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.

Use of thin-layer preparations for gynecologic smears with emphasis on the cytomorphology of high-grade intraepithelial lesions and carcinomas.

Thin-layer (TL) technology can improve the detection rate for squamous lesions of the uterine cervix. Studies to date have under-represented high grade lesions and malignancies. The present study utilized a patient population at high risk for such lesions in order to analyze the performance of TL procedures in this group, and in addition, to assess the similarities and differences in morphologic appearances of specimens prepared by the two methods. Conventional (CS) and thin-layer smears (TLS) were made in parallel from the same specimen. Each slide was examined in a blinded fashion. Diagnoses were compared and morphologic observations made. Two hundred fifty-nine cases were included, of which 32 (12%) were high grade dysplasias (11) or carcinomas (21). Thirty five (14%) were atypical or low grade dysplasias. There was exact correlation between Bethesda classification in 231 cases (89%). Of the 21 carcinomas identified, 19 (91%) were present on each preparation. Two cases of endometrial adenocarcinoma were missed on unsatisfactory or negative TLS. One case of squamous cell carcinoma was called high grade squamous intraepithelial lesion (HGSIL) on TLS while the CS was unsatisfactory. Three cases called atypical glandular cells (AGCUS) on TLS, and negative on CS, showed HGSIL (1) or no lesion (2) on follow-up. Morphologic features of low grade lesions were virtually identical on both preparations. Distinct features were noted on TLS in the high grade lesions. These included smaller appearing nuclear areas, less distinct nuclear chromatin, thicker three-dimensional groupings, and more isolated cells. Such findings were most pronounced in the glandular lesions. With training and experience, these features were easily identified in TL preparations, further documenting the utility of this procedure for use in routine practice.

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.

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.