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1.
The ThinPrep Imaging System (TIS) is an automated system that assists cytotechnologists in the primary screening of ThinPrep liquid based cervical samples. Between June 1, 2004, and April 1, 2005, four experienced cytotechnologists participated in the study in which the duration of the screening procedure was timed for each of the 11,354 slides included. In every slide 22 fields of view were reviewed, and the samples that contained potentially abnormal cells were fully screened. The screening time was reduced by 42% (mean) (p < 0.001). By manual rescreening of the negative TIS samples, abnormal cells were found in 10 samples (false negative rate 0.14%). In every case the abnormal cells had been identified by the scanner, but misinterpreted by the cytotechnologist. These findings stressed the importance of carefulness in the interpretation of the marked fields and beyond that helped the cytotechnologists and pathologists to have more confidence in the automated system.  相似文献   

2.
Prospective studies analyzing the ThinPrep Imaging System (TIS) have demonstrated a significant decrease in screening time and detection rates comparable or better than manual screening. We retrospectively analyzed the accuracy of the TIS in detecting cervical abnormalities. Our study included all new HSIL diagnoses in 2007 with previous negative (NIL) pap tests screened with TIS. The original 22 fields of view (FOV) were reviewed by 2 blinded screeners followed by manual screening of all slides. Any ASC-US or above was considered "abnormal." Of a total of 111,080 pap tests performed in 2007, 180 were reported as HSIL. Of these, 45 cases had a previous NIL pap diagnosed within the last year, screened with TIS. Following re-examination of the NIL pap, 31 diagnoses remained unchanged and 9 were reclassified as abnormal on the basis of cells present within the original FOV. When manually reviewed, all nine cases were confirmed as abnormal. Four cases were reclassified as abnormal on the basis of the manual screen (abnormal cells absent in the FOV). The sensitivity of TIS for the detection of abnormality was 99.95% (false-negative rate FNR: 0.05%) and the sensitivity for detection of HSIL was 99.07% (FNR: 0.92%). When analyzing the cytotechnologist interpretation of the FOV, the sensitivity for detection of abnormality and HSIL was 99.89% (FNR: 0.1%), and 99.53% (FNR: 0.4%), respectively. On retrospective analysis based on newly diagnosed HSIL cases, the sensitivity of TIS was comparable to that of manual screening with a slightly decreased rate of false negatives.  相似文献   

3.
The Papanicolaou test has proven to be the most effective cancer screening test ever developed. However, with a declining number of skilled cytotechnologists, there is an increased need for computer assistance in cervical cancer screening. The ThinPrep Imaging System (Cytyc Corporation, Marlborough, MA) is a unique system that combines computer imaging technology and human interpretive expertise in the review of ThinPrep Pap test slides. The purpose of this study is to report on the introduction and validation of this technology and present data related to the performance and productivity in our laboratory.Following completion of the ThinPrep Imaging System validation protocol, all imaged ThinPrep Pap test results were tracked and compared with year-2003 manually screened results to identify whether the Imaging System was effective in aiding human interpretive skills. Cases rescreened in the 10% random quality control (QC) program from the negative population that showed abnormal cells consistent with low-grade squamous intraepithelial lesion (LSIL) and above were compared with imaged versus non-imaged cases to establish an estimated laboratory false-negative (F/N) rate.The study compared results of 82,063 manually screened ThinPrep Pap tests in 2003 with 84,473 imaged ThinPrep Pap tests in 2004. Results demonstrated a significant increase in LSIL (37%) and high-grade squamous intraepithelial lesion (HSIL) (42%) detection on the Imager cohort. The F/N rate was reduced by half.The evaluation period after validation of the Imager showed a significant increase in LSIL and HSIL detection with the ThinPrep Imaging System compared to manual screening. These results demonstrate that the Imager has the potential to allow the cytotechnologists to detect more disease and reduce the false-negative rate for the laboratory. Although not evaluated in this study, cytotechnologists reported increased job satisfaction.  相似文献   

