Comparing the Cervista HPV HR test and Hybrid Capture 2 assay in a Dutch screening population: improved specificity of the Cervista HPV HR test by changing the cut-off.

The diagnostic performance of the widely-used Cervista HPV HR test was compared to the Hybrid Capture 2 (HC2) test in a Dutch population-based cervical cancer screening program. In 900 scrapings of women with normal cytomorphology, specificity was 90% (95%CI: 87.84-91.87) for the Cervista HPV HR test and 96% (95%CI: 94.76-97.37) for the HC2 test with 93% agreement between both tests (κ = 0.5, p<0.001). The sensitivity for CIN2+ using 65 scrapings of women with histological-confirmed CIN2+ was 91% (95%CI: 80.97-96.51) for the Cervista HPV HR test and 92% (95%CI: 82.94-97.43) for the HC2 test with 95% agreement between both tests (κ = 0.7, p<0.001). Fifty-seven of 60 HC2 negative/Cervista positive cases tested HPV-negative with PCR-based HPV assays; of these cases 56% were defined as Cervista triple-positive with FOZ values in all 3 mixes higher than the second cut-off of 1.93 (as set by manufacturer). By setting this cut-off at 5.0, specificity improved significantly without affecting sensitivity. External validation of this new cut-off at 5.0 in triple-positive scrapings of women selected from the SHENCCASTII database revealed that 22/24 histological normal cases now tested HPV-negative in the Cervista HPV HR test, while CIN2+ lesions remained HPV-positive. The intra-laboratory reproducibility of the Cervista HPV HR test (n = 510) showed a concordance of 92% and 93% for cut-off 1.93 and 5.0 (κ = 0.83 and κ = 0.84, p<0.001) and inter-laboratory agreement of the Cervista HPV HR test was 90% and 93% for cut-off 1.93 and 5.0 (κ = 0.80 and κ = 0.85, p<0.001). In conclusion, the specificity of the Cervista HPV HR test could be improved significantly by increasing the second cut-off from 1.93 to 5.0, without affecting the sensitivity of the test in a population-based screening setting.

Application of the ThinPrep imaging system in urine cytology: a prospective study.

BACKGROUND: In this prospective study, for the first time, the authors compared the accuracy of reading urine specimens using the ThinPrep Imager System (TIS) with the accuracy of conventional screening for the detection of abnormal urine cells. METHODS: ThinPrep slides were made from 1455 urine specimens and were read with conventional screening and with TIS. Findings were categorized as "unsatisfactory or failure to read the slide," "benign," or "abnormal." The Cohen κ coefficient was calculated to determine inter-rater agreement between both methods. Urine samples that were followed by biopsies were used to compare the sensitivity, specificity, positive predictive value, and negative predictive value of both methods. From 22 urine specimens, the screening times were measured and compared. RESULTS: There was substantial agreement between both methods (κ score, 0.77). Of 175 urine specimens that were followed by bladder biopsies, for conventional screening, the sensitivity was 51.3%, specificity was 68.4%, the positive predictive value was 77.2%, and the negative predictive value was 40.2%; for TIS screening, the respective values were 54.6%, 68.4%, 78.3%, and 41.9%. The average time was 5.2 minutes for conventional screening and 3.9 minutes for TIS. CONCLUSIONS: With a κ score of 0.77, the current study demonstrated a good correlation between reading urine specimens with conventional screening and with TIS. Using TIS resulted in slightly increased sensitivity, positive predictive value, and negative predictive value compared with conventional screening and had the same specificity. These results indicate that reading urine specimens using TIS is equally reliable as conventional cytology.

Diagnostic value and cost considerations of routine fine-needle aspirations in the follow-up of thyroid nodules with benign readings.

BACKGROUND: Fine-needle aspiration (FNA) is the most accurate tool to identify malignancy in solitary thyroid nodules. Although some recommend routinely repeating FNA for nodules that are initially read as benign, there is no consensus. We evaluated clinical relevancy and considered costs of routine follow-up FNA in nodules initially read as benign. METHODS: We reviewed the records of all 739 patients who underwent FNA of solitary thyroid nodules at our institution from 1988 to 2004. A total of 815 aspirations were required to obtain satisfactory specimens. According to their physicians practice, some patients had a "follow-up biopsy" after an initially benign FNA reading as a matter of routine (Group I approach) or if their clinical status changed (Group II approach). The outcome information for at least 4 years after the initial FNA in these two groups was compared. In addition, hypothetical costs relating to both methods for deciding whether to do a follow-up FNA were considered. RESULTS: The initial FNA was benign in 576 (78%), suspicious for follicular neoplasms in 106 (14.4%), and malignant in 57 patients (7.7%). Follow-up FNA was performed in 292 patients with initially benign lesions, 235 in Group I approach and 57 in Group II approach. The FNA diagnosis according to Group I approach remained benign on follow-up biopsy in 96.2% (226/235), was altered to follicular neoplasm in 3% (7/235), and was suspicious for malignancy in 0.8% (2/235). When following Group II approach, the follow-up FNA was benign in 93% (53/57), undetermined in 1.7% (1/57), and showed follicular neoplasm in 5.3% (3/57). Combining Groups I and II methods, 5 of 292 patients had a malignant nodule on histological examination, a false-negative rate of 1.7% for the initial FNA, but without a difference in prevalence of thyroid malignancy between the groups. Cost-consequence analysis showed no benefit in routine follow-up FNA after initially benign FNA readings. CONCLUSIONS: Routine follow-up FNA in patients whose initial FNA is benign has a low diagnostic upgrading value and is relatively costly. In patients whose initial FNA is benign, we recommend the FNA be repeated only if clinically suspicious signs or complaints develop.