Human papillomavirus oncogenic mRNA testing for cervical cancer screening: baseline and longitudinal results from the CLEAR study.
OBJECTIVE
This study determined the longitudinal clinical performance of a high-risk human papillomavirus (HR-HPV) E6/E7 RNA assay (Aptima HPV [AHPV]; Hologic, San Diego, CA) compared with an HR-HPV DNA assay (Hybrid Capture 2 [HC2]; Qiagen, Gaithersburg, MD) as an adjunctive method for cervical cancer screening.


METHODS
Women 30 years or older with a negative result for intraepithelial lesions or malignancy cytology (n = 10,860) positive by AHPV and/or HC2 assays and randomly selected women negative by both assays were referred to colposcopy at baseline. Women without baseline cervical intraepithelial neoplasia (CIN) grade 2 or higher (CIN2+) continued into the 3-year follow-up.


RESULTS
The specificity of AHPV for CIN2 or lower was significantly greater at 96.3% compared with HC2 specificity of 94.8% (P < .001). Estimated sensitivities and risks for detection of CIN2+ were similar between the two assays. After 3 years of follow-up, women negative by either human papillomavirus test had a very low risk of CIN2+ (<0.3%) compared with CIN2+ risk in women with positive AHPV results (6.3%) or positive HC2 results (5.1%).


CONCLUSIONS
These results support the use of AHPV as a safe and effective adjunctive cervical cancer screening method.
From Hologic, Incorporated, San Diego, CA;
Jennifer L
JL
Reid
Department of Pathology, Columbia University School of Medicine, New York, NY;
Thomas C
TC
Wright
University of Virginia Health System, Charlottesville;
Mark H
MH
Stoler
Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK; and.
Jack
J
Cuzick
Global Cancer Initiative, Chestertown, MD.
Philip E
PE
Castle
From Hologic, Incorporated, San Diego, CA;
Janel
J
Dockter
From Hologic, Incorporated, San Diego, CA; damon.getman@hologic.com.
Damon
D
Getman
From Hologic, Incorporated, San Diego, CA;
Cristina
C
Giachetti
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D055088:Early Detection of Cancer / Q000379:methods; D005260:Female; D005820:Genetic Testing; D006801:Humans; D008137:Longitudinal Studies; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques; D027383:Papillomaviridae / Q000235:genetics* / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000175:diagnosis*; D011247:Pregnancy; D012333:RNA, Messenger / Q000235:genetics*; D012367:RNA, Viral / Q000235:genetics / Q000302:isolation & purification*; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis
D012333:RNA, Messenger; D012367:RNA, Viral
Adjunct screening; Aptima HPV; Cervical cancer; Cervical intraepithelial neoplasia; E6/E7 mRNA