4.
The Papanicolaou stained cervicovaginal smear (Pap smear) is a gynecologic cytologic screening tool that has dramatically reduced the incidence and mortality of cervical cancer. Recently, a number of problems with the Pap smear test, including severe cytotechnologist shortages, lack of internal quality controls, and high false negative rates have been emphasized by the scientific community and the general public. To address some of these problems, there has been increased development of a number of automated and semiautomated cytologic screening systems. A semiautomated screening system (PAPNET®) was used to retrospectively evaluate 527 conventionally prepared Pap smears from 500 consecutive unselected patients. This system scanned the slides and displayed 128 of the most “abnormal” areas of each slide on a monitor. A screener reviewed these “abnormal” images in a blinded fashion and decided whether they represented variants of normal cytology, were inadequate for evaluation, or were abnormal and warranted manual review of the material. The screener's evaluations were then compared to the previously made diagnosis and discrepancies were reviewed. After review of the images from 500 patients, 343 (69%) were deemed to be normal cytology, 140 (28%) were abnormal and needed manual review, and 17 (3%) were inadequate. Of the 343 called normal using this system, 338 were previously called normal and five patients were previously diagnosed with either atypical squamous cells of undetermined significance (ASQUS) or low grade squamous intraepithelial lesions (LGSIL). Of the 140 thought to need review, 43 were previously diagnosed with squamous or glandular disease and 97 were previously diagnosed as normal. Slides from the apparent false negatives and false positives were again reviewed in a blinded fashion. Of the 97 thought to need review by the automated system but with previously normal diagnosis, 15 additional cases were thought to have cytopathic changes (12 ASQUS and 3 LGSIL). Of the five patients that were called normal using the automated review but with previous disease, only two were felt to be true false negatives. Semiautomated Pap smear screening appears to be a sensitive as well as specific method for the identification of cervical pathology. Further, it may be incorporated as a mechanism for quality control in the laboratory. © 1995 Wiley-Liss, Inc.  相似文献   

5.
Based on current literature and the best available research to date, the current FDA workload limits for automated image‐assisted screening, including the ThinPrep Imaging System and the FocalPoint GS, of 100 slides/day (imaged only slides counted as 0.5) are extremely high and may be associated with significant reduction in sensitivity. This task force has proposed six recommendations relating to cytotechnologist (CT) workload in automated image‐guided Pap test screening, which have already been endorsed by major pathology professional societies. These evidence‐based recommendations, however, pertain only to gynecologic specimens with image‐assisted screening, as there is no current available data to justify modifying screening practices regarding non‐gynecologic specimens. The proposed recommendations are as follow: 1) CT workday should not include more than 7 hours of Pap test screening in a 24‐hr period, and an 8‐hr shift day must include at least 2 paid mini‐breaks of 15 minutes each and a 30‐minute lunch break. 2) Future Studies examining CT workload should use actual hours of screening rather than lesser number of hours extrapolated to 8‐hour days. 3) Average laboratory CT workload should NOT exceed 70 slides/day (slides counted per 2010 FDA bulletin). 4) Proportion of imaged slides that undergo full manual review should be at least either 15%, or twice (2×) the epithelial cell abnormality (ECA) rate, whichever is greater. 5) ECA‐adjusted workload measure is a promising method for calculating and monitoring CT workload, but further studies of this method are necessary before full endorsement. 6) CT productivity and workload limits are just one aspect of a good quality assurance program in a cytology laboratory, so other quality indicators to assess CT performance are essential. Diagn. Cytopathol. 2013. © 2012 Wiley Periodicals, Inc.  相似文献   

