Clinical trials of the CytoRich specimen-preparation device for cervical cytology. Preliminary results.

OBJECTIVE: To obtain preliminary data on the Roche CytoRich thin-layer system for the preparation of gynecologic cytology specimens, derived from a preclinical startup evaluation of the instrument and comparing the CytoRich method to conventional smears. STUDY DESIGN: At six different clinical sites, 286 pairs of conventional and CytoRich slides derived from the same patient sample were compared for the following: final Bethesda classification diagnosis, specimen adequacy and presence of microorganisms. RESULTS: The study showed agreement between the methods for an exact Bethesda diagnosis in 78% and agreement within one Bethesda diagnosis category in 95%. The CytoRich method diagnosed more cases of squamous intraepithelial lesion (SIL) than did the conventional method, and the differences in SIL detection were statistically significant. The CytoRich method identified similar numbers of cases with microorganisms as did the conventional smears, and the CytoRich system improved overall specimen adequacy as compared to the conventional method, with fewer cases of unsatisfactory and less-than-optimal smears. CONCLUSION: The CytoRich method may improve the overall sensitivity and specificity of the cervical cytology procedure. Clinical trials to verify these preliminary data are ongoing.

The effects of endocervical canal topography, tubal metaplasia, and high canal sampling on the cytologic presentation of nonneoplastic endocervical cells.

Use of new endocervical cytologic sampling devices has correlated with increased numbers of cases showing endocervical "atypia." To ascertain the potential causes, a cytologic and histologic correlative study of the normal endocervical canal was undertaken. Hysterectomy specimens from 25 patients with no history of cervical disease were used. The anterior and posterior endocervical canals were divided into three equal sections. Each of the sections of the anterior canal were sampled cytologically, with the corresponding posterior canal processed for histology. Endocervical gland number, depth, and cellular crowding were most pronounced in the middle third of the canal. Tubal metaplasia (present in 100% of cases) was most prominent in the upper third. The most cellular cytologic samples were obtained from the middle third. "Atypical" endocervical groups were most commonly identified in the upper third. The normal topography of the endocervical canal, with sampling of the upper regions by newly utilized devices, may account for the increase in samples showing cytologic patterns that mimic endocervical neoplasia.

Sensitivity of the AutoPap 300 QC System for cervical cytologic abnormalities. Biopsy data confirmation.

OBJECTIVE: To assess the AutoPap 300 QC System's sensitivity to cases of high grade squamous intraepithelial cervical lesion and invasive cervical cancer, a comparison of outcome was made in cases that had surgical biopsy confirmation. STUDY DESIGN: The sensitivity of the device to biopsy-confirmed diagnostic categories at the level of high grade squamous intraepithelial lesion (HSIL) and greater was calculated. At two of six clinical trial sites, biopsy data were available and were compared to device scores indicating whether a case would or would not be selected for 10% or 20% quality control rescreening. RESULTS: In 86 biopsy-positive cases that had a cytologic diagnosis of HSIL or greater, the device indicated inclusion in the 10% or 20% review fraction for 66 slides (77%) and 74 (86%), respectively. This figure indicated an approximately eightfold improvement in the ability of the device to include such cases for quality control rescreening when compared to a 10% random case selection process. CONCLUSION: These data showed that the sensitivity of the AutoPap in identifying cases of HSIL and greater was similar to that previously calculated for these diagnostic categories in clinical trials, when calculated on the basis of an alternate or "higher" standard of tissue confirmation.

Breast fine-needle aspiration. A comparison of thin-layer and conventional preparation.

Two hundred forty-two breast fine-needle aspirates prepared by the Cytyc ThinPrep Processor were compared with aspirates prepared by the conventional smear method. Palpable and nonpalpable mammographic breast lesions were aspirated and the first half of the aspirate was submitted for conventional smears and the second half was rinsed into a proprietary fixative and loaded on the ThinPrep Processor for monolayer slide preparation. The matched pairs were diagnosed and analyzed separately in a double-blinded manner and later paired for comparison. Diagnoses correlated exactly in 62% of cases. The diagnosis of fibroadenoma was made in only 4 of 21 cases on ThinPrep (19% correlation). Semiquantitative analysis of several cytologic features indicated potential pitfalls for accurate diagnosis using the ThinPrep Processor. These included loss of background constituents (such as stroma and adipose tissue), decreased cellularity and single ductal epithelial cells, and decreased cytologic detail including size, shape and nuclear texture. The ThinPrep Processor may play a role in breast fine-needle aspiration, but further investigation is warranted before it is used as a sole preparatory method.

A prospective, randomized, blinded trial of cytological yield with disposable cytology brushes in upper gastrointestinal tract lesions.

Brush cytology is an important technique in the diagnosis of upper gastrointestinal tract lesions. Optimum cytological yields depend on cellularity (a measure of the amount of epithelial cellular material) and preservation (a measure of artifact induced by desiccation). We sought to determine the cytological yield of four disposable cytology brushes. Seventy-eight patients were studied, with a total of 80 disposable cytology brushes from four different manufacturers (Wilson-Cook, Microvasive, Mill-Rose, and Hobbs). Cellularity and preservation were assessed in a blinded fashion by experienced cytotechnologists. There was no significant difference in cellularity between the different non-disposable brushes. However, the Wilson Cook disposable cytology brush was significantly superior to the other disposable cytology brushes (P < 0.05) with regard to preservation. Its unique design features (longer head and more acutely angled bristles) may account for the better results.