Skip Navigation LinksHome > April 2014 - Volume 18 - Issue 2 > Evaluation of a Low-Cost Liquid-Based Pap Test in Rural El S...
Journal of Lower Genital Tract Disease:
doi: 10.1097/LGT.0b013e31829aa052
Original Articles

Evaluation of a Low-Cost Liquid-Based Pap Test in Rural El Salvador: A Split-Sample Study

Guo, Jin MD1; Cremer, Miriam MD, MPH2; Maza, Mauricio MD3; Alfaro, Karla MD3; Felix, Juan C. MD1

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Abstract

Objective: We sought to test the diagnostic efficacy of a low-cost, liquid-based cervical cytology that could be implemented in low-resource settings.

Materials and Methods: A prospective, split-sample Pap study was performed in 595 women attending a cervical cancer screening clinic in rural El Salvador. Collected cervical samples were used to make a conventional Pap (cell sample directly to glass slide), whereas residual material was used to make the liquid-based sample using the ClearPrep method. Selected samples were tested from the residual sample of the liquid-based collection for the presence of high-risk Human papillomaviruses.

Results: Of 595 patients, 570 were interpreted with the same diagnosis between the 2 methods (95.8% agreement). There were comparable numbers of unsatisfactory cases; however, ClearPrep significantly increased detection of low-grade squamous intraepithelial lesions and decreased the diagnoses of atypical squamous cells of undetermined significance. ClearPrep identified an equivalent number of high-grade squamous intraepithelial lesion cases as the conventional Pap. High-risk human papillomavirus was identified in all cases of high-grade squamous intraepithelial lesion, adenocarcinoma in situ, and cancer as well as in 78% of low-grade squamous intraepithelial lesions out of the residual fluid of the ClearPrep vials.

Conclusions: The low-cost ClearPrep Pap test demonstrated equivalent detection of squamous intraepithelial lesions when compared with the conventional Pap smear and demonstrated the potential for ancillary molecular testing. The test seems a viable option for implementation in low-resource settings.

Copyright © 2014 by the American Society for Colposcopy and Cervical Pathology

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