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The Cytyc ThinPrep Imaging System was FDA approved based on a multi-institutional clinical trial, in which the HSIL+ prevalence rate was 0.7%. This study determines the effectiveness of the Imager in clinical practice at an academic medical center with a historical HSIL+ rate of 0.25%. Cytological interpretations were compared for two 12-month periods pre- and post-Imager implementation. Data was compiled by cytologic diagnoses, and variations in prevalence rates were analyzed for statistical significance. Interpretations of ASC-US, ASC-H, and LSIL were correlated with Digene Hybrid Capture2 High Risk HPV DNA testing; interpretations of ASC-H, LSIL, and HSIL+ were correlated with subsequent surgical follow-up. ASC-US, ASC-H, and LSIL detection rates increased 34, 48, and 29%, respectively, with the Imager (P<0.001); whereas the detection of HSIL increased 24% (P<0.051). Surgical correlation revealed no statistical differences in the positive predictive value (PPV) for ASC-H and LSIL. However, an increase in the PPV of HSIL was found (P<0.05). High risk HPV results were lower for ASC-US (P<0.001), but statistically equivalent for ASC-H and LSIL. Results of surgical correlation and HPV testing validated an increase in detection rates of ASC-H, LSIL, and HSIL, as well as increased PPV of HSIL with the ThinPrep Imaging System.

Background: A survey of the distribution of human papillomavirus (HPV) types across the spectrum of cervical cytologic categories defined by the Bethesda 2001 guidelines was conducted with the objective of examining how HPV detection by polymerase chain reaction (PCR) analysis may benefit the management of patients who have abnormal Papanicolaou (Pap) test results., Methods: DNA samples from women with no intraepithelial lesion or malignancy (NLM) (n = 300 samples); atypical squamous cells of undetermined significance (ASC-US) (n = 200 samples); low-grade squamous intraepithelial lesion (LSIL) (n = 200 samples); atypical squamous cells, cannot rule out high-grade squamous intraepithelial lesion (ASC-H) (n = 200 samples); and high-grade squamous intraepithelial lesion (HSIL) (n = 200 samples) were tested for HPV using a modified general primer (GP)5+/GP6+ PCR assay and dot-blot hybridization with type-specific oligonucleotide probes (PCR assay analytical sensitivity: 1-100 copies of HPV, depending on the HPV type, in a background of 100 ng human DNA)., Results: HPV was detected in 27% of NLM samples, in 89.5% of ASC-US samples, in 97.5% of LSIL samples, in 93% of ASC-H samples, and in 96.5% of HSIL samples. Thirty-seven different HPV types were identified in total. One or more of 13 high-risk (HR) HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) were detected in 53% of samples that were diagnosed as ASC-US (59.0% of patients younger than age 30 yrs; 45.5% of patients age 30 yrs and older), in 55.5% of samples that were diagnosed as LSIL (60.0% of patients younger than age 30 yrs; 44.0% of patients age 30 yrs and older), in 80% of samples that were diagnosed as ASC-H, and in 87.5% of samples that were diagnosed as HSIL (P < 0.001). HPV-16 was detected in 17.5% of ASC-US samples, in 15.5% of LSIL samples, in 48.5% of ASC-H samples, and in 49.0% of HSIL samples (P < 0.001). Among abnormal smears, HR HPV was significantly more common in women younger than age 30 years compared with women age 30 years and older (P < 0.002). Follow-up biopsy data were obtained for 359 patients. A "benign" biopsy result was recorded for 47 of 64 women (73.5%) with ASC-US, 30 of 66 women (45.5%) with LSIL, 39 of 87 women (45.0%) with ASC-H, and 26 of 142 women (18.0%) with HSIL and was most common in women age 30 years and older (P < 0.0001). Cervical intraepithelial neoplasia (CIN) Grade I (CIN-I) was found in 14.0% of women with ASC-US, in 39.5% of women with LSIL, in 8.0% of women with ASC-H, and in 7.0% of women with HSIL. CIN-II was diagnosed in 9.5% of women with ASC-US, in 13.5% of women with LSIL, in 19.5% of women with ASC-H, and in 24.0% of women with HSIL. CIN-III was identified in 2 women (3.0%) with ASC-US, in 1 woman (1.5%) with LSIL, in 24 women (27.5%) with ASC-H, and in 71 women (50.0%) with HSIL., Conclusions: HR HPV testing by PCR of samples diagnosed according to the Bethesda 2001 guidelines may benefit the management of patients with ASC-US or patients with LSIL, especially among women age 30 years and older, by allowing exclusion from referral for biopsy of women who are negative for HR HPV types. However, the small numbers of women who had CIN-III detected after a diagnosis of ASC-US or LSIL limited the assessment of test sensitivity.

