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Siemens Advia 2120血细胞分析仪复检规则的制定及应用 被引量:21

Establishment of review criteria for Siemens Advia 2120 hematology analyzer and its application
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摘要 目的 建立Siemens Advia 2120血细胞分析仪的复检规则,并详细分析规则建立的必要环节,以期对其他医院建立合理的复检规则提供依据.方法 采集北京协和医院30个临床科室的1223份血标本,通过血细胞分析仪检测血常规,通过人工镜检法进行血细胞计数和形态学检查,参考国际血液学复检专家组制定的"41条"规则,通过调整规则降低假阳性率,控制漏诊率,建立适合本医院的血细胞分析的复检规则,并通过301例血液病、肿瘤放化疗及感染等有阳性或假阳性倾向的病例验证规则的有效性.结果 根据"41条"规则,复检率高达37.9%(464/1223),假阳性率为23.3%(285/1223),漏诊率为1.9%(23/1223),无血液恶性肿瘤漏诊.假阳性病例中占据前8位的单条触发规则依次为:小红细胞、大红细胞、不均一性红细胞、核左移、WBC〈4.0×109/L或〉30.0×109/L、未成熟细胞、原始细胞和PLT〈100.0×109/L或〉1000.0×109/L.未成熟细胞和原始细胞是血液恶性肿瘤容易出现的提示,不能被删除;核左移与重度细菌性感染密切相关,与WBC具有部分相同的意义,不被首先考虑改变;删除小红细胞(+)、大红细胞(+)和不均一性细胞(+);WBC由〈4.0×109/L降至〈3.0×109/L;PLT由〈100.0×109/L降至〈80.0×109/L,由此,假阳性率降至17.5%(214/1223),复检率降至31.1%(380/1223),漏诊率略上升为2.9%(36/1223),无血液恶性肿瘤漏诊,从而形成本医院Siemens Advia 2120血细胞分析仪的复检规则,有效性验证的漏诊率为0.结论 "41条"规则适用于Siemens Advia 2120血细胞分析仪,但复检率过高不被大型医院采用,优化后,规则的复检率和漏诊率具有临床可操作性和有效性. Objective To establish the blood smear review criteria for Siemens Advia 2120,and the detailed description of all the implement procedures could be helpful for other hospitals when they set up their own review criteria. Methods The total 1223 blood samples were collected from 30 clinical departments in Peking Union Medical College Hospital. After detection by Advia 2120, blood smear examination was complemented to provide CBC and morphology information. The suggested criteria by international consensus group for hematology review ( "41 rules" ) was used to analyze all the data. Based on the statistics, the rules were adjusted in order to reduce the false positive rate and keep the false negative rate acceptable by clinical. After establishment of the review criteria, another 301 samples were tested for validation. Results Using the original "41 rules", the study got a high review rate of 37.9% (464/ 1223), false positive rate of 23. 3% (285/1223 ) and false negative rate of 1.9% ( 23/1223), and no leukemia was missed. Among the false positive cases, the most cases triggered 8 rules: Micro RBC, Macro RBC, Aniso RBC, Left shift, WBC 〈4. 0 × 109/L or 〉30 × 109/L, immature granucyte (IG) , Blast, and PLT 〈 100. 0×109/L or 〉 1 000. 0 × 109/L. Using the adjusted rules, the review rate and false positive rate were both reduced to 31. 1% and 17. 5% , The false negative rate increased a little bit, to 2. 9%. No leukemia missing was observed. Validated by 301 samples, the optimized rules showed no false negative case. Conclusions When applied to Siemens Advia 2120 analyzer, "41 rules" shows a high review rate which was unpractical in the routine work due to a very high sample volume. The optimized review criteria are suitable and practical for the routine work and can meet the need of clinical in both review rate and false negative rate. The method of establishing the review criteria can be used as reference for other hospital.
出处 《中华检验医学杂志》 CAS CSCD 北大核心 2010年第7期674-679,共6页 Chinese Journal of Laboratory Medicine
关键词 血细胞计数 血液学试验 诊断设备 自动分析 评价研究 Blood cell count Hematologic tests Diagnostic equipment Autoanalysis Evaluation studies
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