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":null,"pages":null},"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\":null,\"pages\":null},\"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
Effect of pneumococcal conjugate vaccination on pneumococcal carriage in hospitalised children aged 2-59 months in Mongolia: an active pneumonia surveillance programme. Blood transcriptomic analyses do not support SARS-CoV-2 persistence in patients with post-COVID-19 condition with chronic fatigue syndrome. Saliva as a reliable, non-invasive specimen for detecting and monitoring Mycobacterium leprae. Endocarditis associated with contamination of cardiovascular bioprostheses with Mycobacterium chelonae: a collaborative microbiological study. Addressing urgent priorities in antibiotic development: insights from WHO 2023 antibacterial clinical pipeline analyses.
×
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