Bioline™疟疾抗原Pf/Pan检测试剂盒和Bioline™疟疾抗原Pf/Pv检测试剂盒用于疟疾诊断的性能：马达加斯加国内评估

Performance of the Bioline™ Malaria Ag Pf/Pan and Bioline™ Malaria Ag Pf/Pv for Malaria Diagnostics: Madagascar In-Country Evaluation.

作者信息

Rakotoarisoa Malalanandrianina A, Rakotomanga Tovo A, Fenomanana Jocia, Musango Laurent, Raobela Oméga, Salava Julien, Andrianarivelo Andry M, Kialozafy Maximilienne, Andrianaivoniaina Fanambinantsoa C, Rasolozakandrainibe Fanirisoa, Mandrosovololona Vatsiharizandry, Rakotondrandriana Antsa, Razanatsila Armel, Rabarisoa Hajalalaina, Menard Didier, Rakotosaona Rianasoambolanoro, Ratsimbasoa Arsène

机构信息

National Center for Pharmaceutical Research and Applications, Antananarivo, Madagascar.

Faculty of Medicine, University of Antananarivo, Antananarivo, Madagascar.

出版信息

Am J Trop Med Hyg. 2024 Dec 17;112(3):610-619. doi: 10.4269/ajtmh.24-0334. Print 2025 Mar 5.

DOI:10.4269/ajtmh.24-0334

PMID:39689361

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11884285/

Abstract

Malaria remains a significant public health concern in Madagascar. The WHO recommends using parasitological methods to confirm Plasmodium infection before treatment. This study evaluated the performance of two rapid diagnostic tests (RDTs), Bioline™ Malaria Ag Pf/Pan (Abbott Point of Care, Princeton, NJ) and Bioline™ Malaria Ag Pf/Pv (Abbott Point of Care, Princeton, NJ), compared with microscopy and polymerase chain reaction (PCR) as reference methods. A prospective, diagnostic performance study was conducted in two malaria-endemic districts with different epidemiological contexts: Ifanadiana (Plasmodium falciparum [P. falciparum] transmission) and Mandoto (Plasmodium vivax transmission). Symptomatic patients and asymptomatic individuals aged 3-81 years were enrolled between April and July 2023. Finger prick blood samples were used for RDTs, Giemsa-stained blood films, and molecular analysis. Among 675 participants (401 symptomatic, 274 asymptomatic), the performance for detecting P. falciparum and non-falciparum/vivax malaria in symptomatic patients for Bioline™ Malaria Ag Pf/Pan was 96.5% (95% CI: 93.4-98.4%) and 91.5% (95% CI: 82.5-96.8%) sensitivity and 76.0% (95% CI: 64.7-85.1%) specificity, and the performance for Bioline™ Malaria Ag Pf/Pv was 95.0% and 91.5% sensitivity and 76.0% specificity. In asymptomatic individuals, the performance was 90.3% (95% CI: 83.4-95.0%) and 33.3% (95% CI: 4.3-77.7%) sensitivity and 85.4% (95% CI: 78.9-90.6%) specificity for Bioline™ Malaria Ag Pf/Pan and 80.6% (95% CI: 80.1-93.1%) and 0% (95% CI: 0-84.2%) sensitivity and 86.0% (95% CI: 79.7-91.0%) and 86.1% (95% CI: 79.7-91.0%) specificity for Bioline™ Malaria Ag Pf/Pv. Rapid diagnostic test performance varies with local epidemiology in symptomatic patients. The results emphasize the need for careful consideration of RDT use based on local epidemiology and clinical context. Both RDTs could be used when microscopy and PCR are unavailable.

摘要

疟疾仍是马达加斯加一个重大的公共卫生问题。世界卫生组织建议在治疗前使用寄生虫学方法来确诊疟原虫感染。本研究评估了两种快速诊断检测（RDT），即Bioline™ 疟疾抗原Pf/Pan（雅培即时诊断，新泽西州普林斯顿）和Bioline™ 疟疾抗原Pf/Pv（雅培即时诊断，新泽西州普林斯顿）的性能，并与作为参考方法的显微镜检查和聚合酶链反应（PCR）进行比较。在两个具有不同流行病学背景的疟疾流行地区开展了一项前瞻性诊断性能研究：伊法纳迪亚（恶性疟原虫传播）和曼多托（间日疟原虫传播）。2023年4月至7月期间，纳入了3至81岁的有症状患者和无症状个体。手指刺血样本用于RDT检测、吉姆萨染色血涂片和分子分析。在675名参与者（401名有症状者，274名无症状者）中，对于有症状患者，Bioline™ 疟疾抗原Pf/Pan检测恶性疟原虫和非恶性疟原虫/间日疟原虫疟疾的敏感性分别为96.5%（95%置信区间：93.4 - 98.4%）和91.5%（95%置信区间：82.5 - 96.8%），特异性为76.0%（95%置信区间：64.7 - 85.1%）；Bioline™ 疟疾抗原Pf/Pv的敏感性分别为95.0%和91.5%，特异性为76.0%。在无症状个体中，Bioline™ 疟疾抗原Pf/Pan的敏感性分别为90.3%（95%置信区间：83.4 - 95.0%）和33.3%（95%置信区间：4.3 - 77.7%），特异性为85.4%（95%置信区间：78.9 - 90.6%）；Bioline™疟疾抗原Pf/Pv的敏感性分别为80.6%（95%置信区间：80.1 - 93.1%）和0%（95%置信区间：0 - 84.2%），特异性分别为86.0%（95%置信区间：79.7 - 91.0%）和86.1%（95%置信区间：79.7 - 91.0%）。有症状患者中，快速诊断检测的性能因当地流行病学情况而异。结果强调，需要根据当地流行病学和临床情况仔细考虑RDT的使用。当无法进行显微镜检查和PCR时，两种RDT均可使用。