Clinical Validation Packets

Reconcile known truth against instrument results—automatically.

Enter known positive and negative cases (from PCR, LIS, or culture & sensitivity), upload the matching runs, and LabApps reconciles truth against observed calls into TP/TN/FP/FN findings with concordance metrics. Submit for review, then approve and lock—or reject and re-upload with full history kept.

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Capabilities

What you can do

Deterministic reconciliation

Outcomes and pass/fail come from rules, not guesses.

Smart sample matching

Exact, normalized, AI-suggested, or manual mapping of cases to samples—with confidence shown.

Audited adjustments

Edit observed calls, exclude targets, or override concordance—every change is logged and reflected in metrics.

Attempts preserved

Rejection creates a new attempt; prior attempts stay immutable.

Inspection PDF

Approved packets lock and produce a PDF for the binder.

AI that assists—people stay in control

AI may write narrative and suggest probable causes for discordant results. It never changes findings or approves a packet.

Connected features

Works hand in hand with

PCR & Molecular

Analytical Validation (LOD & Cutoffs)

LOD, Ct distribution, and cutoff suggestion on your actual runs.

LOD study analyzer
Ct distribution analyzer
Cutoff suggestion engine

Learn more

PCR & Molecular

Assay Go-Live & Patient Reports

A controlled path from validated to live—and patient-ready PDFs after.

Submit → Approve → Live
Validation summary
Patient report PDF

Learn more

See Clinical Validation Packets in action.

Start a free organization in minutes, or book a walkthrough with our team. Turn on only the modules you need—add more any time.

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