Performance Evaluation for Diagnostics-old

Performance Evaluation for Diagnostics

In order to put an IVD on the market or into operation, the basic safety and performance requirements relevant to the product must be fulfilled. To prove that the requirements have been fulfilled, a performance evaluation must be carried out.

The performance evaluation that precedes the launch of a product is based on three pillars:

Because of our decade-long experience with in-vitro diagnostics, we can support manufacturers with a very extensive repertoire of products and services in the performance evaluation and in obtaining IVDR conformity for their products.

Do you have any further questions about how scientific validity, analytical performance and clinical performance interact with each other? Would you like to find out more about how these three points are included in the performance evaluation and how BIOMEX can support you with the performance evaluations?

Please contact us for further support:

Scientific Validity

Before a product is launched on the market, scientific validity represents one of the three pillars of performance evaluation (PE). But even after market launch, it is also relevant within the context of Post-Market-Surveillance (PMS). By definition, the scientific validity of an analyte describes the confirmation of an association between an analyte and a specific clinical or physiological condition.

BIOMEX supports manufacturers in confirming scientific validity as well as in the

  • Performance evaluation before market launch (Pre-Market)

  • Post-Market-Surveillance (PMS) after market launch

Scientific validity in the PE before market launch (pre-market)

According to Annex XIII of the IVDR, manufacturers must demonstrate scientific validity using one of the following sources or combinations of these sources:

  • Relevant information on the scientific validity of products for which the same analyte or marker is measured

  • Scientific literature (which has been peer-reviewed)

  • Consistent expert appraisals/expert statements from relevant specialist organizations

  • Results from studies to prove the principle of action

  • Results from clinical performance studies

Scientific validity in Post-Market-Surveillance (PMS)

Your product is on the market, now what?

After it has been launched on the market, manufacturers must be able to guarantee the performance and safety of their products over their entire product life cycle. In accordance with Annex XIII Part B, this is done as part of a follow-up surveillance, whereby the performance evaluation and the associated documents are proactively updated in a continuous process throughout the entire product life cycle.

BIOMEX would be happy to support you in the PMS process, for example with targeted literature searches on investigations into known risks relating to your product. You can also use our additional services for implementing the IVDR (Link). We are your 360° partner!

Please contact us for further support:

Analytical Performance

“Analytical performance” refers to the ability of a product to correctly detect or measure a particular analyte. For this purpose, analytical performance studies must be carried out as a matter of course.

BIOMEX offers confirmation of the parameters listed in Annex I, Chapter II, Paragraph 9.1 a) IVDR for your projects:

Analytical sensitivity can be defined as the detection limit at which the smallest amount of the target marker that can be precisely detected is measured. BIOMEX would be happy to take on the determination of the detection and quantification limits (LoD, LoB, LoQ), the linearity and the measuring range (defined by LoQ and linearity).

The analytical specificity describes the extent to which only the target marker can be detected exclusively with the procedure. Interference and cross-reaction studies are used to check how the presence of other substances/active ingredients in the sample can affect the analytical specificity. Cross-reactants may be in the form of analytes with similar structures, such as precursors, metabolites or related organisms. In contrast, interferences are endogenous (hemolytic, lipemic, icteric, RF +, HAMA).

BIOMEX assays tests for parameters of analytical specificity using panels it has produced itself.

Stability tests are used to check how a diagnostic/pharmaceutical product changes under certain conditions (temperature, humidity, light, storage conditions, freeze-thaw process, matrices ...) over a certain period of time.

BIOMEX plans and implements stability studies for assays and samples, taking into account the EP25 guidelines of the Clinical and Laboratory Standards Institute (CLSI) and the stability aspects listed in Annex II, Section 6.3 of the IVDR, such as the shelf life of the product, the shelf life (e.g. of the reagents) after opening, the transport stability and storage conditions.

BIOMEX also provides services for determining and checking calibration stability, onboard stability, as well as module and device precision.

Trueness describes the level of consistency between the mean value of a series of measurements and the reference value. If the mean value of the measurement series agrees well with the reference value, the trueness is high. For trueness measurements with both quantitative and qualitative tests, BIOMEX uses certified reference material or a certified reference method.

Precision is defined as the level of agreement between individual, independent measurement results in a measurement series. It characterizes the scattering of the measurement results around the mean value and can be represented by the (relative) standard deviation. The measurement method is precise when the individual measurement results are close together.

