Introduction We investigated the interference of haemolysis on ethanol testing carried out with the Synchron assay kit using an AU680 autoanalyser (Beckman Coulter, Brea, USA). Materials and methods Two tubes of plasma samples were collected from 20 volunteers. Mechanical haemolysis was performed in one tube, and no other intervention was performed in the other tube. After centrifugation, haemolysed and non-haemolysed samples were diluted to obtain samples with the desired free haemoglobin (Hb) values (0, 1, 2, 5, 10 g/L). A portion of these samples was then separated, and ethanol was added to the separated sample to obtain a concentration of 86.8 mmol/L ethanol. After that, these samples were diluted with ethanol-free samples with the same Hb concentration to obtain samples containing 43.4, 21.7, and 10.9 mmol/L. Each group was divided into 20 equal parts, and an ethanol test was carried out. The coefficient of variation (CV), bias, and total error (TE) values were calculated. Results The TE values of haemolysis-free samples were approximately 2-5%, and the TE values of haemolysed samples were approximately 10-18%. The bias values of haemolysed samples ranged from nearly - 6.2 to - 15.7%. Conclusions Haemolysis led to negative interference in all samples. However, based on the 25% allowable total error value specified for ethanol in the Clinical Laboratory Improvement Amendments (CLIA 88) criteria, the TE values did not exceed 25%. Consequently, ethanol concentration can be measured in samples containing free Hb up to 10 g/L.
Purpose: Measurement Uncertainty (MU) is a valuable tool for evaluating analytical performance and interpreting results in clinical laboratories. The International Organization for Standardization (ISO) has proposed a practical approach for MU calculation in its ISO/TS 20914:2019 guide. This study aimed to calculate the MU values of 20 clinical chemistry analyses per the ISO guideline and compare them with the Maximum expanded allowable measurement uncertainty (MAU) values. Methods: The study was performed using 6-month internal quality control (IQC) values (uRw) and calibrator uncertainty (ucal) in line with the recommendations of the ISO/TS 20914:2019 guideline. The common MU value was calculated for 20 clinical chemistry tests on two identical devices, Roche Cobas 6000 c501 (Roche Diagnostics, Mannheim, Germany) analyzers. The calculated MU values for the tests were compared with the current MAU values in the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Biological Variation database (the current Clinical Laboratory Improvement Amendments/CLIA recommendation for Ethanol has been selected). Results: MU values for Alanine aminotransferase, C-reactive Protein, Iron, Ethanol, Total Bilirubin, Triglyceride, and Blood urea nitrogen remained within the MAU limits. The MU values of the other 13 tests (excluding Aspartate aminotransferase, Glucose, and Potassium Level 2 IQC) exceeded the MAU values. Conclusion: It was observed that the uRw value affected the MU value the most. Close monitoring and evaluation of uRw and thus IQC and implementation of corrective and preventive actions may reduce MU.
Aim: The objective of this study is to evaluate blood gas analysis (BGA) sample rejection ratios (SRRs) in our laboratory and investigate the effect of various BGA syringes on SRR. Material and Method: 3 groups were formed based on the type and use period of BGA syringes. Syringes containing spray-dosed droplet liquid Lithium Heparin were used in Group 1 (November 2018–May 2019), syringes containing lyophilized dried Lithium Heparin were used in Group 2 (July 2019–January 2020), and another syringes containing spray-dosed droplet liquid Lithium Heparin were used in Group 3 (March 2020–September 2020), and the groups were determined based on such use. SRRs of these groups were calculated, causes for sample rejection were identified, and department-based investigations were conducted. Comparisons between groups were performed according to the indicated variables. Results: Mean SRRs of the groups by percentage (%) were calculated as 6.1±1.5, 10.0±0.9, and 3.8±0.9, respectively, and showed a statistically significant difference (p
Background Unsuitable samples are common problem for laboratories. The blood collection tubes need to be validated or verified prior to their being used in the routine laboratory for reducing this situation. Objective We aim to compare the technical qualifications of routinely used BD Vacutainer® Serum Separator Tubes™ II Advance Plus with BD Vacutainer® Barricor™ LH Plasma Tubes for local technical validation. Materials and methods Apparently healthy 150 voluntary subjects were enrolled in the study. Samples were collected in two separated tubes by a single phlebotomist. Twelve quality indicators were used to compare these two different types of tubes for local technical validation. Differences (%) between them were calculated with the formula proposed by EFLM. In case of any difference of less than 1% for each indicator, the evaluated tube was considered as non-inferior. Results Indicators, such as tubes with physical defects, that fail to create vacuum, not properly fitting into the blood collection device, under filling (10%), cracked tubes, tubes exterior surface contaminated with blood, hemolysed specimens, including fibrin strand/mass in the sample, red blood cell adhesion, poor/incomplete barrier formation were found non-inferior in Barricor™ tubes. White particulate matter (WPM) was observed in 24.6% of Barricor™. Therefore, the last indicator (tubes including gel/foreign material/WPM in sample after centrifugation) was found inferior for Barricor™. Conclusion Technical local validation studies should be encouraged in terms of quality management. It was thought that WPM would not cause any interference in a properly filled tube. In addition to, Barricor™ was also found to be technically acceptable when evaluated through using all other indicators.
Background: The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE) have recommended an algorithm based on the reference change value (RCV) to evaluate hemolysis. We utilized this algorithm to analyze hemolysis-sensitive parameters. Methods: Two tubes of blood were collected from each of the 10 participants, one of which was subjected to mechanical trauma while the other was centrifuged directly. Subsequently, the samples were diluted with the participant's hemolyzed sample to obtain the desired hemoglobin concentrations (0, 1, 2, 4, 6, 8, and 10 g/L). ALT, AST, K, LDH, T.Bil tests were performed using Beckman Coulter AU680 analyzer. The analytical and clinical cut-offs were based on the biological variation for the allowable imprecision and RCV. The algorithms could report the values directly below the analytical cut-off or those between the analytical and clinical cut-offs with comments. If the change was above the clinical cut-off, the test was rejected. The linear regression was used for interferograms, and the hemoglobin concentrations corresponding to cut-offs were calculated via the interferograms. Results: The RCV was calculated as 29.6% for ALT. Therefore, ALT should be rejected in samples containing >5.9 g/L hemoglobin. The RCVs for AST, K, LDH, and T.Bil were calculated as 27.9%, 12.1%, 19.2%, and 61.2%, while the samples' hemoglobin concentrations for test rejection were 0.8, 1.6, 0.5, and 2.2 g/L, respectively. Conclusions: Algorithms prepared with RCV could provide evidence-based results and objectively manage hemolyzed samples.
Objectives We aimed to compare the levels of hemolysis in the blood collected using the vacuum and aspiration modes via Sarstedt S-Monovette coagulation tubes. Methods Forty volunteers were included in the study. Blood samples were collected using two different modes in the S-Monovette citrate tube (Sarstedt AG). Prothrombin time, active partial thromboplastin time, fibrinogen, and D-dimer analyses were performed using the STA-Compact-Max 3 analyzer (Stago). The hemolysis levels of the samples were measured by both Stago’s semiquantitative hemolysis index (H-index) module and the quantitative H-index measurement of the Roche cobas 6000 (Roche Diagnostics) analyzer. Results Roche’s quantitative H-index values were statistically significantly lower in the aspiration mode. No clinically significant difference was observed between coagulation test results. Conclusions Using the S-Monovette citrate tubes can reduce spurious hemolysis and improve patient safety.
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