] [Google Scholar]
  7. Hildesheim A., Gravitt P., Schiffman M. H., Kurman R. J., Barnes W., Jones S., Tchabo J. G., Brinton L. A., Copeland C., Epp J. Determinants of genital human papillomavirus infection in low-income women in Washington, D.C. Sex Transm Dis. 1993 Sep-Oct;20(5):279–285. doi: 10.1097/00007435-199309000-00008. [DOI] [PubMed] [Google Scholar]
  8. Kiviat N. B., Koutsky L. A., Critchlow C. W., Galloway D. A., Vernon D. A., Peterson M. L., McElhose P. E., Pendras S. J., Stevens C. E., Holmes K. K. Comparison of Southern transfer hybridization and dot filter hybridization for detection of cervical human papillomavirus infection with types 6, 11, 16, 18, 31, 33, and 35. Am J Clin Pathol. 1990 Nov;94(5):561–565. doi: 10.1093/ajcp/94.5.561. [DOI] [PubMed] [Google Scholar]
  9. Koutsky L. A., Holmes K. K., Critchlow C. W., Stevens C. E., Paavonen J., Beckmann A. M., DeRouen T. A., Galloway D. A., Vernon D., Kiviat N. B. A cohort study of the risk of cervical intraepithelial neoplasia grade 2 or 3 in relation to papillomavirus infection. N Engl J Med. 1992 Oct 29;327(18):1272–1278. doi: 10.1056/NEJM199210293271804. [DOI] [PubMed] [Google Scholar]
  10. Lorincz A. T., Reid R., Jenson A. B., Greenberg M. D., Lancaster W., Kurman R. J. Human papillomavirus infection of the cervix: relative risk associations of 15 common anogenital types. Obstet Gynecol. 1992 Mar;79(3):328–337. doi: 10.1097/00006250-199203000-00002. [DOI] [PubMed] [Google Scholar]
  11. Moscicki A. B., Palefsky J., Smith G., Siboshski S., Schoolnik G. Variability of human papillomavirus DNA testing in a longitudinal cohort of young women. Obstet Gynecol. 1993 Oct;82(4 Pt 1):578–585. [PubMed] [Google Scholar]
  12. Muñoz N., Bosch F. X., de Sanjosé S., Tafur L., Izarzugaza I., Gili M., Viladiu P., Navarro C., Martos C., Ascunce N. The causal link between human papillomavirus and invasive cervical cancer: a population-based case-control study in Colombia and Spain. Int J Cancer. 1992 Nov 11;52(5):743–749. doi: 10.1002/ijc.2910520513. [DOI] [PubMed] [Google Scholar]
  13. Schiffman M. H., Bauer H. M., Hoover R. N., Glass A. G., Cadell D. M., Rush B. B., Scott D. R., Sherman M. E., Kurman R. J., Wacholder S. Epidemiologic evidence showing that human papillomavirus infection causes most cervical intraepithelial neoplasia. J Natl Cancer Inst. 1993 Jun 16;85(12):958–964. doi: 10.1093/jnci/85.12.958. [DOI] [PubMed] [Google Scholar]
  14. Schiffman M. H., Bauer H. M., Lorincz A. T., Manos M. M., Byrne J. C., Glass A. G., Cadell D. M., Howley P. M. Comparison of Southern blot hybridization and polymerase chain reaction methods for the detection of human papillomavirus DNA. J Clin Microbiol. 1991 Mar;29(3):573–577. doi: 10.1128/jcm.29.3.573-577.1991. [DOI] [PMC free article] [PubMed] [Google Scholar]
  15. Schiffman M. H., Schatzkin A. Test reliability is critically important to molecular epidemiology: an example from studies of human papillomavirus infection and cervical neoplasia. Cancer Res. 1994 Apr 1;54(7 Suppl):1944s–1947s. [PubMed] [Google Scholar]
  16. Schiffman M. H. Validation of hybridization assays: correlation of filter in situ, dot blot and PCR with Southern blot. IARC Sci Publ. 1992;(119):169–179. [PubMed] [Google Scholar]
  17. Sherman M. E., Schiffman M. H., Lorincz A. T., Manos M. M., Scott D. R., Kuman R. J., Kiviat N. B., Stoler M., Glass A. G., Rush B. B. Toward objective quality assurance in cervical cytopathology. Correlation of cytopathologic diagnoses with detection of high-risk human papillomavirus types. Am J Clin Pathol. 1994 Aug;102(2):182–187. doi: 10.1093/ajcp/102.2.182. [DOI] [PubMed] [Google Scholar]
  18. Vlaspolder F., Mutsaers J. A., Blog F., Notowicz A. Value of a DNA probe assay (Gen-Probe) compared with that of culture for diagnosis of gonococcal infection. J Clin Microbiol. 1993 Jan;31(1):107–110. doi: 10.1128/jcm.31.1.107-110.1993. [DOI] [PMC free article] [PubMed] [Google Scholar]
  19. zur Hausen H. Molecular pathogenesis of cancer of the cervix and its causation by specific human papillomavirus types. Curr Top Microbiol Immunol. 1994;186:131–156. doi: 10.1007/978-3-642-78487-3_8. [DOI] [PubMed] [Google Scholar]

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