Results Of Interlaboratory Comparison Research Articles

Establishment of human post-vaccination SARS-CoV-2 standard reference sera

There is a critical need to understand the effectiveness of serum elicited by different SARS-CoV-2 vaccines against SARS-CoV-2 variants. We describe the generation of reference reagents comprised of post-vaccination sera from recipients of different primary vaccines with or without different vaccine booster regimens in order to allow standardized characterization of SARS-CoV-2 neutralization in vitro. We prepared and pooled serum obtained from donors who received a either primary vaccine series alone, or a vaccination strategy that included primary and boosted immunization using available SARS-CoV-2 mRNA vaccines (BNT162b2, Pfizer and mRNA-1273, Moderna), replication-incompetent adenovirus type 26 vaccine (Ad26.COV2·S, Johnson and Johnson), or recombinant baculovirus-expressed spike protein in a nanoparticle vaccine plus Matrix-M adjuvant (NVX-CoV2373, Novavax). No subjects had a history of clinical SARS-CoV-2 infection, and sera were screened with confirmation that there were no nucleocapsid antibodies detected to suggest natural infection. Twice frozen sera were aliquoted, and serum antibodies were characterized for SARS-CoV-2 spike protein binding (estimated WHO antibody binding units/ml), spike protein competition for ACE-2 binding, and SARS-CoV-2 spike protein pseudotyped lentivirus transduction. These reagents are available for distribution to the research community (BEI Resources), and should allow the direct comparison of antibody neutralization results between different laboratories. Further, these sera are an important tool to evaluate the functional neutralization activity of vaccine-induced antibodies against emerging SARS-CoV-2 variants of concern. ImportanceThe explosion of COVID-19 demonstrated how novel coronaviruses can rapidly spread and evolve following introduction into human hosts. The extent of vaccine- and infection-induced protection against infection and disease severity is reduced over time due to the fall in concentration, and due to emerging variants that have altered antibody binding regions on the viral envelope spike protein. Here, we pooled sera obtained from individuals who were immunized with different SARS-CoV-2 vaccines and who did not have clinical or serologic evidence of prior infection. The sera pools were characterized for direct spike protein binding, blockade of virus-receptor binding, and neutralization of spike protein pseudotyped lentiviruses. These sera pools were aliquoted and are available to allow inter-laboratory comparison of results and to provide a tool to determine the effectiveness of prior vaccines in recognizing and neutralizing emerging variants of concern.

Interlaboratory comparison as a source of information about the problem

Methods of evaluation of interlaboratory comparison results are prescribed by ISO standards. Ruler is probably one of the most widely used length measuring instrument in the world. For laboratories that plan to be accredited for the calibration of Ruler, the acquisition of a specialized Measuring bench is not economically feasible. Confidence in the measured result depends on the measurement uncertainty, and where deficiencies are observed, the values that contribute to the measurement uncertainty should be investigated. This paper describes an interlaboratory comparison for a small number of laboratories on the example of a Measuring bench for calibrating Ruler and indicates the procedure for problem identification; diagnosis of causes; consideration of solutions; initiation of action for improvement and monitoring of the results of applied solutions. The authors documented the problem and listed the elements that contributed to "Unsatisfactory" result in interlaboratory comparisons. They described the actions they took to overcome the "Unsatisfactory" result, analyzed whether the proposed solutions led to "Satisfactory" result and took actions accordingly. The paper presents the results of the international interlaboratory comparison, which are a confirmation of the competence of the personnel, measuring calibration equipment and calibration method.

Evaluation of Inter-Laboratory Comparison Results: Representative Examples

The primary purpose of inter-laboratory comparisons is to verify the CMC claims of the participating laboratories. The most commonly used evaluation criterion, the normalized error │Eni│, has flaws, particularly if the comparison uncertainty ucomp,i is large relative to the reference standards being compared. According to the recommendations of CIPM Working Group for Fluid Flow, the uncertainty ucomp,i should be considered by including the uncertainty of the transfer standard and the repeatability of the calibrations. A review of previous comparison reports shows the importance of this task for many other measurands beside the field of fluid flow. In this paper, we propose the use of comparison uncertainty ucomp,i as a better tool for assessing the power of the comparison. We applied the comparison evaluation criteria to recent comparison results to illustrate their benefits over the │Eni│≤ 1 criterion. A probability-based approach evaluates the comparison results and we recommend its usage in future comparisons.

