感染管理系统（IMS）作为一种新型基于血细胞计数的菌血症检测工具：在布基纳法索疟疾流行地区的一项诊断准确性研究。
Infection Manager System (IMS) as a new hemocytometry-based bacteremia detection tool: A diagnostic accuracy study in a malaria-endemic area of Burkina Faso.
机构信息
Nijmegen Institute of International Health, Radboudumc, Nijmegen, the Netherlands.
Radboud Center for Infectious Diseases, Radboudumc, Nijmegen, the Netherlands.
出版信息
PLoS Negl Trop Dis. 2021 Mar 1;15(3):e0009187. doi: 10.1371/journal.pntd.0009187. eCollection 2021 Mar.
BACKGROUND
New hemocytometric parameters can be used to differentiate causes of acute febrile illness (AFI). We evaluated a software algorithm-Infection Manager System (IMS)-which uses hemocytometric data generated by Sysmex hematology analyzers, for its accuracy to detect bacteremia in AFI patients with and without malaria in Burkina Faso. Secondary aims included comparing the accuracy of IMS with C-reactive protein (CRP) and procalcitonin (PCT).
METHODS
In a prospective observational study, patients of ≥ three-month-old (range 3 months- 90 years) presenting with AFI were enrolled. IMS, blood culture and malaria diagnostics were done upon inclusion and additional diagnostics on clinical indication. CRP, PCT, viral multiplex PCR on nasopharyngeal swabs and bacterial- and malaria PCR were batch-tested retrospectively. Diagnostic classification was done retrospectively using all available data except IMS, CRP and PCT results.
FINDINGS
A diagnosis was affirmed in 549/914 (60.1%) patients and included malaria (n = 191) bacteremia (n = 69), viral infections (n = 145), and malaria-bacteremia co-infections (n = 47). The overall sensitivity, specificity, and negative predictive value (NPV) of IMS for detection of bacteremia in patients of ≥ 5 years were 97.0% (95% CI: 89.8-99.6), 68.2% (95% CI: 55.6-79.1) and 95.7% (95% CI: 85.5-99.5) respectively, compared to 93.9% (95% CI: 85.2-98.3), 39.4% (95% CI: 27.6-52.2), and 86.7% (95% CI: 69.3-96.2) for CRP at ≥20mg/L. The sensitivity, specificity and NPV of PCT at 0.5 ng/ml were lower at respectively 72.7% (95% CI: 60.4-83.0), 50.0% (95% CI: 37.4-62.6) and 64.7% (95% CI: 50.1-77.6) The diagnostic accuracy of IMS was lower among malaria cases and patients <5 years but remained equal to- or higher than the accuracy of CRP.
INTERPRETATION
IMS is a new diagnostic tool to differentiate causes of AFI. Its high NPV for bacteremia has the potential to improve antibiotic dispensing practices in healthcare facilities with hematology analyzers. Future studies are needed to evaluate whether IMS, combined with malaria diagnostics, may be used to rationalize antimicrobial prescription in malaria endemic areas.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT02669823) https://clinicaltrials.gov/ct2/show/NCT02669823.
背景
新的血液学参数可用于区分急性发热性疾病（AFI）的病因。我们评估了一种软件算法-感染管理器系统（IMS）-该算法使用Sysmex 血液学分析仪生成的血液学数据，用于检测布基纳法索有无疟疾的 AFI 患者中菌血症的准确性。次要目标包括比较 IMS 与 C 反应蛋白（CRP）和降钙素原（PCT）的准确性。
方法
在一项前瞻性观察性研究中，纳入了年龄≥3 个月（3 个月至 90 岁）的 AFI 患者。在纳入时进行 IMS、血培养和疟疾诊断，并根据临床指征进行额外的诊断。CRP、PCT、鼻咽拭子的病毒多重 PCR 以及细菌和疟疾 PCR 进行了回顾性批量测试。诊断分类是使用除 IMS、CRP 和 PCT 结果外的所有可用数据进行回顾性的。
结果
在 914 名患者中，549 名（60.1%）患者得到了确诊，包括疟疾（191 名）、菌血症（69 名）、病毒感染（145 名）和疟疾-菌血症合并感染（47 名）。对于年龄≥5 岁的患者，IMS 检测菌血症的总体敏感性、特异性和阴性预测值（NPV）分别为 97.0%（95%CI：89.8-99.6）、68.2%（95%CI：55.6-79.1）和 95.7%（95%CI：85.5-99.5），而 CRP≥20mg/L 的敏感性、特异性和 NPV 分别为 93.9%（95%CI：85.2-98.3）、39.4%（95%CI：27.6-52.2）和 86.7%（95%CI：69.3-96.2）。PCT 为 0.5ng/ml 时，敏感性、特异性和 NPV 分别为 72.7%（95%CI：60.4-83.0）、50.0%（95%CI：37.4-62.6）和 64.7%（95%CI：50.1-77.6）。IMS 在疟疾病例和年龄<5 岁的患者中的诊断准确性较低，但仍等于或高于 CRP 的准确性。
结论
IMS 是一种区分 AFI 病因的新诊断工具。其对菌血症的高 NPV 有可能改善具有血液学分析仪的医疗机构中抗生素的使用。需要进一步研究以评估 IMS 是否与疟疾诊断相结合，可用于合理使用疟疾流行地区的抗菌药物。
临床试验注册号
ClinicalTrials.gov（NCT02669823）https://clinicaltrials.gov/ct2/show/NCT02669823。
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