Clinical relevance of the borderline results of the Hybrid Capture 2 High-Risk HPV DNA assay with cervical samples collected in Specimen Transport Medium

1 Ursič Vrščaj M, Rakar S, Možina A, Kobal B, Takač I, Deisinger I, et al. [Guidelines for management of women with cervical precancerous lesions]. [Slovenian]. In: Ursic-Vrscaj M, editor. Ljubljana: Institute of Oncology Ljubljana; 2011. Ursič Vrščaj M Rakar S Možina A Kobal B Takač I Deisinger I et al [Guidelines for management of women with cervical precancerous lesions]. [Slovenian] In Ursic-VrscajM editor Ljubljana Institute of Oncology Ljubljana 2011Search in Google Scholar

2 Hybrid Capture 2 (hc2) High Risk HPV DNA test kit [package insert]. Gaithersburg, MD: Digene; 2004. Hybrid Capture 2 (hc2) High Risk HPV DNA test kit [package insert] Gaithersburg, MD Digene 2004Search in Google Scholar

3 Castle PE, Lorincz AT, Mielzynska-Lohnas I, Scott DR, Glass AG, Sherman ME, et al. Results of human papillomavirus DNA testing with the Hybrid Capture 2 assay are reproducible. J Clin Microbiol 2002; 40: 1088-90. doi: 10.1158/1055-9965.EPI-07-2904 Castle PE Lorincz AT Mielzynska-Lohnas I Scott DR Glass AG Sherman ME et al Results of human papillomavirus DNA testing with the Hybrid Capture 2 assay are reproducible J Clin Microbiol 2002 40 1088 90 10.1158/1055-9965.EPI-07-2904270514118483347Open DOISearch in Google Scholar

4 Castle PE, Wheeler CM, Solomon D, Schiffman M, Peyton CL; ALTS Group. Interlaboratory reliability of Hybrid Capture 2. Am J Clin Pathol 2004; 122: 238-45. doi: 10.1158/1055-9965.EPI-07-2904 Castle PE Wheeler CM Solomon D Schiffman M PeytonCL ALTS Group. Interlaboratory reliability of Hybrid Capture 2 Am J Clin Pathol 2004 122 238 45 10.1158/1055-9965.EPI-07-2904270514118483347Open DOISearch in Google Scholar

5 Carozzi FM, Del Mistro A, Confortini M, Sani C, Puliti D, Trevisan R, et al. Reproducibility of HPV DNA testing by Hybrid Capture 2 in a screening setting. Am J Clin Pathol 2005; 124: 716-21. doi: 10.1309/84E5WHJQHK83BGQD Carozzi FM Del Mistro A Confortini M Sani C Puliti D Trevisan R et al Reproducibility of HPV DNA testing by Hybrid Capture 2 in a screening setting Am J Clin Pathol 2005 124 716 21 10.1309/84E5WHJQHK83BGQDOpen DOISearch in Google Scholar

6 Seme K, Fujs K, Kocjan BJ, Poljak M. Resolving repeatedly borderline results of Hybrid Capture 2 HPV DNA Test using polymerase chain reaction and genotyping. J Virol Methods 2006; 134: 252-6. doi: 10.1016/j. jviromet.2005.12.004 Seme K Fujs K Kocjan BJ Poljak M Resolving repeatedly borderline results of Hybrid Capture 2 HPV DNA Test using polymerase chain reaction and genotyping J Virol Methods 2006 134 252 6 10.1016/j.jviromet.2005.12.00416417931Open DOISearch in Google Scholar

7 Origoni M, Carminati G, Sideri M, Clementi M, Rolla S, Candiani M. “Low-grade positivity” of HPV viral load after atypical squamous cells of undetermined significance (ASC-US) cytology identifies women at low-risk for cervical intraepithelial neoplasia grade 2 and 3. Eur J Gynaecol Oncol 2012; 33: 261-4. PMID: 22873095 Origoni M Carminati G Sideri M Clementi M Rolla S Candiani M. “Low-grade positivity” of HPV viral load after atypical squamous cells of undetermined significance (ASC-US) cytology identifies women at low-risk for cervical intraepithelial neoplasia grade 2 and 3 Eur J Gynaecol Oncol 2012 33 261 4 PMID: 22873095Search in Google Scholar

