Background: This review describes and evaluates the most relevant preanalytical errors and their impact on subsequent laboratory diagnostics. Quality management for laboratory processes remains extremely important, despite current advancements in information technologies and fully automated routine procedures. Methods: This review is focused on specific preanalytical requirements for the blood bank and transfusion laboratory. Conclusions are done based on literature review. Results: Human errors, or lack of procedures, continue to be the cause of many errors within laboratory processes. The medical laboratory needs an impetus and stipulation to improve processes, to help eliminate errors, and meet regulatory guidelines. Conclusions: General preanalytical rules exist for clinical and research laboratories but differences in laboratory specialty and provided services influence compliance
SARS-CoV-2 Omicron emergence occurred in Canada during the period from November 2021 to January 2022. This study assessed the ability of donor plasma collected earlier (January to March 2021) to generate any neutralizing capacity against Omicron BA.1 SARS-CoV-2.
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.
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