Stringent thresholds for SARS-CoV-2 IgG assays result in under-detection of cases reporting loss of taste/smell
David W Eyre,
Sheila F Lumley,
Philippa C Matthews,
Stephanie B Hatch,
Brian D Marsden,
David I. Stuart,
Gavin R. Screaton,
Derrick W Crook,
Christopher P Conlon,
Timothy M Walker,
Tim EA Peto
Posted 25 Jul 2020
medRxiv DOI: 10.1101/2020.07.21.20159038
Posted 25 Jul 2020
Thresholds for SARS-CoV-2 antibody assays have typically been determined using samples from symptomatic, often hospitalised, patients. Assay performance following mild/asymptomatic infection is unclear. We assessed IgG responses in asymptomatic healthcare workers with a high pre-test probability of Covid-19, e.g. 807/9292(8.9%) reported loss of smell/taste. The proportion reporting anosmia/ageusia increased at antibody titres below diagnostic thresholds for both an in-house ELISA and the Abbott Architect chemiluminescent microparticle immunoassay (CMIA): 424/903(47%) reported anosmia/ageusia with a positive ELISA, 59/387(13.2%) with high-negative titres, and 324/7943(4.1%) with low-negative results. Adjusting for the proportion of staff reporting anosmia/ageusia suggests the sensitivity of both assays is lower than previously reported: Oxford ELISA 90.8% (95%CI 86.1-92.1%) and Abbott CMIA 80.9% (77.5-84.3%). However, the sensitivity may be lower if some anosmia/ageusia in those with low-negative titres is Covid-19-associated. Samples from individuals with mild/asymptomatic infection should be included in SARS-CoV-2 immunoassay evaluations. Reporting equivocal SARS-CoV-2 antibody results should be considered.
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