Quality control: possible effect between-lot-to-lot variation on application of 13s and 22s control rules

Snigireva N.V.; Polovnikova A.U.; Moshkin A.V.

doi:https://doi.org/10.17116/labs20211003158

Snigireva N.V.

CKDL Lmd

Polovnikova A.U.

CKDL Lmd

Moshkin A.V.

Association of Experts and Organizations of the Laboratory Service “Federation of Laboratory Medicine”

ORCID: 0000-0002-9965-4578

Quality control: possible effect between-lot-to-lot variation on application of 13s and 22s control rules

Authors:

Snigireva N.V., Polovnikova A.U., Moshkin A.V.

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Journal: Laboratory Service. 2021;10(3): 58‑61

DOI: 10.17116/labs20211003158

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To cite this article:

Snigireva NV, Polovnikova AU, Moshkin AV. Quality control: possible effect between-lot-to-lot variation on application of 13s and 22s control rules. Laboratory Service. 2021;10(3):58‑61. (In Russ.)
https://doi.org/10.17116/labs20211003158

Подписка 2025 Лабораторная служба (Laboratory Service)

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Abstract:

We used a «long» lot of control materials for internal quality control of immunochemical tests (21 analytes). We revealed a relationship between the frequency of changing lots of reagents and the number of breaking of the 1_3s and 2_2s rules. There was no «classical» pattern of the between-lot variation on the Levey-Jennings control charts. Perhaps we are faced with a small shift in the arithmetic mean on the Levey-Jennings after switching to a new lot of reagents. Probable, it needed a control charts correction after changing the lot of reagents by analogy with changing the lot of control materials.

Keywords:

IQC

control rules

between-reagent lot variation

quality specification

Authors:

Snigireva N.V.

CKDL Lmd

Polovnikova A.U.

CKDL Lmd

Moshkin A.V.

Association of Experts and Organizations of the Laboratory Service “Federation of Laboratory Medicine”

ORCID: 0000-0002-9965-4578

Received:

29.06.2021

Accepted:

05.08.2021

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References:

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