With precision, a distinction is made on the one hand between repeatability, which refers to measurements of the same parameter under constant measurement conditions  (e.g. the same test specimen, the same tester, the same measuring equipment, the same place or time), and on the other reproducibility, which refers to measurements of the same parameter under changed measurement conditions (e.g. several devices of the same type, different testers, different place or time).

The accuracy is a measure of the agreement between the (individual) measurement result and the reference value. A high level of accuracy is fulfilled when both the precision and the trueness are high.

BIOMEX supports manufacturers in determining analytical performance - and much more!

  • Limits of detection and quantitation

  • Measuring range

  • Linearity

  • Cut off

How can we help you with the realization of your projects? 

Clinical Performance

Clinical performance is the third pillar of performance evaluation and describes the ability of a test to provide results that correlate with a specific clinical condition or a physiological or pathological process or condition.

Demonstration of clinical performance can be provided from one or a combination of the following sources:

  • Studies on clinical performance

  • The scientific literature

  • Published experience from routine diagnostic tests

Together with data on scientific validity and analytical performance, the data on clinical performance flows into the clinical performance evaluation. Here, too, BIOMEX has the appropriate know-how and supports manufacturers in carrying out clinical performance evaluation studies.

BIOMEX is happy to support IVD manufacturers in providing confirmation of clinical performance in the following areas:

  • Performance Evaluations acc. to ISO 20916, Common Specifications (CS) and relevant CLSI Guidelines

  • Near-Patient Testing (NPT)

  • Layman studies

Common Specifications (CS)

The CS (Common Specifications) provide IVD manufacturers with defined criteria and procedures for assessing the conformity of their products.

In-vitro diagnostics from Class D, C, and possibly also B are tested for the following parameters as part of the clinical performance assessment before market launch (pre-market), taking into account the CS and the CLSI Guideline EP24-A2 and EP28-A3c:

  • Diagnostic sensitivity

    This describes the probability that the product will produce a positive result if the target marker is present.

  • Diagnostic specificity

    This describes the probability that the product will produce a negative result if the target marker is absent.

  • Positive/negative predictive value

    This describes the ability of a product to separate true positive/negative results from false positive / negative results for a certain attribute in a certain population.

  • Likelihood ratio (LR)

    The LR indicates how the result of a diagnostic test affects the probability of a disease being present.

  • Expected values

    in affected and unaffected population groups.

BIOMEX has many years of experience in validating IVDs in accordance with the current CS and supports manufacturers, for example, by providing the necessary reference samples and analysis data. As an option, we can also carry out the entire implementation of a clinical performance evaluation study, from project planning, defining the study design, to monitoring and evaluating the results, so that the prescribed evidence level of the study can be guaranteed right from the start.

Near-Patient Testing (NPT)

A “device for near-patient testing” is defined in Article 2 No. 6 of the IVDR as “any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a healthcare professional”.

By using it outside of the traditional clinical laboratory, for example, a shortened Turn-around-Time can improve patient care and at the same time save costs. For the approval of a device intended for NPT, in addition to the conformity assessment compliant with the applicable procedure listed in Annexes IX to XI IVDR, the manufacturer must also follow the procedure for assessing the technical documentation specified in Annex IX, Section 5.1.

The unique infrastructure of BIOMEX makes it possible to support manufacturers in the conformity assessment of their IVDs for near-patient testing in a 360° approach.

Layman Studies

IVD devices that can be used by laypeople in the household environment according to the intended purpose specified by the manufacturer (devices for personal use), undergo a conformity assessment procedure with the participation of notified bodies, which, among other things, monitor compliance with the common specifications. These prescribe additional lay studies for the purposes of rapid tests, e.g. for HIV or SARS-CoV-2. Why?

Tests for self-use must be produced in such a way that the device (including instructions for use, labeling, etc.) is sufficiently usable in terms of performance and safety for self-use by a layperson, and the quality of the results can be ensured under these conditions of use. This encompasses the entire application of the test and also includes the consideration of suitable and reliable sampling and result presentation and is checked as part of a layman (=self-test) study.

BIOMEX has already supported several manufacturers in the validation of their SARS-CoV-2 antigen rapid tests and has the required know-how and the corresponding infrastructure to implement layman studies in a timely manner.

Our Experts for Diagnostics

We solve problems for our customers that go far beyond the mere supply of products. We procure clinical samples worldwide, such as dengue fever and chikungunya samples from freshly infected people in Africa, all the HIV subtypes and also progressive samples from Lyme disease patients.

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