TY - JOUR
T1 - Cervista HR and HPV 16/18 assays vs hybrid capture 2 assay
T2 - Outcome comparison in women with negative cervical cytology
AU - Kurian, Elizabeth M.
AU - Caporelli, Mandi Lee
AU - Baker, Stephen
AU - Woda, Bruce
AU - Cosar, Ediz F.
AU - Hutchinson, Lloyd
PY - 2011/11
Y1 - 2011/11
N2 - Sensitive and specific assays for human papillomavirus (HPV) are essential for patient management. In this study, we directly compared the efficacy of the Hybrid Capture 2 (HC2; Qiagen, Valencia, CA) and Cervista assays (Hologic, Madison, WI). Consecutive cervical cytology specimens (n = 601) were tested using HC2, Cervista HR, and Cervista HPV 16/18 with analysis of only cytology-negative cases (n = 533). Results indicated no significant difference (P = .458) in prevalence rates between HC2 (7.5%) and Cervista HR (8.5%). The Cervista 16/18 prevalence was 1.6%. The negative percentage of agreement was 95.1% (468/492) vs a 70% (28/40) positive percentage of agreement. No false-negative results were detected by the Cervista internal DNA control. Our data show 29 discordant positive results (12 HC2 and 17 Cervista HR), suggesting some women with negative cytology may be triaged for unnecessary follow-up with either assay. For clinical screening, Cervista HR and HC2 are comparable and, by extension, should provide excellent negative predictive value for histologically relevant disease.
AB - Sensitive and specific assays for human papillomavirus (HPV) are essential for patient management. In this study, we directly compared the efficacy of the Hybrid Capture 2 (HC2; Qiagen, Valencia, CA) and Cervista assays (Hologic, Madison, WI). Consecutive cervical cytology specimens (n = 601) were tested using HC2, Cervista HR, and Cervista HPV 16/18 with analysis of only cytology-negative cases (n = 533). Results indicated no significant difference (P = .458) in prevalence rates between HC2 (7.5%) and Cervista HR (8.5%). The Cervista 16/18 prevalence was 1.6%. The negative percentage of agreement was 95.1% (468/492) vs a 70% (28/40) positive percentage of agreement. No false-negative results were detected by the Cervista internal DNA control. Our data show 29 discordant positive results (12 HC2 and 17 Cervista HR), suggesting some women with negative cytology may be triaged for unnecessary follow-up with either assay. For clinical screening, Cervista HR and HC2 are comparable and, by extension, should provide excellent negative predictive value for histologically relevant disease.
KW - Cervista 16/18
KW - Cervista HPV HR
KW - Cytology
KW - HC2
KW - HPV molecular assay
KW - High-risk human papillomavirus
KW - Hybrid capture 2
KW - Papanicolaou smears
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UR - http://www.scopus.com/inward/citedby.url?scp=80355138124&partnerID=8YFLogxK
U2 - 10.1309/AJCPCQD7B7DPVHLH
DO - 10.1309/AJCPCQD7B7DPVHLH
M3 - Article
C2 - 22031321
AN - SCOPUS:80355138124
SN - 0002-9173
VL - 136
SP - 808
EP - 816
JO - American journal of clinical pathology
JF - American journal of clinical pathology
IS - 5
ER -