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Hazardous Materials: Harmonization With International Standards
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مشخصات فایل: Harmonisation of Testing Practice for High Temperature Materials
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Until recently, no central organizing body existed for coordinating the various standardization and harmonization activities conducted worldwide to minimize duplication of effort or to optimize the use of resources. In , an international leadership forum of the American Association for Clinical Chemistry AACC recommended that an infrastructure be created to coordinate worldwide efforts to harmonize measurands In , the AACC, working with its domestic and international partners, formed the International Consortium for Harmonization of Clinical Laboratory Results to implement these recommendations, including prioritizing analytes that require harmonization and coordinating harmonization work among different organizations.
The governing body is a council made up of organizations from around the world that contribute financially to support the administration of the program. Reference materials used as calibrators or to verify the accuracy of a measurement procedure are key components for establishing metrological traceability. Like reference measurement procedures, reference materials must meet certain criteria for key characteristics, including homogeneity and stability. In recent years, commutability has come to be recognized as another critically important characteristic of reference materials The importance of commutability became apparent in situations in which measurement procedures were calibrated to be traceable to the same reference material but patient samples measured using these methods showed substantial differences in results 3 , 24 — Commutability is an essential property of reference materials used in a traceability chain This definition can be restated in the context of clinical laboratory measurement procedures as the closeness of agreement between 2 relations: the procedure 1 vs.
Figure 3A shows the concept of commutability, in which the relation of the results between 2 measurement procedures for patient samples and the analogous relation for reference materials are quite similar. Figure 3B shows the concept of noncommutability, in which the relation of the results between 2 measurement procedures for patient samples is quite different from that for reference materials. Figure 3C shows that the use of the noncommutable reference materials shown in Figure 3B as calibrators will cause inaccurate measurement of patient samples. As per the above definition of commutability, a reference material is described as commutable or noncommutable with patient samples among a group of measurement procedures.
Scatter plots comparing the hypothetical results of 2 measurement procedures. The plots illustrate how test outcomes for 20 patient samples are affected by the commutability of RMs. In panel A, the 3 RMs are commutable and thus, when analyzed by measurement procedures 1 and 2, yield results consistent with those of patient samples. In panel B, the 3 RMs are noncommutable and thus, when analyzed by measurement procedures 1 and 2, yield results inconsistent with those of patient samples.
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In panel C, the 2 measurement procedures are calibrated by using 3 noncommutable RMs; because the RMs are noncommutable, using them to calibrate the 2 measurement procedures leads to discrepant, inaccurate results for patient samples. In panels A and B, the line shown is the regression line for the comparison of patient sample results across the 2 measurement procedures.
In panel C, the line shown is the regression line for the comparison of 3 noncommutable RMs results across the 2 measurement procedures.
RM, reference material. Higher-order reference measurement procedures are designed to have a high degree of analytical specificity for the substance being measured and a level of accuracy that is independent of the specimen matrix. Consequently, commutability is rarely an issue for reference materials used to calibrate higher-order reference measurement procedures. Nor is commutability an issue for higher-order reference measurement procedures when assigning target values to a secondary reference material, which usually has a matrix similar to that of pertinent clinical samples.
However, commutability of secondary reference materials becomes a critical consideration when those secondary reference materials are intended for use with less-specific measurement procedures, such as routine clinical laboratory procedures and the steps through which manufacturers assign values to the calibrators used in routine clinical laboratory procedures.
In these situations, commutability of secondary reference materials is an essential requirement for ensuring accurate and reliable measurements in patient samples. A study investigating the accuracy of 16 TSH measurement procedures, all claiming to be traceable to the same WHO reference material, showed that 3 of these tests were inaccurate because the reference material used for calibration traceability was not commutable for these measurement procedures Unfortunately, there are a substantial number of secondary reference materials in use today for which commutability has not been examined; findings similar to those described for TSH have been reported for other analytes 24 — The CLSI has published a consensus guideline to facilitate validation of the commutability of reference materials In this example, a linear relation between 2 measurement procedures is obtained for the patient samples.
Limitations of current approaches for commutability evaluation include the following: 1 the dependence of the evaluation criteria on patient samples being representative of the disease condition or conditions for which a laboratory test is typically used and 2 the analytical precision and measurand specificity of the measurement procedures. Suitable analytical specificity implies that all measurement procedures measure the same biomarker without influence from interfering substances that may be present in the patient samples.
In this situation, values for reference materials may fall within the prediction interval, and although they fulfill the criteria for commutability, the apparent closeness of agreement with widely scattered patient samples may be inadequate to allow the use of such reference materials as calibrators in a traceability scheme.
At the other extreme, appropriate patient samples measured by highly precise and specific methods could lead to very narrow prediction intervals. In this situation, reference materials could be slightly outside the prediction interval, and thus considered noncommutable, when they are actually suitable for use as calibrators in a traceability scheme, because the bias introduced would not be clinically relevant. These examples show that conclusions from an assessment of commutability need to be drawn in the context of the overall method performance and the clinical requirements for measurement accuracy.
Standardization and harmonization are collaborative efforts conducted by national and international organizations and institutions. These efforts require long-term commitments of technical and financial resources. A clearly defined measurand and appropriate implementation of metrological traceability with suitable reference methods and commutable reference materials are fundamental to achieving comparability of measurement results independent of time, place, and measurement procedure.
Procedures and protocols that exist or are in development in the area of thyroid function testing include several for defining measurands clearly and for implementing appropriate reference methods and commutable reference materials in standardization and harmonization programs. WGM received a research grant from Abbott Diagnostics. The authors reported no conflicts of interest related to the study.