scholarly journals Certified reference material against PR3 ANCA IgG autoantibodies. From development to certification

2019 ◽  
Vol 57 (8) ◽  
pp. 1197-1206 ◽  
Author(s):  
Evanthia Monogioudi ◽  
Joanna Sheldon ◽  
Pier Luigi Meroni ◽  
Dana Petronela Hutu ◽  
Heinz Schimmel ◽  
...  
Keyword(s):  
Reference Material ◽  
Certified Reference Material ◽  
Certified Reference Materials ◽  
Feasibility Studies ◽  
Autoimmune Disorder ◽  
Accurate Diagnosis ◽  
Clinical Samples ◽  
Appropriate Use ◽  
Comparability Of Results

Abstract Background The importance of the standardisation of immunoassays for autoantibodies has been widely discussed. The appropriate use of certified reference materials (CRM) could contribute to a more accurate diagnosis and follow-up of a series of diseases such as small vessel-associated vasculitis. This is a systemic autoimmune disorder during which two autoantibodies can be present, MPO ANCA IgG and PR3 ANCA IgG. Results from different commercially available immunoassays used for PR3 ANCA IgG measurement can vary significantly. Therefore the potential for improvement using a suitable certified reference material was assessed and led to the development of a CRM. Methods Thirty clinical samples were evaluated using 10 immunoassays. The correlation between results from these assays was assessed in a pairwise manner. Feasibility studies were conducted in order to find a reference material format most suitable for the preparation of a CRM. Results The evaluation of two sets of 30 clinical samples with 10 assays showed that differences between assays can result in different interpretations for individual clinical samples. Most of the samples had the same result classification in all assays. However, six of the samples tested led to inconsistent results. Conclusions The correlation between results from clinical samples was systematically good for combinations of eight of those assays. Therefore, it should be possible to improve the comparability of results using a commutable CRM for calibration. Based on these studies, a final format for the CRM was selected and eventually produced and certified for its PR3 ANCA IgG content.

Experience with Certified Reference Material Proficiency Testing for Quality Control of Wheat

1998 ◽  
Vol 6 (A) ◽  
pp. A53-A61
Author(s):  
Judit Budai ◽  
Judit Fükó
Keyword(s):  
Quality Control ◽  
Reference Material ◽  
Proficiency Testing ◽  
Reference Materials ◽  
Certified Reference Material ◽  
Certified Reference Materials ◽  
Long Term Stability ◽  
Determining Factors ◽  
Chemical Section

The Chemical Section of OMH1,2 embarked on the preparation of a series of wheat samples as Certified Reference Materials (CRMs) in 1992. The certification processes were carried out according to the recommendations of ISO. Since then we have developed a series of flour samples as well. The investigations of the long-term stability and the application of wheat and flour CRMs are continuous. Wheat is one of the most widely grown crops in Hungary and it is one of the major determining factors of the economy. Its uniform and objective qualification is of great importance. There are well-equipped laboratories available with sufficient experience but, as the proficiency testing regularly showed, certified samples need to be used to achieve exact and uniform measuring results.

scholarly journals Preparation of certified reference materials for cotton fabric’s dye transfer inhibition performance test of household washing machines

2020 ◽  
Vol 15 ◽  
pp. 155892502094116 ◽  
Author(s):  
Mingqi Guo ◽  
Yun He ◽  
Li Jiang ◽  
Qingbo Yang ◽  
Jianli Liu ◽  
...  
Keyword(s):  
Reference Material ◽  
Cotton Fabric ◽  
Reference Materials ◽  
Certified Reference Material ◽  
Performance Test ◽  
Certified Reference Materials ◽  
Dye Transfer ◽  
Washing Machines ◽  
Dyed Fabric ◽  
Transfer Inhibition

At present, many well-known brands of washing machines in the market are equipped with dye transfer inhibition washing procedures. However, there is no standardized sample available for the evaluation of the dye transfer inhibition washing procedure, and there is no comparability and access standard of the high-quality washing machine with the related functions. In this article, the certified reference materials for the evaluation of the dye transfer inhibition function will be prepared, which consist of certified reference material of white cotton fabric and that of dyed cotton fabric. The certified reference material of white fabric is made of bleached plain fabric, and that of dyed fabric is made with different reactive red dyes and dyeing processes. The size and manufacturing process of the whole set of standardized samples for the evaluation of dye transfer inhibition are selected and determined through experiments. The preparation of the standardized sample for the evaluation of dye transfer inhibition will improve the research and design of the functional washing procedure, which can better solve the pain point when dark and light clothes are washed together.