The risk of a different assessment of the performance of cementitious ceramic tile adhesives in the light of the results of interlaboratory comparisons

The article presents the current state of knowledge on the measurement of the adhesion of cementitious ceramic tile adhesives [CTAs] using the pull-off technique. The author discusses the results of the systematic literature review for the keywords of this article with particular attention to the interlaboratory comparisons [ILCs]. The cementitious CTAs adhesion measurements, particularly the results obtained in the ILCs, became the basis for analyzing the relationship between the participants of the conformity assessment of construction products. The analysis considers the links between science and industry and their environment resulting from formal and legal conditions related to the evaluation of construction products. Based on the study, the author proposes a mind map showing the relationships between potential participants in the CTAs compliance assessment process, with particular emphasis on ILCs. It indicates that using different criteria for evaluating the results of cementitious CTAs adhesion measurement by science and industry is not conducive to developing mutual relations between the two worlds.

Melting Point Certified Reference Materials for Organic Substances: Development Perspectives

The field of the melting point measurements of high-purity organic substances today includes a large number of measuring instruments used in the field of medicine, biology, and the production of perfumery and cosmetic products.The purpose of the research is to identify the features and justify approaches to the development of melting point certified reference materials of organic substances provided with metrological traceability to the SI base measurement units «temperature» (°C).The objectives of the research included justification of the choice of substances-candidates for CRMs; determination of the certification procedure for RMs; establishment of restrictions affecting the certification procedure; estimation of uncertainty for certified values of the melting point CRMs.In the course of the research, a state analysis of metrological assurance in the field of melting point measurements was performed. An overview of the reference complex designed to measure the melting point and purity of organic substances in the range from +40 °C to +250 °C is presented, its functional diagram is given. The basic requirements for substancescandidates for CRMs are identified. The study presents the results of determining the melting point of benzophenone, benzoic acid, succinic acid, anthracene, and caffeine obtained by direct measurements of the phase transition temperature and by indirect measurements based on recording the moment of optical transparency of the substances under study. The results of interlaboratory comparisons on samples of the studied substances are presented, which made it possible to obtain reliable data on the temperature of the emergence of optical transparency at different heating rates. A method for reconciling the results is proposed; it consists in presenting the certified value of the melting point determined by the method of direct measurements of the phase transition temperature in the thermodynamic mode, as well as the certified values of the optical transparency temperature at various heating rates as additional characteristics of the substance in the passports of the developed CRMs. Research objectives for further work are formulated.The theoretical significance of the results obtained lies in the development of theoretical and methodological approaches to the certification of melting point CRMs based on pure organic substances, which make it possible to improve the measurement accuracy in the field of thermal analysis at a higher quality level.

Advances in the metrological traceability and performance of X-ray computed tomography

X-ray computed tomography (XCT) is increasingly being used for evaluating quality and conformance of complex products, including assemblies and additively manufactured parts. The metrological performance and traceability of XCT nevertheless remains an important research area that is reviewed in this paper. The error sources influencing XCT measurement results are discussed, along with related qualification, calibration and optimization procedures. Moreover, progress on performance verification testing and on the determination of task-specific measurement uncertainty is covered. Results of interlaboratory comparisons are summarized and performance in various dimensional measurement fields is illustrated. Conclusions and an outlook for future research activities are also provided.

Inter-laboratory Pressure Comparison Measurement In Gas Medium at ± 150 hPa Range

Results of interlaboratory comparisons and proficiency tests are a significant parameter for the calibration and testing laboratories for assuring the quality of test and calibration results performed by those laboratories. Accredited and non-accredited laboratories that have a quality system for their working areas are expected to join into inter-comparisons and proficiency tests in certain periods to show a degree of equivalence among the participant laboratories and assure their service quality. The necessity of participating in comparison measurements (ILC) and proficiency tests (PT) are stated in the EN ISO/IEC 17025:2017 International Standard that accredited laboratories or laboratories applying for accreditation must participate in ILC and PT from parameters related to measurement quantities within the scope of accreditation and have achieved successful results, and it is also a requirement sought by accreditation bodies. This study gives the organisation steps and the obtained results of a bilateral pressure comparison measurement of digital pressure gauge in the hydraulic medium between UME and an accredited laboratory in industry between ± 150 hPa.

