Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel;
Department of Pediatrics, Bnai-Zion Medical Center, Haifa, Israel.
Pediatrics. 2017 Oct;140(4). doi: 10.1542/peds.2016-3453. Epub 2017 Sep 13.
Reliably distinguishing bacterial from viral infections is often challenging, leading to antibiotic misuse. A novel assay that integrates measurements of blood-borne host-proteins (tumor necrosis factor-related apoptosis-inducing ligand, interferon γ-induced protein-10, and C-reactive protein [CRP]) was developed to assist in differentiation between bacterial and viral disease.
We performed double-blind, multicenter assay evaluation using serum remnants collected at 5 pediatric emergency departments and 2 wards from children ≥3 months to ≤18 years without ( = 68) and with ( = 529) suspicion of acute infection. Infectious cohort inclusion criteria were fever ≥38°C and symptom duration ≤7 days. The reference standard diagnosis was based on predetermined criteria plus adjudication by experts blinded to assay results. Assay performers were blinded to the reference standard. Assay cutoffs were predefined.
Of 529 potentially eligible patients with suspected acute infection, 100 did not fulfill infectious inclusion criteria and 68 had insufficient serum. The resulting cohort included 361 patients, with 239 viral, 68 bacterial, and 54 indeterminate reference standard diagnoses. The assay distinguished between bacterial and viral patients with 93.8% sensitivity (95% confidence interval: 87.8%-99.8%) and 89.8% specificity (85.6%-94.0%); 11.7% had an equivocal assay outcome. The assay outperformed CRP (cutoff 40 mg/L; sensitivity 88.2% [80.4%-96.1%], specificity 73.2% [67.6%-78.9%]) and procalcitonin testing (cutoff 0.5 ng/mL; sensitivity 63.1% [51.0%-75.1%], specificity 82.3% [77.1%-87.5%]).
Double-blinded evaluation confirmed high assay performance in febrile children. Assay was significantly more accurate than CRP, procalcitonin, and routine laboratory parameters. Additional studies are warranted to support its potential to improve antimicrobial treatment decisions.
可靠地区分细菌感染和病毒感染常常具有挑战性，这导致了抗生素的滥用。一种新的检测方法整合了血液来源的宿主蛋白（肿瘤坏死因子相关凋亡诱导配体、γ-干扰素诱导蛋白 10 和 C 反应蛋白[CRP]）的测量，以帮助区分细菌性和病毒性疾病。
我们在 5 个儿科急诊室和 2 个病房进行了双盲、多中心检测评估，纳入了年龄≥3 个月至≤18 岁的疑似急性感染的儿童（=68 例）和无疑似急性感染的儿童（=529 例）。感染性队列纳入标准为发热≥38°C 和症状持续时间≤7 天。参考标准诊断基于预先确定的标准，以及对检测结果不知情的专家进行裁决。检测执行者对参考标准不知情。检测的截断值是预先设定的。
在 529 例疑似急性感染的潜在合格患者中，100 例不符合感染性纳入标准，68 例血清不足。最终纳入 361 例患者，其中 239 例为病毒感染，68 例为细菌感染，54 例为参考标准诊断不确定。该检测方法对细菌和病毒患者的敏感性为 93.8%（95%置信区间：87.8%-99.8%），特异性为 89.8%（85.6%-94.0%）；11.7%的检测结果不确定。该检测方法优于 CRP（截断值 40 mg/L；敏感性 88.2%[80.4%-96.1%]，特异性 73.2%[67.6%-78.9%]）和降钙素原检测（截断值 0.5 ng/mL；敏感性 63.1%[51.0%-75.1%]，特异性 82.3%[77.1%-87.5%]）。
双盲评估证实了该检测方法在发热儿童中的高检测性能。该检测方法明显比 CRP、降钙素原和常规实验室参数更准确。需要进一步的研究来支持其改善抗菌治疗决策的潜力。
