Analytical testing
Beyond storing specimens, lims-core runs assays on them. The analytical layer sits on the same core as the biobank workflow: a worksheet batches orders into an instrument run, the run draws down reagent lots, results are checked against specifications, and a passing run can be released as a certificate. Everything here is audited and versioned like the rest of the system.
Worksheets and runs
Section titled “Worksheets and runs”A worksheet groups analysis orders into a run that moves through
draft → in_progress → completed (ADR-0018). It is the batch an analyst
actually works: the samples on the bench together, the assay they share, and the
reagents they consume.
Reagent consumption
Section titled “Reagent consumption”Recording a run’s reagent use draws from a lot through the append-only inventory consumption ledger, and links the worksheet to the exact ledger row it drew from. That link is the seam between QC and inventory: a result is traceable to the specific reagent lot that produced it, and a lot’s remaining quantity reflects every run that touched it (ADR-0018).
Specifications and calculated results
Section titled “Specifications and calculated results”Results entered on a run are evaluated against each service’s
acceptance criteria and stamped pass,
out_of_spec, or not_evaluated (ADR-0017). Services can also be calculated
— their value derived from other results via a safe server-side expression
(ADR-0020) — so a computed yield or ratio is produced and versioned without
manual arithmetic.
The QC release gate
Section titled “The QC release gate”Release is gated on quality control. A run’s results cannot be released while its QC controls are out of control: the gate keys on the control material and holds the whole run’s results back until QC passes (ADR-0021). This is why QC lives next to the run rather than as a separate afterthought — see quality control for the control samples and Westgard rules behind the verdict.
Certificate of Analysis
Section titled “Certificate of Analysis”Once a sample’s results are complete and released, a Certificate of Analysis can be issued: a point-in-time PDF snapshot of the sample, its results, and their QC status, generated on demand (ADR-0022). The certificate is content-hashed and recorded, so an issued certificate is tied to exactly the results it reported.