End-User Scanner Validation

Objective

Confirm the slide preparation protocol, digital scanner, and upload process produce a scan that the Sporecyte algorithm can process and classify.

Scope

The end-user location sites perform the scanner validation testing. This validation tests whether sample preparation, scanning equipment, and the upload process at the site are suitable for the Sporecyte algorithm to analyze the uploaded scans.

Responsibility

Each site is responsible for executing and documenting the recommended validation according to this protocol.

Sporecyte recommends that sites follow their internal process for documentation and labeling of the validation process, including the date performed, results, and validation expiration.

Procedure

The validation procedure is intended to establish that the slide samples used through the Sporecyte application produce equivalent results to those obtained using manual light microscopy.

1. Select five samples from available samples in the clinic.
   1. These samples should include cells representative of the type of cells the algorithm analyzes.
2. Prepare a slide from each sample according to the site's standard procedure.
3. The lab professional should identify and classify individual cells using the manual light microscopy process for each sample.
4. The lab professional will then run the same samples through the Sporecyte application and use the software to review, verify, and re-classify scans as applicable.
5. Compare the results of the two methods to confirm that the lab professional has correctly identified cells using the Sporecyte application.
   1. All slides must be within the Sporecyte-provided 95% confidence-interval error margins for all classes.
   2. The process should be repeated if any class on any slide is outside the error margin. If the process failure persists, slide preparation will need to be modified.

Validation Intervals

Sporecyte recommends that end-user scanner validation be performed at the site after a scanner is installed or changes to the slide preparation protocol are made, or at least yearly if no changes have occurred.