IVDR Analytical Performance Strategy

Analytical evidence must be claim-driven, protocol-defined and traceable to the final PER. We define the study matrix, review protocols before laboratory execution, and verify data integrity against Notified Body expectations.

Plan Your IVDR Analytical Performance Studies

13 Key Analytical Performance Characteristics

Analytical sensitivity & detection limits (LoB, LoD, LoQ)

Analytical specificity & discrimination capability

Trueness / systematic bias against certified reference materials

Precision: Repeatability (within-run) & Reproducibility (between-day/site/operator)

Measuring range, linearity and hook effect determination

Cut-off determination for qualitative and semi-quantitative assays

Interference testing (endogenous substances like bilirubin/hemoglobin & drug metabolites)

Cross-reactivity against phylogenetically related or homologous targets

Carry-over assessment in automated analyzers

Specimen matrix equivalence, collection tube validation and specimen stability

Reagent, calibrator and control in-use, onboard and transport stability

Metrological traceability of calibrator values (ISO 17511)

Lot-to-lot consistency and assay robustness against environmental variations

Protocol Review Questions We Challenge Upfront

1Does the study material / matrix accurately represent true clinical specimens?

2Are lots, operators, testing sites, instruments and days sufficient to challenge reproducibility?

3Are specimen concentrations and edge-of-range samples statistically sound?

4Are tested interferents and potential cross-reactants scientifically justified?

5Is the comparator / reference measurement procedure appropriate?

6Were statistical acceptance criteria predefined and justified prior to testing?

7Are experimental deviations transparently reported with impact evaluations?

8Can the final study report be mapped directly to the GSPR claim and PER?

Laboratory Coordination

Pre-Execution Protocol Vetting

Where external laboratory testing is required, NKB Regovanta coordinates with ISO 17025 accredited facilities, reviews test protocols before bench work begins, and audits final reports to guarantee they directly close the regulatory evidence gap.

Applicable CLSI Guidelines

• EP05-A3: Precision Evaluation

• EP17-A2: LoB, LoD, LoQ Limits

• EP07-A3: Interference Testing

• EP06-A: Linearity & Range

• EP25-A: In-Vitro Stability Testing

Protocol Review

Have our analytical assay experts review your testing protocols prior to running expensive bench runs.

Review Assay Protocol

Execute Flawless Analytical Performance Studies for EU IVDR Clearance

Our assay specialists design protocols, power calculations, and testing matrices that Notified Bodies approve.

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