Uncertainty of Measurement in Medical Laboratories

Pereira, Paulo

doi:10.5772/62437

Cited by 7 publications

(8 citation statements)

References 24 publications

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“…This document examines the practical experience in assessing the uncertainty of measurement in chemical laboratories, and emphasizes the need to integrate procedures that assess the uncertainty of measurement with measurements of existing quality control carried out in laboratories. In this way, the validation of the method in the MU assessment was clearly enabled, and in full compliance with the GUM document, which enabled the empirical approach or the top-down model of the MU assessment in the routine medical laboratories (9).…”

Section: Models For Calculating the Measurement Uncertainty Of The Rementioning

confidence: 95%

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Uncertainty of Measurement in Laboratory Medicine

Milinković

Ignjatović

Šumarac

et al. 2018

Journal of Medical Biochemistry

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SummaryAn adequate assessment of the measurement uncertainty in a laboratory medicine is one of the most important factors for a reliable interpretation of the results. A large number of standards and guidelines indicate the need for a proper assessment of the uncertainty of measurement results in routine laboratory practice. The available documents generally recommend participation in the proficiency schemes/ external quality control, as well as the internal quality control, in order to primarily verify the quality performance of the method. Although all documents meet the requirements of the International Standard, ISO 15189, the standard itself does not clearly define the method by which the measurement results need to be assessed and there is no harmonization in practice regarding to this. Also, the uncertainty of measurement results is the data relating to the measured result itself, but all factors that influence the interpretation of the measured value, which is ultimately used for diagnosis and monitoring of the patient's treatment, should be taken into account. So in laboratory medicine, an appropriate assessment of the uncertainty of the measurement results should have the ultimate goal of reducing diagnostic uncertainty. However, good professional laboratory practice and understanding analytical aspects of the test for each individual laboratory is necessary to adequately define the uncertainty of measurement results for specific laboratory tests, which helps to implement good clinical practice. Also, setting diagnoses in medicine is a decision with a certain degree of uncertainty, rather than statistically and mathematically calculated conclusion.

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Section: Models For Calculating the Measurement Uncertainty Of The Rementioning

confidence: 95%

“…factors leading to the final MU, i.e. has a very large budget of uncertainty (a list of factors leading to MU) (9). It is necessary to define a large number of variations and covariances and use complex mathematical modeling, so it is not suitable for use in routine laboratory medicine.…”

Section: Models For Calculating the Measurement Uncertainty Of The Rementioning

confidence: 99%

Uncertainty of Measurement in Laboratory Medicine

Milinković

Ignjatović

Šumarac

et al. 2018

Journal of Medical Biochemistry

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“…Компоненты неопределенности на аналитическом этапе: -ошибки калибровки; -случайные и систематические ошибки из-за деградации реагента или плохого обслуживания прибора и аналитической вариабельности; -эффекты окружающей среды на аналитические процессы (например, высокая температура в помещении или прямой солнечный свет); -субъективные ошибки, включая ошибки манипуляции с образцами; -инструментальная погрешность в точке принятия решения; -ошибки приписанных значений калибраторов; -аппроксимации, включенные в измерения [3].…”

Section: значение неопределенности измерений (ни) в практике клинико-unclassified

“…Расчет является результатом применения статистических методов, учитывающих все эти компоненты. Как правило, такие расчеты недоступны для медицинских лабораторий и используются в референсных лабораториях для моделирования неопределенности внедряемой методики [3,6].…”

Section: описание референсного метода оценки ниunclassified

The implementation of 'measurement uncertainty' concept to clinical diagnostics lab practice according to the requirements of GOST ISO 15189 - 2015

Kolupaev¹

2019

Lab. sluzh.

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РЕЗЮМЕ В настоящее время все большее число российских лабораторий проявляет интерес к организации своих процессов в соответствии с международным стандартом качества и компетентности ИСО 15189. Даже если лаборатория не готова внедрить все требования стандарта, рекомендации этого документа являются полезным руководством по улучшению качества результатов и одновременно способом показать, что лабораторные процессы управляемы и не приводят к увеличению риска диагностической ошибки. Менеджмент риска на стадии выдачи результатов лечащему врачу во многом связан с внедрением концепции «неопределенности измерений» (НИ). В настоящей статье кратко изложен современный взгляд на практическую роль НИ в интерпретации полученных результатов, постановке диагноза, а также менеджменте качества лаборатории. Ключевые слова: менеджмент качества, неопределенность измерений.

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“…[6]). The determination of measurement uncertainty is demonstrated uniquely in ordinal diagnostic tests [25,26]. In such cases, this terminology could be adapted to "measurement uncertainty of binary results."…”

Section: General Conceptmentioning

confidence: 99%

Evaluation of Rapid Diagnostic Test Performance

Pereira¹

2016

Proof and Concepts in Rapid Diagnostic Tests and Technologies

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Rapid diagnostic tests are used for the determination of binary qualitative results not only uniquely in nonhospital-based but also in hospital-based tests. Principally, in developing countries, rapid diagnostic tests are the primary option since tests to be used in medical laboratories are discarded due to the higher cost. The test's performance is evaluated to assure that the chance of results to be false is clinically acceptable. Therefore, the diagnostic accuracy of results diagnostic sensitivity and specificity is assessed to guarantee the safety of postclinical decision. The statistical approach requires that representative samplings of the populations of infected and healthy individuals are tested. The area under the receiver-operating characteristic ROC curve is a complementary measurement using the same samplings. It represents the diagnostic accuracy in a single outcome. When samplings with known diagnostics are unavailable, samplings with known outcomes from a comparative test are used to determine the agreement of results. However, this approach is secondary, due to diagnostic accuracy to be unmeasurable. The seronegative period is another critical measurement that allows determining an individual biological bias during a period where results of an infected individual are false-negatives due to seroconversion. The claimed requirements should be defined for diagnostic accuracy and agreement outcomes. " spreadsheet is used to estimate the results considering the absolute value and the % confidence interval.

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Uncertainty of Measurement in Medical Laboratories

Cited by 7 publications

References 24 publications

Uncertainty of Measurement in Laboratory Medicine

Uncertainty of Measurement in Laboratory Medicine

The implementation of 'measurement uncertainty' concept to clinical diagnostics lab practice according to the requirements of GOST ISO 15189 - 2015

Evaluation of Rapid Diagnostic Test Performance

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