Abstract
BackgroundNew screening techniques may affect the optimal approachesfor 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.MethodsIn 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 Cervista® 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+).ResultsAmong the eligible participants, 18.4% were PCR-RDB HR-HPV-positive, while 16.9% were Cervista® HR-HPV-positive, 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 PCR-RDB 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.ConclusionsThe 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.
Highlights
New screening techniques may affect the optimal approaches for the prevention of cervical cancer
Fujian Province Cervical Lesions Screening Cohorts (FCLSCs) are cervical cancer screening cohorts established in Fujian Province, with more than 200,000 cases used to assess the value of introducing HR-human papillomavirus (HPV) testing into screening
Comparison of the consistency of the PCR‐RDB HPV genotyping and Cervista® HR‐HPV assays for detecting HR‐HPV infection In total, 32,306 women who participated in the cervical cancer screening program were enrolled for testing with high-risk human papillomavirus (HR-HPV) and cytology assays in this study
Summary
New screening techniques may affect the optimal approaches for the prevention of cervical cancer. 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]. Cytologic screening has effectively reduced the incidence and mortality, the accuracy of cytological results varies widely, ranging from 55 to 94% [6] Cervical cancers and their precursors are closely related to persistent infection of high-risk human papillomavirus (HR-HPV) [7, 8]. HPV assays are more sensitive than cytology, and a negative result can better predict a low risk of developing cervical cancer [11]. Combined HR-HPV and cytology screening can improve the detection rate of HPV-negative cervical cancer women and reduce missed diagnoses; it is suitable for China, which has low screening coverage.
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