Inter-laboratory Comparisons and Their Roles in Accreditation

Results of interlaboratory comparisons and proficiency tests are a significant parameter for the calibration and testing laboratories for assuring the quality of test and calibration results performed by those laboratories. If test and calibration laboratories want to demonstrate that they operate according to a management system, that they are technically competent and that they can produce technically valid results in the tests and calibrations they perform for their customers, the general requirements they must meet are defined in ISO/IEC 17025:2017. This international standard forms the basis of international laboratory accreditation. Clause 7.7 Ensuring the validity of results in this standard requires laboratories to establish the procedures and instructions and other technical documentation needed to ensure the results of the tests and calibrations they perform. Participation in inter-laboratory comparison or proficiency testing programs is one of the most important of these activities. Participation in inter-laboratory comparisons provides an opportunity for laboratories to independently evaluate their analytical performance, both in absolute terms and in comparison, to other techniques. In this study, information about calibration laboratories and accreditation activities is given and the importance of inter-laboratory comparison studies is explained to ensure the results of the measurements made by calibration laboratories.

Interlaboratory comparisons of calibration results of a multifunctional calibrator of electrical quantities

Article is dedicated to organization and conduct of the calibration results of reciprocal interlaboratory comparisons for the multifunctional calibrator of electric quantities: DC voltage, AC voltage, DC current and AC current. The interlaboratory comparisons of electric quantities measurement instruments calibration results are represented. Evaluation of the laboratory calibration results bias is provided using the modified criterion. Analysis and conclusions concerning participating laboratory competence are provided.

Comparison of ph measurement results in buffer solution

As a result of the increasing need to study the choice of the assigned value during the inter-laboratory comparisons is becoming more and more relevant. Since the assigned value is a reference point when comparing the results of the participants of the qualification test. Frequently, qualification verification providers face a number of problems when choosing the assigned value. An incomplete analysis of the results of interlaboratory comparisons will lead to an inaccurate assessment of the competence of the laboratory, which contributes to the revocation of the certification of the accreditation of the laboratory participant. This article attempts to provide a complete statistical analysis of the results of interlaboratory comparisons from the beginning to the end of the tour with the content of all statistical analyses recommended in GOST ISO/IEC 17043-2013. The results of interlaboratory comparisons conducted in testing laboratories of Kazakhstan aimed at ensuring metrological traceability of pH measurements in a buffer solution are presented. The reference values of the buffer solution are determined in the state scientific metrological center.

Interlaboratory comparison results of vibration transducers between TÜBITAK UME and Roketsan

This paper presents an interlaboratory comparison on vibration metrology field which can be used as a powerful method of checking the validity of results and measurement capabilities according to ISO 17025. In this standard it is advised to participate in an interlaboratory comparison or a proficiency test in order to prove measurement capabilities of calibration providers. In this study it is aimed to statistically evaluate the measurements results in the scope of sinusoidal acceleration between TÜBITAK UME (National Metrology Institute of Turkey) and Roketsan as per related International Standards. After statistical evaluation, for unsatisfactory results, root cause analyses and corrections to improve measurement quality are presented and conceptually explained.

COMPARISONS OF STANDARDS OF LIQUID CONSUMPTION UNITS AS AN EFFECTIVE MEASURE TO ENSURE THE UNIFORMITY OF MEASUREMENTS WHEN TAKING INTO ACCOUNT RESOURCES IN THE SYSTEMS OF HEAT AND WATER SUPPLY

Rational use of resources in heat and water supply systems and other industries is impossible without reliable measurement results of fluid consumption. The reliability of the measurement results is confirmed by their traceability to national standards. To ensure the traceability of flow standards, which cannot be directly connected to the national standard, it is necessary to carry out a comparison using a transfer standard. The main results of interlaboratory comparisons of fluid flow standards are considered. Comparisons, the pilot laboratory of which was State Enterprise "Ukrmetrteststandart", carried out with the participation of Firm "Sempal CO LTD", Kiev. The aim of the project was to carry out comparisons in the field of flow measurements between water meter calibration laboratories. Based on the results of comparisons, it was established: there are no significant deviations of the real parameters from those specified in the instructions; according to the agreed range of comparisons for flow rates from 13 m3/h to 350 m3/h, all the results of the installations are in good agreement; degree of equivalence "Laboratory to CRV" and "Laboratory to laboratory" Ei ≤ 1, laboratories are in good agreement; all results are completely satisfactory with a degree of equivalence less than 1.

Evaluation of the results of regional metrology organisation comparisons and national inter-laboratory comparisons for electrical quantities

The global metrological traceability fully depends on the implementation of international mutual recognition agreements in field of metrology. The linked results of international comparisons of national standards for alternating current/direct current (AC/DC) voltage transfer difference measurements and electrical power measurements, and national inter-laboratory comparison AC/DC voltage transfer difference and electrical power measurements at industrial frequency was presented. The main goal of this inter-laboratory comparison was the assessment of calibration laboratories capabilities that perform calibration in AC/DC voltage transfer difference and electrical power measurements. The consistency of the data obtained using the En numbers and Chi² test was estimated.