8 de Cremoux P, Coste J, Sastre-Garau X, Thioux M, Bouillac C, Labbe S, et al. Efficiency of the Hybrid Capture 2 HPV DNA test in cervical cancer screening. A study by the French Society of Clinical Cytology. Am J Clin Pathol 2003; 120: 492-9. doi: 10.1309/XFUC-PP6M-5XUA-94B8 de CremouxP CosteJ Sastre-GarauX ThiouxM BouillacC LabbeS et al Efficiency of the Hybrid Capture 2 HPV DNA test in cervical cancer screening. A study by the French Society of Clinical Cytology Am J Clin Pathol 2003 120 492 9 10.1309/XFUC-PP6M-5XUA-94B814560561Open DOISearch in Google Scholar

9 Muldrew KL, Beqaj SH, Han J, Lum SH, Clinard V, Schultenover SJ, et al. Evaluation of a Digene-recommended algorithm for human papillomavirus low-positive results present in a “retest zone”. Am J Clin Pathol 2007; 127: 97-102. doi: 10.1309/4WCPTUV506HLP06P Muldrew KL Beqaj SH Han J Lum SH Clinard V Schultenover SJ et al Evaluation of a Digene-recommended algorithm for human papillomavirus low-positive results present in a “retest zone” Am J Clin Pathol 2007 127 97 102 10.1309/4WCPTUV506HLP06P17145630Open DOISearch in Google Scholar

10 Rao A, Sandri MT, Sideri M, Young S, Sharma A, Behrens C. Comparison of hybrid capture 2 High-Risk HPV results in the low positive range with cobas® HPV Test results from the ATHENA study. J Clin Virol 2013; 58: 161-7. doi: 10.1016/j.jcv.2013.06.041 Rao A Sandri MT Sideri M Young S Sharma A Behrens C Comparison of hybrid capture 2 High-Risk HPV results in the low positive range with cobas® HPV Test results from the ATHENA study J Clin Virol 2013 58 161 7 10.1016/j.jcv.2013.06.04123895930Open DOISearch in Google Scholar

11 Knoepp SM, Kuebler DL, Wilbur DC. Resolution of equivocal results with the Hybrid Capture II high-risk HPV DNA test: a cytologic/histologic review of 191 cases. Diagn Mol Pathol 2007; 16: 125-9. doi: 10.1097/ PDM.0b013e31805c99ae Knoepp SM Kuebler DL Wilbur DC Resolution of equivocal results with the Hybrid Capture II high-risk HPV DNA test: a cytologic/histologic review of 191 cases Diagn Mol Pathol 2007 16 125 9 10.1097/PDM.0b013e31805c99ae17721319Open DOISearch in Google Scholar

12 Knoepp SM, Kuebler DL, Wilbur DC. Correlation between hybrid capture II high-risk human papillomavirus DNA test chemiluminescence intensity from cervical samples with follow-up histologic results: a cytologic/ histologic review of 367 cases. Cancer Cytopathol 2010; 118: 209-17. doi: 10.1002/cncy.20093 Knoepp SM Kuebler DL Wilbur DC Correlation between hybrid capture II high-risk human papillomavirus DNA test chemiluminescence intensity from cervical samples with follow-up histologic results: a cytologic/ histologic review of 367 cases Cancer Cytopathol 2010 118 209 17 10.1002/cncy.2009320578088Open DOISearch in Google Scholar

13 LaMere BJ, Castle PE, Fetterman B, Poitras N, Stanley M, Shieh J, et al. A study of borderline positive Hybrid Capture 2 tests in the Kaiser Permanente Northern California cervical screening program: evidence against retesting. J Virol Methods 2013; 189: 77-9. doi: 10.1016/j.jviromet.2013.01.011 LaMere BJ Castle PE Fetterman B Poitras N Stanley M Shieh J et al A study of borderline positive Hybrid Capture 2 tests in the Kaiser Permanente Northern California cervical screening program: evidence against retesting J Virol Methods 2013 189 77 9 10.1016/j.jviromet.2013.01.011365266023384678Open DOISearch in Google Scholar

