{"id":10613,"date":"2025-10-23T22:34:21","date_gmt":"2025-10-23T19:34:21","guid":{"rendered":"https:\/\/medilab.km.ua\/?p=10613"},"modified":"2026-04-20T18:53:34","modified_gmt":"2026-04-20T15:53:34","slug":"laboratory-testing-as-a-basis-for-modern-medicine-from-methodology-to-clinical-significance","status":"publish","type":"post","link":"https:\/\/medilab.km.ua\/en\/laboratory-testing-as-a-basis-for-modern-medicine-from-methodology-to-clinical-significance\/","title":{"rendered":"Laboratory testing as the basis of modern medicine: from methodology to clinical significance"},"content":{"rendered":"<div class=\"kk-star-ratings kksr-auto kksr-align-left kksr-valign-top\"\n    data-payload='{&quot;align&quot;:&quot;left&quot;,&quot;id&quot;:&quot;10613&quot;,&quot;slug&quot;:&quot;default&quot;,&quot;valign&quot;:&quot;top&quot;,&quot;ignore&quot;:&quot;&quot;,&quot;reference&quot;:&quot;auto&quot;,&quot;class&quot;:&quot;&quot;,&quot;count&quot;:&quot;281&quot;,&quot;legendonly&quot;:&quot;&quot;,&quot;readonly&quot;:&quot;&quot;,&quot;score&quot;:&quot;5&quot;,&quot;starsonly&quot;:&quot;&quot;,&quot;best&quot;:&quot;5&quot;,&quot;gap&quot;:&quot;5&quot;,&quot;greet&quot;:&quot;Rate this post&quot;,&quot;legend&quot;:&quot;5\\\/5 - (281 votes)&quot;,&quot;size&quot;:&quot;24&quot;,&quot;title&quot;:&quot;\u041b\u0430\u0431\u043e\u0440\u0430\u0442\u043e\u0440\u043d\u0435 \u0442\u0435\u0441\u0442\u0443\u0432\u0430\u043d\u043d\u044f \u044f\u043a \u043e\u0441\u043d\u043e\u0432\u0430 \u0441\u0443\u0447\u0430\u0441\u043d\u043e\u0457 \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0438: \u0432\u0456\u0434 \u043c\u0435\u0442\u043e\u0434\u043e\u043b\u043e\u0433\u0456\u0457 \u0434\u043e \u043a\u043b\u0456\u043d\u0456\u0447\u043d\u043e\u0457 \u0437\u043d\u0430\u0447\u0443\u0449\u043e\u0441\u0442\u0456&quot;,&quot;width&quot;:&quot;142.5&quot;,&quot;_legend&quot;:&quot;{score}\\\/{best} - ({count} {votes})&quot;,&quot;font_factor&quot;:&quot;1.25&quot;}'>\n            \n<div class=\"kksr-stars\">\n    \n<div class=\"kksr-stars-inactive\">\n            <div class=\"kksr-star\" data-star=\"1\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"2\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"3\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"4\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"5\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n    \n<div class=\"kksr-stars-active\" style=\"width: 142.5px;\">\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n<\/div>\n                \n\n<div class=\"kksr-legend\" style=\"font-size: 19.2px;\">\n            5\/5 - (281 votes)    <\/div>\n    <\/div>\n<h2>Fundamental aspects of laboratory testing: accuracy, validity, and clinical interpretation<\/h2>\n<p>Laboratory testing is a cornerstone of modern diagnostics, as it provides doctors with objective quantitative data about a patient&#039;s health. It is estimated that over <b>70% Clinical Solutions<\/b> are based on the results of laboratory tests. The quality of further treatment and prognosis of diseases depends on the correct choice of method, the accuracy of the test, and the correct interpretation of the result. This material is devoted to an in-depth analysis of the key parameters that ensure the reliability of laboratory data.<\/p>\n<h2>Testing Quality: Preanalytical, Analytical and Postanalytical Stages<\/h2>\n<p>The reliability of any laboratory result depends on strict control at three main stages:<\/p>\n<h4>1. Pre-analytical stage: Basis of reliability<\/h4>\n<p>This is the least controlled stage by the laboratory, but it is critically important. It includes patient preparation, collection of biological material (blood, urine, cerebrospinal fluid, etc.), labeling, storage, and transportation to the laboratory. For example, improper preparation (eating before the glucose tolerance test) or improper storage of the sample (excessive heating) can lead to <b>falsely overestimated or underestimated results<\/b>.<\/p>\n<h4>2. Analytical stage: Method accuracy<\/h4>\n<p>At this stage, the sample is directly analyzed. Standardized methods such as enzyme-linked immunosorbent assay (ELISA) are used.<a href=\"https:\/\/medilab.km.ua\/en\/ifa-analysis-for-infection-accurate-diagnostic-method\/\">ELISA<\/a>), polymerase chain reaction (PCR), mass spectrometry, and flow cytometry. <b>Internal and external quality control<\/b> are mandatory to ensure accuracy (closeness of the measured value to the true value) and precision (repeatability of results) of the equipment.