Multi-center, Two-arm Clinical Study Evaluating the Performance of the Techcyte Sureview Cervical Cytology System and Its Subsystems for the Assessment of Pap Tests
Trial ID: NCT06767111
Status: ENROLLING_BY_INVITATION
Study type: OBSERVATIONAL
Start date: 2024-12-01
Completion date: 2025-12
Sponsor: Techcyte, Inc.
Conditions: Cervical Cytology; PAP
Interventions: Digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm in vitro diagnostic (IVD) device
Locations: Techcyte
Countries: United States
Enrollment: 4596
Age range: 18 Years - None
Sex: FEMALE

Summary:
The clinical study is a multi-center, retrospective, blinded, matched-pair, two-arm clinical study in which one test assessment and a control assessment of liquid-based cytology (LBC) pap tests are performed and compared to a reference.

The control method is defined as the assessment of LBC pap tests performed by a cytotechnologist (CT) and/or cytopathologist (CP) using standard laboratory cervical cytology practices (i.e. a manual assessment) and following The Bethesda System for Reporting Cervical Cytology (TBS). The control method is referred to as the "standard method".

The test method is referred to as the AI-assisted method. The AI-assisted method is defined as the assessment of the same LBC pap test as in the standard method, but with the Techcyte SureView Cervical Cytology System, which has pap tests being scanned on the Pramana SpectralHT Cubiq whole slide scanner, analyzed with the Techcyte Cervical Cytology Algorithm (TCCA) and presented on the Techcyte Viewer, using the Dell U3223QE Monitor for assessment by a CT/CP following the TBS.

In addition, the time spent reviewing the samples with both methods will be measured such that the CT workload limit for AI-assisted assessment can be established.

The LBC pap tests to be assessed in the clinical study must have been prepared with either ThinPrep® Pap Test (Hologic) or BD SurePath™ (Beckton, Dickinson and Company). The study aims to enroll for each preparation method an equal number of samples.

Eligibility criteria:
Inclusion Criteria:

* Glass slides with cervical cytology specimens prepared with Hologic ThinPrep according to the pap test manufacturers Instructions for Use (IFU) using any of Hologic's processors (i.e. ThinPrep2000, ThinPrep 3000, ThinPrep 5000, ThinPrep Genesis). OR Glass slides with cervical cytology specimens prepared with BD SurePath according to the pap test manufacturers IFU using any of BD's processors (i.e. BD Totalys MultiProcessor, BD Totalys SlidePrep, BD PrepStain).
* Slide has the original diagnosis available.
* Slides that fit within the required sample size strata using the sample collection procedure.
* Glass slides with QR code, barcodes, or plain text labels.
* Glass slides with coverslips.
* Slides that are 5 years old or less, except where rare specimens require it. Those specimens will have to be reviewed for degradation per the sample collection procedure.
* Only one sample per patient and all are to be collected, processed and scanned.

Exclusion Criteria:

* Broken or cracked slides.
* Slides with air bubbles or scratched, cracked or broken/missing cover slips.
* Slides with markings (e.g., handwritten pen marking) that cannot be removed according to standard laboratory procedures.
* Degraded slides (ex: slides whose stains have lost color or specimens that are not intact).
* Glass slides with cervical cytology specimens prepared with methods other than Hologic ThinPrep or BD SurePath.
* Glass slides with specimens other than cervical cytology specimens.
* Slides from the same patient.

Outcomes:
Sensitivity and specificity when comparing pap tests using the Techcyte SureView Cervical Cytology System