BLT Stages

Abstract Bachelor Project 2018-2019: The verification of the Sysmex hematology analyzer XN-1000

The aim of this research project is to perform a verification of the new Sysmex hematology analyzer XN-1000 for complete blood count (CBC) and white blood cell (WBC) differentiation in peripheral blood in Labo Maenhout Waregem. The XN-1000 should offer a higher quality and better performance compared to the XT-4000i, which is currently used in routine.

CBC and WBC differentiation is of great importance for the diagnosis and follow-up of patients. The results need to be reported as soon as possible and they still need to be as correct as possible. Therefore, the evolution of hematology analyzers is a welcoming fact. The hematology analyzer needs to be validated according to the medical standards before using it in routine; therefore, a verification was performed on the XN-1000.

The verification consists of a practical and statistical verification. The practical verification included a comparison of the flags (EPU-rules), sensitivity and specificity, throughput and workload. The statistical verification included background check, correctness, imprecision, carry- over, accuracy and an analyzer comparison. For the performing of these parameters, patient blood samples (K2EDTA) and control samples (Sysmex) have been used.

The analyzer comparison showed that the XN-1000 outperforms the XT-4000i for cell count as well as the differentiation. The other parameters gave good results. After performing a background check there is nothing left that may lead to an interference with a next sample. The reported results are correct and precise, which also leads to a good accuracy. Only the accuracy of the monocytes is a bit above the permitted limits (CV% = 4.17 %; limits: ±2.00 %).

Comparison with the literature showed that this is a common problem for Sysmex hematology analyzers. No carry-over was determined from one sample to another. The practical verification showed that the flags on the XN-1000 are more specific. The XN-1000 can make a better differentiation between monocytes and lymphocytes which results in less flags. The throughput of both analyzers is equal but when all channels are used, the XN-1000 is a bit faster. The comparison of the flags and the throughput leads both to a reduced workload. This is a positive evolution as there is now more time for more difficult samples.

There can be concluded that the XN-1000 meets the standard requirements for cell count and differentiation and can be used in the laboratory as the new routine hematology analyzer. Manual differentiation is still needed for some patient samples, but in a lower amount due to the better analyze techniques.

Abstract bachelorproef 2016-2017: Evaluatie en vergelijking van drie verschillende toestellen voor urinesediment analyse

Urinalysis has become more important over recent years, because there are many disorders that can be found in urine. Various commercially available analyzers have been developed for measuring urine in a routine laboratory. The analyzers should produce fast and accurate results providing both the practitioner and the patient with the information for an appropriate diagnosis, treatment and follow-up.

The purpose of this study was to compare three available automated platforms for urinalysis (the current deliver (Aution Max and Sysmex UF-500i), Menarini (Aution Max and SediMax) and Analis (FUS)) with respect to correlation against the current laboratory urinalysis set-up (Aution Max and Sysmex UF-500i), analytical performance, functionality and subjective evaluation.

The validation and comparison of the three urinalysis set-ups were performed over a period of three weeks. During this period a series of standardized tests are executed and operator observations are recorded. The accuracy of each analyzer, including the current laboratory analyzers, is assessed by using the calibrated controls. The maximum allowed percentage bias is 10%. Repeatability was measured by placing five times the same samples on the device. Reproducibility was determined by checking the same control during eight consecutive days. For both criteria the calculated coefficient of variation CV must be maximum 20%. The selectivity and sensitivity are determined by 40 samples where the number of white blood cells and the matching culture were compared with each other. A WBC count > 25 /µl was considered positive for adults, while a WBC count > 10 /µL was considered positive for children. The correlation was calculated for 40 patient samples to determine the white blood cell count on the current device and a new device and then compare to each other. Calculations and graphs of the linear regression with correlation coefficient r, the Intercept A, slope B at a confidence level of 95%, are performed using Passing Bablok regression. Lastly, the functionality and the observations made while testing, in particular the features, the complexity, the required preparations, the quality of the reports, the software and the user interface are evaluated.

The coefficient of variation is acceptable for all three analyzers, although the CVs of the repeatability and the reproducibility for the current device is lower than for the two other instruments. The concordance for WBC and RBC count was acceptable between all 3 analyzers. Concerning the current analyzer (UF-500i) has a better sensitivity, but the FUS-2000 has a better specificity. Passing-Bablok regression executed on the three analyzers compared with the current device shows only for Menarini an intercept A outside the confidence interval of 95%.

The analyzer with the best user interface, the least complexity and generating the fastest and the best reports is the FUS-2000 analyzer by Analis.