<\/p>\n<h4>3. Post-analytical stage: Interpretation and validation<\/h4>\n<p>This stage includes checking the results, validating them by the laboratory technician, and transmitting them to the clinician. Even a technically correct result can be clinically erroneous if it is not correlated with the patient&#039;s age, gender, medical history, and medication intake.<\/p>\n<h2><img decoding=\"async\" class=\"alignnone size-full wp-image-10615\" src=\"https:\/\/medilab.km.ua\/wp-content\/uploads\/2025\/10\/komp-uternoe-programmnoe-obespecenie-na-fotoelektriceskom-zavode-ispol-zuemoe-dla-optimizacii-proizvodstvennogo-potoka.jpg\" alt=\"ROC curve graph illustrating the sensitivity and specificity of a diagnostic test\" width=\"1200\" height=\"800\" srcset=\"https:\/\/medilab.km.ua\/wp-content\/uploads\/2025\/10\/komp-uternoe-programmnoe-obespecenie-na-fotoelektriceskom-zavode-ispol-zuemoe-dla-optimizacii-proizvodstvennogo-potoka.jpg 1200w, https:\/\/medilab.km.ua\/wp-content\/uploads\/2025\/10\/komp-uternoe-programmnoe-obespecenie-na-fotoelektriceskom-zavode-ispol-zuemoe-dla-optimizacii-proizvodstvennogo-potoka-150x100.jpg 150w, https:\/\/medilab.km.ua\/wp-content\/uploads\/2025\/10\/komp-uternoe-programmnoe-obespecenie-na-fotoelektriceskom-zavode-ispol-zuemoe-dla-optimizacii-proizvodstvennogo-potoka-600x400.jpg 600w, https:\/\/medilab.km.ua\/wp-content\/uploads\/2025\/10\/komp-uternoe-programmnoe-obespecenie-na-fotoelektriceskom-zavode-ispol-zuemoe-dla-optimizacii-proizvodstvennogo-potoka-300x200.jpg 300w, https:\/\/medilab.km.ua\/wp-content\/uploads\/2025\/10\/komp-uternoe-programmnoe-obespecenie-na-fotoelektriceskom-zavode-ispol-zuemoe-dla-optimizacii-proizvodstvennogo-potoka-1024x683.jpg 1024w, https:\/\/medilab.km.ua\/wp-content\/uploads\/2025\/10\/komp-uternoe-programmnoe-obespecenie-na-fotoelektriceskom-zavode-ispol-zuemoe-dla-optimizacii-proizvodstvennogo-potoka-768x512.jpg 768w\" sizes=\"(max-width: 1200px) 100vw, 1200px\" \/><\/h2>\n<h2>Validity and standardization of methods in clinical biochemistry<\/h2>\n<p>To ensure global comparability and reliability, laboratory tests are guided by international standards.<\/p>\n<ul>\n<li><b>Reference ranges:<\/b> These are the ranges of values observed in <b>95% healthy population<\/b>. They depend on the method, equipment and population. Correct interpretation requires the use of reference values established by the specific laboratory where the analysis was performed.<\/li>\n<li><b>Clinical validity:<\/b> This is the degree to which a test accurately measures what it is supposed to measure, given the clinical setting. For example, how accurately a C-reactive protein (CRP) test correlates with the actual inflammatory process.<\/li>\n<li><b>Sensitivity and Specificity:<\/b> Two key parameters that determine the effectiveness of the test.<\/li>\n<\/ul>\n<table>\n<thead>\n<tr>\n<td><strong>Parameter<\/strong><\/td>\n<td><strong>Definition<\/strong><\/td>\n<td><strong>Clinical significance<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><b>Sensitivity<\/b><\/td>\n<td>Test ability <b>correctly identify<\/b> persons who <b>have<\/b> disease (true-positive results).<\/td>\n<td>High sensitivity is important for <b>screening<\/b> \u2014 reduces the number of missed cases (false negatives).<\/td>\n<\/tr>\n<tr>\n<td><b>Specificity<\/b><\/td>\n<td>Test ability <b>correctly identify<\/b> persons who <b>don&#039;t have<\/b> disease (true-negative results).<\/td>\n<td>High specificity is important for <b>confirmation of diagnosis<\/b> \u2014 reduces the number of false alarms (false positives).<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote><p>According to the guidelines <b>FDA (US Food and Drug Administration)<\/b>, medical devices and diagnostic tests are subject to rigorous sensitivity and specificity evaluation before being released to the market to ensure minimal risk of false-positive or false-negative results.<\/p><\/blockquote>\n<h2>Analysis and interpretation of results in clinical practice<\/h2>\n<p>Simply comparing the result with the reference range is not sufficient. Clinical interpretation requires consideration of a number of factors:<\/p>\n<ul>\n<li><b>Biological variation:<\/b> Each indicator has individual biological variation. For example, the level <a href=\"https:\/\/medilab.km.ua\/en\/analysis\/hormonal-panel\/gipotalamo-gipofizarno-nadnyrnykova-systema\/cortisol\/\"><b>cortisol<\/b> <\/a>depends on the time of day (circadian rhythm), and the level <b>creatinine<\/b> \u2014 from muscle mass and diet.<\/li>\n<li><b>Interference:<\/b> The presence of certain substances in the sample (e.g., medications, high bilirubin levels, or lipemia) can interfere with the chemical reactions in the test, leading to distorted results.