Evaluation of a low-cost liquid-based Pap test in rural El Salvador: a split-sample study. J Low Genit Tract Dis 2014 Apr;18(2):151-5
Date
11/26/2013Pubmed ID
24270191DOI
10.1097/LGT.0b013e31829aa052Scopus ID
2-s2.0-84897582765 (requires institutional sign-in at Scopus site) 4 CitationsAbstract
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.
Author List
Guo J, Cremer M, Maza M, Alfaro K, Felix JCAuthor
Juan Felix MD Vice Chair, Director, Professor in the Pathology department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdultCarcinoma, Squamous Cell
Early Detection of Cancer
El Salvador
Female
Humans
Middle Aged
Papanicolaou Test
Papillomaviridae
Prospective Studies
Rural Population
Sensitivity and Specificity
Uterine Cervical Dysplasia