What is novel about certified reference materials?

Wise, Stephen A.

doi:10.1007/s00216-018-0916-y

Cited by 21 publications

(10 citation statements)

References 20 publications

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“…Considering the variability of the serum results across the seven assays, we then used CRMs to investigate comparability based on certified values. As a primary reference material of lyophilized human insulin in buffer that is used to calibrate and validate measurement procedures, the employed CRMs are adept materials to compare the measurement results of different assays 26 . Although CRMs should ideally be commutable across different methods, for which the matrix is the major factor, presently there is no clear statement about commutability for immunoassay‐based analysis in currently available CRMs of human insulin.…”

Section: Resultsmentioning

confidence: 99%

“…As a primary reference material of lyophilized human insulin in buffer that is used to calibrate and validate measurement procedures, the employed CRMs are adept materials to compare the measurement results of different assays. 26 Although CRMs should ideally be commutable across different methods, for which the matrix is the major factor, presently there is no clear statement about commutability for immunoassay-based analysis in currently available CRMs of human insulin. Moreover, there is a significant gap in the concentration ranges between the typical clinical range and the studied CRMs, namely <150 pmol/L compared to >13.4 μmol/L, respectively, which means that repeated dilutions with increments of uncertainty and untraceable loss prevent any meaningful insight into comparability.…”

Section: Matrix Effectmentioning

confidence: 99%

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Measurement comparability of insulin assays using conventional immunoassay kits

Rosli

Kwon

Lim

et al. 2022

Clinical Laboratory Analysis

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Immunoassays are analytical methods that achieve the detection and quantification of analytes, particularly peptides and proteins in biological samples, through the formation of a stable complex between the analyte and a specific antibody. They represent very selective and sensitive techniques that have found application in several areas such as clinical chemistry, bioanalysis, pharmaceutical analysis, toxicological analysis, and environmental analysis. [1][2][3] Owing to their capacity for high throughput and significantly reduced average analytical times, through the simultaneous analysis of numerous samples with ultimate detection sensitivity, immunoassays are the preferred platform for most protein studies, particularly clinical diagnostics and drug development where specificity is critical. 4-6 Among various immunoassays, the most commonly employed in routine clinical settings are the enzyme-linked immunosorbent assay (ELISA)

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Section: Resultsmentioning

confidence: 99%

Section: Matrix Effectmentioning

confidence: 99%

Measurement comparability of insulin assays using conventional immunoassay kits

Rosli

Kwon

Lim

et al. 2022

Clinical Laboratory Analysis

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show abstract

“…In certain cases, a certified reference material linked to higher-order metrology with value and error assignments provided exists. Available compounds can be obtained from various organizations, such as the International Federation of Clinical Chemistry, National Institutes of Science and Technology, Joint Committee for Traceability in Laboratory Medicine, National Measurement Institute Australia, National Metrology Institute of Japan, and Korea Research Institute for Science and Standards [ 10 ]. These materials may also be included in commercial vendor catalogs.…”

Section: Analytical Materialsmentioning

confidence: 99%

Review of the Use of Liquid Chromatography-Tandem Mass Spectrometry in Clinical Laboratories: Part I-Development

Rappold

2022

Ann Lab Med

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The process of method development for a diagnostic assay based on liquid chromatography-tandem mass spectrometry (LC-MS/MS) involves several disparate technologies and specialties. Additionally, method development details are typically not disclosed in journal publications. Method developers may need to search widely for pertinent information on their assay(s). This review summarizes the current practices and procedures in method development. Additionally, it probes aspects of method development that are generally not discussed, such as how exactly to calibrate an assay or where to place quality controls, using examples from the literature. This review intends to provide a comprehensive resource and induce critical thinking around the experiments for and execution of developing a clinically meaningful LC-MS/MS assay.

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“…According to the general requirements for the competence of reference material producers (ISO 17034:2016), a CRM is defined as a “reference material characterized by a metrologically valid procedure for one or more specified properties, accompanied by a reference material certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability” [ 204 ]. Generally, major producers of RMs are NMIs [ 205 ]. However, RMs of SARS-CoV-2 are produced by not only NMIs, but also by commercial institutes and culture collections.…”

Section: Resources and Standardization For Sars-cov-2 Nucleic Acid Testingmentioning

confidence: 99%

Nucleic Acid Testing of SARS-CoV-2

Yoo

Kim

2021

IJMS

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The coronavirus disease 2019 (COVID-19) has caused a large global outbreak. It is accordingly important to develop accurate and rapid diagnostic methods. The polymerase chain reaction (PCR)-based method including reverse transcription-polymerase chain reaction (RT-PCR) is the most widely used assay for the detection of SARS-CoV-2 RNA. Along with the RT-PCR method, digital PCR has emerged as a powerful tool to quantify nucleic acid of the virus with high accuracy and sensitivity. Non-PCR based techniques such as reverse transcription loop-mediated isothermal amplification (RT-LAMP) and reverse transcription recombinase polymerase amplification (RT-RPA) are considered to be rapid and simple nucleic acid detection methods and were reviewed in this paper. Non-conventional molecular diagnostic methods including next-generation sequencing (NGS), CRISPR-based assays and nanotechnology are improving the accuracy and sensitivity of COVID-19 diagnosis. In this review, we also focus on standardization of SARS-CoV-2 nucleic acid testing and the activity of the National Metrology Institutes (NMIs) and highlight resources such as reference materials (RM) that provide the values of specified properties. Finally, we summarize the useful resources for convenient COVID-19 molecular diagnostics.

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What is novel about certified reference materials?

Cited by 21 publications

References 20 publications

Measurement comparability of insulin assays using conventional immunoassay kits

Measurement comparability of insulin assays using conventional immunoassay kits

Review of the Use of Liquid Chromatography-Tandem Mass Spectrometry in Clinical Laboratories: Part I-Development

Nucleic Acid Testing of SARS-CoV-2

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