Cervista HR and HPV 16/18 assays vs hybrid capture 2 assay: outcome comparison in women with negative cervical cytology.
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.
Dept. of Anatomic Pathology, UMass Memorial Medical Center, 1 Innovation Drive, Worcester, MA 01605-4307, USA.
Elizabeth M
EM
Kurian
Mandi-Lee
ML
Caporelli
Stephen
S
Baker
Bruce
B
Woda
Ediz F
EF
Cosar
Lloyd
L
Hutchinson
D000328:Adult; D002584:Cervix Uteri / Q000821:virology; D005260:Female; D052162:Human papillomavirus 16 / Q000235:genetics*; D052161:Human papillomavirus 18 / Q000235:genetics*; D006801:Humans; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D011237:Predictive Value of Tests; D011379:Prognosis; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology
D011933:Reagent Kits, Diagnostic