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将 COVID-19 血清学检测用于 SARS-CoV-2 疫苗接种运动中的伴随诊断的卫生技术评估。

Health technology assessment to employ COVID-19 serological tests as companion diagnostics in the vaccination campaign against SARS-CoV-2.

机构信息

Università Vita-Salute San Raffaele, Milan, Italy.

IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.

出版信息

Clin Chem Lab Med. 2022 Jun 24;60(9):1463-1477. doi: 10.1515/cclm-2022-0262. Print 2022 Aug 26.

Abstract

OBJECTIVES

In scenarios of vaccine scarcity or contexts of organizational complexity, it is necessary to define prioritization strategies for allocating vaccine doses in compliance with the criterion of equity and efficiency of health resources. In this context, the COVIDIAGNOSTIX project, based on the health technology assessment (HTA), assessed the role of SARS-CoV-2 serological tests as a companion diagnostic in the definition of the vaccination strategies for the vaccine administration. To guarantee evidence support for health policy choices, two different vaccine strategies were analyzed, one based on administering the vaccine booster dose to the entire population (VACCINE strategy) and the other based on allocation criteria (TEST&VACCINE strategy).

METHODS

The decision-oriented HTA (DoHTA) method, integrated with specific modeling and simulation techniques, helped define the perimeter to make health policy choices.

RESULTS

The processing of the scores attributed to the key performance indicators concerning all the evaluation domains shows a performance of 94.34% for the TEST&VACCINE strategy and 83.87% for the VACCINE strategy.

CONCLUSIONS

TEST&VACCINE strategy can be the most advantageous in various scenarios due to greater speed from an operational and an economic point of view. The assessment schemes defined by COVIDIAGNOSTIX (i.e., technologies/intended use/settings) can easily and quickly be exported and adapted to respond to similar health "policy questions".

摘要

目的

在疫苗短缺或组织复杂的情况下,有必要根据公平和卫生资源效率的标准,制定疫苗分配的优先化策略。在这方面,COVIDIAGNOSTIX 项目基于卫生技术评估(HTA),评估了 SARS-CoV-2 血清学检测作为伴随诊断在定义疫苗接种策略中的作用,以用于疫苗接种管理。为了保障卫生政策选择的证据支持,分析了两种不同的疫苗策略,一种基于为整个人群接种疫苗加强针(VACCINE 策略),另一种基于分配标准(TEST&VACCINE 策略)。

方法

面向决策的 HTA(DoHTA)方法,结合特定的建模和模拟技术,有助于确定做出卫生政策选择的范围。

结果

处理与所有评估领域相关的关键绩效指标的得分表明,TEST&VACCINE 策略的性能为 94.34%,VACCINE 策略的性能为 83.87%。

结论

由于从运营和经济角度来看速度更快,TEST&VACCINE 策略在各种情况下可能更具优势。COVIDIAGNOSTIX 定义的评估方案(即技术/预期用途/设置)可以轻松快速地导出和调整,以应对类似的卫生“政策问题”。

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