ABSTRACT

Introduction

Although, in the past few decades molecular diagnostics of parasitic infections have been accepted as first-line diagnostics, laboratories tend to be reluctant of introducing nucleic acid based tests as they dread the validation of laboratory developed tests (LDTs) compliant with ISO1589.

Areas covered

This paper describes how to set tailor-made performance characteristics for the validation of laboratory developed tests (LDTs) for the molecular diagnosis of intestinal parasitic infections complying with the ISO 15189 guidelines. Then, just as important, maintaining these tests by daily monitoring, external quality assessment schemes, and reassessment of the test set-up.

Expert opinion

Tailoring performance characteristics for the validation of LDTs defining criteria that make sense and actually leading to a process of continuous quality improvement in the day-to-day practice of a diagnostic laboratory. It is essential or even obligatory to modify these characteristics, skip, or to add additional characteristics based on personal or changing insights fitted for a specific setting.

中文翻译：

---

验证和维护实验室开发了符合 ISO15189 的分子测试，用于诊断肠道寄生虫感染

摘要

介绍

尽管在过去的几十年中，寄生虫感染的分子诊断已被接受为一线诊断，但实验室往往不愿引入基于核酸的测试，因为他们害怕验证符合 ISO1589 的实验室开发测试 (LDT)。

涵盖的领域

本文描述了如何为符合 ISO 15189 指南的肠道寄生虫感染分子诊断的实验室开发测试 (LDT) 的验证设置量身定制的性能特征。然后，同样重要的是，通过日常监控、外部质量评估计划和重新评估测试设置来维护这些测试。

专家意见

定制用于验证 LDT 的性能特征，定义有意义的标准，并在诊断实验室的日常实践中实际导致持续质量改进的过程。根据适合特定环境的个人或不断变化的见解，修改这些特征、跳过或添加其他特征是必不可少的，甚至是强制性的。