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Verification of basic parameters of complete blood count using analyser Sysmex XT 4000i, result comparison of patients' samples with analyser Sysmex XT 2000i in accredited laboratory.
MOUČKOVÁ, Lenka
Central Laboratories of Strakonice Hospital, joint stock company, are accredited according to CSN EN ISO 15189 Medical laboratories - Particular requirements of quality and competence. Requirements of verification and validation of methods emerge from this accreditation. Results of validation and verification processes are used to evaluate the uncertainty of measurement and assessment for continuity and comparability of measurement results. Introduction of a new type of automated hematology analyzer Sysmex XT-4000i in Central laboratories in Strakonice Hospital, joint stock company, in the hematology and blood storage section, requires verification and validation of basic examined blood count parameters on hematology analyzer Sysmex XT-4000i.The theme of the work is based on the requirements of CSN EN ISO 15189 and SOPO-C-06 Method validation/verification procedure for introducing laboratory hematology analyzer. Measurements of the basic parameters of blood count , namely leukocytes, erythrocytes, platelets, hemoglobin, hematocrit and mean corpuscular volume were done according to this document. Measurements of these parameters were used to evaluate a precision in terms of repeatability, precision in terms of reproducibility and accuracy. Parameters leukocytes, erythrocytes, platelets, hemoglobin, hematocrit and mean corpuscular volume were measured from twenty patient samples at two concentration levels to evaluate the precision in terms of repeatability. Basic parametres of blood count validated in EHK process were measured to evaluate the precision in terms of reproducibility. Reference materials e-check level 1 and e-check level 2 from Sysmex manufacturer were used as hematology control materials which moved within the physiological range. Measurements of these two reference materials were carried out daily during 20 days in a singlet. These measurements were used as the basis to calculate basic statistical parameters, the variational coefficient of repeatability and the variational coefficient of reproducibility from which variational analytical coefficient was calculated. The variational coefficient of reproducibility was used to compare methods of investigated parameters to the data specified by the manufacturer of the analyzer, as the manufacturer of the analyzer does not give the variational coefficient of repeatability. To estimate the validity, basic parametres of blood counts were measured to control materials from the company SEKK, Ltd.These materials are used to measure performance parametres. Validity measurements were used to calculate basic statistical parameters of which bias was calculated. It served to calculate the total analytical error of a laboratory and also it served to be compared to the total maximum error recommended by the company SEKK Ltd. in 2012. Passing-Bablock regression analysis was used to compare hematology analyzer Sysmex XT-2000i and hematology analyzer Sysmex XT-4000i, namely to compare the existing and the introducing analyzer and to compare open and closed mode of the introducing analyzer Sysmex XT-4000i. To compare analyzer Sysmex XT-4000i and Sysmex XT-2000i, which was regarded as referential, 40 patient samples were measured in a closed mode. To compare open and closed modes of analyzer Sysmex XT-4000i, 168 patient samples were measured. The measured values of all basic parameters were evaluated using MedCalc programme. The study showed that the device Sysmex XT-4000i meets the criteria required by CSN EN ISO 15189 Medical laboratories - Particular requirements for quality and competence and SOPO-C-06 Method validation/verification procedure for introducing laboratory hematology analyzer in Central laboratories Strakonice Hospital, Inc. section of hematology and blood storage. Comparison of the new hematology analyzer Sysmex XT-4000i to the current Sysmex XT-2000i showed that both analyzers are comparable.
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Quality assessment of pneumatic linear drives
Pecl, Tomáš ; Jankových, Róbert (referee) ; Budík, Tomáš (advisor)
This Master’s thesis deals with the evaluation of quality pneumatic linear drives. The theoretical part describes the problems in the field of pneumatic cylinders and statistical methods to perform the analysis. The practical part includes the execution and evaluation of the statistical analysis of the measurement process and pneumatic cylinders, also brings recommendations to optimize the measurement process. The methods used included analysis Gage R & R, Analysis control charts and data analysis using the process capability. The study was made for the purpose of improving test equipment Norgren Ltd. Used computer programs was Minitab Statistical Software and MS Excel.
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Repeatable Torque Load Equipment Design for Vehicle Steering System Testing
Novák, Pavel ; Ludvík, Jan (referee) ; Ramík, Pavel (advisor)
The object of this work is design braking device with high repeatability and reproducibility that is used to analyse the measurement system. I developed this work in cooperation with TRW-DAS Dačice a.s. At the beginning, I made a search of the chassis system, testing of ball joints and steering. Furthermore, I made search of the MSA and the types of braking devices. The rest of the work is focused on the design and the thermal analysis of braking device. Then there are the actual test.
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Determination of chlorides in pharmaceutical substances
Čutová, Michaela ; Pharm.Dr.Tomáš Schenk (referee) ; Omelková, Jiřina (advisor)
The topic of this bachelor work is a validation of the method for „Determination of chlorides in pharmaceutical substance“ is made in a form of validation of an analythical method. This titration method with potentiometric indication was developed in a company Sicor and it is used for determination of the residual chlorides volume in the substance called Pemetrexed. Validation is a process which assess suitability of a given analythic system for gaining relevant data (results). Validation constists of four tests: precision, reproducibility, lineraity and test of solution stability, although the test of reproducibility was realized in other laboratory (QC). For determnination of the chlorides was applyed titrator 716 DMS Titrino with argent combined electrode. For a data evaluation were used software tiamo 1.1 and MS Excel.
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Assessment of animal personality based on recaptures in bank vole (\kur{Clethrionomys glareolus})
ELEXHAUSEROVÁ, Anna
The aim of this study was to investigate the personality of bank vole using recaptures. Some behavioural types were determined (for example shy and bold) and influence of some factors on animal personality was defined (especially the daytime). The rate of repeatability of behaviour was also specified and the dependence of behaviour change on number of days between two captures was defined. Last, two types of tests used for animal personality were compared, indicating the differences between them.
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Diagnosis of diabetes mellitus in children and young adults
TURKOVÁ, Aneta
Diabetes mellitus is a disease resulting in disordered metabolism of carbohydrates. They include very serious metabolic diseases but still one third of patients remain undiagnosed. Diabetes is one of the most common chronic diseases in children. It can affect children of any age. Diabetes mellitus type 1 occurs more often in children. Diabetes mellitus type 2 was once considered to be only a disease of adults, but today there is an alarming increase of incidence in children and young adults as a result of improper lifestyle and severe obesity. In the theoretical part of my thesis I deal with the issue of hyperglycaemia and I present laboratory methods used to diagnose diabetes mellitus and long-term or short-term compensation of this disease. In detail I focus on the importance of using own glucose meter for self-monitoring. Objective of the thesis and its implementation are set in the practical part. The objective of my thesis was to verify the quality of blood glucose meter Optium Omega manufactured by Abbot using routine method of Clinical Chemistry Laboratory in strict accordance with its intended use within POCT. To verify functionality of blood glucose meter Optium Omega I used recommended statistical procedures.
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