Preliminary evaluation of a cervical self-sampling device with liquid-based cytology and multiparameter molecular testing.

OBJECTIVE

To compare the collection of a liquid-based cell sample using a cervical self-sampling device and traditional sampling using cytologic and molecular-based tests.

STUDY

DESIGN

This study evaluated the sampling efficiency of the Fournier Cervical Self-Sampling Device (BPG, LLC, Miami, Florida) with regard to overall cell volume of the sample, cytologic diagnoses Path, TriPath Imaging, Burlington, North Carolina) and molecular-based tests for Chlamydia, Gonorrhoeae and human papillomavirus (Hybrid Capture 2, Digene Corp., Gaithersburg, Maryland). Paired samples were blinded and prepared using the SurePath method.

RESULTS

The self-collected samples showed an overall increase in cellularity when compared to the cellularity of samples obtained from traditional sampling. Cytologic results were comparable for the 2 sampling methods. The self-sampling device showed greater sensitivity with regard to molecular-based human papillomavirus testing.

CONCLUSION

The Fournier Device shows promise in the area of cytology and molecular diagnostics. The ability to perform cytology and molecular-based assays using a single sample obtained directly by the patient can lower the costs of screening and provide an efficient method of screening women in resource-poor countries or when cultural barriers exist to the use of traditional sampling methods.