DRVVT法检测狼疮抗凝物标准化流程的建立及应用结果分析

但刚; 孙巍; 陈清红; 胡莉娜; 郭郑斌; 张建华; 张睿; 刘媛

doi:10.16766/j.cnki.issn.1674-4152.003643

DRVVT法检测狼疮抗凝物标准化流程的建立及应用结果分析

doi: 10.16766/j.cnki.issn.1674-4152.003643

中国人民解放军西部战区总医院检验科，四川成都 610083

基金项目:

四川省科技厅重点研发项目 2021YJ0191

详细信息

通讯作者:
刘媛，E-mail：liuyuan198231@163.com

中图分类号: R593 R446.11
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出版历程
- 收稿日期: 2024-03-18
- 网络出版日期: 2024-11-19

Establishment and application of standard operation procedure for the entire process of lupus anticoagulant DRVVT detection

Department of Laboratory Medicine, the General Hospital of Western Theater Command PLA, Chengdu, Sichuan 610083, China

摘要

摘要: 目的探讨建立使用稀释鲁赛尔蝰蛇毒时间(DRVVT)法检测狼疮抗凝物(LA)全流程的标准化程序，以保证LA检测结果准确性并为临床诊断治疗提供支撑。方法本研究遵循相关行业要求，包括《医疗机构实验室管理办法》和《临床血液学检验常规项目分析质量要求WS/T 406-2012》等，从DRVVT法检测LA整个流程包含检验前、检验中、检验后等阶段，对检测步骤进行全程标准化要求，建立以标准操作流程为核心的“DRVVT法狼疮抗凝物检测手册”，并对检测结果进行全流程的跟踪监控，以确保LA检测结果的准确性，并为临床诊断治疗提供支持。本研究对象为西部战区总医院2021—2023年进行LA检测的共计3 595例标本，通过对送检标本量、送检科室分布、年度增长量等方面进行分析，探讨标准化检测流程建立后临床对此项目的认可程度、对疾病诊断准确度等方面的提升效果。结果通过建立一系列标准化的操作和检测流程，实现对检测结果有效监控，能准确反映患者体内LA的含量，为诊断和治疗提供有效支持。随着标准化流程的持续展开，临床对相关项目的认可度持续提升，送检科室和送检量持续上升。送检量从2021年的841例上升到2023年的1 460例，增大幅度为73.0%；从送检科室的分布来看：2021年送检科室16个，2023年达到29个，增长幅度为81.3%；完全达到了支撑临床、与临床积极互动的良好效果。结论建立针对DRVVT法LA检测的标准化程序，可以为临床提供准确、真实反映病情的检测结果，加深与临床的沟通，并对相关性疾病的诊断和治疗起到积极的支持作用。
- 狼疮抗凝物 /
- 稀释鲁赛尔蝰蛇毒时间 /
- 标准化操作
Abstract: Objective To investigate the standardized procedure for the entire process of lupus anticoagulant (LA) detection using the dilute Russell viper venom time (DRVVT) method to ensure the accuracy of LA test results and to aid in clinical diagnosis and treatment. Methods This study followed relevant industry requirements, including "Management Measures for Medical Institution Laboratory Management" and "Quality Requirements for Routine Analysis of Clinical Hematology Tests WS/T 406-2012". The entire process of LA detection using the DRVVT method, including pretest, test and posttest phases stages, was standardized. A "DRVVT Method Lupus Anticoagulant Detection Manual" was created based on standard operating procedures (SOP), and test results were tracked and monitored throughout the process to ensure the accuracy of LA test results and to aid in clinical diagnosis and treatment. The study included a total of 3 595 specimens for LA testing in General Hospital of Western Theater Command PLA, from 2021 to 2023. By analyzing aspects such as the number of specimens submitted, the distribution of submitting departments and annual growth, the study examined the degree of clinical recognition of this project and the improvement in the accuracy of disease diagnosis after establishing a standardized testing process. Results By establishing a set of standardized operation and detection procedures, we can effectively monitor the test results, and accurately reflect the concentration of LA in patients, to provide effective support for diagnosis and treatment. With the continuous implementation of standardized procedures, the clinical recognition of relevant items has been improved, leading to a sustained increase in the number of specimens and departments submitting specimen. The number of specimens increased from 841 in 2021 to 1 460 in 2023, with a growth rate of 73.0%. In terms of departments submitting specimen, there were 16 departments in 2021 and this number reached 29 departments in 2023, with a growth rate of 81.3%. This has fully achieved the desired effect of supporting the clinic and actively interacting with the clinical department. Conclusion Establishing a standard process for the detection of LA can provide accurate and truthful detection results to the clinical, deepen communication with the clinical on related diseases, and play a positive role in supporting the diagnosis and treatment of related diseases.
- Lupus anticoagulant /
- Dilute Russell ' s viper venom time /
- Standard operating procedure

