Analytical performance is the ability of an in vitro diagnostic medical device to correctly detect or measure a specific analyte. It describes the quality of the measurement itself and is, alongside scientific validity and clinical performance, an independent component of performance evaluation under the IVDR. <\/p>\n
Depending on the type of test, analytical sensitivity and specificity, trueness, precision, repeatability, reproducibility, linearity, measuring range, limit of detection, and robustness are part of the analytical evaluation. Not every characteristic is equally relevant for every IVD. The manufacturer must justify which characteristics are appropriate for the intended purpose, sample, measurement method, and claimed performance. <\/p>\n
Analytical specificity examines, among other things, whether interfering or cross-reacting substances influence the result. Precision considers the dispersion of repeated measurements under defined conditions. Such characteristics do not provide an abstract quality grade but must be substantiated with predefined acceptance criteria and suitable samples. <\/p>\n
Analytical performance addresses whether the test correctly measures or detects the analyte. Clinical performance, in contrast, concerns the relationship of a test result to the patient’s clinical situation, such as diagnostic sensitivity and specificity in a target population. An analytically sound result is therefore not sufficient as proof of clinical utility. <\/p>\n
The scientific validity of an analyte, in turn, answers a preceding question: Why is this analyte associated with a clinical condition at all? The three levels must not be conflated. A performance evaluation is only conclusive if the analyte reference, measurement quality, and clinical interpretation are each supported by appropriate data. <\/p>\n
Analytical performance studies should reflect the relevant sample matrix, concentration ranges, and usage scenarios. A test may function stably at high analyte concentrations but be unreliable at the clinically critical lower measuring range. Planning must therefore demonstrate why the chosen samples and criteria cover the claimed application. <\/p>\n
For multiple sites, operators, or device configurations, it must be checked whether this variability needs to be part of the evidence. Changes to reagents, software, or calibration may also require a re-evaluation of analytical data. Results must be reported in a way that the measurement method, evaluation, and deviations remain comprehensible for the performance evaluation. <\/p>\n
Analytical planning distinguishes between errors of the measurement method and errors before or after measurement. Hemolysis, improper storage, or unsuitable sample collection can influence a result, even if the device is technically working correctly. To the extent that these factors can occur in the intended application, the performance evaluation must consider their effects. Otherwise, the evidence would be limited to ideal laboratory conditions. <\/p>\n
Acceptance criteria should be medically and technically justified. A small measurement deviation may be inconsequential for one analyte but significant for a clinical decision threshold. Therefore, it must be explained why an acceptable error does not jeopardize the intended purpose. In this way, analytical performance links measurement statistics with the application of the specific IVD. <\/p>\n
For qualitative tests, the presentation differs from quantitative measurement methods. Here, agreement, limit of detection, and cross-reactions may be central, while linearity or measuring range are less relevant. The performance study must therefore not schematically list all possible key figures but must justify the characteristics that are meaningful for the test type. <\/p>\n
The measuring range must correspond to the concentrations at which the result is used clinically or diagnostically. If a medically relevant value lies at the edge of the validated range, the indication of a formally present measuring range may be insufficient. The analytical study should therefore show how the test reacts precisely in the critical range. <\/p>\n
For multi-parameter procedures, it must also be checked whether one channel or analyte influences the result of another. Such interactions may remain hidden during individual measurements but impair the performance of the intended overall system. Planning must take this specificity of the particular procedure into account. <\/p>\n
In a performance study, the analytical question determines which reference method, number of samples, and statistical key figures are required. For a detection test, different aspects are paramount than for a quantitative procedure with a measuring range and linearity. If samples from multiple centers are used, pre-analytics, transport, and storage must be controlled, as they can falsify the measured performance. <\/p>\n
Full-service CROs like Mediconomics provide support in developing analytical study plans, organizing sample logistics and data management, defining statistical evaluations, and preparing results for performance evaluation.<\/p>\n
Is analytical sensitivity the same as clinical sensitivity?<\/strong><\/p>\n No. Analytical sensitivity refers to the test’s measurement capability, while clinical sensitivity refers to the detection of a clinical condition in the target population. <\/p>\n Why are interferences important for analytical performance?<\/strong><\/p>\n They can falsify a test result and must therefore be investigated for the relevant sample matrix and intended application.<\/p>\n Can an IVD be sufficiently substantiated analytically without clinical performance data?<\/strong><\/p>\n Analytical performance can be investigated independently; whether further clinical performance data are required depends on the intended purpose and performance evaluation.<\/p>\n Analytical performance is the ability of an in vitro diagnostic medical device to correctly detect or measure a specific analyte. It describes the quality of the measurement itself and is, alongside scientific validity and clinical performance, an independent component of performance evaluation under the IVDR. Measurement Characteristics of the IVD Depending on the type of […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[24],"class_list":["post-7840","glossary","type-glossary","status-publish","hentry","glossary-cat-medizinprodukte-ivd"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7840","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7840\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7840"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7840"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
\n