[ADVIA 120/2120及不同系列血液分析仪的评审标准制定与评估]

[Establishment and evaluation of review criteria for ADVIA 120/2120 and different series of hematology analyzers].

作者信息

Xing Ying, Wang Jian-Zhong, Pu Cheng-Wei, Shang Ke, Yan Zhen-Lin, Bai Yu-Zhu, Yang Wen-Shuang, Li Tao, Zhang Shi-Min

机构信息

Department of Laboratory Medicine, Peking University First Hospital, Beijing 100034, China.

出版信息

Zhonghua Yi Xue Za Zhi. 2010 Jun 8;90(22):1526-30.

PMID:20973232

Abstract

OBJECTIVE

To establish the suitable review criteria for ADVIA 120/2120 and those for different series of hematology analyzers.

METHODS

A total of 2400 samples, including 6 blood neoplasms, were detected with ADVIA 120/2120 hematology analyzer, in which 1200 samples were detected by Sysmex XE-2100 and Beckman-Coulter LH750 hematology analyzers. In the meantime, blood smears were reviewed, and the results were analyzed statistically. The new review criteria were established by consulting and modifying the one as recommended by an international consensus group. Finally 300 samples were selected to validate the new review criteria.

RESULTS

The results of 2400 samples detected by ADVIA 120/2120 hematology analyzer were analyzed statistically according to the international consensus review rules and blood smear positive criteria formulated by Chinese experts. The true positive rate was 22.1% (n = 530), false positive rate 28.1% (n = 675), true negative rate 44.3% (n = 1063), false negative rate 5.5% (n = 132), and the smear review rate 50.2% (n = 1205). The false negative rate was over the acceptable limit of 5%. The new review criteria were established by amending the blood smear positive criteria, i. e. increasing the percentage of band neutrophils, eosinophils, basophils and monocytes and adjusting the international consensus review rules. Then the results were re-analyzed. The true positive rate, false positive rate, true negative rate and false negative rate were 15.5% (n = 371), 18.7% (n = 449), 61.6% (n = 1479) and 4.2% (n = 101) respectively. The smear review rate was 34.2% (n = 821) and no specimen of blood neoplasms was missed. On that basis, the current review criteria for ADVIA 120/2120, XE-2100 and LH750 hematology analyzer were proposed by adding some specific parameters. The results of 1200 samples with three instruments were analyzed according to the current criteria. And the false negative rates were 4.3%, 4.6% and 4.6%, and false positive rate 14.7%, 17.5% and 12.7% respectively. And no specimen of blood neoplasm was missed. The false negative rates of three instruments were 3.8%, 4.3% and 4.0% in validation teses.

CONCLUSION

The review criteria for three different series of hematology analyzers have been formulated for large general hospitals.

摘要

目的

建立适用于ADVIA 120/2120及不同系列血液分析仪的审核标准。

方法

用ADVIA 120/2120血液分析仪检测包括6种血液肿瘤在内的共2400份样本，其中1200份样本同时用Sysmex XE - 2100和贝克曼 - 库尔特LH750血液分析仪检测。同时进行血涂片审核，并对结果进行统计学分析。通过参考并修改国际共识小组推荐的审核标准建立新的审核标准。最后选取300份样本验证新的审核标准。

结果

按照国际共识审核规则及中国专家制定的血涂片阳性标准，对ADVIA 120/2120血液分析仪检测的2400份样本结果进行统计学分析。真阳性率为22.1%（n = 530），假阳性率为28.1%（n = 675），真阴性率为44.3%（n = 1063），假阴性率为5.5%（n = 132），涂片审核率为50.2%（n = 1205）。假阴性率超过了可接受的5%的限度。通过修改血涂片阳性标准，即增加杆状核中性粒细胞、嗜酸性粒细胞、嗜碱性粒细胞和单核细胞的百分比并调整国际共识审核规则，建立了新的审核标准。然后重新分析结果。真阳性率、假阳性率、真阴性率和假阴性率分别为15.5%（n = 371）、18.7%（n = 449）、61.6%（n = 1479）和4.2%（n = 101）。涂片审核率为34.2%（n = 821），且未漏检血液肿瘤标本。在此基础上，通过增加一些特定参数，提出了当前ADVIA 120/2120、XE - 2100和LH750血液分析仪的审核标准。按照当前标准分析三种仪器检测的1200份样本结果。假阴性率分别为4.3%、4.6%和4.6%，假阳性率分别为14.7%、17.5%和12.7%。且未漏检血液肿瘤标本。验证试验中三种仪器的假阴性率分别为3.8%、4.3%和4.0%。