The AutoPap 300 QC system multicenter clinical trials for use in quality control rescreening of cervical smears

Patten, Stanley F.; Lee, James S.J.; Wilbur, David C.; Bonfiglio, Thomas A.; Colgan, Terence J.; Richart, Ralph M.; Cramer, Harvey; Moinuddin, Shamin

doi:10.1002/(sici)1097-0142(19971225)81:6<337::aid-cncr7>3.0.co;2-i

Cited by 40 publications

(20 citation statements)

References 6 publications

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“…This level of sensitiv-ity is comparable to clinical trial data which found a sensitivity for an endocervical component of 82.1%. 44 In the present study, the identification of an endocervical component on manual screening was determined solely on the presence of endocervical glandular cells. The decision not to include squamous metaplastic cells in the assessment of specimen adequacy was based on published findings which suggest that these cells are identified less reproducibly than endocervical columnar cells.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of automated cervical cytology rescreening using the AutoPap® 300 QC System

et al. 1997

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This study assesses the performance of the AutoPap® 300 QC System in identifying false‐negative (FN) smears in a slide population previously screened as normal and compares the detection rate to that achieved with a random rescreen of the same slide population. A total of 1,840 “normal” smears were rescreened both manually and by the AutoPap® 300 QC System. Overall, a total of 7 FN slides were detected. At QC selection rates of 30% and 20% the device achieved sensitivities for detection of FN smears of 57.19% (4/7) and 42.8% (3/7), respectively. This represents a three‐ to fourfold enrichment in the number of FN smears over that obtained by a random rescreen of a similar proportion of cases. None of the FN slides were identified by either method at a 10% rescreening rate. The ability of the device to detect slides previously classified as abnormal (n = 139) and FN (n = 40) was also studied. The overall sensitivity to abnormal smears at QC selection rates of 10%, 20%, and 50% was 61.9%, 77.0%, and 94.2%, respectively. Improved sensitivity to smears classified as LSIL or worse (n = 112) was obtained for corresponding selection rates (61.6%, 75.9%, and 93.8%). Sensitivity to FN slides classified as LSIL or worse (n = 17) for QC selection rates of 10%, 20%, and 50% was 29.4%, 70.6%, and 88.2%, respectively. The sensitivity and specificity of the device to an adequate squamous and endocervical cell component was also determined. At predetermined thresholds, the overall sensitivity to slides with an inadequate squamous cell component (n = 55) and to those smears with an endocervical cell component (n = 1,587) was 81.8%, and 82.7% respectively. The study demonstrated that the AutoPap® 300 QC System is superior to human random rescreen for the identification of FN smears although only a marginal improvement was noted due to the small sample. Further studies are required using a larger number of smears to fully assess the value of the device in quality control mode. The device also has the potential to improve the accuracy of specimen adequacy determinations and to serve as a useful adjunct to existing quality control measures designed to monitor individual performance and reporting accuracy. Diagn. Cytopathol. 16:505–512, 1997. © 1997 Wiley‐Liss, Inc.

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Section: Discussionmentioning

confidence: 99%

Effectiveness of automated cervical cytology rescreening using the AutoPap® 300 QC System

et al. 1997

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“…Most studies aimed at assessing AutoPap system performance have focused on higher sensitivity and on reduced reading workload compared with conventional reading,1–5, 12 and few have addressed specifically the issue of the NPV of an NFR report 11. NPV for CIN2+ is assumed to be very high, but not absolute, and because some false negatives are expected, a routine quality control measure, such as manual review of a random subset of cases reported as NFR, can be suggested.…”

Section: Discussionmentioning

confidence: 99%

“…Automated reading of Papanicolaou (Pap) smears by the AutoPap (AutoPap Primary Screening System 300, Tripath Imaging Inc., Burlington, NC) system (presently commercialized as FocalPoint) has been proposed as a measure to reduce manual reading workload, and possibly overall costs, in current screening practice 1–5. AutoPap is reported to code as No Further Review (NFR) up to 25% of total smears, which may be safely assumed to be negative without conventional manual reading 3…”

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confidence: 99%

Reliability of sparing papanicolaou test conventional reading in cases reported as No Further Review at AutoPap-assisted cytological screening

Troni

Cariaggi

Bulgaresi

et al. 2007

Cancer

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“…The FDA‐approved algorithm in‐use today ranks slides for severity, typically within batches of about 150 stained slides. The initial indication was to define women whose cytology indicated such low risk that cytotechnologist review was not needed . However, instead we developed a new algorithm that defines the most severely abnormal slides among HPV‐positive women.…”

Section: Methodsmentioning

confidence: 99%

“…FocalPoint performs a high‐speed, magnified scan, and outputs 160 binary or quantitative “features” of the cytology slide, such as presence of different cell types, nuclear size, chromatin density, and nuclear contour . The preset algorithm is designed for general screening, i.e ., review of batches of mainly negative slides from mainly HPV‐negative women.…”

Section: Methodsmentioning

confidence: 99%

Proof-of-principle study of a novel cervical screening and triage strategy: Computer-analyzed cytology to decide which HPV-positive women are likely to have ≥CIN2

Schiffman

Dunn

et al. 2016

Int. J. Cancer

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A challenge in implementation of sensitive HPV-based screening is limiting unnecessary referrals to colposcopic biopsy. We combined 2 commonly recommended triage methods: partial HPV typing and “reflex” cytology, evaluating the possibility of automated cytology. This investigation was based on 1,178 exfoliated cervical specimens collected during the enrollment phase of The Study to Understand Cervical Cancer Early Endpoints and Determinants (SUCCEED, Oklahoma City, Oklahoma). We chose a colposcopy clinic population to maximize number of outcomes, for this proof-of-principle cross-sectional study. Residual aliquots of PreservCyt were HPV-typed using Linear Array (LA, Roche Molecular Systems, Pleasanton, CA). High-risk HPV typing data and cytologic results (conventional and automated) were used jointly to predict risk of histologically defined ≥CIN2. We developed a novel computer algorithm that uses the same optical scanning features that are generated by the FocalPoint Slide Profiler (BD, Burlington, NC). We used the LASSO (Least Absolute Shrinkage and Selection Operator) method to build the prediction model based on a training dataset (n=600). In the validation set (n=578), for triage of all HPV-positive women, a cytologic threshold of ≥ASC-US had a sensitivity of 0.94, and specificity of 0.30, in this colposcopy clinic setting. When we chose a threshold for the severity score (generated by the computer algorithm) that had an equal specificity of 0.30, the sensitivity was 0.91. Automated cytology also matched ≥ASC-US when partial HPV typing was added to the triage strategy, and when we re-defined cases as ≥CIN3. If this strategy works in a prospective screening setting, a totally automated screening and triage technology might be possible.

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The AutoPap 300 QC system multicenter clinical trials for use in quality control rescreening of cervical smears

Abstract: The AutoPap 300 QC System provides the potential for a marked increase in the number of false-negative cervical cytology cases that can be detected on QC rescreening. A significant reduction in laboratory false-negative rates can be expected if this device is utilized in routine practice.

Cited by 40 publications

References 6 publications

Effectiveness of automated cervical cytology rescreening using the AutoPap® 300 QC System

Effectiveness of automated cervical cytology rescreening using the AutoPap® 300 QC System

Reliability of sparing papanicolaou test conventional reading in cases reported as No Further Review at AutoPap-assisted cytological screening

Proof-of-principle study of a novel cervical screening and triage strategy: Computer-analyzed cytology to decide which HPV-positive women are likely to have ≥CIN2

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