Abstract：
:Although the measures to improve quality in the clinical laboratory have been enormous in the past years, not least of all due to the introduction of the ISO standards 15189 and 17025, the handling of validation and verification of method performance often still differs widely from laboratory to laboratory. Much of what is published on the topic contains complex statistics and is difficult to implement in routine laboratories. The result is, that this point is often neglected or implemented incorrectly, which in turn can lead to false conclusions about method performances, potentially compromising patient safety or contributing to incorrect diagnoses. As it has long become a standard requirement for accredited laboratories to evaluate and document the analytical performance of all methods not only prior to their first implementation, but also during ongoing operation, there is a need for clear, standardized and practical guidelines on the subject. This review summarizes the current literature on the topic, focusing on the requirements for method validations, or as the case may be, verifications and describes when to validate, when to verify and which statistical tests are appropriate for each. Proper interpretation of statistical test results and acceptance criteria for each procedure are alluded to. Specific topics, which are addressed, are precision and bias verification of quantitative, qualitative and semi-quantitative procedures, method comparisons with Bland-Altman Plots, Passing-Bablok regression analysis, 2×2 contingency tables and bubble charts, linearity studies, analytical sensitivity and specificity, performing carry-over studies and establishing and confirming reference ranges.
journal_name
Adv Clin Chemjournal_title
Advances in clinical chemistryauthors
Pum Jdoi
10.1016/bs.acc.2019.01.006subject
Has Abstractpub_date
2019-01-01 00:00:00pages
215-281eissn
0065-2423issn
2162-9471pii
S0065-2423(19)30006-Xjournal_volume
90pub_type
杂志文章,评审abstract：:Multidrug resistance represents a major obstacle in the successful therapy of neoplastic diseases. Studies have demonstrated that this form of drug resistance occurs in cultured tumor cell lines as well as in human cancers. P-glycoprotein appears to play an important role in such cells by acting as an energy-dependent...
journal_title：Advances in clinical chemistry
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journal_title：Advances in clinical chemistry
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journal_title：Advances in clinical chemistry
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doi：10.1016/bs.acc.2017.01.006
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journal_title：Advances in clinical chemistry
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journal_title：Advances in clinical chemistry
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journal_title：Advances in clinical chemistry
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journal_title：Advances in clinical chemistry
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journal_title：Advances in clinical chemistry
pub_type： 杂志文章,评审
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journal_title：Advances in clinical chemistry
pub_type： 杂志文章,评审
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journal_title：Advances in clinical chemistry
pub_type： 杂志文章,评审
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journal_title：Advances in clinical chemistry
pub_type： 杂志文章,评审
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journal_title：Advances in clinical chemistry
pub_type： 杂志文章,评审
doi：10.1016/bs.acc.2018.07.004
更新日期：2018-01-01 00:00:00
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journal_title：Advances in clinical chemistry
pub_type： 杂志文章,评审
doi：10.1016/b978-0-12-394317-0.00012-1
更新日期：2012-01-01 00:00:00
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journal_title：Advances in clinical chemistry
pub_type： 杂志文章,评审
doi：10.1016/bs.acc.2019.07.004
更新日期：2019-01-01 00:00:00
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journal_title：Advances in clinical chemistry
pub_type： 杂志文章,评审
doi：10.1016/b978-0-12-801401-1.00007-4
更新日期：2014-01-01 00:00:00
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journal_title：Advances in clinical chemistry
pub_type： 杂志文章,评审
doi：10.1016/bs.acc.2017.06.002
更新日期：2017-01-01 00:00:00
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journal_title：Advances in clinical chemistry
pub_type： 杂志文章,评审
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journal_title：Advances in clinical chemistry
pub_type： 杂志文章,评审
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journal_title：Advances in clinical chemistry
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journal_title：Advances in clinical chemistry
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doi：10.1016/bs.acc.2018.12.006
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journal_title：Advances in clinical chemistry
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journal_title：Advances in clinical chemistry
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journal_title：Advances in clinical chemistry
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journal_title：Advances in clinical chemistry
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journal_title：Advances in clinical chemistry
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journal_title：Advances in clinical chemistry
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abstract：:Metabolomics is the quantitative analysis of a large number of low molecular weight metabolites that are intermediate or final products of all the metabolic pathways in a living organism. Any metabolic profiles detectable in a human biological fluid are caused by the interaction between gene expression and the environ...
journal_title：Advances in clinical chemistry
pub_type： 杂志文章,评审
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abstract：:During winter hibernation, small mammals fall into long periods of deep cold torpor where metabolic rate is suppressed by > 90% and core body temperature can fall to near 0 degrees C. Studies with hibernators illustrate the molecular regulatory mechanisms that coordinate the suppression of metabolic functions during t...
journal_title：Advances in clinical chemistry
pub_type： 杂志文章,评审
doi：
更新日期：2010-01-01 00:00:00
