Alabi Ayodele, Musangomunei Fungai P, Lotola-Mougeni Fabrice, Bie-Ondo Juste C, Murphy Kristin, Essone Paulin N, Kabwende Anita L, Mahmoudou Saidou, Macé Aurélien, Harris Victoria, Ramharter Michael, Grobusch Martin P, Yazdanbakhsh Maria, Fernandez-Carballo B Leticia, Escadafal Camille, Kremsner Peter G, Dittrich Sabine, Agnandji Selidji T
Biomedicine and Social Sciences research group, Department of Biologicals and Therapeutics, Centre de Recherches Médicales de Lambaréné, CERMEL, BP 242, Lambaréné, Gabon.
Institut für Tropenmedizin, Universitätsklinikum Tübingen and German Centre for Infectious Diseases Research (DZIF), Tübingen, Germany.
Infection. 2025 Feb;53(1):285-295. doi: 10.1007/s15010-024-02366-y. Epub 2024 Aug 23.
The consequent use of malaria rapid diagnostic tests (RDTs) preceding a treatment decision has improved the global management of malaria. A combination RDT, including an inflammation marker to potentially guide antibiotic prescription, could improve the management of acute febrile illness (AFI).
We performed a prospective, cross-sectional study in Gabon evaluating the STANDARD Malaria/CRP DUO (S-DUO) RDT. Participants aged 2 to 17 years with fever at presentation and/or a history of fever < 7 days were enrolled. Expert microscopy, SD Bioline Malaria Ag P.f/Pan test for malaria detection, and NycoCard CRP device for CRP were used as comparators. AFI cases were classified on a spectrum encompassing bacterial vs. non-bacterial infection.
415 participants with AFI were enrolled. S-DUO RDT sensitivity and specificity for malaria detection vs. microscopy were 99·1% (95·2-100%) and 72·7% (64·3-80·1%); and for CRP detection (20 mg/L and above) 86·9% (80-92%) and 87% (79·2-92·7%), respectively. The difference in CRP levels between bacterial infection (mean = 41·2 mg/L) and other causes of fever, measured from our study population using the Nycocard device, was statistically significant (p < 0·01); CRP precision-recall AUC to distinguish bacterial infection class vs. non-bacterial classifications was 0·79.
S-DUO RDT is suitable for malaria detection in moderate-to-high malaria transmission settings such as in Lambaréné; however, a CRP band detection limit > 40 mg/L is more adequate for indication of antibiotic prescription for AFI cases in Gabon.
在做出治疗决策前使用疟疾快速诊断检测（RDT）改善了全球疟疾管理。一种包含炎症标志物以潜在指导抗生素处方的联合RDT，可能会改善急性发热性疾病（AFI）的管理。
我们在加蓬进行了一项前瞻性横断面研究，评估标准疟疾/C反应蛋白双联（S-DUO）RDT。纳入就诊时发热和/或有发热病史＜7天的2至17岁参与者。将专家显微镜检查、用于疟疾检测的SD Bioline疟疾抗原P.f/Pan检测以及用于C反应蛋白检测的NycoCard CRP设备用作对照。AFI病例根据包括细菌感染与非细菌感染的范围进行分类。
纳入了415例AFI参与者。S-DUO RDT检测疟疾与显微镜检查相比的敏感性和特异性分别为99.1%（95.2 - 100%）和72.7%（64.3 - 80.1%）；检测C反应蛋白（20mg/L及以上）的敏感性和特异性分别为86.9%（80 - 92%）和87%（79.2 - 92.7%）。使用NycoCard设备从我们的研究人群中测量的细菌感染（平均 = 41.2mg/L）与其他发热原因之间的C反应蛋白水平差异具有统计学意义（p ＜ 0.01）；区分细菌感染类别与非细菌感染类别的C反应蛋白精确召回曲线下面积为0.79。
S-DUO RDT适用于中等至高疟疾传播环境（如在兰巴雷内）的疟疾检测；然而，对于加蓬的AFI病例，C反应蛋白条带检测限＞40mg/L更适合用于指示抗生素处方。
