Are there any reasons to use three levels of quality control materials instead of two and if so, what are the arguments?
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Oswald Sonntag
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Giuseppe Lippi
To the Editor,
Quality control (QC) materials are essential in laboratory medicine to ensure the accuracy and reliability of patient test results. They help to monitor the performance of laboratory instruments, reagents, and personnel over time. QC materials come in different levels, typically categorized as two (low and high) or three (low, medium, and high). The choice between two or three levels depends on various factors, and both options have their own advantages and limitations [1].
Using two levels of QC materials (low and high) will have the advantages of (i) simplicity (two-level QC material is straightforward and easier to manage), (ii) cost-effectiveness (needs fewer QC materials and resources), and (iii) rapid assessment (provides a basic check of instrument and test system performance).
On the other hand, disadvantages are (i) less complete information (it may not detect certain issues, such as shifts or trends within a larger analytical range as would be allowed using one additional level of QC), and (ii) lower precision (two-level QC will provide as much granularity for identifying minor deviations throughout the analytical process).
Using three levels of QC materials (low, medium and high) will instead have the advantages of (i) higher sensitivity (three-level QC allows for better detection of shifts, trends, or issues throughout the analytical range of measurements), (ii) enhanced troubleshooting (helps pinpoint the source of errors more precisely), and (iii) improved risk assessment (provides a more comprehensive picture of the overall test system performance). Nonetheless, the disadvantages would be (i) complexity (managing three levels of QC material can be more challenging in terms of logistics, costs, and personnel time), and (incremental cost requires more QC materials and resources, especially reagents, compared to two-level QC materials).
In our view, the decision between two or three levels of QC depends on several factors, including clinical significance (consider the clinical impact of errors in test results; for tests with critical clinical impact, a more comprehensive three-level QC may be preferred and therefore part of routine testing), regulatory requirements (regulatory bodies, such as the Clinical Laboratory Improvement Amendments (CLIA) in the US, may specify required QC procedures for certain tests), laboratory resources (budget, personnel, and QC materials; laboratories with limited resources may opt for two-level QC materials), and test complexity (some tests are more prone to error or drift over time; complex tests may benefit from a more extensive QC scheme).
In summary, the choice between two or three levels of quality control materials in laboratory medicine depends on a combination of clinical, regulatory, resource, and test-specific factors. Laboratories should carefully consider their needs and select the appropriate QC strategy to ensure the accuracy and reliability of their test results, while considering practical limitations. A typical example for using a three levels QC material is cardiac troponin testing, as it is necessary to use a specific control material with concentration close to the limit of quantitation, along with two other levels with concentrations close to the upper reference limit (URL) and to the upper part of the measuring range [2].
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Research ethics: Not applicable.
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Informed consent: Not applicable.
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Author contributions: The authors have accepted responsibility for the entire content of this manuscript and approved its submission. OS/GL conceptualization, writing original draft preparation, writing reviewing and editing.
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Competing interests: The authors state no conflict of interest.
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Research funding: None declared.
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Data availability: Not applicable.
References
1. Wolek, T, Nascimento, A. Quality control levels – keys to determine how many levels of QC to implement. Adv Lab 2015;24:34–6.Suche in Google Scholar
2. Hickman, PE, Koerbin, G, Badrick, T, Oakman, C, Potter, JM. The importance of low level QC for high sensitivity troponin assays. Clin Biochem 2018;58:60–3. https://doi.org/10.1016/j.clinbiochem.2018.05.007.Suche in Google Scholar PubMed
© 2024 the author(s), published by De Gruyter, Berlin/Boston
This work is licensed under the Creative Commons Attribution 4.0 International License.
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- Editorial
- Six years of progress – highlights from the IFCC Emerging Technologies Division
- IFCC Papers
- Skin in the game: a review of single-cell and spatial transcriptomics in dermatological research
- Bilirubin measurements in neonates: uniform neonatal treatment can only be achieved by improved standardization
- Validation and verification framework and data integration of biosensors and in vitro diagnostic devices: a position statement of the IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MBHLM) and the IFCC Scientific Division
- Linearity assessment: deviation from linearity and residual of linear regression approaches
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- General Clinical Chemistry and Laboratory Medicine
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- Potential medical impact of unrecognized in vitro hypokalemia due to hemolysis: a case series
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