Diagnostic accuracy of a host response test in suspected community-Acquired pneumonia during the COVID-19 era

IF 4.3 2区医学 Q1 INFECTIOUS DISEASES

International Journal of Infectious Diseases Pub Date : 2025-09-02 DOI:10.1016/j.ijid.2025.108045

Christina S. Saghaug , Dagfinn L. Markussen , Siri T. Knoop , Benedicte C. Holvik , Sondre Serigstad , Elling Ulvestad , Christian Ritz , Synne Jenum , Harleen M.S. Grewal

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Abstract

Community-acquired pneumonia [CAP] is a leading cause of morbidity and mortality, often complicated by diagnostic uncertainty and antibiotic overuse. This study evaluated the MeMed BV® host-response test in adults with suspected CAP, using clinical management and molecular detection as reference standards.

Among 744 patients presenting with suspected CAP at Haukeland University Hospital, Bergen, Norway (2019-2023), across three prospective studies, 453 were included in the present study. Patients were classified using: [1] clinical management [antibiotic timing/duration], and [2] molecular detection via BioFire® FilmArray Pneumonia Plus panel on lower respiratory tract samples. MeMed BV® testing was performed retrospectively on stored serum/plasma, categorising results as bacterial, viral, or equivocal. Healthy controls [n = 20] were also tested.

Among 442 patients classified by clinical management, the MeMed BV® test demonstrated a positive percent agreement [PPA] of 90.0% (95% CI: 86.4-92.7) and a negative percent agreement [NPA] was 44.1% (95% CI: 34.4-54.2). In 370 patients classified by molecular testing, PPA was 88.2% (95% CI: 83.6-91.7) and NPA was 30.1% (95% CI: 20.8-41.4. Equivocal results occurred in 7.5%. The test agreed with clinical management in 96.1% of cases with no detected pathogen. None of the healthy controls had bacterial scores.

Conclusion

MeMed BV® demonstrated high sensitivity in identifying bacterial infections but limited specificity in viral infections, notably SARS-CoV-2. It may aid early triage when combined with clinical and microbiological data.

Trial registration

ClinicalTrials.gov NCT04660084

Abstract Image

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COVID-19时期宿主反应试验对疑似社区获得性肺炎的诊断准确性

社区获得性肺炎（CAP）是发病率和死亡率的主要原因，通常因诊断不确定和抗生素过度使用而复杂化。本研究以临床管理和分子检测为参考标准，对疑似CAP成人患者的MeMed BV®宿主反应试验进行评估。在挪威卑尔根豪克兰大学医院（Haukeland University Hospital, Bergen, Norway）的744名疑似CAP患者（2019-2023年）中，在三项前瞻性研究中，453名患者被纳入本研究。对患者进行分类：[1]临床管理（抗生素时间/持续时间）和[2]分子检测，通过BioFire®FilmArray Pneumonia Plus面板对下呼吸道样本进行检测。对储存的血清/血浆进行回顾性MeMed BV®检测，将结果分类为细菌、病毒或模棱两可。健康对照[n=20]也进行了检测。在按临床管理分类的442例患者中，MeMed BV®检测显示阳性一致性[PPA]为90.0% (95% CI: 86.4-92.7)，阴性一致性[NPA]为44.1% （95% CI: 34.4-54.2）。在370例分子检测分类患者中，PPA为88.2% (95% CI: 83.6-91.7)， NPA为30.1% （95% CI: 20.8-41.4）。7.5%出现模棱两可的结果。96.1%未检出病原菌的病例符合临床管理。健康对照组没有细菌得分。结论：MeMed BV®对细菌感染具有较高的敏感性，但对病毒感染的特异性有限，尤其是SARS-CoV-2。当与临床和微生物数据相结合时，它可能有助于早期分类。试验注册：ClinicalTrials.gov NCT04660084。

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 Infectious Diseases 医学-传染病学

CiteScore

18.90

自引率

2.40%

发文量

1020

审稿时长

30 days

期刊介绍： International Journal of Infectious Diseases (IJID) Publisher: International Society for Infectious Diseases Publication Frequency: Monthly Type: Peer-reviewed, Open Access Scope: Publishes original clinical and laboratory-based research. Reports clinical trials, reviews, and some case reports. Focuses on epidemiology, clinical diagnosis, treatment, and control of infectious diseases. Emphasizes diseases common in under-resourced countries.