Development of a new tetrandrine certified reference material for clinical chemistry and pharmaceutical analysis

2015 ◽  
Vol 7 (11) ◽  
pp. 4763-4768 ◽  
Author(s):  
Dezhi Yang ◽  
Fengfeng Wang ◽  
Li Zhang ◽  
Yang Lv
Keyword(s):  
Reference Material ◽  
Reference Materials ◽  
Certified Reference Material ◽  
Pharmaceutical Analysis ◽  
Certified Reference Materials ◽  
Clinical Chemistry ◽  
Reliability And Validity ◽  
Metrological Characteristics ◽  
Analytical Measurements

Certified reference materials (CRMs) with good metrological characteristics are essential tools to guarantee the reliability and validity of analytical measurements.

scholarly journals DEVELOPMENT OF REFERENCE MATERIAL OF HOLMIUM OXIDE FOR SPECTROMETERS WAVELENGTH CALIBRATION: FEASIBILITY STUDIES

2018 ◽  
Vol 15 (29) ◽  
pp. 243-250
Author(s):  
D. E. GONÇALVES ◽  
J. F. S. GOMES ◽  
A. P. D. ALVARENGA ◽  
T. de O. ARAUJO ◽  
P. P. BORGES
Keyword(s):  
Quality Assurance ◽  
Reference Material ◽  
Wavelength Range ◽  
Certified Reference Material ◽  
Metrological Traceability ◽  
Feasibility Studies ◽  
Wavelength Calibration ◽  
Material Production ◽  
Important Requirement

The use of certified reference material (CRM) in chemical analyzes is an important requirement in quality assurance systems, since it allows the metrological traceability of results, thus achieving valid and comparable results. This work describes the development and production of holmium oxide reference material that, after certification, will be used in the calibration of the wavelength range of UV-Vis spectrometers and also the necessary feasibility studies to establish the measurement parameters to be used in the next steps of the material production and certification.

scholarly journals IFCC Working Group Recommendations for Correction of Bias Caused by Noncommutability of a Certified Reference Material Used in the Calibration Hierarchy of an End-User Measurement Procedure

2020 ◽  
Vol 66 (6) ◽  
pp. 769-778 ◽  
Author(s):  
W Greg Miller ◽  
Jeffrey Budd ◽  
Neil Greenberg ◽  
Cas Weykamp ◽  
Harald Althaus ◽  
...  
Keyword(s):  
Reference Material ◽  
Certified Reference Material ◽  
Clinical Laboratory ◽  
Metrological Traceability ◽  
Measurement Procedure ◽  
Clinical Samples ◽  
End User ◽  
Assigned Value ◽  
The Difference ◽  
Specific Correction

Abstract Establishing metrological traceability to an assigned value of a matrix-based certified reference material (CRM) that has been validated to be commutable among available end-user measurement procedures (MPs) is central to producing equivalent results for the measurand in clinical samples (CSs) irrespective of the clinical laboratory MPs used. When a CRM is not commutable with CSs, the bias due to noncommutability will be propagated to the CS results causing incorrect metrological traceability to the CRM and nonequivalent CS results among different MPs. In a commutability assessment, a conclusion that a CRM is commutable or noncommutable for use with a specific MP is made when the difference in bias between the CRM and CSs meets or does not meet a criterion for that specific MP when compared to other MPs. A conclusion regarding commutability or noncommutability requires that the magnitude of the difference in bias observed in the commutability assessment remains unchanged over time. This conclusion requires the CRM to be stable and no substantive changes in the MPs. These conditions should be periodically reverified. If an available CRM is determined to be noncommutable for a specific MP, that CRM can be used in the calibration hierarchy for that MP when an appropriately validated MP-specific correction for the noncommutability bias is included. We describe with examples how a MP-specific correction and its uncertainty can be developed and applied in a calibration hierarchy to achieve metrological traceability of results for CSs to the CRM’s assigned value.

scholarly journals Development of a certified reference material for anti-β2-glycoprotein I IgG – commutability studies

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Evanthia Monogioudi ◽  
Gustavo Martos ◽  
Joanna Sheldon ◽  
Pier Luigi Meroni ◽  
Stefanie Trapmann ◽  
...  
Keyword(s):  
Reference Material ◽  
Antiphospholipid Syndrome ◽  
Certified Reference Material ◽  
Immunoglobulin G ◽  
Clinical Diagnostics ◽  
Clinical Samples ◽  
Candidate Reference Material ◽  
Glycoprotein I ◽  
Freeze Dried ◽  
The Impact

