Real-World Retrospective Audit on the Use of the TechnoClone TECHNOSCREEN ADAMTS-13 Assay in the Diagnostic Process for Thrombotic Thrombocytopenic Purpura at LabPlus, New Zealand

IF 2.2 4区医学 Q3 HEMATOLOGY

International Journal of Laboratory Hematology Pub Date : 2024-12-18 DOI:10.1111/ijlh.14413

Stephen Hong Chun Wong, Gabriel Thalari, Anna Ruskova, Nicola Eaddy

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引用次数: 0

Abstract

Introduction

The TECHNOSCREEN ADAMTS-13 assay (ADSC) is a new lateral flow test which is simple and quick to perform, with a high negative predictive value (NPV); it may improve the diagnostic workflow for TTP. LabPlus in Auckland, New Zealand, performs all ADAMTS13 tests in the Auckland and Northland regions. The ADSC was used at LabPlus between 2022 and 2023 as part of a protocol where results of 0 IU/mL and 0.1 IU/mL were confirmed with the TECHNOZYM ADAMTS-13 Activity chromogenic ELISA assay (ADATS). The aim was to improve cost efficiency by reducing the need for the labour-intensive ADATS, particularly in low probability requests. This retrospective audit analyses the efficacy and efficiency of the testing protocol.

Methods

All ADAMTS-13 tests performed in the year before the ADSC (March 2021–March 2022) and after the ADSC protocol was introduced (March 2022–March 2023) were collected from the LabPlus laboratory information system (LIS), and correlated with clinical information from the electronic health record. Statistical analysis was performed.

Results

Ninety-four test requests were audited. ADSC had an NPV of 100% on diagnostic samples. The protocol increased the median turn-around time (TAT) by 18 h (p = 0.01). If an ADSC of 0.1 IU/mL was taken as a negative, the median TAT was decreased by 17 h (p = 0.0003) in diagnostic samples from LabPlus adjacent hospitals.

Conclusion

ADSC has a high NPV but did not improve TAT when used as part of a testing protocol for our central laboratory receiving samples from a large area.

查看原文本刊更多论文

新西兰LabPlus公司在血栓性血小板减少性紫癜诊断过程中使用TechnoClone TECHNOSCREEN ADAMTS-13检测的真实世界回顾性审计。

介绍：TECHNOSCREEN ADAMTS-13试验（ADSC）是一种新的横向流动试验，操作简单、快速，具有很高的阴性预测值（NPV）；它可以改善TTP的诊断工作流程。位于新西兰奥克兰的LabPlus在奥克兰和北国地区执行所有ADAMTS13测试。ADSC于2022年至2023年在LabPlus作为方案的一部分使用，其中使用TECHNOZYM ADAMTS-13活性显色ELISA法（ADATS）确认结果为0 IU/mL和0.1 IU/mL。其目的是通过减少对劳动密集型ADATS的需求，特别是在低概率请求中，来提高成本效率。这次回顾性审核分析了测试方案的有效性和效率。方法：从LabPlus实验室信息系统（LIS）中收集ADSC前一年（2021年3月至2022年3月）和ADSC方案引入后一年（2022年3月至2023年3月）进行的所有ADAMTS-13测试，并与电子健康记录中的临床信息进行关联。进行统计学分析。结果：审核了94个测试请求。ADSC对诊断样本的NPV为100%。该方案使中位周转时间（TAT）延长18 h （p = 0.01）。如果以0.1 IU/mL的ADSC为阴性，来自LabPlus邻近医院的诊断样本的中位TAT降低了17小时（p = 0.0003）。结论：ADSC具有较高的净现值，但当作为我们中心实验室接收大面积样品的测试方案的一部分时，并没有改善TAT。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Laboratory Hematology 医学-血液学

CiteScore

4.50

自引率

6.70%

发文量

211

审稿时长

6-12 weeks

期刊介绍： The International Journal of Laboratory Hematology provides a forum for the communication of new developments, research topics and the practice of laboratory haematology. The journal publishes invited reviews, full length original articles, and correspondence. The International Journal of Laboratory Hematology is the official journal of the International Society for Laboratory Hematology, which addresses the following sub-disciplines: cellular analysis, flow cytometry, haemostasis and thrombosis, molecular diagnostics, haematology informatics, haemoglobinopathies, point of care testing, standards and guidelines. The journal was launched in 2006 as the successor to Clinical and Laboratory Hematology, which was first published in 1979. An active and positive editorial policy ensures that work of a high scientific standard is reported, in order to bridge the gap between practical and academic aspects of laboratory haematology.