Analytical performance for in-vitro diagnostic device is one of the main factor that need to be taken in consideration before placing an IVD device on the market. According to IVDR 2017/746, the overall performance of In-Vitro Diagnostic Device shall be demonstrated by 3 different factors:
- Scientific Validity
- Analytical Performance
- Clinical Performance
We have already been discussing about IVDR 2017/746 and the main requirements associated to this new European regulation, by handling specific topics such as classification of IVD devices, stability evaluation and labelling for IVD devices. Moreover, we have also been discussing about the Performance Evaluation Plan and the related requirements mentioned within Annex XIII of EU IVDR.
In this article we will discuss in details about a specific topic related to performance evaluation that is the Analytical Performance.
What is Analytical Performance?
Based on Article 2 of IVDR 2017/746, analytical performance is defined as follows:
‘analytical performance’ means the ability of a device to correctly detect or measure a particular analyte
The definition turns out to be rather clear and it is related to the ability of the IVD device to decect or measure a specific analyte. Specifically, the analytical performance focuses on the gathering of evidence that the IVD in question reliably, accurately and consistently measures and/or detects an analyte(s); this includes the detection (thus qualitative output) and the measurement of the analyte (thus quantitative output).
As clearly reported within MDCG 2022-02 – Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) – the analytical performance should always be demonstrated on the basis of analytical performance studies. It is possible to use data from published documentation based on routine diagnostic testing, however this data may be used only as supportive evidence of analytical performance.
It is also very important that the manufacturer verifies that all different specimen types and specimen sampling conditions that are indicated in the IVD’s intended purpose are assessed and demonstrated; so if different specimen types are taken in consideration (e.g. blood, saliva etc), the analytical performance shall be demonstrated for all these specimen types. Specimen collection, storage and transport conditions shall also be included in these verification activities and shall be considered part of the analytical performance study.
What is included in the concept of Analytical Performance
The concept of analytical performance includes different parameters that have to be taken in consideration in the context to ensure quality safety and efficacy of an IVD device. The main parameters included in the concept of analytical performance can be summarised in the table below:
| Concept | Definition/Comments |
|---|---|
| Analytical sensitivity | Analytical sensitivity is defined as the limit of detection, i.e., the smallest amount of the device target that can be accurately detected. |
| Accuracy | Resulting from trueness and precision |
| Trueness (bias) | The closeness of agreement between the measured value and the expected value. |
| Analytical specificity | Analytical specificity describes the extent to which the testing method measures only what it intends to measure. |
| Precision (repeatability and reproducibility) | Agreement between the different independent measurement results of a sample in a measurement series or between different measurement series (various factors such as user, device, reagent batch, etc. may vary). |
| Measuring range | Is defined by the LOQ and the linearity |
| Linearity | Represents the proportional relationship between concentration and measurement signal. |
| Limits of quantification | The lower limit of quantification (LLOQ) is the smallest determinable quantitative value that can be determined with an acceptable level of accuracy and precision. |
| Limits of detection | The limit of detection (LOD) is the smallest value that can be detected by this method. |
| Cut off | The cut-off value divides the range of measured values into test positives and test negatives. |
Correlation between Scientific Validity, Analytical Performance and Clinical Performance
As we know from the iVDR 2017/746 and related MDCG guideline, such as for example MDCG 2022-02 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs), clinical evidence for IVD is related to the collection of data as a result of a performance evaluation study. This performance evaluation is evaluated through analysis of data related to :
- scientific validity,
- analytical performance
- clinical performance
The scientific validity is defined as the extent to which the analyte, or marker to be determined by the IVD is associated with the targeted physiological state or clinical condition; whereas the clinical performance is demonstration of an IVD’s ability to yield results that are correlated with a particular clinical condition or a physiological/pathological process or state in accordance with the target population and intended user.
So as you can see, the clinical evaluation of an IVD is basically made by these three pillars and they are all essential to come up with a appropriate and solid clinical evidence.
Performance Evaluation Plan Template
QualityMeddev has made available a Performance Evaluation Plan Template, fully aligned with the requirements set in Annex XIII ofEU IVDR 2017/746. This is a 14-pages word document, fully editable, with a lot of comments and suggestions on how to properly amend the template in order to include the data related to your device and adequately fulfil the requirements of the EU IVDR.
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