IVD Analytical Performance Scoping
Compare precision, measuring range, interference and method-comparison evidence against the actual assay format and intended-use claims—not an automatic checklist.
Quantitative and qualitative assays differ
For quantitative outputs, consider repeatability and reproducibility across days, operators, instruments and lots; limit of blank, detection and quantitation where appropriate; linearity, measuring range and dilution behavior. Qualitative assays may instead need detection probability, cutoff behavior and precision near the decision threshold. Acceptance criteria must be justified for the specific clinical or research decision.
Interference and comparison
Potential endogenous/exogenous interference, cross-reactivity, carryover and matrix effects depend on analyte, assay chemistry and intended specimens. Compare candidate and reference methods using suitable specimens across the range and near decision boundaries. Correlation alone does not establish agreement or clinical performance; document bias, uncertainty and discordant results.
Software and data integrity
When software influences result processing or interpretation, identify versions, algorithms, units, thresholds and interfaces. Scope verification, traceable raw data, access control, change history, reproducible analysis and deviation review with qualified providers. FDA device-software guidance applies according to the software's intended device function, not simply because a spreadsheet is used.
What to include in your request
Start with the intended decision and available evidence.
- Intended use, research-only versus clinical purpose, biomarker/analyte and decision to support; disclose confidential identities only in private follow-up.
- Assay format, instrument/software versions, qualitative/quantitative output, specimen matrix, collection container, handling and storage conditions.
- Available reference materials, reagent/calibrator lots, candidate/comparator method, target range or decision threshold and existing evidence.
- Proposed claims, report and study design, sample availability, ethics/consent requirements, budget, location and milestones; ask the provider to propose justified methods.
Laboratories with relevant capabilities
No directory profile currently documents this specific capability. Submit a request and we will look for laboratories that cover it.
Sources and scope references
FDA — IVD labeling and performance information
FDA — influenza IVD performance guidance (product-specific example, not universal)
Related testing briefs
B2B molecular assay development
Confirm standard edition, jurisdiction and actual laboratory scope. Service references are not partnerships or endorsements.