Is conventional urinary cytology still reliable for diagnosis of primary bladder carcinoma? Accuracy based on data linkage of a consecutive clinical series and cancer registry.

OBJECTIVE: Reported urine cytology accuracy, particular sensitivity, is highly variable. We evaluated the accuracy of urinary cytology for primary bladder cancer using population data linkage to provide valid estimates. STUDY DESIGN: Consecutive cytology tests processed through a major service between January 2000 and December 2004 were linked to a regional population cancer registry (allowing outcome ascertainment). Sensitivity and specificity were calculated using different thresholds, based on standardized reporting categories (C1 = negative, C2 = reactive, C3 = atypical, C4 = suspicious, C5 = malignant, Cx = inadequate). RESULTS: Cancer registry matching of 2,594 tests revealed 130 incident bladder cancers, of which 97 occurred within 12 months of cytology and were included in calculating accuracy. Sensitivity (C3-C5 considered positive) ranged between 40.2 and 42.3%, and specificity was 93.7-94.1%. If C3 results are counted as negative, sensitivity estimates reduced to 24.7-26.0%. The positive predictive value of a C3, C4 or C5 report was 11.7, 39.2, and 66.6%, respectively. High tumor grade was associated with significantly higher sensitivity compared to low and intermediate grades combined (p = 0.02). CONCLUSION: Urine cytology is highly specific but has intermediate sensitivity, indicating that it has a role in adjunct diagnosis, but not in screening for primary bladder cancer. C3 results should be considered 'positive' and further investigated, and all positive results should prompt further intervention.

Reliability of sparing Papanicolaou test conventional reading in cases reported as No Further Review at AutoPap-assisted cytological screening: survey of 30,658 cases with follow-up cytological screening.

BACKGROUND: AutoPap-assisted smear reading has been proposed prior to conventional manual reading; the latter may be unnecessary for cases reported as No Further Review (NFR) and would be required for cases reported as Review (REV). METHODS: The authors evaluated comparable concurrent screening cohorts who were undergoing a conventional manual (CONV) or an AutoPap-assisted smear reading within the same screening program. The authors evaluated the prevalence of CIN2+ at repeat screening in subjects 1) with a negative report at conventional Papanicolaou test (CONV- = 9605), 2) with a REV report at AutoPap, followed by a negative conventional reading (REV- = 17,576), and 3) with a NFR report at AutoPap, followed by a negative rapid review (NFR- = 3477) at previous (baseline) screening. RESULTS: Crude CIN2+ detection rate was 0.176% (17 of 9605), 0.187% (33 of 17,576), or 0.02% (1 of 3477) among baseline CONV-, REV-, or NFR- subjects, respectively. No significant difference in CIN2+ detection rates was evident when comparing the whole baseline CONV- and AutoPap- cohorts (0.176% versus 0.161%; chi(2) ((df=1)) = 2.48, P = .87), or baseline CONV- with baseline REV- subjects (chi(2) ((df=1)) = 2.49, P = .96), whereas a borderline difference was evident when comparing baseline NFR- with CONV- (chi(2) ((df=1)) = 3.07, P = .079) or with REV- (chi(2) ((df=1)) = 3.61, P = .057) subjects. CONCLUSIONS: The authors' findings suggested that AutoPap assisted reading is comparable to conventional reading, as the frequency of CIN2+ detected at repeat screening did not differ between baseline CONV- or AutoPap- cohorts. The baseline NFR- subgroups showed a lower, borderline significant CIN2+ detection rate when compared to the CONV- cohort. The very low observed negative predictive value of an NFR report (0.02%) suggested that these subjects may safely return to periodic screening and that quality control measures such as rapid review or full manual reading of a random sample are probably not necessary.

Quality control of the autopap screening system employed as a primary screening device: rapid review of smears coded as no further review.

