Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA.
Our Lady of the Lake Regional Medical Center, Baton Rouge, Louisiana, USA.
Acad Emerg Med. 2024 Sep;31(9):883-893. doi: 10.1111/acem.14923. Epub 2024 Apr 21.
Sepsis is one of the most common, costly, and misdiagnosed conditions in U.S. emergency departments (EDs). ED providers often treat on nonspecific signs, subjective suspicion, or presumption of infection, resulting in over- and undertreatment. An increased understanding of host response has opened a new direction for sepsis diagnostics. The IntelliSep test is a U.S. Food and Drug Administration-cleared cellular host response diagnostic that could help distinguish sepsis in ED settings. Our objective was to evaluate the potential of the cellular host response test to expedite appropriate care for patients who present with signs of infection.
We performed a pooled analysis of five adult (≥18 years) cohorts enrolled at seven geographically diverse U.S. sites in separate studies. Structured blinded adjudication was used to classify presence or absence of sepsis, and only patients with high confidence in the adjudicated label were included (n = 1002), defined as patients for whom there was consensus in the determination of sepsis per the Sepsis-3 and severe sepsis per the Sepsis-2 definitions between both the independent adjudication panel and the site-level physician.
Among patients with signs or suspicion of infection, the test achieved similar or better performance compared to other indicators in identifying patients at high risk for sepsis (specificity > 83%) and significantly superior performance in identifying those at low risk (sensitivity > 92%; 0% sepsis-associated mortality). The test also stratified severity of illness, as shown by 30-day in-hospital mortality (p < 0.001), hospital length of stay (p < 0.01), and use of hospital resources (p < 0.001).
Our data suggest that the cellular host response test provides clinically actionable results for patients at both high and low risk for sepsis and provides a rapid, objective means for risk stratification of patients with signs of infection. If integrated into standard of care, the test may help improve outcomes and reduce unnecessary antibiotic use.
脓毒症是美国急诊部（ED）最常见、最昂贵且最易误诊的病症之一。ED 医护人员通常根据非特异性症状、主观怀疑或感染假设进行治疗，导致过度治疗或治疗不足。对宿主反应的深入了解为脓毒症诊断开辟了新的方向。IntelliSep 测试是一种获得美国食品和药物管理局批准的细胞宿主反应诊断测试，可帮助区分 ED 环境中的脓毒症。我们的目标是评估细胞宿主反应测试在为出现感染迹象的患者提供及时治疗方面的潜力。
我们对在七个地理位置不同的美国地点进行的五项独立成人（≥18 岁）队列研究进行了汇总分析。采用结构化盲法裁决来对脓毒症的存在或不存在进行分类，仅纳入裁决标签置信度高的患者（n=1002），即根据 Sepsis-3 和 Sepsis-2 定义，独立裁决小组和现场医生之间对脓毒症的判定具有共识的患者。
在有感染迹象或疑似感染的患者中，该测试在识别有脓毒症高风险的患者方面表现与其他指标相当或更好（特异性>83%），在识别低风险患者方面表现明显更好（敏感性>92%；无与脓毒症相关的死亡率为 0%）。该测试还对疾病严重程度进行了分层，表现在 30 天院内死亡率（p<0.001）、住院时间（p<0.01）和医院资源使用（p<0.001）方面。
我们的数据表明，细胞宿主反应测试为脓毒症高危和低危患者提供了具有临床意义的结果，并为有感染迹象的患者提供了快速、客观的风险分层方法。如果将其纳入标准护理，该测试可能有助于改善结果并减少不必要的抗生素使用。
