一种新型的 29 信使 RNA 宿主反应检测方法，可从全血中准确识别因疑似感染而就诊于急诊科的患者中的细菌和病毒感染：一项前瞻性观察研究。

A Novel 29-Messenger RNA Host-Response Assay From Whole Blood Accurately Identifies Bacterial and Viral Infections in Patients Presenting to the Emergency Department With Suspected Infections: A Prospective Observational Study.

机构信息

Department of Emergency Medicine, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Campus Benjamin Franklin, Berlin, Germany.

Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Institute of Laboratory Medicine, Clinical Chemistry and Pathobiochemistry, Berlin, Germany.

出版信息

Crit Care Med. 2021 Oct 1;49(10):1664-1673. doi: 10.1097/CCM.0000000000005119.

DOI:10.1097/CCM.0000000000005119

PMID:34166284

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8439671/

Abstract

OBJECTIVES

The rapid diagnosis of acute infections and sepsis remains a serious challenge. As a result of limitations in current diagnostics, guidelines recommend early antimicrobials for suspected sepsis patients to improve outcomes at a cost to antimicrobial stewardship. We aimed to develop and prospectively validate a new, 29-messenger RNA blood-based host-response classifier Inflammatix Bacterial Viral Non-Infected version 2 (IMX-BVN-2) to determine the likelihood of bacterial and viral infections.

DESIGN

Prospective observational study.

SETTING

Emergency Department, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin, Germany.

PATIENTS

Three hundred twelve adult patients presenting to the emergency department with suspected acute infections or sepsis with at least one vital sign change.

INTERVENTIONS

None (observational study only).

MEASUREMENTS AND MAIN RESULTS

Gene expression levels from extracted whole blood RNA was quantified on a NanoString nCounter SPRINT (NanoString Technologies, Seattle, WA). Two predicted probability scores for the presence of bacterial and viral infection were calculated using the IMX-BVN-2 neural network classifier, which was trained on an independent development set. The IMX-BVN-2 bacterial score showed an area under the receiver operating curve for adjudicated bacterial versus ruled out bacterial infection of 0.90 (95% CI, 0.85-0.95) compared with 0.89 (95% CI, 0.84-0.94) for procalcitonin with procalcitonin being used in the adjudication. The IMX-BVN-2 viral score area under the receiver operating curve for adjudicated versus ruled out viral infection was 0.83 (95% CI, 0.77-0.89).

CONCLUSIONS

IMX-BVN-2 demonstrated accuracy for detecting both viral infections and bacterial infections. This shows the potential of host-response tests as a novel and practical approach for determining the causes of infections, which could improve patient outcomes while upholding antimicrobial stewardship.

摘要

目的

急性感染和脓毒症的快速诊断仍然是一个严峻的挑战。由于当前诊断方法的局限性，指南建议对疑似脓毒症患者早期使用抗生素，以提高治疗效果，但这是以牺牲抗菌药物管理为代价的。我们旨在开发和前瞻性验证一种新的、基于 29 个信使 RNA 的宿主反应分类器 Inflammatix 细菌病毒非感染版本 2（IMX-BVN-2），以确定细菌和病毒感染的可能性。

设计

前瞻性观察性研究。

地点

德国柏林夏洛蒂医科大学本杰明富兰克林校区急诊部。

患者

312 名成年患者因疑似急性感染或脓毒症就诊，至少有一项生命体征改变。

干预措施

无（仅观察性研究）。

测量和主要结果

从提取的全血 RNA 中定量测量基因表达水平，并使用 NanoString nCounter SPRINT（NanoString Technologies，西雅图，WA）进行检测。使用 IMX-BVN-2 神经网络分类器计算了存在细菌和病毒感染的两个预测概率评分，该分类器是在独立的开发集上进行训练的。与降钙素相比，IMX-BVN-2 细菌评分对确诊细菌感染与排除细菌感染的受试者工作特征曲线下面积为 0.90（95%置信区间，0.85-0.95），而降钙素的受试者工作特征曲线下面积为 0.89（95%置信区间，0.84-0.94）。IMX-BVN-2 病毒评分对确诊病毒感染与排除病毒感染的受试者工作特征曲线下面积为 0.83（95%置信区间，0.77-0.89）。