Experience of the National Institute of Metrology (INM) in development and certification of reference materials used in the metrological assurance of clinical laboratory measurements

1998 ◽  
Vol 360 (3-4) ◽  
pp. 479-485
Author(s):  
Mirella Buzoianu
Keyword(s):  
Reference Materials ◽  
Clinical Laboratory ◽  
Metrological Assurance ◽  
Laboratory Measurements ◽  
Materials Used

scholarly journals Multianalyte Conventional Reference Material (MacRM): A Useful Tool for Nationwide Standardization of Laboratory Measurements for Medical Care—A Model Study in Japan

2016 ◽  
Vol 62 (2) ◽  
pp. 392-406 ◽  
Author(s):  
Katsuyuki Shinohara ◽  
Naotaka Hamasaki ◽  
Yasushi Takagi ◽  
Yutaka Yatomi ◽  
Hiroshi Kikuchi ◽  
...  
Keyword(s):  
Reference Material ◽  
Reference Materials ◽  
Clinical Laboratory ◽  
Certified Reference Materials ◽  
Laboratory Measurements ◽  
Clinical Laboratories ◽  
Model Study ◽  
Low Concentrations ◽  
Target Values ◽  
Measurement Results

Abstract BACKGROUND The Japanese Committee for Clinical Laboratory Standards (JCCLS) has developed a multianalyte conventional reference material (MacRM) for nationwide standardization of laboratory measurements. METHODS To prepare the MacRM, pooled sera were obtained from healthy Japanese individuals. Target values of the pooled sera for 30 analytes were assigned on the basis of the measurement results of 45 certified clinical laboratories whose calibration was verified by measuring certified reference materials (CRMs) provided by the National Institute of Standards and Technology, the Institute for Reference Materials and Measurements, and JCCLS. Commutability of MacRM was assessed by comparison with results for 150 individual inpatients at Fukuoka University Chikushi Hospital. Survey samples were prepared by essentially the same method for MacRM but without target values. The survey samples were used to assess agreement among 165 laboratories that used various assay kits and platforms calibrated with the MacRM. RESULTS The commutability of MacRM was confirmed for 30 analytes with sera from 150 individual patients. The imprecision (CV) of measurements of survey samples (high and low concentrations) among the 165 laboratories was 0.4%–10.0%. Twenty-six of 30 analytes were within the goals for interinstitutional allowable bias. An aliquot of MacRM stored frozen at −80 °C remained stable for ≥4 years. CONCLUSIONS The MacRM was successfully applied as a calibrator to achieve nationwide standardization for 30 analytes measured by 165 laboratories that used various methods from different manufacturers.

scholarly journals Wearable sensors enable personalized predictions of clinical laboratory measurements

2021 ◽  
Author(s):  
Jessilyn Dunn ◽  
Lukasz Kidzinski ◽  
Ryan Runge ◽  
Daniel Witt ◽  
Jennifer L. Hicks ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Wearable Sensors ◽  
Laboratory Measurements

scholarly journals Development of reference materials for thermodynamic properties: metrological support of measurements in the field of thermal analysisand calorimetry in Russia

2019 ◽  
Vol 15 (3) ◽  
pp. 15-22
Author(s):  
A. M. Nepomiluev ◽  
V. V. Kazantsev ◽  
A. P. Shipitsyn
Keyword(s):  
Thermal Analysis ◽  
Thermodynamic Properties ◽  
Reference Materials ◽  
Metrological Support ◽  
Current State ◽  
Materials Used

This paper is aimed at analysing the current state and prospects of metrological support and standardisation in the field of thermal analysis in Russia. Main characteristics of reference materials used for testing, graduating, calibrating, and verifying thermal analysis instruments are described.

Application of clinical laboratory measurements to issues of environmental health

1992 ◽  
Vol 206 (1-2) ◽  
pp. 83-93
Author(s):  
Robert Rej ◽  
Jay B. Silkworth ◽  
Anthony P. DeCaprio
Keyword(s):  
Environmental Health ◽  
Clinical Laboratory ◽  
Laboratory Measurements

Near-Infrared Spectrophotometry: A New Dimension in Clinical Chemistry

1992 ◽  
Vol 38 (9) ◽  
pp. 1623-1631 ◽  
Author(s):  
J W Hall ◽  
A Pollard
Keyword(s):  
Near Infrared ◽  
Serum Proteins ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Electronic Transitions ◽  
Chemical Information ◽  
Pharmaceutical Chemical ◽  
Laboratory Measurements ◽  
Nondestructive Technique ◽  
Combination Bands

Abstract The near-infrared (NIR) spectral region (700-2500 nm) is a fertile source of chemical information in the form of overtone and combination bands of the fundamental infrared absorptions and low-energy electronic transitions. This region was initially perceived as being too complex for interpretation and consequently was poorly utilized. Advances in chemometric techniques that can extract massive amounts of chemical information from the highly overlapped, complex spectra have led to extensive use of NIR spectrophotometry (NIRS) in the food, agriculture, pharmaceutical, chemical, and polymer industries. The application of NIRS in clinical laboratory measurements is still in its infancy. NIRS is a simple, quick, nondestructive technique capable of providing clinically relevant analyses of biological samples with precision and accuracy comparable with the method used to derive the NIRS models. Analyses can be performed with little or no sample preparation and no reagents. The success of NIRS in any particular case is determined by the complexity of the sample matrix, relative NIR absorptivities of the constituents, and the wavelengths and regression technique chosen. We describe the general approach to data acquisition, calibration, and analysis, using serum proteins, triglycerides, and glucose as examples.

