全自动尿液颗粒分析仪UF-1500的评估。

IF 2.6 4区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Journal of Clinical Laboratory Analysis Pub Date : 2023-12-01 Epub Date: 2023-12-02 DOI:10.1002/jcla.24993
Yoshifumi Morita, Rin Yokoyama, Masami Tanaka, Naru Nakatsuka, Takashi Hisasue, Yoshikazu Ono, Makoto Kurano
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引用次数: 0

摘要

背景和目的:本研究主要评估了新型紧凑型全自动尿液颗粒分析仪UF-1500的性能,并将其与现有的UF-5000仪器进行了比较。材料与方法:随机收集648份残尿标本,采用UF-1500、UF-5000仪器及人工显微镜检查。对于每个参数,将UF-1500与UF-5000对手工显微镜的一致性率和检测精度进行比较。结果:UF-1500与人工镜检的符合率为75.3% ~ 98.5%。在一组协议中,除YLCs外,所有参数的UF-1500一致性率均>90%。与UF-5000相比,UF-1500和手动显微镜在一组协议内的差异微不足道,除了ec和ylc例外。UF-1500检测红细胞、白细胞、白细胞的敏感性和特异性。ECs、BACT阳性预测值均超过80%,ECs、cast阳性预测值均低于70%。结论:UF-1500具有与现有仪器UF-5000相当的性能,适合在临床推广使用。对于疑似假阳性或假阴性结果的样品,需要进行人工显微镜检查以进行准确检测。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Evaluation of the fully automated urine particle analyzer UF-1500.

Background and aims: This study primarily assessed the performance of the UF-1500, the novel and compact model of the fully automated urine particle analyzer and evaluated its performance against the existing UF-5000 instrument.

Materials and methods: A total of 648 residual urine specimens were randomly collected and examined using both the UF-1500 and UF-5000 instruments as well as manual microscopy. For each parameter, the concordance rates and detection accuracy of the UF-1500 against manual microscopy were compared with the UF-5000.

Results: The concordance rates between the UF-1500 and manual microscopy were 75.3%-98.5%. The UF-1500 concordance rates within one group agreement were observed to be >90%, for all parameters except for YLCs. The differences within one group agreement between the UF-1500 and manual microscopy were insignificant, in comparison to the UF-5000, with exceptions noted for ECs and YLCs. The sensitivity and specificity of the UF-1500 for RBCs, WBCs, Squa.ECs, and BACT exceeded 80%, while the positive predictive values of ECs and CASTs were below 70%.

Conclusion: The UF-1500 exhibited a performance that was comparable to the existing instrument, the UF-5000, and was suitable to be introduced in clinical practice. For the samples with suspected false-positive or false-negative results, a manual microscopic examination is required for accurate testing.

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来源期刊
Journal of Clinical Laboratory Analysis
Journal of Clinical Laboratory Analysis 医学-医学实验技术
CiteScore
5.60
自引率
7.40%
发文量
584
审稿时长
6-12 weeks
期刊介绍: Journal of Clinical Laboratory Analysis publishes original articles on newly developing modes of technology and laboratory assays, with emphasis on their application in current and future clinical laboratory testing. This includes reports from the following fields: immunochemistry and toxicology, hematology and hematopathology, immunopathology, molecular diagnostics, microbiology, genetic testing, immunohematology, and clinical chemistry.
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