AIMS AND BACKGROUND: Automated reading of smears is increasingly used in cervical screening, and quality control procedures to check its performance are required. The aim of the present study was to evaluate the usefulness of rapid review of all smears coded as "no further review" (NFR) by the AutoPap system as a quality control procedure. METHODS: From 2002-2005, 153,269 smears were processed by AutoPap at the Centro per lo Studio e la Prevenzione Oncologica of Florence, Italy, and 24,503 (15.9%) were coded as NFR. All NFR smears underwent immediate rapid review by expert readers. RESULTS: Sixty-five of 118 NFR cases reviewed as ASCUS-R complied to recommended 6 months cytology, and 25 of 30 NFR cases reviewed as ASCUS-SIL or more severe accepted immediate colposcopy. As a result of such assessment, one single case of microinvasive carcinoma was detected in a woman aged 34 years: NFR smear had been reviewed as AGCUS, was followed by repeat AGCUS cytology and repeat negative colposcopy, and finally underwent conization. CONCLUSIONS: NFR report at AutoPap was associated with an extremely high negative predictive value, which might suggest using AutoPap as a primary screening tool, with NFR report prompting a "return to screening" recommendation. Rapid review of NFR smears is not recommended as a quality control measure for the negligible yield of high-grade lesions detected.

A feasibility study of the use of the AutoPap screening system as a primary screening and location-guided rescreening device.

BACKGROUND: The AutoPap 300 QC system (Tripath Imaging, Inc., Burlington, NC) is an automated device that was designed to screen conventionally prepared cervical smears and, more recently, thin-layer slide preparations. The system has been tested in large clinical trials. METHODS: A total of 14,145 cervical smears obtained from participants in the Florence screening program were eligible for the study. Smears were processed first with the AutoPap system and were classified into three different categories: 1) no further review (NFR), 2) review, and 3) process review (PR). Conventional manual reading was performed by 10 experienced cytopathologists. RESULTS: After AutoPap processing, 2398 smears were classified as NFR (16.9%), and 1818 smears were classified as PR (12.8%). Overall, there were 188 inadequate smears (1.3%) at conventional review and 125 inadequate smears (0.88%) at AutoPap review. Six-month repeat smears were prompted by 330 conventional reviews (2.3%) and by 222 AutoPap reviews (1.56%). Similarly, referral to colposcopy was prompted by 179 conventional reviews (1.2%) and by 147 AutoPap reviews (1.0%). Overall, 32 patients were diagnosed with high-grade cervical intraepithelial neoplasia as a result of assessment. Conventional reading detected 31 patients (28 patients were referred for colposcopy, and 3 patients were referred for repeat cytology), and the AutoPap system detected 30 patients (27 patients were referred for colposcopy, and 3 patients were referred for repeat cytology). CONCLUSIONS: The current experience suggested that conventional reading and AutoPap reading of cervical smears had essentially the same sensitivity, with slightly greater specificity for the AutoPap system. Thus, comparisons of the AutoPap system and conventional reading should focus mainly on cost analysis.

Conventional pap smear and liquid-based cervical cytology smear: comparison from the same patient.

BACKGROUND: The results of blind reading of smears obtained with liquid-based cytology in patients previously screened by conventional cytology were compared. MATERIAL AND METHODS: Cases selected for the study were a consecutive series of 99 subjects undergoing colposcopy within the screening program of the Florence District. The Pap test samples were processed utilizing the Thin Prep 2000 (Cytyc Corporation, Boxborough, MA). The liquid-base cytology smears were randomly admixed and read by seven expert cytologists with more than 15 years of experience in Pap smear reading. For each case, a consensus diagnosis was created and considered as the definitive diagnosis. Cytologic reports in conventional and liquid-based cytology smears were compared by the kappa statistic to evaluate diagnostic agreement. RESULTS: The study showed that the conventional and liquid-based cytology provide comparable cytologic reports and that the latter is not less sensitive than the former in detecting CIN2+ lesions of the cervix. DISCUSSION: Such evidence suggests the feasibility of randomized studies comparing the two methods, which are needed before adopting liquid-based cytology as the current method when screening for cervical cancer.