1. Feasibility and accuracy evaluation of three human papillomavirus assays for FTA card-based sampling: a pilot study in cervical cancer screening.
- Author
-
Shao-Ming Wang, Shang-Ying Hu, Wen Chen, Feng Chen, Fang-Hui Zhao, Wei He, Xin-Ming Ma, Yu-Qing Zhang, Jian Wang, Sivasubramaniam, Priya, You-Lin Qiao, Wang, Shao-Ming, Hu, Shang-Ying, Chen, Wen, Chen, Feng, Zhao, Fang-Hui, He, Wei, Ma, Xin-Ming, Zhang, Yu-Qing, and Wang, Jian
- Subjects
- *
PAPILLOMAVIRUS disease diagnosis , *CERVICAL cancer , *EARLY detection of cancer , *COLPOSCOPY , *SENSITIVITY & specificity (Statistics) , *PAPILLOMAVIRUSES , *SAMPLING (Process) , *GENETICS , *CLINICAL trials , *COMPARATIVE studies , *DNA , *RESEARCH methodology , *MEDICAL cooperation , *PAP test , *PAPILLOMAVIRUS diseases , *RESEARCH , *PILOT projects , *EVALUATION research , *CERVICAL intraepithelial neoplasia , *GENOTYPES , *DIAGNOSIS ,RESEARCH evaluation ,CERVIX uteri tumors - Abstract
Background: Liquid-state specimen carriers are inadequate for sample transportation in large-scale screening projects in low-resource settings, which necessitates the exploration of novel non-hazardous solid-state alternatives. Studies investigating the feasibility and accuracy of a solid-state human papillomavirus (HPV) sampling medium in combination with different down-stream HPV DNA assays for cervical cancer screening are needed.Methods: We collected two cervical specimens from 396 women, aged 25-65 years, who were enrolled in a cervical cancer screening trial. One sample was stored using DCM preservative solution and the other was applied to a Whatman Indicating FTA Elute® card (FTA card). All specimens were processed using three HPV testing methods, including Hybrid capture 2 (HC2), careHPV™, and Cobas®4800 tests. All the women underwent a rigorous colposcopic evaluation that included using a microbiopsy protocol.Results: Compared to the liquid-based carrier, the FTA card demonstrated comparable sensitivity for detecting high grade Cervical Intraepithelial Neoplasia (CIN) using HC2 (91.7 %), careHPV™ (83.3 %), and Cobas®4800 (91.7 %) tests. Moreover, the FTA card showed a higher specificity compared to a liquid-based carrier for HC2 (79.5 % vs. 71.6 %, P = 0.015), comparable specificity for careHPV™ (78.1 % vs. 73.0 %, P > 0.05), but lower specificity for the Cobas®4800 test (62.4 % vs. 69.9 %, P = 0.032). Generally, the FTA card-based sampling medium's accuracy was comparable with that of liquid-based medium for the three HPV testing assays.Conclusions: FTA cards are a promising sample carrier for cervical cancer screening. With further optimization, it can be utilized for HPV testing in areas of varying economic development. [ABSTRACT FROM AUTHOR]- Published
- 2015
- Full Text
- View/download PDF