Hybrid ELISA: Simple and specific one-tier assay for Lyme disease
混合 ELISA:针对莱姆病的简单而特异的一层检测
基本信息
- 批准号:9886194
- 负责人:
- 金额:$ 29.98万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-03-06 至 2022-02-28
- 项目状态:已结题
- 来源:
- 关键词:AccountingAdverse effectsAmoxicillinAntibiotic ResistanceAntibiotic TherapyAntibioticsAntibodiesAntigensBacterial AntigensBacterial InfectionsBindingBiological AssayBloodBlood donorBorreliaBorrelia burgdorferiCellsCenters for Disease Control and Prevention (U.S.)Chronic DiseaseClinicalClinical ResearchClinical SensitivityCommunicable DiseasesDetectionDevelopmentDiagnosisDiagnosticDiagnostic testsDiseaseDoxycyclineEnzyme-Linked Immunosorbent AssayEpitopesExanthemaEyeFormulationGeographic LocationsGold ColloidGrantGrowthHorseradish PeroxidaseHybridsImmunochemistryImmunoglobulin GImmunoglobulin MIn VitroIndividualInfectionLaboratoriesLegitimacyLyme DiseaseMedicalMethodologyMethodsNatureOrder SpirochaetalesOutcomePatientsPeptidesPerformancePeroxidasesPhasePhysiciansPlasmaPolymersProcessProteinsProtocols documentationPublic HealthReagentRecombinant ProteinsRecording of previous eventsRestRiskSamplingScreening ResultSensitivity and SpecificitySerologic testsSerologicalSerumShort-Term CourseSignal TransductionSpecificityStatistical Data InterpretationStep TestsSymptomsTest ResultTestingTimeUnited StatesVector-transmitted infectious diseasebasecross reactivityerythema migransnovelparticleprospectiveprototypescreeningsynthetic peptide
项目摘要
Abstract
Lyme disease, caused by infection with the spirochete Borrelia burgdorferi or closely related species, is the
most common vector-borne disease in the United States, accounting for over 300,000 infections per year
according to public health estimates. It is also one of the few infectious diseases that requires a two-step
laboratory testing protocol, comprising a screening assay, typically ELISA, followed by a confirmatory
immunoblot. This protocol is followed where the disease has progressed beyond the hallmark erythema
migrans rash, or the rash cannot be identified, and symptoms or history suggest Lyme disease. The two-step
protocol is a result of the poor specificity of most Lyme screening tests, which results in a high false positive
rate. This in turn is due to the cross-reactive nature of many bacterial antigens, combined with the limitations
of conventional ELISA immunochemistry. In principle, a confirmatory result must be obtained prior to initiating
treatment, but in practice, the multi-day delay that is often incurred for this purpose leads to physicians
frequently prescribing antibiotic treatment in the absence of definitive lab results. As the vast majority of the
roughly three million annual Lyme tests in the U.S. are carried out on individuals who do not have Lyme
disease, this practice leads to the unnecessary prescription and use of antibiotics, contributing to the growth of
antibiotic resistance which has become a significant threat to public health. A first step test with significantly
higher specificity would avoid the need for a second step test and enable clinicians to make informed treatment
decisions in a timely manner, based on credible test results.
This project is aimed at bringing about a significant change in medical practice by reducing Lyme testing from
the current two-step process to a one-step process. To achieve this objective, we have developed a novel
ELISA methodology for Lyme antibody detection that enables exceptionally high assay specificity. The test is
based on well-established, highly specific and sensitive Borrelia antigens in a unique immunochemical format.
The novel ELISA immunochemistry eliminates almost all non-specific reactivity, yielding results comparable in
both sensitivity and specificity to those obtained with the conventional two-tier testing protocol. Consequently,
this assay promises to deliver a one-step testing solution for Lyme disease, at a time when alternatives to the
original two-step method are gaining legitimacy at the scientific as well as regulatory level.
In this Phase I project, we will develop a prototype ELISA assay, proving feasibility by demonstrating sensitivity
and specificity on retrospective samples comprising Lyme patients and controls, in comparison with two-tier
testing results. In Phase II, we will complete development of a commercial product, carry out prospective and
retrospective clinical studies and submit an application to FDA for in vitro diagnostic claims, allowing
commercial launch upon approval.
