Techcyte SureView Cervical Cytology System Clinical Validation Study

Launched by TECHCYTE, INC. · Jan 6, 2025

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

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.