| 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 |
| Companion Diagnostic (CDx) Study | Establishes biomarker predicts therapeutic response/safety. | PPV/NPV for treatment response, hazard ratio (biomarker+ vs. biomarker- arms) |
| 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 |
| 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 |
