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Evaluation of Folate Receptor-Mediated Cervical Dyeing as a Method for Detection of Cervical Lesions

Zhao, Yun MD, PhD1; Li, Mingzhu MD, PhD1; Li, Yali MD2; Lv, Qiubo MB3; Chen, Fei MD4; Li, Bin MD5; Zhang, Zhenyu MD6; Guo, Hongyan MD7; Lu, Dan MD8; Wang, Fengying MD9; Zhai, Jianjun MD10; Feng, Limin MD11; Lai, Ailuan MD12; Li, Hongxia MD13; Yao, Chen MD14; Wei, Lihui MD1

Journal of Lower Genital Tract Disease: April 2019 - Volume 23 - Issue 2 - p 133–137
doi: 10.1097/LGT.0000000000000411
HPV-Associated Disease: Diagnosis and Management
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Objectives The aim of the study was to evaluate the performance of a folate receptor–mediated tumor detection (FRD) assay for detection of cervical high-grade lesions.

Materials and Method A total of 1504 patients with abnormal cytology and/or positive human papillomavirus (HPV) testing during primary screening from November 2014 to August 2015 were enrolled. The patients were recruited from the Peking University People's Hospital and 12 other hospitals. Folate receptor–mediated tumor detection was applied in all the patients before colposcopy to compare the detection rate, sensitivity, specificity, positive predictive value, negative predictive value, and coincidence rate with HPV and cytology tests according to the pathologic diagnosis.

Results In the total of 1504 patients, 503 patients were negative for intraepithelial lesion or malignancy, 440 patients were cervical intraepithelial neoplasia (CIN) 1, 254 patients were CIN 2, 257 patients were CIN 3, 46 patients were squamous cell carcinoma, and 4 patients were adenocarcinoma in situ. The sensitivity of FRD was 77.72%, which was less than cytology (80.39%) and HPV testing (95.54%). The specificity of FRD was 60.02%, which was greater than cytology (30.12%) and HPV testing (14.95%). The coincidence rate of FRD to the pathologic diagnosis (66.62%) was also significantly greater than atypical squamous cells of undetermined significance cytology and above (48.87%) and HPV testing (45.01%, p < .0001). The detection rate of FRD for all grades of lesions increased with the severity of lesions.

Conclusions Folate receptor–mediated tumor detection has a slightly lower sensitivity and a higher specificity than cytology and HPV testing for detection of CIN 2+. Simplicity of FRD requires less professional skill. Folate receptor–mediated tumor detection could be a candidate test for cervical cancer screening especially in low- and middle-income countries. However, FRD still needs more clinical trial data to demonstrate its ability in general screening population.

1 Department of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China;

2Department of Obstetrics and Gynecology, Chinese PLA General Hospital, Beijing, China;

3Department of Obstetrics and Gynecology, Beijing Hospital, Beijing, China;

4Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, China;

5Department of Obstetrics and Gynecology, Beijing Anzhen Hospital, Beijing, China;

6Department of Obstetrics and Gynecology, Beijing Chaoyang Hospital, Beijing, China;

7Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China;

8Department of Obstetrics and Gynecology, Beijing Maternity Hospital, Beijing, China;

9Department of Obstetrics and Gynecology, Beijing Xuanwu Hospital, Beijing, China;

10Department of Obstetrics and Gynecology, Beijing Tongren Hospital, Beijing, China;

11Department of Obstetrics and Gynecology, Beijing Tiantan Hospital, Beijing, China;

12Department of Obstetrics and Gynecology, Beijing Fuxing Hospital, Beijing, China;

13Department of Obstetrics and Gynecology, Beijing Shijitan Hospital, Beijing, China; and

14Department of Statistics, Peking University First Hospital, Beijing, China

Correspondence to: Lihui Wei, MD, Department of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China. E-mail: weilhpku@163.com

The authors have declared they have no conflicts of interest.

Z.Y. and L.M. are the co-first authors.

The study was supported by Beijing Natural Science Foundation (7174359).

The study was reviewed and approved by the institutional review board of Peking University People's Hospital as the institution of the principal investigator of the study and filed or reviewed by the institutional review board of all the involved hospitals.

Copyright © 2019 by the American Society for Colposcopy and Cervical Pathology