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

Int J Infect Dis. 2022 Dec:125:51-57. doi: 10.1016/j.ijid.2022.10.011. Epub 2022 Oct 12.

Abstract

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.

Keywords: Cost comparison; Dried blood spots; Hepatitis B; Rapid diagnostic tests; Seroprevalence survey; Vietnam.

MeSH terms

  • Dried Blood Spot Testing / methods
  • Hepatitis B Surface Antigens*
  • Hepatitis B* / diagnosis
  • Humans
  • Immunoassay / methods
  • Rapid Diagnostic Tests*
  • Sensitivity and Specificity
  • Vietnam / epidemiology

Substances

  • Hepatitis B Surface Antigens