Original Article
Performance of point-of-care testing for cervical cancer screening
Zhao Shuang, Zhao Xuelian, Hu Shangying, Ma Junfei, Su Caifeng, Wang Debin, Zhang Xun, Zhao Fanghui
Published 2022-02-06
Cite as Chin J Prev Med, 2022, 56(2): 165-170. DOI: 10.3760/cma.j.cn112150-20210220-00162
Abstract
ObjectiveTo evaluate the performance of point-of-care testing for cervical cancer and precancerous lesions screening.
MethodsIn September 2020, 197 and 273 women were selected by using simple random sampling method from "self-sampling" cohort and "physician-sampling" cohort established in Xiangyuan county, Shanxi Province, China, respectively. Cervical exfoliated cells were collected by women themselves or gynecologists. All samples were detected by POCT and women with positive result were directly referred for colposcopy. Subsequently, all the samples were detected by careHPV and PCR test. Colposcopy and punch biopsy were performed for women with POCT negative but careHPV or PCR test positive at another visit. Using histopathological diagnosis as the gold standard, we calculated sensitivity, specificity and drew the receiver operating characteristic (ROC) curves. The accuracy of POCT was analyzed and compared to that of careHPV and conventional PCR test in cervical cancer and precancerous lesions screening.
ResultsThe median (Q1, Q3) age of 470 women was 51 (45, 57) years old. Based on self-sampling, the sensitivity and specificity of POCT for CIN2+ were 100.00% (95%CI: 56.56%-100.00%) and 28.95% (95%CI: 22.97%-35.76%), respectively. Compared with POCT, POCT HPV16/18 test had similar sensitivity and higher specificity of 89.47% (95%CI: 84.30%-93.08%). Self-sampling POCT HPV16/18 test had an AUC of 0.947 (95%CI:0.910-0.985), which was higher than that of careHPV and PCR test. Physician-sampling POCT test had 100.00% sensitivity (95%CI: 64.57%-100.00%) and 55.85% specificity (95%CI: 49.83%-61.70%) for detecting CIN2+. POCT HPV16/18 test had lower sensitivity (71.43%, 95%CI: 35.90%-91.76%) and higher specificity (92.45%, 95%CI: 88.63%-95.06%). POCT HPV16/18 test generally showed similar AUC on both self-collected samples and clinician-collected samples (0.947 vs 0.819, P=0.217).
ConclusionPOCT HPV16/18 test is an effective method with relatively high sensitivity and specificity for cervical cancer screening.
Key words:
Uterine cervical neoplasms; Cervical intraepithelial neoplasia; Point-of-care testing; Screen and treat; Screening
Contributor Information
Zhao Shuang
Department of Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Zhao Xuelian
Department of Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Hu Shangying
Department of Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Ma Junfei
Xiangyuan County Women and Children′s Hospital, Changzhi 046200, China
Su Caifeng
Xiangyuan County Women and Children′s Hospital, Changzhi 046200, China
Wang Debin
Xiangyuan County Women and Children′s Hospital, Changzhi 046200, China
Zhang Xun
Department of Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Zhao Fanghui
Department of Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