14 Elkins CT, de Vries CE, Stephens J, Suarez AA. Hybrid capture 2 test results after an initial equivocal RLU/CO value are dependent on age. Am J Clin Pathol 2013; 139: 605-10. doi: 10.1309/AJCPARHTB40DTVFV Elkins CT de VriesCE StephensJ SuarezAA Hybrid capture 2 test results after an initial equivocal RLU/CO value are dependent on age Am J Clin Pathol 2013 139 605 10 10.1309/AJCPARHTB40DTVFV386923123596112Open DOISearch in Google Scholar

15 Ramirez-Hidalgo A, Musset-Biarnes M, Vilamala-Muns M, Laso-Perez E, Serrano-Munne L, Alameda-Quitllet F. Hybrid capture 2 high-risk human papillomavirus test: should “grey zone” results justify repeating the test? Anal Quant Cytopathol Histpathol 2013; 35: 152-6. PMID: 24344502 Ramirez-Hidalgo A Musset-BiarnesM Vilamala-MunsM Laso-PerezE Serrano-MunneL Alameda-QuitlletF Hybrid capture 2 high-risk human papillomavirus test: should “grey zone” results justify repeating the test? Anal Quant Cytopathol Histpathol 2013 35 152 6 PMID: 24344502Search in Google Scholar

16 de Vries CE, Shen R, Stephens J, Suarez AA. Equivocal and weakly positive hybrid capture 2 test in women aged 50 and older. Diagn Cytopathol 2012; 40: 708-12. doi: 10.1002/dc.21710 de VriesCE ShenR StephensJ SuarezAA Equivocal and weakly positive hybrid capture 2 test in women aged 50 and older Diagn Cytopathol 2012 40 708 12 10.1002/dc.2171021557535Open DOISearch in Google Scholar

17 Ivanus U, Jerman T, Fokter AR, Takac I, Prevodnik VK, Marcec M, et al. Randomised trial of HPV self-sampling among non-attenders in the Slovenian cervical screening programme ZORA: comparing three different screening approaches. Radiol Oncol 2018; 52: 399-412. doi: 10.2478/ raon-2018-0036 Ivanus U Jerman T Fokter AR Takac I Prevodnik VK Marcec M et al Randomised trial of HPV self-sampling among non-attenders in the Slovenian cervical screening programme ZORA: comparing three different screening approaches Radiol Oncol 2018 52 399 412 10.2478/raon-2018-0036628718330216191Open DOISearch in Google Scholar

18 Kurman RJ, Carcangiu ML, Herrington CS, Young RH, editors. WHO classification of tumours of female reproductive organs. 4th edition. Lyon: International Agency for Research on Cancer; 2014. Kurman RJ Carcangiu ML Herrington CS Young RH editors WHO classification of tumours of female reproductive organs 4th edition Lyon International Agency for Research on Cancer 2014Search in Google Scholar

19 R Core Team. The R Project for Statistical Computing R: A Language and Environment for Statistical Computing. Vienna: R Foundation for Statistical Computing; 2019. [cited 2019 May 15]. Available at: http://www.R-project.org/ R Core Team The R Project for Statistical Computing R: A Language and Environment for Statistical Computing. Vienna: R Foundation for Statistical Computing 2019 [cited 2019 May 15] Available at http://www.R-project.org/Search in Google Scholar

20 Kotaniemi-Talonen L, Malila N, Nieminen P, Anttila A, Tarkkanen J, Laurila P, et al. Test positivity cutoff level of a high risk human papillomavirus test could be increased in routine cervical cancer screening. Int J Cancer 2008; 123: 2902-6. doi: 10.1002/ijc.23839. Kotaniemi-Talonen L Malila N Nieminen P Anttila A Tarkkanen J Laurila P et al Test positivity cutoff level of a high risk human papillomavirus test could be increased in routine cervical cancer screening Int J Cancer 2008 123 2902 6 10.1002/ijc.2383918792100Open DOISearch in Google Scholar

21 Ronco G, Giorgi-Rossi P, Carozzi F, Dalla Palma P, Del Mistro A, De Marco L, et al. Human papillomavirus testing and liquid-based cytology in primary screening of women younger than 35 years: results at recruitment for a randomised controlled trial. Lancet Oncol 2006; 7: 547-55. doi: 10.1016/ S1470-2045(06)70731-8 Ronco G Giorgi-Rossi P Carozzi F Dalla Palma P Del Mistro A De Marco L et al Human papillomavirus testing and liquid-based cytology in primary screening of women younger than 35 years: results at recruitment for a randomised controlled trial Lancet Oncol 2006 7 547 55 10.1016/S1470-2045(06)70731-816814206Open DOISearch in Google Scholar

