Comparative study on the accuracy of SysmexUF5000 and UF1000i automatic urine sediment analyzer for urine specimen detection
Abstract
Background: Urinalysis includes the physical examination of urine and the examination of formation scores, and the microscopic evaluation of the visible components in urine is a time-consuming process with high labor intensity and requires solid morphological expertise. Objective: To assess the Sysmex UF5000 automatic urine sediment analyzer’s diagnostic capability and contrast its accuracy with UF1000i urine samples. Methods: The precision, contamination rate, linear range, and reportable range of UF5000 were evaluated according to relevant regulations and verification methods provided by manufacturers. Urine samples were detected by UF5000 and UF1000 sediment analyzers, respectively. The accuracy of the false positive rate, false negative rate, sensitivity, and specificity of urine samples detected by the two instruments were compared using the results of centrifugal microscopy as the gold standard. Results: Red blood cells (RBC), White blood cells (WBC), and Epithelial cells (m) were detected by the Sysmex UF5000 urinary sediment analyzer. The intra-batch precision and inter-batch precision of EC), tubular type (CAST) and bacteria (BACT) were all within the required range. The contamination rate and linear range of RBC, WBC, and BACT met the requirements and could be reported widely. The false positive rate of UF5000 RBC was significantly lower than UF1000i, while the false positive rate of CAST was higher than UF1000i, the difference was statistically significant. In UF5000, the false negative rate of MALE WBC was significantly lower than that of females, and the difference was statistically significant. There was no difference in the specificity of white blood cells detected by the two instruments. When compared to UF1000i, UF5000 had much higher specificity for erythrocyte and tube types, and the sensitivity of three commonly used parameters of UF5000 was significantly higher than that of UF1000i, with statistical significance (P < 0.05). Conclusion: Compared with the UF1000i, the UF5000 showed similar or better diagnostic performance on most parameters.
References
1. Enko D, Stelzer I, Böckl M, et al. Comparison of the diagnostic performance of two automated urine sediment analyzers with manual phase-contrast microscopy. Clinical Chemistry and Laboratory Medicine (CCLM). 2019; 58(2): 268–273. doi: 10.1515/cclm-2019-0919
2. Coorevits L, Heytens S, Boelens J, et al. The resident microflora of voided midstream urine of healthy controls: standard versus expanded urine culture protocols. European Journal of Clinical Microbiology & Infectious Diseases. 2016; 36(4): 635–639. doi: 10.1007/s10096-016-2839-x
3. Kim SY, Park Y, Kim H, et al. Rapid Screening of Urinary Tract Infection and Discrimination of Gram-Positive and Gram-Negative Bacteria by Automated Flow Cytometric Analysis Using Sysmex UF-5000. Bourbeau P, ed. Journal of Clinical Microbiology. 2018; 56(8). doi: 10.1128/jcm.02004-17
4. Cai T, Mazzoli S, Verze P, et al. The adherence to European Association of Urology guidelines on urological infection in a tertiary referral hospital is the right way for increasing the antimicrobial stewardship among general practitioners. European Urology Supplements. 2017; 3(16): 150–151. doi: 10.1016/S1569-9056(17)30155-0
5. Wang L, Guo Y, Han J, et al. Establishment of the intelligent verification criteria for a routine urinalysis analyzer in a multi-center study. Clinical Chemistry and Laboratory Medicine (CCLM). 2019; 57(12): 1923–1932. doi: 10.1515/cclm-2019-0344
6. Chen Y, Zhang Z, Lin Z, et al. Sysmex UF-5000 Automatic Urine Sediment Analyzer Can Improve the Accuracy of Epithelial Cell Detection. Annals of Clinical & Laboratory Science. 2021; 51(4), 562–569.
7. Chen Y, Zhang Z, Diao Y, et al. Combination of UC-3500 and UF-5000 as a quick and effective method to exclude bacterial urinary tract infection. Journal of Infection and Chemotherapy. 2023; 29(7): 667–672. doi: 10.1016/j.jiac.2023.03.008
8. Chen Y, Zhang Z, Diao Y, et al. Sysmex UC-3500 and UF-5000 urine pipeline can quickly and effectively exclude bacterial urinary tract infection. Published online April 1, 2022. doi: 10.21203/rs.3.rs-1453006/v1
9. Shukuya K, Morita Y, Hisasue T, et al. Comparison of the clinical performance of the Atyp.C parameter of the UF-5000 fully automated urine particle analyzer with that of microscopic urine sediment analysis. Practical Laboratory Medicine. 2023; 36: e00328. doi: 10.1016/j.plabm.2023.e00328
10. Aden D, Khambra P, Ranga S. Comparison of two Automated Urine Analysers (UriScan Super+ YD Diagnostics and Sysmex UC-3500 -UF 5000 Urine Chemistry Analyzer) with Routine microscopy. Published online November 9, 2023. doi: 10.22541/au.169956723.37933086/v1
11. Demirel O, Sonkaya M. Comparison of sysmex UF-5000 flow cytometer and fuchs-rosenthal chamber urine sediment analysis. Medicine Science | International Medical Journal. 2022; 11(1): 367. doi: 10.5455/medscience.2022.01.015
12. Cho J, Byun JH, Lee SG, et al. Evaluation of five automated urine analyzers as screening instruments for enhancing diagnostic efficiency in urinary tract infection. Annals of Clinical Microbiology. 2021; 24(3): 83–96
13. Williams H. Screening by Sysmex Urine Analyzers to Reduce Unnecessary Urine Cultures. Published online 2023. doi: 10.2139/ssrn.4504265
14. Cho H, Yoo J, Kim H, et al. Diagnostic Characteristics of Urinary Red Blood Cell Distribution Incorporated in UF-5000 for Differentiation of Glomerular and Non-Glomerular Hematuria. Annals of Laboratory Medicine. 2022; 42(2): 160–168. doi: 10.3343/alm.2022.42.2.160
15. Delanghe J. New screening diagnostic techniques in urinalysis. Acta Clinica Belgica. 2007; 62(3): 155–161. doi: 10.1179/acb.2007.026
16. Wang Yanfeng LX, & Yinxiang H. Study on the main performance of Assume UF5000 automatic urine sediment analyzer. The Journal of Medical Theory and Practice. 2018; 31(22).
