Cost-effectiveness and accuracy of cervical cancer screening with a high-risk HPV genotyping assay vs a nongenotyping as
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PRIMARY RESEARCH
Cancer Cell International Open Access
Cost‑effectiveness and accuracy of cervical cancer screening with a high‑risk HPV genotyping assay vs a nongenotyping assay in China: an observational cohort study Binhua Dong1,2†, Lihua Chen1†, Wenyu Lin1, Yingying Su3, Xiaodan Mao1,2, Diling Pan4, Guanyu Ruan1,2, Huifeng Xue5, Yafang Kang1,2 and Pengming Sun1,2*
Abstract Background: New screening techniques may affect the optimal approaches for the prevention of cervical cancer. We evaluated the cost-effectiveness and accuracy of alternative screening strategies to provide evidence for cervical cancer screening guidelines in China. Methods: In total, 32,306 women were enrolled. The current screening with Cervista® high-risk human papillomavirus (HR-HPV) nongenotyping and cytology cotesting (Cervista® cotesting) was compared with PCR-reverse dot blot HR-HPV genotyping and cytology cotesting (PCR-RDB cotesting). All eligible participants were divided into Arm 1, in which both HR-HPV assays were performed, and Arms 2 and 3, in which the PCR-RDB HPV or C ervista® HR-HPV assay, respectively, was performed. Outcome indicators included the cases, sensitivity, negative predictive value (NPV), colposcopy referral rate and cost of identifying cervical intraepithelial neoplasia of grade 2/3 or worse (CIN2+/CIN3+). Results: Among the eligible participants, 18.4% were PCR-RDB HR-HPV-positive, while 16.9% were C ervista® HR-HPVpositive, which reflects good agreement (k = 0.73). PCR-RDB cotesting identified more CIN3+ cases than Cervista® cotesting in the first round of screening in Arm 1 (37 vs 32) and Arms 2/3 (252 vs 165). The sensitivity and NPV of PCRRDB cotesting for identifying CIN3+ in Arm 1 (sensitivity: 94.9% vs 86.5%; NPV: 99.9% vs 99.7%) and Arms 2/3 (sensitivity: 95.1% vs 80.9%; NPV: 99.9% vs 99.6%) were higher than those of Cervista® cotesting, but the cost was similar. Conclusions: The PCR-RDB HR-HPV genotyping and Cervista® HR-HPV assay results were consistent. PCR-RDB cotesting possesses optimal cost-effectiveness for cervical cancer screening in China, which has the highest number of cases globally but low screening coverage. Keywords: Human papillomavirus, Genotyping, Cervical cancer, Cancer screens, Cotesting
*Correspondence: [email protected] † Binhua Dong and Lihua Chen contributed equally to this work 1 Department of Gynecology, Laboratory of Gynecologic Oncology, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, 18 Daoshan Road, Fuzhou 350001, Fujian, People’s Republic of China Full list of author information is available at the end of the article
Background Cervical cancer is the second most common cancer among women worldwide [1], and 85% of cases occur in developing countries [2]. China has the highest number of cervical cancer patients, with 98,900 new cases and 30,500 deaths each year [3] due to inadequate screening, lack of a human papillomavirus (HPV) vaccine and increased HPV infection rates [4]. Unfortunately, the first
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