Analytical performance of the Investigational Use Only Cervista™ HPV HR test as determined by a multi-center study

Journal of Clinical Virology

Volumn 45, Issue SUPPL. 1, 2009, Pages

  Day, Stephen P ^a   Hudson, Angela ^a   Mast, Andrea ^a   Sander, Tamara ^a   Curtis, Michelle ^a   Olson, Sarah ^a   Chehak, LuAnne ^a   Quigley, Neil ^b   Ledford, Joellen ^b   Yen Lieberman, Belinda ^c   Kohn, Debra ^c   Quigley, Denise I ^d   Olson, Marilyn ^a  

^a HOLOGIC INC   (United States)

^b Molecular Pathology Laboratory Network Inc   (United States)

^c LERNER RESEARCH INSTITUTE   (United States)

^d MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

Author keywords

Analytical Performance; Cervista; HPV; Invader; Papillomavirus

Indexed keywords

ANALYTIC METHOD; ARTICLE; CANCER RISK; CANCER SCREENING; CONTROLLED STUDY; CROSS REACTION; DIAGNOSTIC ACCURACY; DIAGNOSTIC PROCEDURE; DNA EXTRACTION; DNA SEQUENCE; HUMAN PAPILLOMAVIRUS TYPE 16; HUMAN PAPILLOMAVIRUS TYPE 18; HUMAN PAPILLOMAVIRUS TYPE 31; HUMAN PAPILLOMAVIRUS TYPE 33; HUMAN PAPILLOMAVIRUS TYPE 35; HUMAN PAPILLOMAVIRUS TYPE 39; HUMAN PAPILLOMAVIRUS TYPE 45; HUMAN PAPILLOMAVIRUS TYPE 51; HUMAN PAPILLOMAVIRUS TYPE 52; HUMAN PAPILLOMAVIRUS TYPE 56; HUMAN PAPILLOMAVIRUS TYPE 58; HUMAN PAPILLOMAVIRUS TYPE 59; HUMAN PAPILLOMAVIRUS TYPE 66; HUMAN PAPILLOMAVIRUS TYPE 68; LABORATORY TEST; MICROORGANISM; NONHUMAN; NUCLEIC ACID AMPLIFICATION; PAPILLOMA VIRUS; PRIORITY JOURNAL; REPRODUCIBILITY; RISK ASSESSMENT; SENSITIVITY AND SPECIFICITY; UTERINE CERVIX CANCER; UTERINE CERVIX CYTOLOGY; VIRUS DETECTION; WART VIRUS;

CERVICAL INTRAEPITHELIAL NEOPLASIA; CERVIX UTERI; FEMALE; HUMANS; MASS SCREENING; PAPILLOMAVIRIDAE; PAPILLOMAVIRUS INFECTIONS; REAGENT KITS, DIAGNOSTIC; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 67949114406     PISSN: 13866532     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1386-6532(09)70010-1     Document Type: Article

References (22)

1. National Cancer Institute website (2008). www.cancer.gov
2. Cervix cancer screening. IARC handbooks of cancer, Vol. 10. Lyons (France): IARC; 2005.
3. Wright Jr. T.C. HPV DNA testing for cervical cancer screening. Int J Gynaecol Obstet 95 Suppl 1 (2006) S239-S246
4. Meijer C.J., Snijders P.J., and Castle P.E. Clinical utility of HPV genotyping. Gynecol Oncol 103 (2006) 12-17
5. Cogliano V., Baan R., Straif K., et al. Carcinogenicity of human papillomaviruses. Lancet Oncol 6 (2005) 204
6. Wright Jr. T.C., Massad L.S., Dunton C.J., et al. 2006 consensus guidelines for the management of women with abnormal cervical cancer screening tests. Am J Obstet Gynecol 197 4 (2007) 346-355
7. Sherman M.E., Schiffman M., and Cox T.J. Effects of age and human papilloma viral load on colposcopy triage: data from the randomized Atypical Squamous Cells of Undetermined Significance/Low-grade Squamous Intraepithelial Lesion Triage Study (ALTS). J Natl Cancer Inst 94 2 (2002) 102-107
8. Solomon D., Schiffman M., and Tarone R. Comparison of three management strategies for patients with atypical squamous cells of undetermined significance: baseline results from a randomized trial. J Natl Cancer Inst 93 4 (2001) 293-299
9. Wright T.C., Cox T.J., Massad L.S., et al. 2001 Consensus guidelines for the management of women with cervical cytological abnormalities. JAMA 287 (2002) 2120-2129
10. Davey D.D., Neal M.H., Wilbur D.C., et al. Bethesda 2001 implementation and reporting rates: 2003 practices of participants in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology. Arch Path Lab Med 128 (2004) 1224-1229
11. Stoler M.H., Castle P.E., Solomon D., et al. The expanded use of HPV testing in gynecologic practice per ASCCP-guided management requires the use of well-validated assays. Am J Clin Pathol 127 (2007) 335-337
12. de Arruda M., Lyamichev V.I., Eis P.S., et al. Invader technology for DNA and RNA analysis: principles and applications. Expert Rev Mol Diag 2 5 (2002) 487-496
13. Day S.P., and Mast A. "Invader Assay". In: Fuchs J., Podda M., and Goethe J.W. (Eds). Encyclopedia of Diagnostic Genomics and Proteomics (2005), Marcel Dekker, New York 682-686
14. Tholan W.D., Linnet K., Kondratovich M., et al. Protocols for determination of limits of detection and limits of quantitation; approved guideline. CLSI guideline EP17-A 24 34 (2004)
15. Gravitt P.E., Peyton C.L., Alessi T.Q., et al. Improved amplification of genital human papillomaviruses. J Clin Microbiol 38 (2000) 357-361
16. Saslow D., Runowicz C.D., Solomon D., et al. American Cancer Society guideline for the early detection of cervical neoplasia and cancer. CA Can J Clin 53 (2002) 342-362
17. Wright Jr. T.C., Schiffman M., Solomon D., et al. Interim guidance for the use of human papillomavirus DNA testing as an adjunct to cervical cytology for screening. Obstet Gynecol 103 (2004) 304-309
18. Nolte F.S., Arbique J.C., Cockerill F.R., et al. Molecular diagnostic methods for infectious diseases; approved guideline Second Edition. CLSI guideline MM3-A2 26 8 (2006)
19. Wilson J.A., Zoccoli M.A., Jacobson J.W., et al. Verification and validation of multiplex nucleic acid assays; approved guideline. CLSI guideline MM17-A 28 9 (2007)
20. Poljak M., Marin I.J., Seme K., et al. Hybrid Capture II HPV test detects at least 15 human papillomavirus genotypes not included in its current high-risk probe cocktail. J Clin Virol 25 (2002) S89-S97
21. Digene HC2 [package insert] 2005.
22. Schutzbank T.E., Jarvis C., Kahmann N., et al. Detection of high-risk papillomavirus DNA with commercial invader-technology-based analyte-specific reagents following automated extraction of DNA from cervical brushings in ThinPrep media. J Clin Microbiol 45 12 (2007) 4067-4069