6.
In 1998, the AutoPap 300 received FDA approval for primary screening of conventional cervical smears. As approved, smears categorized as "no further review" and comprising up to 25% of the smears screened by the AutoPap 300 can be reported as negative for malignant and dysplastic cells without screening by a cytotechnologist. We studied 106 conventional cervical smears in which glandular endometrial cells had been identified by manual screening to assess the ability of the AutoPap System (TriPath Imaging, Inc., Burlington, NC) to (1) designate conventional Papanicolaou smears that contain endometrial cells for "review," and (2) stratify smears that contain endometrial cells as more or less likely to be abnormal. Although the number of cases in our study was small, our findings indicate that (1) the AutoPap System is slightly less sensitive than manual screening by experienced cytotechnologists for the detection of endometrial cells in conventional smears, as the System designated for "review" 94.3% of all smears containing endometrial cells, 92.9% of smears reported as atypical glandular cells of undetermined significance (AGUS) or endometrial adenocarcinoma, and 100% of the four smears with subsequently confirmed endometrial adenocarcinomas, (2) ranking of smears into quintiles by the AutoPap System did not provide additional diagnostically useful information with respect to endometrial pathology, (3) the number of endometrial cells in the smears did not correlate with quintile assignment, and (4) for most patients, routine use of the AutoPap System for primary screening of conventional cervical smears is unlikely to contribute to delay in the diagnosis of clinically significant endometrial lesions.  相似文献   

7.
Exome and genome sequencing are increasingly utilized in research studies and clinical care and can provide clinically relevant information beyond the initial intent for sequencing, including medically actionable secondary findings. Despite ongoing debate about sharing this information with patients and participants, a growing number of clinical laboratories and research programs routinely report secondary findings that increase the risk for selected diseases. Recently, there has been a push to maximize the potential benefit of this practice by implementing proactive genomic screening at the population level irrespective of medical history, but the feasibility of deploying population‐scale proactive genomic screening requires scaling key elements of the genomic data evaluation process. Herein, we describe the motivation, development, and implementation of a population‐scale variant‐first screening pipeline combining bioinformatics‐based filtering with a manual review process to screen for clinically relevant findings in research exomes generated through the DiscovEHR collaboration within Geisinger's MyCode® research project. Consistent with other studies, this pipeline yields a screen‐positive detection rate between 2.1 and 2.6% (depending on inclusion of those with prior indication‐based testing) in 130,048 adult MyCode patient‐participants screened for clinically relevant findings in 60 genes. Our variant‐first pipeline affords cost and time savings by filtering out negative cases, thereby avoiding analysis of each exome one‐by‐one, as typically employed in the diagnostic setting. While research is still needed to fully appreciate the benefits of population genomic screening, MyCode provides the first demonstration of a program at scale to help shape how population genomic screening is integrated into routine clinical care.  相似文献   

8.
The ISBT Working Party on Transfusion‐Transmitted Infectious Diseases, Bacterial Subgroup (TTID‐WP‐BS) held a meeting during the 2017 ISBT Congress covering topics on safety of platelet components (PC), which are highlighted in this review. The TTID‐WP‐BS along with the Paul Ehrlich Institute have pioneered the development of bacterial strain repositories for PC and red blood cells (RBC) to be used for the validation of detection and pathogen reduction (PR) technologies. Results of the development of the RBC repository strains indicated that six bacterial strains were selected for further testing in international studies, complementing the previous study developed for PC. The THERAFLEX UV‐Platelets PR technology has used the bacterial strain repository for PC to test the effectiveness of the system with data presented in this report. Other PR studies described herein include a report of inactivation of Serratia marcescens by the INTERCEPT Blood System for PC at the levels of the PR claim. Furthermore, a summary of current and future developments of the Mirasol PR system was presented with emphasis on PR in whole blood. Advances in PC screening for bacterial contamination were covered by a comparative study of the BacT/ALERT 3D and BacT/ALERT VIRTUO systems, demonstrating that the latter has a shorter time to detection. Finally, data on septic transfusion reactions involving PC produced in plasma and platelet additive solutions indicated different clinical outcomes and screening results. The topics covered during the TTID‐WP‐BS meeting generated insightful scientific discussions and advanced knowledge, one of the most relevant activities of the Bacterial Subgroup.  相似文献   

