Extracting manufacturer claims from a package insert

Let the AI assistant read precision, reportable range and detection limit claims from a package insert PDF; nothing is saved until you review it.

A package insert states the performance the manufacturer claims for an assay. Verification studies compare your lab's results with those claims, so Legion Diagnostics can read them from the insert for you. This is a beta feature. Because the AI assistant does the reading, it needs AI turned on for your organization and your account. Without AI access, you can still upload and keep the insert.

What is read from the insert

The assistant reads:

• precision: repeatability (within-run) and within-laboratory precision for each level, with the level, its target concentration, units, CV % and SD
• reportable range: the lower and upper limits and units (quantitative assays)
• detection limits: limit of blank and limit of detection (quantitative assays)
• notes, plus suggestions for the assay method, operating temperature and reagent product

Where the insert gives only a CV or only an SD, the other is calculated from the target concentration and the calculation is noted. The AI never estimates it.

One analyte

When adding an analyte, leave "Include manufacturer claims" set to "Yes", click "Next", then click "Upload and extract with AI". For an existing analyte, open it, go to "Package Insert Information" and click "Upload with assistant".

Drop the insert as a PDF (up to 25 MB). The assistant opens with the file attached and reads it. Very long documents are narrowed to their performance pages, and password-protected or oversized PDFs are refused before anything is read.

To keep the file without extraction, click "Upload without extraction" (or "Upload insert without AI"). Either way, the PDF is stored on the analyte and appears in the "Claims PDF" column.

Reviewing before anything is saved

Nothing becomes a claim until a person agrees to it. The extracted values appear in "Review extracted claims", where you can correct any number before you click "Save claims". At least one precision row is needed, and each row needs a target and an SD.

A "Check this source before saving" box appears when something deserves a second look, for example when:

• the document does not look like a package insert (an operator manual or a QC insert)
• a value is a specification limit ("≤") rather than a measured result
• a level is claimed over a concentration range, which needs a single target you confirm
• within-run or within-laboratory precision is missing

Sometimes extraction fails because the insert names a different analyte, cannot be read, or holds no usable data. You can then save the file only, upload a different file, or retry with instructions.

Many analytes at once

On an analyzer's page, click "Add", then "Package inserts" to handle several analytes:

1. Tick the analytes.
2. Drop their PDFs. Each is matched to an analyte by file name or chosen by hand, and one insert can serve several analytes.
3. Click "Upload" and keep the tab open while the files upload. Extraction then carries on in the background.

A banner counts progress. Click "Review package inserts" to walk through each analyte, where you can click "Save claims" or "Skip analyte", save the file only, or run the extraction again.

Where saved claims are used

Saved claims are used in several places:

• Precision verification can compare your results with the claimed precision. Choose "Compare to Manufacturer Claims" and select the claimed levels to test against.
• Study plans fill a blank claimed reportable range for calibration verification and linearity from the saved claims.
• Limit of blank studies start from the claimed limit of blank when the units match.
• SOP drafting can draw on the package insert.

You can edit saved claims at any time from the analyte's "Manufacturer Claims". Removing the insert removes its claims.