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J Low Genit Tract Dis. 2014 Apr;18(2):151-5. doi: 10.1097/LGT.0b013e31829aa052.

Evaluation of a low-cost liquid-based Pap test in rural El Salvador: a split-sample study.

Author information

1
1Division of Cytopathology, Department of Pathology, Keck School of Medicine, University of Southern California, Los Angeles, CA; 2Department of Obstetrics and Gynecology, University of Pittsburgh Medical Center/Basic Health International, Pittsburgh, PA; and 3Health International, San Salvador, El Salvador.

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.

Comment in

PMID:
24270191
DOI:
10.1097/LGT.0b013e31829aa052
[Indexed for MEDLINE]

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