In case of a device such as the innovative PREDYSTIC® Infliximab RA Kit, the clinical study is the base of the clinical performance evaluation. Egis conducted an international multicentric clinical study with the enrollment of 217 bio-naïve rheumatoid arthritis patients.
For the clinicians, clinical performance characteristics are crucial references especially for a complementary diagnostic such as the PREDYSTIC® Infliximab RA Kit.
In addition to specificity and sensitivity, the test even predicts the Disease Activity Score (DAS28 CRP) for the 6th month of the treatment.
The PREDYSTIC® Infliximab RA Kit has the following clinical performance characteristics:
- Specificity = 94%
- Sensitivity = 79%
- ROC-AUC = 86%
- PPV (Positive Predictive Value) = 87%
- NPV (Negative Predictive Value) = 89%
- The error of the prediction for the 6th month of the treatment in Disease Activity Score (DAS28-CRP) is ± 0.77
For the latest information, visit the Linkedin page of the PREDYSTIC® Infliximab RA Kit.