Objective: This study analyzes pediatric and adolescent Papanicolaou (Pap) smear diagnoses to determine the prevalence rates of squamous intraepithelial lesion (SIL) as well as infectious and reactive processes in this age group., Design: A total of 10 296 Pap smear diagnoses from patients 10 to 19 years of age collected over a 1-year period and classified according to the Bethesda system were reviewed. This population was almost exclusively white, the majority residing in rural or suburban areas of Maine, New Hampshire, and Vermont. The percentage of abnormal smear results was then compared with data generated for older age subsets., Results: The following diagnoses were made on 10 296 Pap smears from patients 10 to 19 years of age: 7208 (70.01%) normal; 1689 (16.4%) benign cellular change; 1004 (9.75%) atypical squamous cells of undetermined significance; 388 (3.77%) squamous intraepithelial lesion (SIL); and 7 (0.06%) atypical glandular cells of undetermined significance. A total of 1503 (14.6%) of smears showed infectious processes. Compared with the results of adult Pap smears collected over the same time period, the age 20 to 29 subset with 27 067 Pap smears and the age 30+ subset with 42 617 Pap smears showed 11.79% and 8.43% infectious processes and 3.49% and 1.27% SIL, respectively. Therefore, the highest rate of infectious processes and SIL was found in the subset of patients age 10 to 19 years., Conclusions: Because the development of SIL and hence cervical cancer is causally related to sexually transmitted human papilloma virus (HPV) infection, this high rate of abnormal Pap smear results of both an infectious and precancerous nature in this population may reflect a high level of sexual activity among adolescent girls. These data reinforce the importance of implementing early cervical Pap smear screening in the sexually active pediatric and adolescent population.

Objective: To compare the cytologic diagnoses and specimen adequacy of the ThinPrep Pap Test with historical data within a distinct patient population to assess test performance and its impact on clinical practice., Study Design: A total of 16,314 ThinPrep Pap tests were processed and evaluated at Fletcher Allen Health Care over a seven-month period. A subset of 8,574 tests from a selected provider group (cohort) was compared to the historical conventional cervical cytologic smear data from the cohort population for both cytologic diagnoses and specimen adequacy. The cohort consisted of 12 practice groups, including 60 physicians and providers, utilizing the ThinPrep Pap Test as their primary cervical cancer screening sampling technique. Cytologic diagnoses and specimen adequacy were classified using the Bethesda system., Results: Using a three-tiered diagnostic system similar to the Cytyc clinical trials (within normal limits [WNL], atypical squamous cells of undetermined significance [ASCUS]/atypical glandular cells of undetermined significance [AGUS] and low grade squamous intraepithelial lesion and higher [LSIL]+), the ThinPrep method increased the percentage of cases that could be definitively diagnosed as WNL by 1.71%, lowered the percentage of ambiguous or borderline cases diagnosed as ASCUS/AGUS by 26.59% and increased the percentage of cases diagnostic of LSIL+ by 52.15% in the cohort population. Further subdivision by the Bethesda classification showed that the identification of infectious agents increased 25.51% and the detection of high grade squamous intraepithelial lesion/carcinoma increased 55.14%. Concurrently, cases reported as benign cellular changes (reactive/reparative) decreased 23.1%, and the percentage of cases reported as unsatisfactory/"limited by ..." was reduced 52.71%. Histologic correlation of cases reported as squamous intraepithelial lesion revealed that the percentage of patients with subsequent benign biopsies was reduced by 31.7% utilizing the ThinPrep technique. Further, the percentage of ThinPrep patients with histologically confirmed cervical intraepithelial neoplasia (CIN) 1 and CIN 2/3 increased by 16.3% and 9.3%, respectively., Conclusion: Implementation of the ThinPrep Pap Test resulted in statistically significant improvements in both diagnostic yield and specimen adequacy, as seen by others in clinical trials. Comparison of results to historical data within a cohort population reinforced earlier data and lent further support to the claim that the ThinPrep Pap Test is "significantly more effective" than the conventional smear in clinical practice.