Evaluation of veterinary laboratory proficiency based on results of interlaboratory comparisons organized by FGBI “ARRIAH” in 2018–2019

Laboratory diagnosis is a crucial component in implementation of the set of anti-epidemic measures aimed at contagious animal disease control. The need for unswerving trust in the quality of laboratory performance is a matter of importance not only for service providers and customers, but also for inspecting organiza­tions, accreditation bodies, etc. that establish performance requirements for diagnostic laboratories. Incorrect laboratory test results can lead to a misdiagnosis and, therefore, to grave consequences. One of the forms of experimental verification of a laboratory’s performance with a view to determine the laboratory’s competence and to verify its compliance with accreditation criteria as part of inspection control of the laboratory’s activities is interlaboratory comparison. The laboratory can prove its competence at a particular time, as well as clearly demonstrate how stable the quality of its test results is by summarizing and analyzing the results of its participation in interlaboratory comparisons. The analysis of the results of the interlaboratory comparisons (programmes for detection of causative agents or antibodies to the causative agents of avian influenza, Newcastle disease, rabies, classical swine fever, African swine fever, bluetongue, lumpy skin disease) organized by the FGBI “ARRIAH” for the veterinary laboratories of the Russian Federation in 2018–2019 is presented. The results showed that most of the laboratories had passed the tests successfully. The results submitted by participants were unsatisfactory in some interlaboratory comparison programmes (rabies virus detection using fluorescent antibody technique; detection of avian influenza, classical swine fever and lumpy skin disease viruses using polymerase chain reaction). That highlights the need for those participants who failed the tests to improve their laboratory testing quality.

Linking the Results of Inter-laboratory Comparisons for DC Electrical Resistance Measures

The article presents the results of the first round of inter-laboratory comparisons of the measures of electric resistance of 1 Ω, 10 Ω and 100 Ω on a direct current. The reference laboratory has studied the measures of electrical resistance as a means of comparison, defined the reference values of comparison with the calculation of their expanded uncertainties. The comparison of the results of measurements obtained during the calibration of the measures of electrical resistance of eight laboratories took place according to the radial scheme from 2018 to 2019.The linking procedure of inter-laboratory comparisons is described and used for rounds of said inter-laboratory comparisons. The deviations of the corrected results obtained by each laboratory were determined and their correctness was evaluated taking into account the uncertainty of measurements by one of the criteria for performance statistics for the selected electrical resistance ratings. A comparative analysis of the corrected results of the calibration of resistance measures for laboratories that took part in the first and second rounds was carried out.

Review of Shanghai glycohemoglobin harmonization program

Objective To review the results of inter-laboratory comparisons in Shanghai glycohemoglobin harmonization program from 2010 to 2018, and to analyze the evolution of quality levels of HbA1c determination, so as to provide the reference for improving the HbA1c determination quality in China. Methods Retrospective analysis. The comparison data of Shanghai Glycohemoglobin Harmonization Program from 2010 to 2018 was collected. And the change trend was analyzed about hospital and determination method distribution. The judgment criteria, quarterly and annual pass rate, bias and coefficient of variation of the results of the inter-laboratory comparison were analyzed retrospectively, and the results were compared with the results of External Quality Assessment Programme carried out by the National Center for Clinical Laboratories, Shanghai Center for Clinical Laboratories and College of American Pathologists (CAP). The data in the first quarter of 2019 was collected and the imprecision, bias and sigma were calculated, which were drew in the evaluation model of sigma combined with biomedical variation parameters. Results The number of participating laboratories increased from 9 in Shanghai to 192 in the whole country, with an average annual growth rate of 76.6%. The quarterly comparison improved from ±8% to ±6% and the passing rate of participating laboratories increased from 39.1% to nearly 90%. The maximum CV of each instrument among laboratories decreased from 14.3% to 4.8%. In the first quarter of 2019, nearly 60% of the laboratories met 6σcriteria and more than 95% of the laboratories met the standard criteria in the model of biological variation parameters. Conclusion Shanghai Glycohemoglobin harmonization program has improved the harmonization of HbA1c test results among the participating laboratories. Key words: Diabetes mellitus; Glycated hemoglobin A; Reproducibility of results

Supplementary comparison COOMET.M.P-S4 of gas absolute pressure standards up to 7 MPa, and gauge up to 2 MPa

