Clinical Study Types
| Study Type | Definition | Typical Parameters |
|---|---|---|
| Point of Care (POC) | A clinical performance study conducted in the actual near-patient care setting where the test is intended to be used evaluating how the assay performs under real-world conditions, operators, and workflows representative of its intended use environment. | Sensitivity/specificity/PPV/NPV in the POC setting vs. central lab reference method; turnaround time (sample-to-result); operator type (nurse, MA, lay user, pharmacist); % invalid/error results; agreement between POC result and lab-based comparator; usability/ease-of-use metrics; environmental variability (temperature, humidity, altitude) at POC sites |
| CLIA Waiver | Demonstrates the test is simple to use and has an insignificant risk of erroneous results when performed by untrained/minimally trained operators in real-world POC settings | Overall/positive/negative percent agreement vs. comparator method; error rate by untrained users; usability/readability scores |
| Companion Diagnostics (CDx) Study | Establishes biomarker predicts therapeutic response/safety. | PPV/NPV for treatment response, hazard ratio (biomarker+ vs. biomarker- arms) |
| Human Factors Study | Evaluation of a device interface, labeling, packaging, and instructions for use to assure intended users can use it safely and effectively under actual conditions of use. Demonstrate that use errors which could cause clinically significant harm have been eliminated or mitigated to an acceptable level. | Independent variables include the user group tested (age, literacy, visual/motor ability, prior experience, language), the device lot and IFU version, the simulated use environment (lighting, noise, home vs. clinical setting), and the training condition (untrained “cold” IFU use versus trained use). Dependent variables include quantitative measures of task success/failure, number and type of use errors, close calls (self-corrected errors), task completion time, number of attempts/retries, error rate per step, and result-reading accuracy. |
Clinical Performance Study Types
| Study Type | Definition | Typical Parameters |
|---|---|---|
| Clinical/Diagnostic Accuracy Study | Compares IVD result against a reference standard to establish diagnostic performance. | Sensitivity, specificity, PPV, NPV, likelihood ratios, ROC/AUC |
| Clinical Validation Study | Establishes association between analyte/biomarker and clinical condition. | Correlation coefficients, odds ratios, hazard ratios, biomarker cutoff performance |
| Clinical Utility Study | Demonstrates test use improves outcomes/management decisions. | Change in treatment decisions, outcome rates (survival, response rate), cost-effectiveness measures |
| Method Comparison Study | Compares new IVD to legacy/predicate device. | Percent agreement (overall, positive, negative), Cohen’s Kappa, Bland-Altman/Deming regression |
| Concordance Study | Assesses agreement with an established gold standard. | Overall/positive/negative percent agreement, Kappa statistic |
Analytical Study Types
| Study Type | Definition | Typical Parameters |
|---|---|---|
| Reproducibility (Analytical) | Variation across multiple sites/labs/instruments. | Between-site %CV, total reproducibility SD |
| Linearity Study | Confirms proportional response across range. | Polynomial regression, deviation from linearity, %CV |
| Limit of Blank (LoB) | Lowest signal from a blank sample. | 95th percentile of blank replicate results |
| Limit of Detection (LoD) | Lowest concentration distinguishable from blank. | LoD calculated from LoB + SD of low-concentration samples |
| Limit of Quantitation (LoQ) | Lowest concentration measured with acceptable precision/accuracy. | Total error, %CV at defined acceptability threshold |
| Interference Study | Effect of endogenous/exogenous substances on results. | % Bias/interference at defined concentration of interferent |
| Cross-Reactivity Study | Related substances/pathogens causing false signals. | % Cross-reactivity, false-positive rate |
| Matrix Comparison/Specimen Equivalency | Performance across specimen types. | Correlation/bias between specimen types (e.g., serum vs. plasma) |
| Sample Stability Study | Specimen integrity under storage/transport conditions. | % Recovery/bias over time, freeze-thaw cycle limits |
| Analytical Measurement Range (AMR) | Range of accurate results without dilution. | Linear range boundaries, recovery % at range extremes |
| Carryover/Cross-Contamination Study | No contamination between sequential samples. | % Carryover between high-then-low sample sequences |
| Traceability Study | Traceability to reference standard. | Bias vs. certified reference material/international standard |
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