Ramune Sepetiene¹*, Vaiva Patamsyte², Ninette F Robbins³, Mohamed Ali⁴ and Alexander Carterson⁵

¹Abbott GmbH Max-Planck-Ring 2, Wiesbaden, Germany

*Corresponding Author: Ramune Sepetiene, Abbott GmbH Max-Planck-Ring 2, Wiesbaden, Germany.

Received: May 11, 2022; Published: June 07, 2022

Abstract

The comprehensive analytical phase performance depends on many factors. Discrepant results can occur due to errors coming from outside of laboratory due to improper sample preparation resulting in the presence of hemolysis, lipids and other factors. However, standardizing testing methodology and performance characteristics such as sensitivity, specificity, accuracy, precision, and linearity is useful to ensure a final quality-based test result. Despite the benefits of fully automated processes, the quality of the analytical phase has major issues. A reported analysis of data evaluated using the Westgard rules has demonstrated that estimates on a σ scale for clinical chemistry are not satisfactory, from 3 to 4σ, at the best situation. Unfortunately, a relatively high frequency of analytical errors has been found for immunoassays with subsequent adverse clinical outcomes. Following the Good Laboratory Practice experience, we created memorable figures, called the Five Fingers (on CLIA established guidelines) and 5W rules (by ISO 15189 standardization requirements) which could be attractive to create informative and logical QA templates of each clinical laboratory procedure.

Objective: This review summarizes publications specific for immunoassay testing procedures within fully automated laboratories that follow the standardization requirement points and the best laboratory practice with intention for all staff who participates in total investigation.

Data Sources: Literature review, assays manuals, ISO standards and guidelines.

Conclusion: There are analytical performance analysis, comparison of different immunoassay methodologies, discussion of interference factors and main characteristics of calibration and quality control within clinical laboratory routine procedures focused on quality requirements discussed in this review.

Keywords: ISO Standards; Testing; Chemiluminescent Magnetic Immunoassay (CMIA)

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Citation

Citation: Ramune Sepetiene., et al. “Analytical Phase in Laboratory - Quality Issues and Insights for Immunoassays Testing". Acta Scientific Microbiology 5.7 (2022): 22-28.

Copyright

Copyright: © 2022 Ramune Sepetiene., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.