22 Ronco G, Segnan N, Giorgi-Rossi P, Zappa M, Casadei GP, Carozzi F, et al. Human papillomavirus testing and liquid-based cytology: results at recruitment from the new technologies for cervical cancer randomized controlled trial. J Natl Cancer Inst 2006; 98: 765-74. doi: 10.1093/jnci/djj209 Ronco G Segnan N Giorgi-Rossi P Zappa M Casadei GP Carozzi F et al Human papillomavirus testing and liquid-based cytology: results at recruitment from the new technologies for cervical cancer randomized controlled trial J Natl Cancer Inst 2006 98 765 74 10.1093/jnci/djj20916757701Open DOISearch in Google Scholar

23 Ronco G, Giorgi-Rossi P, Carozzi F, Confortini M, Dalla Palma P, Del Mistro A, et al. Results at recruitment from a randomized controlled trial comparing human papillomavirus testing alone with conventional cytology as the primary cervical cancer screening test. J Natl Cancer Inst 2008; 100: 492-501. doi: 10.1093/jnci/djn065 Ronco G Giorgi-Rossi P Carozzi F Confortini M Dalla Palma P Del Mistro A et al Results at recruitment from a randomized controlled trial comparing human papillomavirus testing alone with conventional cytology as the primary cervical cancer screening test J Natl Cancer Inst 2008 100 492 501 10.1093/jnci/djn06518364502Open DOISearch in Google Scholar

24 Sargent A, Bailey A, Turner A, Almonte M, Gilham C, Baysson H, et al. Optimal threshold for a positive hybrid capture 2 test for detection of human papillomavirus: data from the ARTISTIC trial. J Clin Microbiol 2010; 48: 554-8. doi: 10.1128/JCM.00896-09 Sargent A Bailey A Turner A Almonte M Gilham C Baysson H et al Optimal threshold for a positive hybrid capture 2 test for detection of human papillomavirus: data from the ARTISTIC trial J Clin Microbiol 2010 48 554 8 10.1128/JCM.00896-09281564720007387Open DOISearch in Google Scholar

25 Clavel C, Masure M, Bory JP, Putaud I, Mangeonjean C, Lorenzato M, et al. Human papillomavirus testing in primary screening for the detection of high-grade cervical lesions: a study of 7932 women. Br J Cancer 2001; 84: 1616-23. doi: 10.1054/bjoc.2001.1845 Clavel C Masure M Bory JP Putaud I Mangeonjean C Lorenzato M et al Human papillomavirus testing in primary screening for the detection of high-grade cervical lesions: a study of 7932 women Br J Cancer 2001 84 1616 23 10.1054/bjoc.2001.1845236367911401314Open DOISearch in Google Scholar

26 Rijkaart DC, Coupe VM, van Kemenade FJ, Heideman DA, Hesselink AT, Verweij W, et al. Comparison of Hybrid capture 2 testing at different thresholds with cytology as primary cervical screening test. Br J Cancer 2010; 103: 939-46. doi: 10.1038/sj.bjc.6605869 Rijkaart DC Coupe VM van Kemenade FJ Heideman DA Hesselink AT Verweij W et al Comparison of Hybrid capture 2 testing at different thresholds with cytology as primary cervical screening test Br J Cancer 2010 103 939 46 10.1038/sj.bjc.6605869296587420808310Open DOISearch in Google Scholar

27 Rebolj M, Bonde J, Njor SH, Lynge E. Human papillomavirus testing in primary cervical screening and the cut-off level for hybrid capture 2 tests: systematic review. BMJ 2011; 23: 342. doi: 10.1136/bmj.d2757 Rebolj M Bonde J Njor SH Lynge E Human papillomavirus testing in primary cervical screening and the cut-off level for hybrid capture 2 tests: systematic review BMJ 2011 23 342 10.1136/bmj.d2757309954321606136Open DOISearch in Google Scholar