Katagiri Daisuke, Asai Yusuke, Ohmagari Norio, Ishikane Masahiro, Hikida Sayaka, Iwamoto Noriko, Nagashima Maki, Suzuki Minami, Takano Hideki, Takasaki Jin, Hojo Masayuki, Sugiyama Haruhito, Tokunaga Katsushi, Miyashita Yoshihiro, Omata Masao, Ohata Keiichi, Bliden Kevin P, Tantry Udaya S, Dahlen Jeffrey R, Sugaya Takeshi, Gurbel Paul A, Noiri Eisei
Department of Nephrology, National Center for Global Health and Medicine, Tokyo, Japan.
Antimicrobial Resistance Clinical Reference Center, Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan.
Crit Care Explor. 2023 Mar 9;5(3):e0873. doi: 10.1097/CCE.0000000000000873. eCollection 2023 Mar.
Early detection of illness trajectory in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infected patients is crucial for patients and healthcare workers. An effective, noninvasive approach, with simple measurement for decision-making, is necessary in a pandemic to discriminate between high- and low-risk patients, even though both groups may exhibit mild symptoms in the beginning.
To predict COVID-19 disease severity within 10 days, distinguishing cases that will progress to moderate or severe versus mild, patient urinary L-type fatty acid-binding protein (L-FABP) was assayed within 4 days of receiving a diagnosis. The study also examined whether L-FABP point of care (POC) test is helpful in risk screening.
Symptomatic subjects who tested positive for SARS-CoV-2 and were hospitalized were prospectively enrolled at the National Center for Global Health and Medicine (NCGM), Yamanashi Prefectural Central Hospital (YPCH), and Sinai Hospital in Maryland. The outcome of each case was evaluated 7 days after admission and the diagnostic performance of L-FABP was assessed.
Subjects were treated for COVID-19 at public healthcare centers in Japan from January 31, 2020, to January 31, 2021, to NCGM, YPCH, and at Sinai Hospital in Baltimore, MD, during the same period.
The primary outcome was to determine whether urinary L-FABP within 48 hours of admission can predict the patient's severity of COVID-19 1 week later. We obtained demographic data, information on clinical symptoms, radiographic images, and laboratory data.
Diagnostic performance was assessed using receiver operating characteristic analysis. Of the 224 participants in the study, 173 initially had a mild form of COVID-19. The area under the curve (AUC) for a severe outcome was 93.5%. L-FABP POC risk prediction of a severe outcome had an AUC of 88.9%.
Urinary L-FABP can predict patient risk of COVID-19 illness severity. L-FABP POC is implementable for patient management. (ClinicalTrials.gov number, NCT04681040).
对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)感染患者的疾病轨迹进行早期检测,对患者和医护人员至关重要。在大流行期间,需要一种有效的、非侵入性的方法,通过简单测量来辅助决策,以区分高风险和低风险患者,尽管这两组患者在初期可能都表现出轻微症状。
为了在10天内预测新型冠状病毒肺炎(COVID-19)疾病的严重程度,区分病情将进展为中度或重度与轻度的病例,在患者确诊后4天内检测其尿液中的L型脂肪酸结合蛋白(L-FABP)。该研究还考察了L-FABP即时检测(POC)是否有助于风险筛查。
对在日本国立全球健康与医学中心(NCGM)、山梨县立中央医院(YPCH)以及马里兰州的西奈医院住院治疗且SARS-CoV-2检测呈阳性的有症状受试者进行前瞻性招募。在入院后第7天评估每个病例的结果,并评估L-FABP的诊断性能。
研究对象为2020年1月31日至2021年1月31日期间在日本公共医疗中心接受COVID-19治疗的患者,以及同期在NCGM、YPCH和马里兰州巴尔的摩市西奈医院接受治疗的患者。
主要结局是确定入院后48小时内尿液中的L-FABP是否能够预测患者1周后COVID-19的严重程度。我们收集了人口统计学数据、临床症状信息以及影像学和实验室数据。
使用受试者工作特征分析评估诊断性能。在该研究的224名参与者中,173人最初患有轻度COVID-19。严重结局的曲线下面积(AUC)为93.5%。L-FABP POC对严重结局的风险预测AUC为88.9%。
尿液中的L-FABP能够预测COVID-19疾病严重程度的患者风险。L-FABP POC可用于患者管理。(ClinicalTrials.gov编号,NCT04681040)