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We perform pre-clinical testing multiple facilities that operate to the latest Clinical and Laboratory Standards Institute (CLSI) guidelines.
The characteristics of your in vitro diagnostic (IVD) will be measured against prespecified performance criteria. Our team will use automated instrumentation, advanced IT platforms and standardized procedures to ensure accuracy, precision and reproducibility in support of the medical decision point under study.
What do these criteria entail?
- Precision: Repeatability validation, reproducibility
- Trueness: Reference measurement procedure or comparator (qualitative, quantitative, semi-quantitative assays); inclusivity and recovery (as appropriate)
- Linearity
- Sensitivity (blank, detection and quantitation limit analysis)
- Specificity (interfaces with exogenous and endogenous substances, cross-reactivity and mixed measurands for multiplex assays)
- Traceability
- Analytical, extended and Hook effect measuring interval
- Carryover effect and cross-contamination
- Reference interval and expected values
- Matrix equivalence (as required)
- Stability testing (reagents, controls, calibrators and sample stability)
- Flex (stress) studies for CUA waivers
Secure with these results, your IVD can then move on to clinical validation studies.