Objective: To test the ThinPrep Processor for fine needle aspiration., Study Design: One hundred unfixed, surgically removed specimens were aspirated. One pass was directly smeared, fixed and stained with the Papanicolaou technique. The other pass was rinsed in a proprietary fixative, and a single ThinPrep slide was made. Smears were diagnosed without knowledge of the histologic diagnosis., Results: Cellularity and architectural integrity of cell groups were superior on the conventional slides. Preservation and detail of both epithelial and stromal cells were superior with the ThinPrep Processor. Preservation of background material, such as mucus and colloid, was slightly superior on the ThinPrep slides. Diagnostic sensitivity and specificity for malignancy and unsatisfactory rates were all slightly better on the ThinPrep slides., Conclusion: The ThinPrep Processor offers an alternative to direct smears in situations in which expertise in slide preparation is not available.

Cell yields on cytologic preparations made in the Cytospin II cytocentrifuge and the ThinPrep Processor were compared. Slides were prepared by each method using calibrated volumes (25 microliters) of cell suspensions from 13 nongynecologic specimens. Cell counts for each slide were calculated by counting cells in predetermined fields using a gridded reticle at 40 x magnification, then extrapolating to the total surface area of the preparation. The cell counts demonstrated that when processing equal amounts of cell suspension, the ThinPrep method retained three times as many cells as the cytocentrifuge method. The ThinPrep method, with a higher rate of cell recovery, may provide a valuable tool toward more accurate cytologic diagnosis, particularly for cytologic samples with small numbers of cells.

Report is made of the first two cases in which psammoma bodies were detected in peritoneal washings. The significance of psammoma bodies in a cytologic specimen is reviewed. These case reports and review of the literature make it clear that the cytologic detection of psammoma bodies should be a stimulus for further investigation but that the diagnosis of malignancy cannot be based on their presence alone.

The technique and application of fine-needle aspiration cytology in the management of gynecologic cancer are discussed. The authors report 90 cases that have been evaluated by means of fine-needle technique. The technique has been applied both for primary diagnosis and for follow-up evaluation. Among the 90 cases reported, there was two false negatives and one false positive and three cases in which the histologic findings were false negative.

All 503 fine needle aspirations (FNAs) of the breast performed over a three-year period at the Medical Center Hospital of Vermont were analyzed. There were 93 aspirates diagnosed as "positive," all of which were from patients eventually shown to have cancer. However, there were 38 patients with primary carcinoma in which the FNA was not diagnosed as positive, for a diagnostic failure rate of 31.4%. In order to determine the possible effect of technique as practiced by an experienced aspirator in diminishing such diagnostic failures, we compared 190 aspirates obtained by a single individual with 193 aspirates obtained by 15 individuals in the same community. For the single experienced aspirator, the technical failure rate was 9.8% whereas in the group with many aspirators it was 45.9%. This finding confirms that, although fine needle aspiration of the breast is considered easy to perform, skill on the part of the aspirator is important for satisfactory results.

In a 32-year-old Laotian immigrant who presented with a two-day history of vomiting, abdominal pain and jaundice, ultrasound examination revealed a posthepatic obstruction. Characteristic parasitic ova were present in bile fluid submitted for cytologic evaluation. Subsequent biopsy of the patient's bile duct lesion revealed a coexistent cholangiocarcinoma. The life cycles of Clonorchis sinensis and Ospisthorchis viverrini are reviewed along with the clinical and pathologic complications of infestation by these parasites in humans. The cytologic features of liver fluke infestation are characteristic and should be appreciated, as should the importance of its early diagnosis in the prevention of bile duct neoplasms.