<\/li>\n<li><b>Comparison with dynamics:<\/b> The most informative is not a single result, but <b>dynamics of change<\/b> indicator over time. If a previously high indicator decreases to the upper limit of normal during treatment, this may indicate a positive response from the body.<\/li>\n<\/ul>\n<p><b>Mayo Clinic<\/b> emphasizes that each laboratory result should be considered as part of a larger clinical picture, not as a diagnosis in itself. A comprehensive approach that includes physical examination, medical history, and laboratory data is key to an accurate diagnosis.<\/p>\n<h2>The future of laboratory diagnostics<\/h2>\n<p>Technological developments, especially in the field of molecular diagnostics (e.g. next-generation sequencing), are opening up new perspectives. This allows us to move from diagnosing an existing disease to <b>personalized and predictive medicine<\/b>. Molecular testing already helps identify genetic predisposition to certain diseases and select targeted therapy (pharmacogenetics), ensuring maximum treatment effectiveness.<\/p>\n<p>Laboratory testing is a high-tech process that requires constant improvement of methodology and strict adherence to international standards, which is guaranteed through quality control systems recommended by organizations such as <b>WHO<\/b> and <b>FDA<\/b>. Ultimately, a reliable laboratory result is a fundamental element in maintaining and restoring a patient&#039;s health.<\/p>\n<h2>Sources<\/h2>\n<ol start=\"1\">\n<li>World Health Organization (WHO). <i>Guidance on regulations for the in vitro diagnosis (IVD) industry<\/i>. 2021.<\/li>\n<li>US Food and Drug Administration (FDA). <i>In Vitro Diagnostics<\/i>. Official guidelines and device classification.<\/li>\n<li>Mayo Clinic Laboratories. <i>Test Ordering and Interpretation Policies<\/i>. Guidelines on preanalytical variables and result validation.<\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>Fundamental Aspects of Laboratory Testing: Accuracy, Validity, and Clinical Interpretation Laboratory testing is the cornerstone of modern diagnostics because it provides physicians with objective<\/p>","protected":false},"author":627,"featured_media":10614,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-10613","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>\u041b\u0430\u0431\u043e\u0440\u0430\u0442\u043e\u0440\u043d\u0435 \u0442\u0435\u0441\u0442\u0443\u0432\u0430\u043d\u043d\u044f: \u0422\u043e\u0447\u043d\u0456\u0441\u0442\u044c, 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Gromashevsky \u2022 2010, 2015, 2021 \u2014 organization and management of healthcare \u2022 2017 \u2014 clinical laboratory diagnostics, Ukrainian Military Medical Academy \u2022 2017 \u2014 clinical biochemistry, Ukrainian Military Medical Academy \u2022 2018 \u2014 clinical immunology, Ukrainian Military Medical Academy \u2022 2025 \u2014 topical issues of modern medicine and pharmacy, Kharkiv Polytechnic Institute Work experience \u2022 1979\u20131982 \u2014 hospital nurse \u2022 1982\u20131986 \u2014 assistant epidemiologist \u2022 1986\u20131987 \u2014 laboratory assistant \u2022 1987\u20132007 \u2014 head of a centralized serological laboratory \u2022 Since 2007 \u2014 director of Medi Lab Plus LLC Key competencies Organization and management of medical laboratories, implementation of modern methods of laboratory diagnostics (PCR, immunological and biochemical studies), quality control of laboratory processes in accordance with state and international standards.","url":"https:\/\/medilab.km.ua\/en\/author\/medilab-an\/"}]}},"_links":{"self":[{"href":"https:\/\/medilab.km.ua\/en\/wp-json\/wp\/v2\/posts\/10613","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medilab.km.ua\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medilab.km.ua\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medilab.km.ua\/en\/wp-json\/wp\/v2\/users\/627"}],"replies":[{"embeddable":true,"href":"https:\/\/medilab.km.ua\/en\/wp-json\/wp\/v2\/comments?post=10613"}],"version-history":[{"count":0,"href":"https:\/\/medilab.km.ua\/en\/wp-json\/wp\/v2\/posts\/10613\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medilab.km.ua\/en\/wp-json\/wp\/v2\/media\/10614"}],"wp:attachment":[{"href":"https:\/\/medilab.km.ua\/en\/wp-json\/wp\/v2\/media?parent=10613"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medilab.km.ua\/en\/wp-json\/wp\/v2\/categories?post=10613"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medilab.km.ua\/en\/wp-json\/wp\/v2\/tags?post=10613"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}