Feasibility and accuracy evaluation of three human papillomavirus assays for FTA card-based sampling: a pilot study in cervical cancer screening.

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; Wang, Jian

<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.

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; RESEARCH evaluation; CERVIX uteri tumors; PILOT projects; EVALUATION research; CERVICAL intraepithelial neoplasia; GENOTYPES; DIAGNOSIS

BMC Cancer, 2015, Vol 15, p1

1471-2407

Academic Journal

10.1186/s12885-015-1882-9