评估和验证基于 PrintrLab 的 LAMP 检测方法,以确定玻利维亚新生儿中的克鲁斯锥虫:概念验证研究。

IF 20.9 1区 生物学 Q1 INFECTIOUS DISEASES Lancet Microbe Pub Date : 2024-09-01 DOI:10.1016/S2666-5247(24)00110-1
{"title":"评估和验证基于 PrintrLab 的 LAMP 检测方法,以确定玻利维亚新生儿中的克鲁斯锥虫:概念验证研究。","authors":"","doi":"10.1016/S2666-5247(24)00110-1","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Vertical transmission of <em>Trypanosoma cruzi</em> represents approximately 20% of new Chagas disease cases. Early detection and treatment for women of childbearing age and newborns is a public health priority, but the lack of a simple and reliable diagnostic test remains a major barrier. We aimed to evaluate the performance of a point-of-care loop-mediated isothermal amplification (LAMP) assay for the detection of <em>T cruzi</em>.</p></div><div><h3>Methods</h3><p>In this proof-of-concept study, we coupled a low-cost 3D printer repurposed for sample preparation and amplification (PrintrLab) to the Eiken <em>T cruzi-</em>LAMP prototype to detect vertically transmitted <em>T cruzi</em>, which we compared with standardised PCR and with the gold-standard algorithm (microscopy at birth and 2 months and serological study several months later). We screened pregnant women from two hospitals in the Bolivian Gran Chaco province, and those who were seropositive for <em>T cruzi</em> were offered the opportunity for their newborns to be enrolled in the study. Newborns were tested by microscopy, LAMP, and PCR at birth and 2 months, and by serology at 8 months.</p></div><div><h3>Findings</h3><p>Between April 23 and Nov 17, 2018, 986 mothers were screened, among whom 276 were seropositive for <em>T cruzi</em> (28·0% prevalence, 95% CI 25·6–31·2). In total, 224 infants born to 221 seropositive mothers completed 8 months of follow-up. Congenital transmission was detected in nine of the 224 newborns (4·0% prevalence, 1·9–7·5) by direct microscopy observation, and 14 more cases were diagnosed serologically (6·3%, 3·6–10·3), accounting for an overall vertical transmission rate of 10·3% (6·6–15·0; 23 of 224). All microscopy-positive newborns were positive by PrintrLab-LAMP and by PCR, while these techniques respectively detected four and five extra positive cases among the remaining 215 microscopy-negative newborns.</p></div><div><h3>Interpretation</h3><p>The PrintrLab-LAMP yielded a higher sensitivity than microscopy-based analysis. Considering the simpler use and expected lower cost of LAMP compared with PCR, our findings encourage its evaluation in a larger study over a wider geographical area.</p></div><div><h3>Funding</h3><p>Inter-American Development Bank.</p></div>","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"5 9","pages":"Article 100887"},"PeriodicalIF":20.9000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666524724001101/pdfft?md5=e5fdd2cd8e083b58c863871674c0eec7&pid=1-s2.0-S2666524724001101-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Evaluation and validation of a PrintrLab-based LAMP assay to identify Trypanosoma cruzi in newborns in Bolivia: a proof-of-concept study\",\"authors\":\"\",\"doi\":\"10.1016/S2666-5247(24)00110-1\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Vertical transmission of <em>Trypanosoma cruzi</em> represents approximately 20% of new Chagas disease cases. Early detection and treatment for women of childbearing age and newborns is a public health priority, but the lack of a simple and reliable diagnostic test remains a major barrier. We aimed to evaluate the performance of a point-of-care loop-mediated isothermal amplification (LAMP) assay for the detection of <em>T cruzi</em>.</p></div><div><h3>Methods</h3><p>In this proof-of-concept study, we coupled a low-cost 3D printer repurposed for sample preparation and amplification (PrintrLab) to the Eiken <em>T cruzi-</em>LAMP prototype to detect vertically transmitted <em>T cruzi</em>, which we compared with standardised PCR and with the gold-standard algorithm (microscopy at birth and 2 months and serological study several months later). We screened pregnant women from two hospitals in the Bolivian Gran Chaco province, and those who were seropositive for <em>T cruzi</em> were offered the opportunity for their newborns to be enrolled in the study. Newborns were tested by microscopy, LAMP, and PCR at birth and 2 months, and by serology at 8 months.</p></div><div><h3>Findings</h3><p>Between April 23 and Nov 17, 2018, 986 mothers were screened, among whom 276 were seropositive for <em>T cruzi</em> (28·0% prevalence, 95% CI 25·6–31·2). In total, 224 infants born to 221 seropositive mothers completed 8 months of follow-up. Congenital transmission was detected in nine of the 224 newborns (4·0% prevalence, 1·9–7·5) by direct microscopy observation, and 14 more cases were diagnosed serologically (6·3%, 3·6–10·3), accounting for an overall vertical transmission rate of 10·3% (6·6–15·0; 23 of 224). All microscopy-positive newborns were positive by PrintrLab-LAMP and by PCR, while these techniques respectively detected four and five extra positive cases among the remaining 215 microscopy-negative newborns.</p></div><div><h3>Interpretation</h3><p>The PrintrLab-LAMP yielded a higher sensitivity than microscopy-based analysis. Considering the simpler use and expected lower cost of LAMP compared with PCR, our findings encourage its evaluation in a larger study over a wider geographical area.</p></div><div><h3>Funding</h3><p>Inter-American Development Bank.</p></div>\",\"PeriodicalId\":46633,\"journal\":{\"name\":\"Lancet Microbe\",\"volume\":\"5 9\",\"pages\":\"Article 100887\"},\"PeriodicalIF\":20.9000,\"publicationDate\":\"2024-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2666524724001101/pdfft?md5=e5fdd2cd8e083b58c863871674c0eec7&pid=1-s2.0-S2666524724001101-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Lancet Microbe\",\"FirstCategoryId\":\"99\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2666524724001101\",\"RegionNum\":1,\"RegionCategory\":\"生物学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Lancet Microbe","FirstCategoryId":"99","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2666524724001101","RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
引用次数: 0

