CytoProcessor^TM: A New Cervical Cancer Screening System for Remote Diagnosis

Abstract

Background: Current automated cervical cytology screening systems still heavily depend on manipulation of glass slides. We developed a new system called CytoProcessor^TM (DATEXIM, Caen, France), which increases sensitivity and takes advantage of virtual slide technology to simplify the workflow and save worker time. We used an approach based on artificial intelligence to identify abnormal cells among the tens of thousands in a cervical preparation. Objectives: We set out to compare the diagnostic sensitivity and specificity of CytoProcessor^TM and the ThinPrep Imaging System (HOLOGIC, Marlborough, MA, USA). Methods: A representative population of 1,352 cases was selected from the routine workflow in a private laboratory. Diagnoses were established using the ThinPrep Imaging System and CytoProcessor^TM. All discordances were resolved by a consensus committee. Results: Compared to the ThinPrep Imaging System, CytoProcessor^TM significantly improves diagnostic sensitivity without compromising specificity. The sensitivity of detection of “atypical squamous cells of undetermined significance (ASC-US) and more severe” and “low-grade squamous intraepithelial lesion and more severe” was significantly higher using CytoProcessor^TM. Considering that cases with a truth diagnosis of ASC-US or more severe required clinical follow-up, 1.5% of the cases (21/1,360) would have been missed if the CytoProcessor^TM diagnosis had been used for clinical decision-making. In contrast, 4% of the cases (54/1,360) were missed when the ThinPrep Imaging System diagnosis was used for clinical decision-making. There were 2.6 times fewer false negatives using CytoProcessor^TM. The CytoProcessor^TM workflow was 1.5 times faster in terms of worker time. Conclusions: CytoProcessor^TM is the first of a new generation of automated screening systems, demonstrating improved sensitivity and yielding significant gains in processing time. In addition, the fully digital nature of slide presentation in CytoProcessor^TM allows the remote diagnosis of Papanicolaou tests for the first time.

Adaptation of CytoProcessor for cervical cancer screening of challenging slides

“…The risk of a false-negative diagnosis was remarkably low (1.4%), despite the challenges of Novaprep slides. This was nearly identical to that observed in our previous study (1.5% risk of false-negative) which incorporated a larger test population of 1352 cases 7. In the context of the routine workflow, this performance was obtained with the added benefit of approximately 1.6 times faster diagnosis.As explained in Section 2, there were significant biases against CytoProcessor.…”

“…The elimination of slide handling steps in the CytoProcessor workflow saves a further 10.85 min for every 100 slides (transferring slides to trays, transferring trays to screeners and pathologists, matching slides with data sheets, distributing slides to screeners; data from Reference ). The only additional manual step required in the CytoProcessor workflow compared to the conventional workflow is loading the scanner, which requires approximately 4.5 min per 100 slides.…”

“…Although the sensitivity of CytoProcessor reported here is already slightly higher than that of the conventional method, we consider it as a baseline. Likewise, the specificity is expected to improve with experience, as already demonstrated in our first study …”

“…We previously demonstrated the performance of CytoProcessor for analysis of ThinPrep slides stained with the standard HOLOGIC protocol. 7 Here, we have shown that the system can be easily adapted to challenging Novaprep slides, a completely different staining protocol, and a different slide scanner.…”

“…To verify this hypothesis, we used artificial intelligence to generate a new algorithm adapted to a completely different preparation system and staining protocol from that previously tested . Our results indicate that CytoProcessor is a robust system that can be adapted to challenging samples, such as Novaprep slides.…”