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粪便自动化分析仪及室内质控品的临床应用评价

Evaluation on clinical application of automatic stool analyzer and internal quality control

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【作者】 修梦凡刘海刘婷于凡缪泉

【Author】 XIU Mengfan;LIU Hai;LIU Ting;YU Fan;MIAO Quan;Department of Clinical Laboratory,West China Second Hospital,Sichuan University/Education Ministry Key Laboratory of Birth Defects and Related Diseases of Women and Children Chengdu;

【通讯作者】 缪泉;

【机构】 四川大学华西第二医院检验科/出生缺陷与相关妇儿疾病教育部重点实验室

【摘要】 目的评价LTS-E100和FA160两种型号粪便自动化分析仪检测粪便标本的临床应用价值及对FA160配套室内质控品的适用性进行分析。方法收集该院2019年6—10月门诊患者的新鲜粪便标本共1 250份,分别应用LTS-E100、FA160两种粪便自动化分析仪和人工镜检法进行粪便常规检测,以人工镜检法作为金标准,对两种分析仪对红细胞、白细胞、脂肪球及似酵母样菌的检出结果进行比较、分析,观察结果的一致性。同时,使用两种仪器分别对FA160配套粪便形态学质控品进行20次检测并分析其结果。结果在1 250份粪便常规检查标本中,LTS-E100、FA160粪便全自动分析仪检测灵敏度分别为红细胞:85.0%、88.0%;白细胞:79.6%、81.3%;脂肪球:86.2%、87.9%;似酵母样菌:71.1%、86.7%。特异度分别为红细胞:98.6%、99.6%;白细胞:97.5%、98.0%;脂肪球:90.6%、99.2%;似酵母样菌:99.7%、99.8%。假阴性率分别为红细胞:2.5%、1.9%;白细胞:6.4%、5.9%;脂肪球:1.4%、1.2%;似酵母样菌:1.1%、0.5%。室内质控品测定结果显示,与其提供的靶值相比,LTS-E100的质控结果中白细胞和似酵母样菌的符合率分别为95.0%、90.0%,红细胞和脂肪球的符合率均为100.0%,FA160各项指标的室内质控结果符合率均为100.0%。结论 LTS-E100和FA160两种粪便自动化分析仪检测粪便常规各指标与人工镜检法有较好的一致性,在临床日常工作中有较高的应用价值,但并不能完全替代人工镜检,遇到阳性标本时仍需人工复核。另外,FA160配套室内质控品亦适用于LTS-E100作为定性质控品,该质控品具有临床推广价值。

【Abstract】 Objective To evaluate the clinical application value of the two types of automatic stool analyzers LTS-E100 and FA160,and to analyze the applicability of the supporting internal quality control products in FA160.Methods A total of 1 250 outpatients′ fresh stool specimens in this hospital from June to October 2019 were collected and conducted the stool routine detection by the manual microscopy and the two kinds of automatic stool analyzers LTS-E100 and FA160.The results of manual microscopy served as the gold standard, the detection results of red blood cells(RBC),white blood cells(WBC),fat globules and yeast like bacteria were analyzed and compared between the two analyzers.The results consistency was observed.Meanwhile, the LTS-E100 and FA160 instruments were used to conduct 20 tests on the supporting fecal morphologic quality control products provided by FA160,and the results were analyzed.Results In 1 250 cases of routine stool examination specimens, the sensitivities of LTS-E100 and FA160 were 85.0% and 88.0% for RBC;79.6% and 81.3% for WBC;86.2% and 87.9% for fat globules; 71.1% and 86.7% for yeast like bacteria.The specificities were 98.6% and 99.6% for RBC;97.5% and 98.0% for WBC;90.6% and 99.2% for fat globules; 99.7% and 99.8% for yeast like bacteria.The false negative rates were 2.5% and 1.9% for RBC;6.4% and 5.9% for WBC;1.4% and 1.2% for fat globules; 1.1% and 0.5% for yeast like bacteria.The internal quality control test results showed that compared with the target values provided by the quality control products, the coincidence rates of WBC and yeast like bacteria in the LTS-E100 quality control results were 95.0% and 90.0% respectively, which of RBC and fat globules were 100.0%,and which of the internal quality control results in FA160 items were 100.0%.Conclusion Both LTS-E100 and FA160 automatic stool analyzer have good consistency with the manual microscopic examination method for routine stool indicators, and have high application value in clinical daily work.However, they can not completely replace the manual microscopic examination, the manual review is still required when the positive specimen is encountered.In addition, the internal quality control products provided by FA160 can also be applied to LTS-E100 as the qualitative quality control products, which has the clinical promotion value.

【基金】 国家自然科学基金项目(81801628)
  • 【文献出处】 国际检验医学杂志 ,International Journal of Laboratory Medicine , 编辑部邮箱 ,2022年04期
  • 【分类号】R446.13
  • 【下载频次】73
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