Efficiency of practical application of standard operational procedures using sigmametry on the example of testing glycated hemoglobin HbA1c

Kolupaev V.E.

LLC «Bio-Rad Laboratorii»

Suhovolskaja S.S.

Diagnostic Clinical Center No. 1 of the Moscow City Health Department

Efimushkina O.A.

Diagnostic Clinical Center No. 1 of the Moscow City Health Department

Efficiency of practical application of standard operational procedures using sigmametry on the example of testing glycated hemoglobin HbA1c

Authors:

Kolupaev V.E., Suhovolskaja S.S., Efimushkina O.A.

More about the authors

Journal: Laboratory Service. 2021;10(1): 24‑31

DOI: 10.17116/labs20211001124

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Kolupaev VE, Suhovolskaja SS, Suhovolskaja SS, Efimushkina OA. Efficiency of practical application of standard operational procedures using sigmametry on the example of testing glycated hemoglobin HbA1c. Laboratory Service. 2021;10(1):24‑31. (In Russ.)
https://doi.org/10.17116/labs20211001124

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The concentration of glycated hemoglobin HbA1c is an important indicator of the hyperglycemia level. It is widely used for diagnostic, monitoring the therapy effectiveness and as a predictor of complications of diabetes mellitus. Characteristics of the analytical process must correspond strict international criteria, so the laboratories should pay attention to the quality management to ensure traceability of clinical test results. It is shown that the sigma metrics, which is calculated according to allowable total error limits, is an effective indicator of quality. Generally accepted limits of the total error can be established as analytical goals of the lab. The practical effectiveness of this approach in the centralized laboratory routine testing of HbA1c is discussed in this article.

Keywords:

standard operational procedure

quality control

standard operational procedure

quality control

Authors:

Kolupaev V.E.

LLC «Bio-Rad Laboratorii»

Suhovolskaja S.S.

Diagnostic Clinical Center No. 1 of the Moscow City Health Department

Efimushkina O.A.

Diagnostic Clinical Center No. 1 of the Moscow City Health Department

Received:

21.10.2020

Accepted:

24.02.2021

List of references:

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