17. Previtali G, Ravasio R, Seghezzi M, et al. Performance evaluation of the new fully automated urine particle analyser UF-5000 compared to the reference method of the Fuchs-Rosenthal chamber. Clinica Chimica Acta. 2017; 472: 123–130. doi: 10.1016/j.cca.2017.07.028
18. Yuqing F, Susu H, Jing L, et al. Analysis of the consistency rate of bacterial channel detection and midstream urine culture with UF-1000I automatic urine analyzer. Lab med. 2018; 33(1): 60–62.
19. Jiahong Y, Lanxiang R, Xuejiao Y, et al. Influence of different placement conditions of urine specimens on related indexes in routine urine examination. Lab med Clin. 2018; 15(9): 1309–1311.
20. Kaneko K, Kabeya M, Kondo H, et al. Proteomic analysis of a urinary stone with two layers composed of calcium oxalate monohydrate and uric acid. Nucleosides, Nucleotides and Nucleic Acids. 2018; 37(12): 717–723. doi: 10.1080/15257770.2018.1478095
21. Xianbin Y, Xiaoli Z, Xiaoling H, et al. Progress of urine visible component analyzer and its application in routine automatic urine analysis. Med equip. 2019; 40(5): 96–102.
22. Bai L, Xu Q, Wu Z. Performance analysis of urine formed element analyzer EH-2090 was found to have good accuracy in detecting RBCs and WBCs when compared to manual microscopic. Translational andrology and urology. 2024 Feb 1;13(2): 218–229.
23. Chunhai X, Shuang L, Minjie H, et al. Comparison of the difference of detection results of bacteria by Roche U701 and UF-1000I urine sediment analyzer with different analysis principles. J Lab med. 2019; 34(04): 132–134.
24. Danwei W, Jun N. Analysis of carrying contamination in hematuria by UF-1000I automatic urine Composition analyzer. Med equip. 2017; 38(07): 101–103.
25. Weiwei C, Yanping M, Zhenlin N, et al. Determination of red blood cells and white blood cells in urine by dRE FUS-2000 Automatic urine analyzer. Med equip. 2017; 38(08): 82–85.
26. Qi H, Lina K, Huan L, et al. Clinical application and reexamination rule of urine analyzer with different detection principles. Lab med clin. 2019; 16(13): 1852–1860.
27. Ren C, Wu J, Jin M, et al. Rapidly Discriminating Culture-Negative Urine Specimens from Patients with Suspected Urinary Tract Infections by UF-5000. Bioanalysis. 2018; 10(22): 1833–1840. doi: 10.4155/bio-2018-0175
28. Muyan X. Effect analysis of microscopical examination and UF-1000I automatic urine sediment analyzer in routine urine examination. j pra med. 2019; 14(01): 75–76.
29. Wang Y, Huang Y. Study on the main performance of Assume UF5000 automatic urine sediment analyzer. The Journal of Medical Theory and Practice. 2018; 31(22).
30. Feng Mingya SW. The value of UC-3500 and UF-5000 pipeline analysis system in the diagnosis of urinary tract infection. Laboratory Medicine and Clinic. 2019; 16(12): 1737–1740.
31. De Rosa R, Grosso S, Lorenzi G, et al. Evaluation of the new Sysmex UF-5000 fluorescence flow cytometry analyser for ruling out bacterial urinary tract infection and for prediction of Gram negative bacteria in urine cultures. Clinica Chimica Acta. 2018; 484: 171–178. doi: 10.1016/j.cca.2018.05.047
Copyright (c) 2024 Chunhua Luo, Yucheng Luo, Qianyuan Li, Jun Luo, Peng Wang
This work is licensed under a Creative Commons Attribution 4.0 International License.
Copyright on all articles published in this journal is retained by the author(s), while the author(s) grant the publisher as the original publisher to publish the article.
Articles published in this journal are licensed under a Creative Commons Attribution 4.0 International, which means they can be shared, adapted and distributed provided that the original published version is cited.
Submit a Paper
