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.


METHODS
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.


CONCLUSIONS
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.
Knesel
Bradley W
BW
Cytology Department, Select Diagnostics, Greensboro, North Carolina, USA.
Dry
Joel C
JC
Wald-Scott
Coridalia
C
Aftab
Asma
A
Aftoh
Asma
A
D000328:Adult; D003585:Cell Biology; D002584:Cervix Uteri / Q000166:cytology*; D002690:Chlamydia Infections / Q000175:diagnosis; D004867:Equipment Design; D005260:Female; D006069:Gonorrhea / Q000175:diagnosis; D006801:Humans; D008403:Mass Screening / Q000379:methods; D030361:Papillomavirus Infections / Q000175:diagnosis; D012648:Self Care; D013048:Specimen Handling; D002577:Uterine Cervical Diseases / Q000175:diagnosis*