Pap smear collection devices: Technical, clinical, diagnostic, and legal considerations associated with their use

Abstract

Pap smear collection devices have been the focus of increasing attention for their perceived role in the reduction of false negative results in Pap smear screening of cervical cancer. New devices are available on the market aimed at improved cellular yield and enhanced cellular preservation. While controversy remains regarding the definition of the "adequate" Pap smear, it has been generally accepted that the adequate Papanicolaou smear consists of a thinly prepared smear which is properly labeled and rapidly fixed. Adequate and relevant patient history should accompany the specimen. The adequate Pap smear should consist of the following: a sufficient number of well preserved epithelial cells that have been collected under direct visualization ' and an endocervical component (defined as either metaplastic cells or endocervical cells) in a premenopausal woman who has a cervix.2Conversely, an unsatisfactory smear is one which does not contain adequate numbers of cells, is poorly preserved or is obscured with inflammatory or hemorrhagic exudate so as to interfere with cytologic interpretation. The Bethesda System format of cervical vaginal cytologic reporting seeks to clearly define what constitutes a satisfactory cervical-vaginal specimen and makes allowances for specimens which may yield valuable information despite problems which may interfere with but not prevent interpreta-Lake City, UT 84117. tion such as air drying artifact, inflammation, or other factors which can be determined by the individual laboratory. The designation "less than optimal" has met with much discussion by the cytologic community and still allows for a great deal of variation between laboratories, a seemingly contradictory goal of the attempt to standardize nomenclature for Pap smear reporting.To date, no one sampling method or collection device has enjoyed universal acceptance or been shown to produce adequate Pap smears in all types of clinical settings and in all patient populations. Previous studies have rated the effectiveness of various sampling devices and made recommendations for decreasing the number of inadequate smears by advocating one particular type of spatula, brush, or other instrument or a combination of devices. MI The cytopathologic interpretation of smears made using the various Pap smear sampling devices requires allowances for artifacts and morphologic changes directly attributable to sampling techniques. Comparative studies and clinical validation must occur as new sampling devices are developed and marketed. Literature accompanying these devices must include details on intended applications, proper use, and contraindications of each sampling device because of the potential for litigation against the manufacturer, the clinician, and the laboratory.This symposium was convened to discuss the following aspects pertaining to Pap smear sampling devices: design rationale, clinical utility, diagnostic and interpretative considerations, and legal implications associated with their use or misuse.The target area of Pap smear sa...

Artifactual endocervical atypia induced by endocervical brush collection

“…Many recent studies of high grade endocervical lesions fail to mention the collection method for the Pap smear, even though instrument artifact has been described in the literature. Boon et al s describe the "toothpick effect" in endocervical brush-collected smears, and Schumann et al 22 clearly delineate the pitfalls in the cytologic interpretation of endocervical brushing smears.…”

Detection ofTrichomonas vaginalis in endocervical and ectocervical smears

“…26 The two most widelyused devices are the spatula and the cytobrush, a number of which are presently available. 27 The spatula scrapes cells from the ectocervix, and the cytobrush samples the transformation zone and endocervix. The combined spatula-cytobrush sampling method results in an increased percentage of adequate smears (smears containing endocervical cells which are located at the upper border of the transformation zone or metaplastic squamous cells) and increased detection rates of dysplasia and carcinoma over spatula sampling alone.26 However, our study suggests that the reliability of cervical cytology for the detection of Trichomonas vaginalis does not appear to be increased by the combined sampling method, which includes an endocervical sample.…”

Comparative Evaluation of Seven Cell Collection Devices for Cervical Smears

“…1,2 Numerous efforts have been made comparing different cell sampling devices in order to find a cell sampling device or combination of two cell sampling devices that yield optimal cytologic results. 2,3,19 For quality control, numerous publications point out the significance of endocervical cells in the smear. 7,10,20 The endocervically used Cytobrush produced the best results in this study.…”