血细胞分析系统自动审核规则建立与确认

Establishment and Validation of Automatic Verification Procedures for Blood Cell Analysis System

目的:建立一套血细胞分析系统的自动审核规则,并对该套规则进行有效性验证。方法:参照国际血液学组织提出的"41条复检规则"及Mindray BC-6800全自动血细胞分析仪的技术水平,建立初步的样本审核规则并录入Mindray lab Xpert样本审核系统;选取上海瑞金医院约1000例临床样本对规则的假阳性、假阴性及自动审核通过率等指标进行验证;根据验证结果对规则进行调整及确认,规则确认后选取不少于1万例样本进行自动审核验证,测试自动审核通过率,人工审核所占比例及镜检审核所占比例。结果:对初步的审核规则验证结果表明,假阴性率小于2%,假阴性的样本主要为中晚幼粒细胞低值(幼稚比例在3%以内)红细胞形态异常及血小板形态异常等情况,假阴性样本中不存原始细胞增多及幼稚比例3%以上的样本,临床风险较小;假阳性率较高,接近18%,从而也影响了自动审核通过率。根据假阳性分析结果对规则进行了调整,规则调整后,假阴性率与调整前基本一致,但假阳性率有明显降低,且自动审核通过率有较大的提升;采用确定的规则运行了1万多例样本,自动审核通过率为76.4%。而导致自动审核不通过的主要因素为IMG%增高、未成熟细胞报警及WBC超出设定的范围等因素;采用该套系统后,平均TAT(turnaround time)缩短了4.1分钟。结论:采用Mindray CAL 8000血细胞分析系统及配套的Lab Xpert样本审核软件对样本进行分析及自动审核,制定严谨的自动审核规则,可以保证较低假阴性前提下,实现大部分样本自动审核(75%以上),提高检验科的工作效率。同时医生可以将更多的时间与精力用于异常样本复检上,使血常规报告的质量大大提高。

Objective： To establish a series of automatic verification procedures for blood cell analysis system, and verify the validity of these procedures. Methods： The initial verification procedures were established and input into Mindray labXpert sample verification system by reference to ＂41 review rules＂ settled by the international henaatological organization and the technical level of M indray BC-6800 automatic blood cell analyzer, About 1000 blood samples were collected from Shanghai Ruijin Hospital and detected by Mindray BC-6800 to achieve false positive rate, false negative rate and the pass rate of automatic verification of such initial procedures. After analyzed the obtained data, the verification procedures were adjusted and confirmed. Subsequently more than 10000 blood samples were collected to test the pass rate of automatic verification, the proportion of human review and the proportion of microscopic examination. Results： The results of initial automatic verification procedures examination showed that false negative rate was lower than 2% and false positive rate was relatively high that is almost 18%.And the false negative samples were the samples with low level of myelocyte and metamyelocyte （naive ratio is less than 3%）, abnormal morphological erythrocyte, abnormal morphological platelet and so on. And what is most important that there was no false negative sample with increased archaeocytc or more than 3% naive ratio, leaving small clinical risk. Relatively high false positive rate also influenced the pass rate of automatic verification. Verification procedures were adjusted by reference to false positive results, and after adjustment, false negative rate had a great consistency with before and false positive rate had a significant reduction along with the rising of pass rate of automatic verification. More than 10000 blood samples were detected under the confirmed automatic verification procedures, and the pass rate of automatic verification was 76.4%. The major factors influence the pass rate of automatic verification were that increasing IMG%, warning of immature blood cells, WBC counting beyond setting and so on. Moreover, average turnaround time was shortened 4.1 minutes after such procedures were employed. Conclusion： Mindray CAL 8000 blood cell analysis system and suitable LabXpert sample verification soRware were employed and simultaneously precise automatic verification procedures were settled. ARer that more than 75% blood samples could be automatic verified with assured lower false negative rate, leaving higher work efficiency in department of laboratory. At the sarae time, doctors could spend more time and energy on the review of abnormal samples, to improve the quality of blood routine report greatly.