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

IF 1.6 4区 医学 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH American Journal of Tropical Medicine and Hygiene Pub Date : 2024-12-17 Print Date: 2025-03-05 DOI:10.4269/ajtmh.24-0334
Malalanandrianina A Rakotoarisoa, Tovo A Rakotomanga, Jocia Fenomanana, Laurent Musango, Oméga Raobela, Julien Salava, Andry M Andrianarivelo, Maximilienne Kialozafy, Fanambinantsoa C Andrianaivoniaina, Fanirisoa Rasolozakandrainibe, Vatsiharizandry Mandrosovololona, Antsa Rakotondrandriana, Armel Razanatsila, Hajalalaina Rabarisoa, Didier Menard, Rianasoambolanoro Rakotosaona, Arsène Ratsimbasoa
{"title":"Performance of the Bioline™ Malaria Ag Pf/Pan and Bioline™ Malaria Ag Pf/Pv for Malaria Diagnostics: Madagascar In-Country Evaluation.","authors":"Malalanandrianina A Rakotoarisoa, Tovo A Rakotomanga, Jocia Fenomanana, Laurent Musango, Oméga Raobela, Julien Salava, Andry M Andrianarivelo, Maximilienne Kialozafy, Fanambinantsoa C Andrianaivoniaina, Fanirisoa Rasolozakandrainibe, Vatsiharizandry Mandrosovololona, Antsa Rakotondrandriana, Armel Razanatsila, Hajalalaina Rabarisoa, Didier Menard, Rianasoambolanoro Rakotosaona, Arsène Ratsimbasoa","doi":"10.4269/ajtmh.24-0334","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":7752,"journal":{"name":"American Journal of Tropical Medicine and Hygiene","volume":" ","pages":"610-619"},"PeriodicalIF":1.6000,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11884285/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Tropical Medicine and Hygiene","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.4269/ajtmh.24-0334","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/3/5 0:00:00","PubModel":"Print","JCR":"Q3","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
引用次数: 0

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.

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
用于疟疾诊断的 Bioline™ Malaria Ag Pf/Pan 和 Bioline™ Malaria Ag Pf/Pv 的性能:马达加斯加国内评估。
疟疾仍然是马达加斯加的一个重大公共卫生问题。世卫组织建议在治疗前使用寄生虫学方法确认疟原虫感染。本研究评估了两种快速诊断测试(RDTs)的性能,Bioline™Malaria Ag Pf/Pan (Abbott Point of Care, Princeton, NJ)和Bioline™Malaria Ag Pf/Pv (Abbott Point of Care, Princeton, NJ),与显微镜和聚合酶链反应(PCR)作为参考方法进行了比较。在两个具有不同流行病学背景的疟疾流行区进行了一项前瞻性诊断性能研究:恶性疟原虫传播)和间日疟原虫传播。在2023年4月至7月期间招募了3-81岁的有症状患者和无症状个体。手指刺血样本用于rdt,吉姆萨染色血膜和分子分析。在675名参与者中(401名有症状者,274名无症状者),Bioline™malaria Ag Pf/Pan检测有症状患者恶性疟原虫和非恶性疟原虫/间日疟的灵敏度为96.5% (95% CI: 93.4-98.4%)和91.5% (95% CI: 82.5-96.8%),特异性为76.0% (95% CI: 64.7-85.1%), Bioline™malaria Ag Pf/Pv检测灵敏度为95.0%和91.5%,特异性为76.0%。在无症状个体中,Bioline™Malaria Ag Pf/Pv的敏感性分别为90.3% (95% CI: 83.4-95.0%)和33.3% (95% CI: 4.3-77.7%),特异性分别为85.4% (95% CI: 78.9-90.6%)和80.6% (95% CI: 80.1-93.1%)和0% (95% CI: 0-84.2%),敏感性分别为86.0% (95% CI: 79.7-91.0%)和86.1% (95% CI: 79.7-91.0%)。在有症状的患者中,快速诊断测试的表现因当地流行病学而异。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。当显微镜和PCR无法使用时,这两种rdt都可以使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
American Journal of Tropical Medicine and Hygiene
American Journal of Tropical Medicine and Hygiene 医学-公共卫生、环境卫生与职业卫生
CiteScore
6.20
自引率
3.00%
发文量
508
审稿时长
3 months
期刊介绍: The American Journal of Tropical Medicine and Hygiene, established in 1921, is published monthly by the American Society of Tropical Medicine and Hygiene. It is among the top-ranked tropical medicine journals in the world publishing original scientific articles and the latest science covering new research with an emphasis on population, clinical and laboratory science and the application of technology in the fields of tropical medicine, parasitology, immunology, infectious diseases, epidemiology, basic and molecular biology, virology and international medicine. The Journal publishes unsolicited peer-reviewed manuscripts, review articles, short reports, images in Clinical Tropical Medicine, case studies, reports on the efficacy of new drugs and methods of treatment, prevention and control methodologies,new testing methods and equipment, book reports and Letters to the Editor. Topics range from applied epidemiology in such relevant areas as AIDS to the molecular biology of vaccine development. The Journal is of interest to epidemiologists, parasitologists, virologists, clinicians, entomologists and public health officials who are concerned with health issues of the tropics, developing nations and emerging infectious diseases. Major granting institutions including philanthropic and governmental institutions active in the public health field, and medical and scientific libraries throughout the world purchase the Journal. Two or more supplements to the Journal on topics of special interest are published annually. These supplements represent comprehensive and multidisciplinary discussions of issues of concern to tropical disease specialists and health issues of developing countries
期刊最新文献
Documentation Gaps in Animal Bite Reexposure Cases: Economic and Public Health Implications in a Tertiary Anti-Rabies Clinic in North India. Surgical Retrieval of Grains in a Case of Cystic Actinomycetoma. Rash and Eschar in Japanese Spotted Fever. Diversity of Strongyloides stercoralis Isolates from Humans in Iran. Detection of Multiple Dengue Virus Serotypes Circulating in Somalia.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1