TABLE 5.1Advantages and disadvantages of different assay formats

AssayAdvantagesDisadvantages
Laboratory-based immunoassays (EIA, CLIA, ECL)
  • Currently superior clinical/ diagnostic and analytical sensitivity/specificity for HBsAg
  • High throughput possible (>40 per day per operator)
  • High throughput greater when using automated immunoanalysers
  • Objective, automated reading of results, but not for line blots or simple assays
  • Within-assay procedural quality control
  • Requires laboratory facilities, equipment, e.g. EIA plate washers, readers, incubators or immunoanalysers or random-access analysers.
  • Requires trained laboratory technician
  • Reagents require refrigeration
  • Requires venepuncture to obtain specimen
  • Time to result ∼3 hours and generally batched as one run if manual EIA
Rapid diagnostic tests (RDTs)
  • Accessible at the lowest level of the health-care system (including community settings)
  • Does not specifically require laboratory facilities
  • May be carried out by trained lay providers and health-care workers, as well as laboratory technicians
  • Can be used with less invasive specimens that do not require venepuncture such as capillary whole blood or oral fluid
  • If testing at or near to point of care, same-day results are possible, which may reduce number of individuals that are lost to follow up and therefore do not receive their test results
  • Devices can be stored at 2–30 °C
  • Lower clinical and analytical sensitivity/specificity for HBsAg
  • Less sensitive in certain populations such as immunosuppressed, including HIV-positive individuals
  • Ineffective within-assay quality control, i.e. most RDTs do not control for specimen addition
  • Lack of test kit external control reagents for quality control with most RDTs, but some exceptions, e.g. Oraquick
  • Stability at room temperature is impacted by environmental factors, e.g. heat, humidity, storage conditions
  • Subjective reading and interpretation of results
  • Requires manual transcription of testing results into laboratory logbook/testing register, partially mitigated by automated RDT readers
Nucleic acid testing (NAT) technologies
  • May be used at or near the point of care
  • May be carried out by trained lay providers and health-care workers, as well as laboratory technicians
  • Can be used with less invasive specimens that do not require venepuncture such as capillary whole blood
  • Devices can be stored at 2–30 °C
  • Currently requires laboratory facilities and equipment, but this may not apply to future point-of-care options
  • Requires trained laboratory technician
  • Reagents require refrigeration
  • Requires venepuncture to obtain specimen
  • Time to result ∼3 hours and generally batched as one

From: 5, BACKGROUND – DIAGNOSTICS FOR TESTING FOR HEPATITIS B AND C INFECTION

Cover of WHO Guidelines on Hepatitis B and C Testing
WHO Guidelines on Hepatitis B and C Testing.
Geneva: World Health Organization; 2017 Feb.
Copyright © World Health Organization 2017.

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