Tue, Feb 16, 2021 9:00 AM

Clinical Performance Evaluation

The successful clinical performance evaluation is essential for the EU IVD MD registration, which proves and confirms the efficacy and safety of the PREDYSTIC® Infliximab RA Kit.

Clinical Performance Evaluation

The successful clinical performance evaluation is essential for the EU IVD MD registration, which proves and confirms the efficacy and safety of the PREDYSTIC® Infliximab RA Kit.

Tue, Feb 16, 2021 9:00 AM
Tue, Feb 16, 2021 9:00 AM

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 more information on the PREDYSTIC® Infliximab RA Kit please visit the 1. Personalized Medicine / 1.1. Clinical need / 1.2. Development sections.

For the latest information, visit the Linkedin page of the PREDYSTIC® Infliximab RA Kit.

 

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