AbstractBackgroundSARS-CoV-2 vaccine coverage remains incomplete, being only 15% in low income countries. Rapid point of care tests predicting SARS-CoV-2 infection susceptibility in the unvaccinated might assist in risk management and vaccine prioritisation.MethodsWe conducted a prospective cohort study in 2,826 participants working in hospitals and Fire and Police services in England, UK, during the pandemic (ISRCTN5660922). Plasma taken at recruitment in June 2020 was tested using four lateral flow immunoassay (LFIA) devices and two laboratory immunoassays detecting antibodies against SARS-CoV-2 (UK Rapid Test Consortium’s AbC-19™ Rapid Test, OrientGene COVID IgG/IgM Rapid Test Cassette, SureScreen COVID-19 Rapid Test Cassette, and Biomerica COVID-19 IgG/IgM Rapid Test; Roche N and EUROIMMUN S laboratory assays). We monitored participants for microbiologically-confirmed SARS-CoV-2 infection for 200 days. We estimated associations between test results at baseline and subsequent infection, using Poisson regression models adjusted for baseline demographic risk factors for SARS-CoV-2 exposure.FindingsPositive IgG results on each of the four LFIAs were associated with lower rates of subsequent infection: adjusted incidence rate ratios (aIRRs) 0.00 (95% confidence interval 0.00-0.01), 0.03 (0.02-0.05), 0.07 (0.05-0.10), and 0.09 (0.07-0.12) respectively. The protective association was strongest for AbC-19 and SureScreen. The aIRR for the laboratory Roche N antibody assay at the manufacturer-recommended threshold was similar to those of the two best performing LFIAs at 0.03 (0.01-0.10).InterpretationLateral flow devices measuring SARS-CoV-2 IgG predicted disease risk in unvaccinated individuals over 200 day follow-up. The association of some LFIAs with subsequent infection was similar to laboratory immunoassays.FundingUK GovernmentResearch in contextEvidence before this studyWe searched PubMed for research articles, using the search terms (“COVID-19” OR “SARS-CoV-2” OR “2019-nCoV” OR “coronavirus”) AND (“Antibody” OR “IgG”) AND ((“protection” OR “infection”) identifying studies of cohorts of unvaccinated individuals which reported antibody-associated disease protection published between Dec 1 2019 and 1 April 2022. Additionally, we reviewed studies matching “SARS-CoV-2” and “lateral flow” and “antibody” over the same period.Multiple cohort studies in healthy populations have demonstrated an association between the detection of antibodies to SARS-CoV-2 following natural infection and protection from subsequent symptomatic infection with SARS-CoV-2. Protection estimates were about 85% protection in two overlapping meta-analyses, while in several larger studies increased protection with higher antibody levels was observed.Lateral flow immunoassays (LFIAs) detecting anti-SARS-CoV-2 IgG are a cheap, readily deployed technology which has been used on a large scale in population screening programs. However, there are wide variations in sensitivity and specificity of antibody detection between different devices. No studies have investigated whether LFIA results are associated with subsequent SARS-CoV-2 infection.Added value of this studyIn a prospective cohort study of 2,826 UK key workers, we found positivity in lateral flow test results had a strong negative association with subsequent SARS-CoV-2 infection within 200 days in an unvaccinated population. The performance of different devices in predicting disease protection differed: positivity on more specific but less sensitive tests was associated with markedly decreased rate of disease. By contrast, protection associated with testing positive using more sensitive devices detecting lower levels of anti-SARS-CoV-2 IgG was more modest.Implications of all the available evidenceIf the field performance of these tests against contemporary SARS-CoV-2 infection was similar to that observed in this study, lateral flow tests with high specificity may have a role in estimation of SARS-CoV-2 disease risk in unvaccinated populations and individuals.
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