AbstractObjectivesIn this paper, we describe the steps followed for the development of a certified reference material for immunoglobulin G antibodies against β2-glycoprotein I (also known as apolipoprotein H). These steps include processing of the material, commutability, the impact of dilution, the appropriate reconstitution conditions, homogeneity and stability during transport and storage.MethodsWe analysed 69 clinical samples from patients suffering from antiphospholipid syndrome with several commercial enzyme-linked immunosorbent assays (ELISA) purchased from in vitro diagnostic manufacturers.ResultsAnalysis of the results indicated that the candidate reference material can be safely freeze-dried, and that the user should carefully follow the reconstitution instructions as small changes in e.g. temperature may have unwanted effects. The statistical analysis of the commutability studies indicated that the analytical response of the reference material upon dilution is similar to that of clinical samples, and that correlation between results may differ from assay to assay. Finally yet importantly, the presented and developed candidate reference material is commutable for most assays tested, homogeneous and stable.ConclusionsImmunoglobulin G antibodies against β2-glycoprotein I are associated with a higher risk of thrombosis and pregnancy complications. Their measurement is essential for the diagnosis and monitoring of antiphospholipid syndrome. These antibodies are detected by specific immunoassays, routinely used in clinical diagnostics, but various of these methods show enormous variability, in part due to the lack of a reference material.

An Invasive Hemolymphangioma of the Pancreas in a Young Woman

2019 ◽  
Vol 21 (10) ◽  
pp. 798-800 ◽  
Author(s):  
Zhijun Zhang ◽  
Qinghong Ke ◽  
Weiliang Xia ◽  
Xiuming Zhang ◽  
Yan Shen ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Case Report ◽  
Young Woman ◽  
Benign Tumor ◽  
Abdominal Distension ◽  
Accurate Diagnosis ◽  
Cystic Tumor ◽  
Rare Benign Tumor ◽  
Radical Surgical Resection

Background: Hemolymphangioma is a rare benign tumor. To the best of our knowledge, there were only 10 reports of this tumor of the pancreas until March 2018. Case Report: Here, we reported a large invasive hemolymphangioma of the pancreas in a young woman with a complaint of abdominal distension and an epigastric mass about 3 weeks. She was found to have a huge multilocular cystic tumor at the neck and body of pancreas on computed tomography. She was eventually diagnosed with hemolymphangioma of the pancreas after operation. After 2 years of follow-up, there was no signs of recurrence. Conclusion: From our case and literature, we can conclude that hemolymphangioma of the pancreas is uncommon benign tumor, and it is hard to make an accurate diagnosis preoperatively. Radical surgical resection should be performed whenever possible. The prognosis of this disease seems good.

Development and Certification of Formononetin Reference Material for Quality Control of Functional Foods and Botanical Supplements

2019 ◽  
Vol 15 (5) ◽  
pp. 553-559
Author(s):  
Ningbo Gong ◽  
Baoxi Zhang ◽  
Kun Hu ◽  
Zhaolin Gao ◽  
Guanhua Du ◽  
...  
Keyword(s):  
Quality Control ◽  
Reference Material ◽  
Functional Foods ◽  
Certified Reference Materials ◽  
Coulometric Titration ◽  
Pharmaceutical Formulations ◽  
Uncertainty Estimation ◽  
Expanded Uncertainty ◽  
Scanning Calorimetry ◽  
Botanical Supplements

Background: Formononetin is a common soy isoflavonoid that can be found abundantly in many natural plants. Previous studies have shown that formononetin possesses a variety of activities which can be applied for various medicinal purposes. Certified Reference Materials (CRMs) play a fundamental role in the food, traditional medicine and dietary supplement fields, and can be used for method validation, uncertainty estimation, as well as quality control. Methods: The purity of formononetin was determined by Differential Scanning Calorimetry (DSC), Coulometric Titration (CT) and Mass Balance (MB) methods. Results: This paper reports the sample preparation methodology, homogeneity and stability studies, value assignment, and uncertainty estimation of a new certified reference material of formononetin. DSC, CT and MB methods proved to be sufficiently reliable and accurate for the certification purpose. The purity of the formononetin CRM was therefore found to be 99.40% ± 0.24 % (k = 2) based on the combined value assignments and the expanded uncertainty. Conclusion: This CRM will be a reliable standard for the validation of the analytical methods and for quality assurance/quality control of formononetin and formononetin-related traditional herbs, food products, dietary supplements and pharmaceutical formulations.

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