Comparison between a rapid diagnostic test and dried blood spot-based immunoassay for hepatitis B surface antigen testing: Performance and cost implications in a population-based serosurvey in Vietnam
Comparison between a rapid diagnostic test and dried blood spot-based immunoassay for hepatitis B surface antigen testing: Performance and cost implications in a population-based serosurvey in Vietnam
复制标题
DOI：
10.1016/j.ijid.2022.10.011
复制
发表时间：
2022-11-01
影响因子：
8.4
通讯作者：
Hachiya，Masahiko
中科院分区：
文献类型：
--
作者：
Okawa，Sumiyo;Komada，Kenichi;Hachiya，Masahiko
目的本研究旨在确定B型肝炎表面抗原的快速诊断试验（RDT）和干血斑（DBS）电化学发光免疫分析（ECLIA）之间的一致性，并比较在现场环境中使用RDT和DBS进行血清学调查的成本。方法2019年5月在越南中南部沿海地区进行血清学调查。使用四阶段随机抽样方法招募1-39岁的参与者，并使用RDT试剂盒（Alere Determine）和基于DBS的ECLIA检测B型肝炎表面抗原。使用交叉表和Cohen kappa评估RDT和基于DBS的ECLIA之间的一致性。成本数据按投入（人员、运输、现场消耗品、实验室消耗品和资本项目/间接费用）和调查阶段（调查准备、数据/生物标本收集、实验室检测和协调）进行分类。结果共调查2072人。RDT和基于DBS的ECLIA结果之间有99%的一致性，Cohen kappa为0.9。DBS进行血清调查的估计费用为75 291美元，而RDT为53 182美元。结论RDTs和DBS ECLIA的检测结果具有较高的一致性。就成本而言，RDTs是一个更好的选择，而基于DBS的ECLIA在评估多种传染病时可能是有用的。
Objectives This study aimed to determine the agreement between a rapid diagnostic test (RDT) and a dried blood spot (DBS)-based electrochemiluminescence immunoassay (ECLIA) of hepatitis B surface antigen and to compare the costs of conducting serosurveys using RDTs and DBS in a field setting. Methods A serosurvey was conducted in the South Central Coast region of Vietnam in May 2019. Participants aged 1-39 years were recruited using a four-stage random sampling method and tested for hepatitis B surface antigen using an RDT kit (Alere Determine) and a DBS-based ECLIA. The agreement between the RDT and the DBS-based ECLIA was assessed using cross-tabulation and Cohen kappa. Cost data were categorized by input (personnel, transportation, field consumables, laboratory consumables, and capital item/overhead) and survey phase (survey preparation, data/biospecimen collection, laboratory testing, and coordination). Results A total of 2072 participants were analyzed. There was a 99% agreement between the RDT and the DBS-based ECLIA results, with a Cohen kappa of 0.9. The estimated cost of conducting a serosurvey by DBS was UD $75,291, whereas RDT was $53,182. Conclusion RDTs and DBS-based ECLIA provide test results with high agreements. RDTs are a better option in terms of cost, whereas the DBS-based ECLIA may be useful when evaluating multiple infectious diseases.