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图 1 LA检测及混合试验结果分析流程

Figure 1. LA test and mixed test results analysis process

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表 1 常见影响LA检测的抗凝药物

Table 1. Common anticoagulant drugs that affect LA detection

序号	抗凝药物	服药后处置流程
1	肝素	停药24 h后抽血
2	低分子肝素	停药24 h后抽血
3	Ⅹa因子抑制剂：利伐沙班，阿哌沙班，艾多沙班	停药1 d后抽血
4	Ⅱa因子抑制剂：达比加群酯	停药1 d后抽血
5	抑制维生素K依赖的作用：华法林/双香豆素	建议停药3 d后抽血

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表 2 2021—2023年全院LA送检量情况

Table 2. The situation of number of specimens submitted for LA examination in the whole hospital from 2021 to 2023

送检量	2021年	2022年	2023年
年度送检量(例)	841	1 294	1 460
月平均送检量(例)	70	108	122
送检科室量(个)	16	22	29
科室分布(个)
内科	11	14	17
外科	5	8	12

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表 3 2021—2023年各科室LA送检量分析

Table 3. The analysis of number of specimens submitted for LA examination in each department from 2021 to 2023

2021年			2022年			2023年
科室	年送检量(例)	月均送检量(例/月)	科室	送年检量(例)	月均送检量(例/月)	科室	年送检量	月均送检量(例/月)
风湿免疫科	548	45.7	风湿免疫科	823	68.6	风湿免疫科	926	77.2
呼吸科	65	5.4	呼吸科	103	8.6	呼吸科	117	9.8
神经内科	62	5.2	神经内科	100	8.3	神经内科	88	7.3
消化内科	48	4.0	消化内科	62	5.2	消化内科	73	6.1
内分泌科	20	1.7	心血管内科	42	3.5	妇产科	56	4.6
全科医学科	17	1.4	妇产科	29	2.4	心血管内科	28	2.3
干部病房	16	1.3	中医科	22	1.8	血液科	27	2.2
中医科	14	1.2	干部病房	21	1.8	全科医学科	20	1.7
心血管内科	14	1.2	全科医学科	18	1.5	内分泌	18	1.5
妇产科	13	1.1	内分泌科	18	1.5	中医科	18	1.5
血液科	6	0.5	血液科	16	1.3	干部病房	13	1.1
重症医学科	5	0.4	重症医学科	8	0.7	骨科	13	1.1
眼科	5	0.4	眼科	7	0.6	心胸外科	8	0.7
综合	4	0.3	急诊医学科	6	0.5	肿瘤科	7	0.6
骨科	3	0.3	麻醉疼痛科	5	0.4	儿科	6	0.5
耳鼻喉科	1	0.1	肝胆胰科	5	0.4	急诊医学科	6	0.5
			骨科	4	0.3	重症医学科	6	0.5
			肿瘤科	4	0.3	口腔科	5	0.4
			皮肤科	2	0.2	泌尿外科	5	0.4
			耳鼻喉科	2	0.2	综合门诊	4	0.3
			儿科病房	2	0.2	皮肤科	3	0.3
			创伤中心	1	0.1	烧伤整形科	3	0.3
						肝胆胰	3	0.3
						皮肤	3	0.3
						耳鼻喉科	2	0.2
						康复医学科	2	0.2
						麻醉疼痛	1	0.1
						神经外科	1	0.1
						眼科	1	0.1
注：月均送检量=年送检量/12。

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