{"title":"用干血点检测疫苗可预防疾病的多头血清学检测。","authors":"Paul D Olivo, Sudip Ghatak, Randolph Rasch","doi":"10.2147/RMHP.S506025","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Vaccines are effective tools to improve public health. The effectiveness of vaccines is, however, dependent on the overall level of protection in a population. Antibodies to vaccine-related antigens are good biomarkers of protection and serosurveillance can help target vaccination programs. An integrated approach to perform serosurveillance on multiple vaccine-preventable diseases (VPDs) has been advocated and would be facilitated by a standardized multiplex immunoassay. In this report, we describe the evaluation of the performance of a multi-lyte bead-based serology panel for 12 VPDs which uses a dried blood spot sample from a finger prick (<i>ImmunoProfile Antibody Test System</i>).</p><p><strong>Methods: </strong>Verification/validation studies were performed at a CLIA-certified clinical laboratory (BioAgilytix Labs, Boston, MA) on blood collected from dried blood spot (DBS) card samples from adults and children. In addition, proof-of-principle pilot serosurveillance studies were performed to demonstrate the potential of this test to identify protection gaps in adult and pediatric populations.</p><p><strong>Results: </strong>This study demonstrates that the ImmunoProfile Antibody Test System has the requisite analytical performance to be a reliable tool for determining levels of protection to VPDs. The pilot serosurveillance studies demonstrate that this test reveals gaps in protection comparable to what has been shown using immunoassays for individual antibodies using serum samples.</p><p><strong>Conclusion: </strong>Serological survey data obtained with the validated ImmunoProfile Antibody Test System could provide a wealth of information on levels of protection and could unearth vaccination gaps that may not have been anticipated.</p>","PeriodicalId":56009,"journal":{"name":"Risk Management and Healthcare Policy","volume":"18 ","pages":"923-932"},"PeriodicalIF":2.0000,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11932034/pdf/","citationCount":"0","resultStr":"{\"title\":\"A Multiplex Bead Serology Panel For Vaccine-Preventable Diseases Using Dried Blood Spots.\",\"authors\":\"Paul D Olivo, Sudip Ghatak, Randolph Rasch\",\"doi\":\"10.2147/RMHP.S506025\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Vaccines are effective tools to improve public health. 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引用次数: 0
摘要
背景:疫苗是改善公众健康的有效工具。然而,疫苗的效力取决于人群的总体保护水平。针对疫苗相关抗原的抗体是很好的保护生物标志物,血清监测可以帮助目标疫苗接种计划。已提倡对多种疫苗可预防疾病(VPDs)进行血清监测的综合方法,并将通过标准化的多重免疫测定加以促进。在本报告中,我们描述了一种基于多碱液珠的血清学小组的性能评估,该小组使用从手指刺破的干燥血斑样本(免疫谱抗体测试系统)。方法:在clia认证的临床实验室(BioAgilytix Labs, Boston, MA)对成人和儿童的干血斑(DBS)卡样本采集的血液进行验证/验证研究。此外,还进行了原则性试验血清监测研究,以证明该测试在确定成人和儿科人群中的保护差距方面的潜力。结果:本研究表明,免疫谱抗体测试系统具有必要的分析性能,是确定vpd保护水平的可靠工具。试点血清监测研究表明,与使用血清样本对单个抗体进行免疫分析所显示的结果相比,该测试揭示了保护方面的差距。结论:使用经过验证的ImmunoProfile Antibody Test System获得的血清学调查数据可以提供有关保护水平的丰富信息,并可能发现可能未预料到的疫苗接种差距。
A Multiplex Bead Serology Panel For Vaccine-Preventable Diseases Using Dried Blood Spots.
Background: Vaccines are effective tools to improve public health. The effectiveness of vaccines is, however, dependent on the overall level of protection in a population. Antibodies to vaccine-related antigens are good biomarkers of protection and serosurveillance can help target vaccination programs. An integrated approach to perform serosurveillance on multiple vaccine-preventable diseases (VPDs) has been advocated and would be facilitated by a standardized multiplex immunoassay. In this report, we describe the evaluation of the performance of a multi-lyte bead-based serology panel for 12 VPDs which uses a dried blood spot sample from a finger prick (ImmunoProfile Antibody Test System).
Methods: Verification/validation studies were performed at a CLIA-certified clinical laboratory (BioAgilytix Labs, Boston, MA) on blood collected from dried blood spot (DBS) card samples from adults and children. In addition, proof-of-principle pilot serosurveillance studies were performed to demonstrate the potential of this test to identify protection gaps in adult and pediatric populations.
Results: This study demonstrates that the ImmunoProfile Antibody Test System has the requisite analytical performance to be a reliable tool for determining levels of protection to VPDs. The pilot serosurveillance studies demonstrate that this test reveals gaps in protection comparable to what has been shown using immunoassays for individual antibodies using serum samples.
Conclusion: Serological survey data obtained with the validated ImmunoProfile Antibody Test System could provide a wealth of information on levels of protection and could unearth vaccination gaps that may not have been anticipated.
期刊介绍:
Risk Management and Healthcare Policy is an international, peer-reviewed, open access journal focusing on all aspects of public health, policy and preventative measures to promote good health and improve morbidity and mortality in the population. Specific topics covered in the journal include:
Public and community health
Policy and law
Preventative and predictive healthcare
Risk and hazard management
Epidemiology, detection and screening
Lifestyle and diet modification
Vaccination and disease transmission/modification programs
Health and safety and occupational health
Healthcare services provision
Health literacy and education
Advertising and promotion of health issues
Health economic evaluations and resource management
Risk Management and Healthcare Policy focuses on human interventional and observational research. The journal welcomes submitted papers covering original research, clinical and epidemiological studies, reviews and evaluations, guidelines, expert opinion and commentary, and extended reports. Case reports will only be considered if they make a valuable and original contribution to the literature. The journal does not accept study protocols, animal-based or cell line-based studies.