9.
Liquid‐based cytology continues to be utilized as an adjunct to conventional cytology in most Australian laboratories, even though a direct‐to‐vial ThinPrep protocol has been introduced in many countries with established cervical screening programs. Manual screening of ThinPrep slides has been widely practiced for more than 10 years and the recent introduction of the ThinPrep Imaging System (TPI) has been reported as being more sensitive than the conventional smear (CS) in the identification of high‐grade cervical disease. We report our experience with ThinPrep Imaging since its introduction into our routine gynecological cytology service. 87,284 split sample pairs reported using the Imaging System demonstrated a decrease in unsatisfactory reports (3.65% for CS and 0.87% for TPI) and an increase in possible high grade and definite high‐grade squamous reports (1.57% for CS and 1.62% for TPI). For 1,083 biopsy confirmed high‐grade lesions, the correct diagnosis of high grade or possible high‐grade squamous disease was made on the ThinPrep imaged slide in 61.0% (661/1,083) of cases and on the CS in 59.4% (643/1,083). This was not statistically significant. When all abnormalities identified on cytology were considered, including possible low grade and definite low‐grade abnormalities, the difference in sensitivity for Thinprep imaged slides of 96.0% (1,040/1,083) and CSs of 91.6% (992/1,083) was statistically significant. Diagn. Cytopathol. 2010. © 2009 Wiley‐Liss, Inc.  相似文献   

10.
Viral binding and entry into host cells for various viruses have been studied extensively, yielding a detailed understanding of the overall viral entry process. As cell entry is an essential and requisite process by which a virus initiates infection, it is an attractive target for therapeutic intervention. The advantages of targeting viral entry are an extracellular target site, relatively easy access for biological interventions, and lower toxicity. Several cell‐based strategies and biophysical techniques have been used to screen compounds that block viral entry. These studies led to the discovery of inhibitors against HIV, HCV, influenza, Ebola, and RSV. In recent years, several compounds screened by fragment‐based drug discovery have been approved as drugs or are in the final stages of clinical trials. Among fragment screening technologies, surface plasmon resonance has been widely used because it provides accurate information on binding kinetics, allows real‐time monitoring of ligand‐drug interactions, requires very small sample amounts to perform analyses, and requires no modifications to or labeling of ligands. This review focuses on surface plasmon resonance–based schemes for screening viral entry inhibitors.  相似文献   

11.
《Diagnostic cytopathology》2017,45(10):903-914
Significant changes in cervical cancer screening practice, guidelines, and prevention of cervical cancer have taken place in recent years including the raising of initial cervical cancer screening age, changes in frequency of cytology screening, and the adoption of high risk HPV and cytology co‐testing for some patients; the introduction of the bivalent, quadrivalent, and 9‐valent HPV vaccines; and the recent approval of high risk HPV testing as primary screening with the use of cytology as triage in positive cases. This review discusses the significance of primary HPV screening, the impact of HPV vaccination in the prevalence of cervical cancer and its precursors, the interplay between high risk HPV testing and vaccination, and the implications for clinical and cytological management. Future strategies for cervical screening in the post‐vaccination era are also discussed.  相似文献   

12.
Browser with Rich Internet Application (RIA) Web pages could be a powerful user interface for handling sophisticated data and applications. Then the RIA solutions would be a potential method for viewing and manipulating the most data generated in clinical processes, which can accomplish the main functionalities as general picture archiving and communication system (PACS) viewing systems. The aim of this study is to apply the RIA technology to present medical images. Both Digital Imaging and Communications in Medicine (DICOM) and non-DICOM data can be handled by our RIA solutions. Some clinical data that are especially difficult to present using PACS viewing systems, such as ECG waveform, pathology virtual slide microscopic image, and radiotherapy plan, are as well demonstrated. Consequently, clinicians can use browser as a unique interface for acquiring all the clinical data located in different departments and information systems. And the data could be presented appropriately and processed freely by adopting the RIA technologies.  相似文献   

13.
Automated-primary screening is frequently performed, but conventional smears have to be rescreened on coverslip edges because automated systems do not analyze cells near the coverslip edges because of focusing problems. This disadvantage can be overcome by obtaining conventional samples smeared in the center of the slide, e. g., by the Exact Touch (ET), a single sampler introduced by G. Saccomanno. PAPNET-assisted primary screening was performed on 263 samples collected by ET. The smears were classified as "negative" or as "review." The negative cases were rapidly rescreened but not near the coverslip edges. The review cases were fully reanalayzed by the optic microscope. Ten positive smears were identified among the review cases: 3 smears showed changes due to human papillomavirus, 3 low-grade squamous intraepithelial lesions, and 4 high-grade squamous intraepithelial lesions. The detection of abnormal cells was easy by means of the combined use of ET and PAPNET. The ET-PAPNET technique was very useful in analyzing conventional smears and in reducing the time-consuming process of detecting abnormal cells.  相似文献   