摘要

背景:在新发南美锥虫病病例中,约有 20% 是通过垂直传播感染的。对育龄妇女和新生儿进行早期检测和治疗是公共卫生的当务之急,但缺乏简单可靠的诊断检测方法仍是一大障碍。我们的目的是评估用于检测克鲁斯绦虫的护理点环路介导等温扩增(LAMP)测定的性能:在这项概念验证研究中,我们将用于样品制备和扩增的低成本 3D 打印机(PrintrLab)与 Eiken T cruzi-LAMP 原型相结合,以检测垂直传播的 Truzi,并将其与标准化 PCR 和黄金标准算法(出生时和 2 个月时进行显微镜检查,几个月后进行血清学研究)进行了比较。我们对玻利维亚大查科省两家医院的孕妇进行了筛查,T-cruzi血清反应呈阳性的孕妇有机会让其新生儿参与研究。新生儿在出生和2个月时接受显微镜、LAMP和PCR检测,8个月时接受血清学检测:2018年4月23日至11月17日期间,共筛查了986名母亲,其中276名母亲的T cruzi血清反应呈阳性(流行率为28-0%,95% CI为25-6-31-2)。221 名血清反应阳性母亲所生的 224 名婴儿共完成了 8 个月的随访。通过直接显微镜观察,发现 224 名新生儿中有 9 名是先天性传播(流行率为 4-0%,1-9-7-5),另有 14 例是通过血清学诊断(6-3%,3-6-10-3),总的垂直传播率为 10-3%(6-6-15-0;224 例中有 23 例)。所有显微镜检查阳性的新生儿在 PrintrLab-LAMP 和 PCR 检测中均为阳性,而在其余 215 例显微镜检查阴性的新生儿中,这些技术分别检测出了 4 例和 5 例额外的阳性病例:PrintrLab-LAMP的灵敏度高于显微镜分析。考虑到与 PCR 相比,LAMP 的使用更简单,预期成本更低,我们的研究结果鼓励在更大范围的研究中对其进行评估:资金来源:美洲开发银行。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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
Evaluation and validation of a PrintrLab-based LAMP assay to identify Trypanosoma cruzi in newborns in Bolivia: a proof-of-concept study

Background

Vertical transmission of Trypanosoma cruzi represents approximately 20% of new Chagas disease cases. Early detection and treatment for women of childbearing age and newborns is a public health priority, but the lack of a simple and reliable diagnostic test remains a major barrier. We aimed to evaluate the performance of a point-of-care loop-mediated isothermal amplification (LAMP) assay for the detection of T cruzi.

Methods

In this proof-of-concept study, we coupled a low-cost 3D printer repurposed for sample preparation and amplification (PrintrLab) to the Eiken T cruzi-LAMP prototype to detect vertically transmitted T cruzi, which we compared with standardised PCR and with the gold-standard algorithm (microscopy at birth and 2 months and serological study several months later). We screened pregnant women from two hospitals in the Bolivian Gran Chaco province, and those who were seropositive for T cruzi were offered the opportunity for their newborns to be enrolled in the study. Newborns were tested by microscopy, LAMP, and PCR at birth and 2 months, and by serology at 8 months.

Findings

Between April 23 and Nov 17, 2018, 986 mothers were screened, among whom 276 were seropositive for T cruzi (28·0% prevalence, 95% CI 25·6–31·2). In total, 224 infants born to 221 seropositive mothers completed 8 months of follow-up. Congenital transmission was detected in nine of the 224 newborns (4·0% prevalence, 1·9–7·5) by direct microscopy observation, and 14 more cases were diagnosed serologically (6·3%, 3·6–10·3), accounting for an overall vertical transmission rate of 10·3% (6·6–15·0; 23 of 224). All microscopy-positive newborns were positive by PrintrLab-LAMP and by PCR, while these techniques respectively detected four and five extra positive cases among the remaining 215 microscopy-negative newborns.

Interpretation

The PrintrLab-LAMP yielded a higher sensitivity than microscopy-based analysis. Considering the simpler use and expected lower cost of LAMP compared with PCR, our findings encourage its evaluation in a larger study over a wider geographical area.

Funding

Inter-American Development Bank.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Lancet Microbe
Lancet Microbe Multiple-
CiteScore
27.20
自引率
0.80%
发文量
278
审稿时长
6 weeks
期刊介绍: The Lancet Microbe is a gold open access journal committed to publishing content relevant to clinical microbiologists worldwide, with a focus on studies that advance clinical understanding, challenge the status quo, and advocate change in health policy.
期刊最新文献
Genomic reconstruction of an azole-resistant Candida parapsilosis outbreak and the creation of a multi-locus sequence typing scheme: a retrospective observational and genomic epidemiology study. Reassessing the role of butyrate-producing bacteria in infection risk. Using demographics of patients to inform treatment of shigellosis in England. Variability of Mycobacterium tuberculosis lipid body content in sputum and its implications for treatment response. Therapeutics for Nipah virus disease: a systematic review to support prioritisation of drug candidates for clinical trials.
×
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:481959085
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