摘要
项目成果
期刊论文数量(0)
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科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Andrew E. Levin其他文献
Evaluation of a sequential enzyme immunoassay testing algorithm for Lyme disease demonstrates lack of test independence but high diagnostic specificity.
对莱姆病序贯酶免疫分析测试算法的评估表明缺乏测试独立性,但诊断特异性较高。
- DOI:
- 发表时间:
2018 - 期刊:
- 影响因子:2.9
- 作者:
G. Wormser;Claudia R. Molins;Andrew E. Levin;Susan C. Lipsett;L. Nigrovic;M. Schriefer;J. Branda - 通讯作者:
J. Branda
The Babesia observational antibody (BAOBAB) study: A cross-sectional evaluation of Babesia in two communities in Kilosa district, Tanzania
巴贝虫观察性抗体 (BAOBAB) 研究:坦桑尼亚基洛萨区两个社区巴贝虫横断面评估
- DOI:
10.1371/journal.pntd.0007632 - 发表时间:
2019 - 期刊:
- 影响因子:3.8
- 作者:
E. Bloch;Z. Mrango;M. Kasubi;Jerusha Weaver;Aleksandra Mihailovic;B. Munoz;A. Weimer;Andrew E. Levin;L. Tonnetti;J. Linnen;V. Brès;D. Norris;G. Carpi;S. West - 通讯作者:
S. West
Frequency and magnitude of seroreactivity to <em>Babesia microti</em> in 245 patients diagnosed by PCR in New York State
- DOI:
10.1016/j.diagmicrobio.2020.115008 - 发表时间:
2020-05-01 - 期刊:
- 影响因子:
- 作者:
Susan Madison-Antenucci;Gary P. Wormser;Andrew E. Levin;Susan J. Wong - 通讯作者:
Susan J. Wong
Andrew E. Levin的其他文献
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{{ truncateString('Andrew E. Levin', 18)}}的其他基金
Point-of-care diagnostic test for T. cruzi (Chagas) infection
克氏锥虫(恰加斯)感染的即时诊断测试
- 批准号:
10603665 - 财政年份:2023
- 资助金额:
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Development of an ELISA for serosurveillance of human hookworm
开发用于人类钩虫血清监测的 ELISA
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10697222 - 财政年份:2023
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Rapid Point-of-Care Assay for Diagnosis of Neurocysticercosis in Seizure Patients
用于诊断癫痫患者神经囊尾蚴病的快速护理点检测
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9909230 - 财政年份:2020
- 资助金额:
$ 29.98万 - 项目类别:
Rapid Point-of-Care Assay for Diagnosis of Neurocysticercosis in Seizure Patients
用于诊断癫痫患者神经囊尾蚴病的快速护理点检测
- 批准号:
10084274 - 财政年份:2020
- 资助金额:
$ 29.98万 - 项目类别:
Rapid Point-of-Care Assay for Diagnosis of Neurocysticercosis in Seizure Patients
用于诊断癫痫患者神经囊尾蚴病的快速护理点检测
- 批准号:
10699435 - 财政年份:2020
- 资助金额:
$ 29.98万 - 项目类别:
Biomarker-Based Test of Cure for Chagas Disease
基于生物标记的恰加斯病治愈测试
- 批准号:
10761244 - 财政年份:2019
- 资助金额:
$ 29.98万 - 项目类别:
Hybrid ELISA: Simple and specific one-tier assay for Lyme disease
混合 ELISA:针对莱姆病的简单而特异的一层检测
- 批准号:
10758919 - 财政年份:2019
- 资助金额:
$ 29.98万 - 项目类别:
Biomarker-Based Test of Cure for Chagas Disease
基于生物标记的恰加斯病治愈测试
- 批准号:
9978716 - 财政年份:2019
- 资助金额:
$ 29.98万 - 项目类别:
Point-of-care diagnostic test for T. cruzi (Chagas) infection
克氏锥虫(恰加斯)感染的即时诊断测试
- 批准号:
9757680 - 财政年份:2018
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$ 29.98万 - 项目类别:
Serologic assays for detection of Zika virus antibodies for clinical diagnosis and blood donor counseling
用于检测寨卡病毒抗体的血清学检测,用于临床诊断和献血者咨询
- 批准号:
10221519 - 财政年份:2017
- 资助金额:
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