14.
15.
Nongynecologic (NG) cytology cases usually generate multiple slides. In cases showing overtly malignant or neoplastic cells, the cytotechnologist (CT) may not need to screen all slides. We test the hypothesis that selective screening of a subset of slides by the CT is as effective as "routine screening" of all slides. The selective screening process (SSP) was performed by having the cytotechnologist (CT) screen and mark overtly malignant or neoplastic cells on up to three slides. Cases requiring more slides to be screened were not included in SSP. For each SSP case, the total slide count, number of slides screened, final diagnosis, and cytologic-histologic correlation (CHC) data were collected over 10 months and compared to the data from routinely screened cases. SSP was performed on 191 cases during a 10-month period. An average of 1.9 slides per case was screened by the cytotechnologist using the SSP. The average number of unscreened slides passed to the pathologist was 6.3 per case. On average, SSP resulted in 83.6 min of CT's time saved per day. Quality control by CHC demonstrated no false-positive cases in either the SSP or "routinely screened" groups. The diagnostic accuracy of the specific cytology diagnoses was 98% by SSP and 100% by "routine screening." SSP provides a mechanism for the cytotechnologist to "screen" fewer slides and pass the cases to the pathologist more efficiently without compromising overall patient care.  相似文献   

16.
By imaging large numbers of slides automatically at high resolution, modem automated whole slide imaging (WSI) systems have the potential to become useful tools in pathology practice. This article describes a pilot validation study for use of automated high-speed WSI systems for surgical pathology quality assurance (QA). This was a retrospective comparative study in which 24 full genitourinary cases (including 47 surgical parts and 391 slides) were independently reviewed with traditional microscopy and whole slide digital images. Approximately half the cases had neoplasia in the diagnostic line. At the end of the study, diagnostic discrepancies were evaluated by a pathology consensus committee. The study pathologists felt that the traditional and WSI methods were comparable for case review. They reported no difference in perceived case complexity or diagnostic confidence between the methods. There were 4 clinically insignificant discrepancies with the signed-out cases: 2 from glass slide and 2 with WSI review. Of the 2 discrepancies reported by the WSI method, the committee agreed with the reviewer once and the original report once. At the end of the study, the participants agreed that automated WSI is a viable potential modality for surgical pathology QA, especially in multifacility health systems that would like to establish interfacility QA. The participants felt that major issues limiting the implementation of WSI-based QA did not involve image acquisition or quality but rather image management issues such as the pathologist's interface, the hospital's network, and integration with the laboratory information system.  相似文献   

17.
BD FocalPoint GS? computer‐assisted screening of BD SurePath® liquid‐based cervical cytology slides (SP + FP) was compared with screening an accompanying conventional cervical Papanicolaou (Pap) smear (CON) in a split sample trial of 2,198 routine specimens. The rate of unsatisfactory specimens in the SP + FP arm was 0.2% compared with 4.1% in the conventional Pap smear, a significant reduction. There was no statistically significant difference between SP + FP and CON for the detection of histologically confirmed high‐grade (HG) lesions in the routine split sample specimens (n = 9). To further test the sensitivity of SP + FP for HG lesions, 38 SurePath slides from confirmed HG cases, without an accompanying CON, were interpolated among the routine smears. In every one of the 47 confirmed HG cases, either HG cells were present in the microscope fields selected by FocalPointGS? for review by the screening cytologist (46 of 47), or full screening of the slide was indicated by the FocalPointGS? (1 of 47), confirming the effectiveness of SP + FP technology for primary screening. In a small number of cases, the screening cytologist did not recognize the abnormality even though on review HG cells were present in fields selected by FocalPointGS?. The overall detection rate was 93% for HG squamous lesions; 89% for known HG endocervical glandular lesions; and 91% for known endometrial carcinoma. In conclusion, the SP + FP detected 100% of HG abnormalities in the trial set; significantly reduced the rate of unsatisfactory specimens; and improved the overall screening rate of detection of HG abnormalities particularly of glandular lesions when compared with other screening technologies. Diagn. Cytopathol. 2012. © 2011 Wiley Periodicals, Inc.  相似文献   

