scholarly journals Schemes and Performance Evaluation Criteria of Korean Association of External Quality Assessment (KEQAS) for Improving Laboratory Testing

2021 ◽  
Vol 41 (2) ◽  
pp. 230-239
Author(s):  
Sollip Kim ◽  
Kyunghoon Lee ◽  
Hyung-Doo Park ◽  
Yong-Wha Lee ◽  
Sail Chun ◽  
...  
Author(s):  
Eline A.E. van der Hagen ◽  
Sanne Leppink ◽  
Karin Bokkers ◽  
Carla Siebelder ◽  
Cas W. Weykamp

Abstract Objectives Hemoglobin A1c (HbA1c) is a valuable parameter in the monitoring of diabetic patients and increasingly in diagnosis of diabetes. Manufacturers continuously optimize instruments, currently the main focus is to achieve faster turnaround times. It is important that performance specifications remain of high enough standard, which is evaluated in this study for the new ARKRAY HA-8190V instrument. Methods The Clinical and Laboratory Standards Institute (CLSI) protocols EP-5, EP-9 and EP-10 were applied to investigate imprecision, bias and linearity. In addition potential interferences, performance in External Quality Assessment (EQA) and performance against the HA-8180V instrument in 220 clinical samples was evaluated. Results The HA-8190V demonstrates a CV of ≤0.8% in IFCC SI units (≤0.6% National Glycohemoglobin Standardization Program [NGSP]) at 34 and 102 mmol/mol levels (5.3 and 11.5% NGSP) and a bias of −0.1 mmol/mol (−0.01% NGSP) at a concentration of 50 mmol/mol (6.7% NGSP), but with a significant slope as compared to target values. This results in a bias of −1.0 and 0.9 mmol/mol (−2.0 and 0.9% NGSP) at the 30 and 70 mmol/mol (4.9 and 8.6% NGSP) concentration level. Simulation of participation in the IFCC certification programme results in a Silver score (bias −0.1 mmol/mol, CV 1.1%). Interference in the presence of the most important Hb variants (AS, AC, AE, AD) and elevated HbA2 and HbF concentrations is less than 3 mmol/mol (0.3% NGSP) at a concentration of 50 mmol/mol (6.7% NGSP). Conclusions Analytical performance of the HA-8190V is very good, especially with respect to precision and HbA1c quantification in the presence of the most common Hb variants.


2020 ◽  
Vol 30 (2) ◽  
pp. 242-249 ◽  
Author(s):  
Vladimira Rimac ◽  
Anja Jokic ◽  
Sonja Podolar ◽  
Jelena Vlasic Tanaskovic ◽  
Lorena Honovic ◽  
...  

Introduction: Autovalidation (AV) is an algorithm based on predefined rules designed, among others, to automate and standardize the postanalytical phase of laboratory work. The aim of this study was to examine the overall opinion of Croatian medical biochemistry laboratories regarding various aspects of AV. Material and methods: This retrospective study is an analysis of the responses of a survey about AV comprised of 18 questions, as part of Module 10 (“Postanalytical phase of laboratory testing”) of national External Quality Assessment program, administered by the Croatian Centre for Quality Assessment in Laboratory Medicine. Results were reported as percentages of total number of participants in survey or as proportions of observed data if the overall number of data was <100. Results: 121 laboratories responded to the survey, of which 76% do not use AV, while 11% of laboratories use AV in routine laboratory work. 16/29 laboratories implemented semi-automated AV for general biochemistry (7/29), haematology (5/29), and coagulation (4/29) tests. Analytical measurement ranges, critical values, flags from analysers, interference indices and delta check were the most commonly used rules in the algorithm. 12/29 laboratories performed validation of AV with less than 500 samples (8/29). 7/13 laboratories report the percentage of AV being 20-50%, while 10/13 answered that introduction of AV significantly reduced turnaround time (TAT) (for 20 - 25%), especially for biochemistry tests. Conclusions: Despite of its numerous benefits (i.e. shorter TAT, less manual validation, standardization of the postanalytical phase), only a small number of Croatian laboratories use AV.


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