This report describes the results of a successful two-phase interlaboratory comparison between Georgian National Agency for Standards and Metrology (GeoSTM), Czech Metrology Institute (CMI) and Slovak Metrology Institute (SMU) denoted as COOMET.M.P-S4. The ranges of the absolute pressure from 0 MPa to 7 MPa and gauge pressure from 0 MPa to 2 MPa were chosen as the most suitable for a mutual comparison. A digital pressure gauge, DHI RPM4 served as a transfer standard in both phases. Firstly, bilateral interlaboratory comparison (BILC) between two participants, CMI (pilot and reference laboratory) and GeoSTM, started in March 2017 and finished in April 2017. Secondly, interlaboratory comparison (ILC) between three participants, CMI (pilot and reference laboratory), SMU (co-reference laboratory) and GeoSTM, started in October 2018 and finished in February 2019. SMU took part only in the absolute pressure comparison.Main textTo reach the main text of this paper, click on Final Report. Note that this text is that which appears in Appendix B of the BIPM key comparison database kcdb.bipm.org/.The final report has been peer-reviewed and approved for publication by the CCM, according to the provisions of the CIPM Mutual Recognition Arrangement (CIPM MRA).

Interlaboratory comparisons of the results of the work of the chemical­analytical unit of JSC “The URIR named after A. S. Berezhnoy” in 2018

One of the activity areas of JSC “The URIR named after A. S. Berezhnoy” is assistance to refractory industry enterprises of Ukraine in ensuring their work in the quality monitoring of products and raw materials.
 The comparison of work quality of chemical­analytical units of following enterprises: JSC “KDZ”, PJSC “Chasovoyarsk Refractory Plant”, JSC “Velikoanadol Refractory Plant” and JSC “The URIR named after A. S. Berezhnoy” was carried out. The discrepancy between the average results of components determination in the chemical­analytical units of refractory enterprises and in the chemical­analytical laboratory of JSC “The URIR named after A. S. Berezhnoy” does not exceed the value of in terms of ND. The work quality of chemical­analytical units of central refractory laboratories of all the above mentioned enterprises is satisfactory. Recommendations to improve the accuracy of analysis results are not required.
 The work on interlaboratory comparison of work results of the chemical­analytical unit of JSC “The URIR named after A. S. Berezhnoy” and IP “SGS Ukraine” was completed. The quality of interlaboratory comparisons carried out between the Testing Centre of IP “SGS Ukraine” and JSC “The URIR named after A. S. Berezhnoy” was found to be satisfactory. The test results were accepted by the NAAU during the next inspection as corresponding to DSTU ISO / IEC 17025:2006.

Reviving the inter-laboratory comparison measurement results

Key comparison measurements serve as an ultimate tool of quality assurance of results. Whenever the inter-comparison results indicate inconsistency, the participating laboratory needs to take the corrective actions. Practically, the systematic errors involved in the measuring system confines the achievable accuracy. Therefore, the corrective action involves either empirically determine the influences afresh or intuitively reassigns these error values. Alternatively, an analytical method based on inter laboratory comparison results is proposed. The novelty of the proposal is considering task-specific errors in the model that is used for the analysis of interlaboratory comparison results. Without accounting the uncertainties of task-specific errors, the analysis grows complicated and even sometimes it is not feasible. To supplement the proposed method, task-specific errors due to the imperfect geometry of ring gauge, practical inability in implementing the measurement, and unattended environmental influences are explored. The proposed method is demonstrated using some internal diameter key comparison data. The systematic errors responsible for the outlier in the measurement comparison are clearly distinguished.

Interlaboratory comparisons’ measurement uncertainty in the field of environmental noise

This paper deals with the problem of measurement uncertainty in acoustic measurements regarding the results of interlaboratory comparison (ILC). The measurement results of ILC in the field of environmental noise have been analysed taking into account the proposed methods for standard deviations’ calculation in repeatability and reproducibility conditions. In the field of environmental noise measurements of point sound source, the measurement results as well as the precision and accuracy are discussed bearing in mind the microphone positions. The results for expanded measurement uncertainty calculations are obtained following the ISO 1996-2:2007 and ISO 1996-2017 Standard. The obtained results showed that expanded measurement uncertainty from interlaboratory comparison results calculated from probability density functions is considerably less when compared with the procedure in Standards. A good agreement is gained for the difference between A-weighted level and spectral values from logarithmically averaged measurement results on the reflection surface and close to the reflection surface.