Evaluation of sample homogeneity for geochemical standard reference materials used in microanalysis

1987 ◽  
Vol 110 (1) ◽  
pp. 147-158 ◽  
Author(s):  
R. H. Filby ◽  
S. Nguyen ◽  
S. Campbell ◽  
A. Bragg ◽  
C. A. Grimm
Keyword(s):  
Reference Materials ◽  
Standard Reference Materials ◽  
Materials Used ◽  
Sample Homogeneity

scholarly journals Roadmap for Harmonization of Clinical Laboratory Measurement Procedures

2011 ◽  
Vol 57 (8) ◽  
pp. 1108-1117 ◽  
Author(s):  
W Greg Miller ◽  
Gary L Myers ◽  
Mary Lou Gantzer ◽  
Stephen E Kahn ◽  
E Ralf Schönbrunner ◽  
...  
Keyword(s):  
Reference Materials ◽  
Systematic Approach ◽  
Clinical Laboratory ◽  
Clinical Sample ◽  
Clinical Importance ◽  
Disease Diagnosis ◽  
Laboratory Measurement ◽  
Pure Substance ◽  
Test Results ◽  
Laboratory Test Results

Abstract Results between different clinical laboratory measurement procedures (CLMP) should be equivalent, within clinically meaningful limits, to enable optimal use of clinical guidelines for disease diagnosis and patient management. When laboratory test results are neither standardized nor harmonized, a different numeric result may be obtained for the same clinical sample. Unfortunately, some guidelines are based on test results from a specific laboratory measurement procedure without consideration of the possibility or likelihood of differences between various procedures. When this happens, aggregation of data from different clinical research investigations and development of appropriate clinical practice guidelines will be flawed. A lack of recognition that results are neither standardized nor harmonized may lead to erroneous clinical, financial, regulatory, or technical decisions. Standardization of CLMPs has been accomplished for several measurands for which primary (pure substance) reference materials exist and/or reference measurement procedures (RMPs) have been developed. However, the harmonization of clinical laboratory procedures for measurands that do not have RMPs has been problematic owing to inadequate definition of the measurand, inadequate analytical specificity for the measurand, inadequate attention to the commutability of reference materials, and lack of a systematic approach for harmonization. To address these problems, an infrastructure must be developed to enable a systematic approach for identification and prioritization of measurands to be harmonized on the basis of clinical importance and technical feasibility, and for management of the technical implementation of a harmonization process for a specific measurand.

Flouescence reference materials used for optical and biophotonic applications

2007 ◽  
Author(s):  
A. Engel ◽  
C. Otterman ◽  
J. Klahn ◽  
D. Enseling ◽  
T. Korb ◽  
...  
Keyword(s):  
Reference Materials ◽  
Materials Used

scholarly journals Effective density of Aquadag and fullerene soot black carbon reference materials used for SP2 calibration

2011 ◽  
Vol 4 (12) ◽  
pp. 2851-2858 ◽  
Author(s):  
M. Gysel ◽  
M. Laborde ◽  
J. S. Olfert ◽  
R. Subramanian ◽  
A. J. Gröhn
Keyword(s):  
Black Carbon ◽  
Reference Materials ◽  
Particle Mass ◽  
Effective Density ◽  
Single Particles ◽  
Aerosol Generation ◽  
Fullerene Soot ◽  
Mobility Diameter ◽  
In Series ◽  
Materials Used

Abstract. The mass and effective density of black carbon (BC) particles generated from aqueous suspensions of Aquadag and fullerene soot was measured and parametrized as a function of their mobility diameter. The measurements were made by two independent research groups by operating a differential mobility analyser (DMA) in series with an aerosol particle mass analyser (APM) or a Couette centrifugal particle mass analyser (CPMA). Consistent and reproducible results were found in this study for different production lots of Aquadag, indicating that the effective density of these particles is a stable quantity and largely unaffected by differences in aerosol generation procedures and suspension treatments. The effective density of fullerene soot particles from one production lot was also found to be stable and independent of suspension treatments. Some differences to previous literature data were observed for both Aquadag and fullerene soot at larger particle diameters. Knowledge of the exact relationship between mobility diameter and particle mass is of great importance, as DMAs are commonly used to size-select particles from BC reference materials for calibration of single particle soot photometers (SP2), which quantitatively detect the BC mass in single particles.

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