18.
Rapid screening of methicillin‐resistant Staphylococcus aureus (MRSA) colonization prior to hospital admittance is important to reduce nosocomial infections and health care costs. Molecular detection of mecA and S. aureus specific target genes has become widely established for this purpose. However, there are still limitations in potential for high‐throughput screening in the methods described. We have compared the time aspects and workload of four different DNA preparation platforms, resulting in an automated and simple MRSA screening method which combines two liquid handling systems and a simple lysis buffer. We have further transferred our in‐house dual real‐time PCR to a fast‐PCR protocol, reducing the time and labour spent on these samples to a minimum.  相似文献   

19.
On the selection of systems for automated cytogenetic analysis   总被引:1,自引:0,他引:1  
Impressive technological advances in systems for automated metaphase location and cytogenetic analysis have resulted in a proliferation of commercially available systems offering a variety of performance and price options. Based on the numbers of systems sold, it appears as if automation is becoming an accepted component of cytogenetic laboratories. To address the question of whether automation is useful and, if so, to identify the advantages and disadvantages of some of the systems, we have supplemented our own laboratory experience using the Magiscan routinely for clinical cytogenetic analysis, with information obtained during an on-site survey of other clinical cytogenetic facilities using automated systems (Genetiscan, Karyotype Image Editor, Metachrome, Cytoscan). Some systems provide both metaphase-locating and karyotyping capabilities--some only the latter. The basic structure of all systems is similar: microscope with camera, image processor, mechanism for operator interaction with the computer, hard copy printer. Metaphases are digitized, analyzed, and converted to permanent images. Metaphase-locating systems (Cytoscan, Magiscan, Metachrome) require, in addition, motorized slide-scanning stages. The biggest time savings resulting from use of automation is in the karyotyping steps, especially the production of a hard copy. Consequently, laboratories making many karyotypes will benefit most from such systems. The optimum choice of system will depend on specific laboratory parameters: number and type of specimens processed; operational preferences, e.g., number of bands per metaphase; number of metaphases counted; and karyotypes prepared per case. Laboratories processing chorionic villus specimens and/or bone marrows, where much slide area must be searched, will benefit from fast metaphase locators with multislide stages.(ABSTRACT TRUNCATED AT 250 WORDS)  相似文献   

20.
Fine‐needle aspiration (FNA) is widely utilized due to its short turnaround time (TAT), diagnostic accuracy, and low cost. Controversy exists as to what role cytotechnologists should play in evaluation of FNAs. Some authorities believe all FNAs should be screened by cytotechnologists while others believe that cytotechnologist review is unnecessary. Sixty sequentially performed FNAs without initial review by cytotechnologists were selected from the files of the University of Utah, Department of Pathology. The slides were obtained along with the associated final diagnoses. The slides were reviewed by cytotechnologists given patient history and specimen site but were blinded to the initial pathologist's diagnoses. The initial cytopathologist's diagnoses and subsequent cytotechnologists' diagnoses were recorded and correlated. TATs for these cases were calculated and compared with TATs in a second set of randomly selected FNAs where cytotechnologists had initially screened the cases. Correlation of initial cytopathologists' diagnoses with those of cytotechnologists' revealed no instances where cytotechnologists identified diagnostically significant findings not noted by the original pathologist. TAT for the FNAs reviewed only by a cytopathologist averaged 25.9 hours with a mode of 6 hours. TATs for cases with initial cytotechnologist screening averaged 44.1 hours with a mode of 25 hours. Pre‐sign‐out screening of FNA specimens by cytotechnologists does not appear to increase detection of cytologic abnormalities. Cytotechnologist screening does substantially increased TAT from a mean of 26 hours to approximately 44 hours. Such an extensive delay may reduce the overall clinical utility of the FNA technique. Diagn. Cytopathol. 2014;42:606–608. © 2014 Wiley Periodicals, Inc.  相似文献   

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