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Triage of Women With Negative Cytology and Positive High-Risk HPV: An Analysis of Data From the SHENCCAST II/III Studies

Goodrich, Sarah Kay MD1; Pretorius, Robert G. MD2; Du, Hui MD3; Wu, RuiFang MD3; Belinson, Jerome L. MD1,4

Journal of Lower Genital Tract Disease: April 2014 - Volume 18 - Issue 2 - p 122–127
doi: 10.1097/LGT.0b013e31829f2171
Original Articles

Objectives To determine a management strategy for women testing negative with cervical cytology and positive for high-risk human papillomavirus (HR-HPV).

Methods Using the data from the large population-based Shenzhen Cervical Cancer Screening Trials II and III (SHENCCAST II/III), we compared the risk for cervical intraepithelial neoplasia grade 3 or cancer (CIN 3+) in women with negative cytology but testing positive for HR-HPV DNA using Cervista HPV HR or matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF), followed by secondary screening with type-specific Cervista HPV-16/18 or MALDI-TOF. The study aim was to seek the most sensitive and specific triage assay for referral for colposcopy.

Results A total of 8,556 women had complete data. The proportion of women with negative cytology and positive HR-HPV by Cervista HR-HPV (5.30%, 453/8,556) was slightly lower than that of women with negative cytology and HR-HPV–positive tests by MALDI-TOF (5.82%, 499/8,556, p = .015). The proportion of women having negative cervical cytology and a positive HR-HPV by Cervista HR who have HPV-16 and/or -18 by Cervista HPV-16/18 (11.8%, 53/448) was less than that of women with a negative cervical cytology and positive HR-HPV by MALDI-TOF who have HPV-16 and/or -18 by MALDI-TOF (19.4%, 97/499, p = .001). The proportion of CIN 3+ within negative cervical cytology and positive HR-HPV that were HPV-16 and/or -18 for the Cervista 16/18 assay (61.5%, 8/13) was similar to that for the MALDI-TOF 16/18 assay (66.7%, 10/15, p = 0.8).

Conclusions In the cytology-negative HR-HPV–positive population, Cervista 16/18 as the HPV detection method would refer 11.8% of women for colposcopy and diagnose 61.5% of the CIN 3+, while MALDI-TOF16/18 would refer 19.4% and diagnose 66.7% of the CIN 3+. Cervista HPV-16/18 seems to be the superior triage test. However, in resource-limited settings, an assay that includes 16/18 genotyping in the primary result (rather than a second test) may be more cost efficient.

Adding genotyping for HPV-16/18 as a triage method can reduce the number of colposcopies performed in women with negative cervical cytology and positive HPV tests.

1Women’s Health Institute, Department of Gynecology, Cleveland Clinic, Cleveland, OH; 2Department of Obstetrics and Gynecology, S.C.P.M.G. Fontana, Fontana, CA; 3Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, China; and 4Preventive Oncology International, Cleveland Heights, OH

Reprint requests to: Sarah Kay Goodrich, MD, Women’s Health Institute, Department of Gynecology, Cleveland Clinic, 9500 Euclid Avenue, Desk A81, Cleveland, OH 44195. E-mail:

SHENCCAST is the Shenzhen Cervical Cancer Screening Program.

The current review was supported by Preventive Oncology International. Original studies (SHENCCAST II and III) were funded by Hologic, BGI Shenzhen, and Peking University Shenzhen Hospital (PUSH).

The authors have declared they have no conflicts of interest.

Copyright © 2014 by the American Society for Colposcopy and Cervical Pathology