tetano
Editor, Senior Moderator
Open Forum Infect Dis
. 2021 Oct 4;8(11)
fab496.
doi: 10.1093/ofid/ofab496. eCollection 2021 Nov.
Acceptability, Usability, and Performance of Lateral Flow Immunoassay Tests for Severe Acute Respiratory Syndrome Coronavirus 2 Antibodies: REACT-2 Study of Self-Testing in Nonhealthcare Key Workers
Bethan Davies[SUP] 1 [/SUP], Marzieh Araghi[SUP] 1 [/SUP], Maya Moshe[SUP] 2 [/SUP], He Gao[SUP] 1 [/SUP], Kimberly Bennet[SUP] 1 [/SUP], Jordan Jenkins[SUP] 1 [/SUP], Christina Atchison[SUP] 3 [/SUP], Ara Darzi[SUP] 4 5 [/SUP], Deborah Ashby[SUP] 1 [/SUP], Steven Riley[SUP] 3 [/SUP], Wendy Barclay[SUP] 2 [/SUP], Paul Elliott[SUP] 1 5 [/SUP], Helen Ward[SUP] 3 5 [/SUP], Graham Cooke[SUP] 2 5 [/SUP]
Affiliations
Abstract
Background: Seroprevalence studies are essential to understand the epidemiology of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Various technologies, including laboratory assays and point-of-care self-tests, are available for antibody testing. The interpretation of seroprevalence studies requires comparative data on the performance of antibody tests.
Methods: In June 2020, current and former members of the United Kingdom police forces and fire service performed a self-test lateral flow immunoassay (LFIA), had a nurse-performed LFIA, and provided a venous blood sample for enzyme-linked immunosorbent assay (ELISA). We present the prevalence of antibodies to SARS-CoV-2 and the acceptability and usability of self-test LFIAs, and we determine the sensitivity and specificity of LFIAs compared with laboratory ELISA.
Results: In this cohort of 5189 current and former members of the police service and 263 members of the fire service, 7.4% (396 of 5348; 95% confidence interval [CI], 6.7-8.1) were antibody positive. Seroprevalence was 8.9% (95% CI, 6.9-11.4) in those under 40 years, 11.5% (95% CI, 8.8-15.0) in those of nonwhite ethnicity, and 7.8% (95% CI, 7.1-8.7) in those currently working. Self-test LFIA had an acceptability of 97.7% and a usability of 90.0%. There was substantial agreement between within-participant LFIA results (kappa 0.80; 95% CI, 0.77-0.83). The LFIAs had a similar performance: compared with ELISA, sensitivity was 82.1% (95% CI, 77.7-86.0) self-test and 76.4% (95% CI, 71.9-80.5) nurse-performed with specificity of 97.8% (95% CI, 97.3-98.2) and 98.5% (95% CI, 98.1-98.8), respectively.
Conclusions: A greater proportion of this nonhealthcare key worker cohort showed evidence of previous infection with SARS-CoV-2 than the general population at 6.0% (95% CI, 5.8-6.1) after the first wave in England. The high acceptability and usability reported by participants and similar performance of self-test and nurse-performed LFIAs indicate that the self-test LFIA is fit for purpose for home testing in occupational and community prevalence studies.
Keywords: COVID-19 diagnostic testing; SARS-CoV-2; antibody testing; sensitivity and specificity.
. 2021 Oct 4;8(11)
fab496.doi: 10.1093/ofid/ofab496. eCollection 2021 Nov.
Acceptability, Usability, and Performance of Lateral Flow Immunoassay Tests for Severe Acute Respiratory Syndrome Coronavirus 2 Antibodies: REACT-2 Study of Self-Testing in Nonhealthcare Key Workers
Bethan Davies[SUP] 1 [/SUP], Marzieh Araghi[SUP] 1 [/SUP], Maya Moshe[SUP] 2 [/SUP], He Gao[SUP] 1 [/SUP], Kimberly Bennet[SUP] 1 [/SUP], Jordan Jenkins[SUP] 1 [/SUP], Christina Atchison[SUP] 3 [/SUP], Ara Darzi[SUP] 4 5 [/SUP], Deborah Ashby[SUP] 1 [/SUP], Steven Riley[SUP] 3 [/SUP], Wendy Barclay[SUP] 2 [/SUP], Paul Elliott[SUP] 1 5 [/SUP], Helen Ward[SUP] 3 5 [/SUP], Graham Cooke[SUP] 2 5 [/SUP]
Affiliations
- PMID: 34796246
- PMCID: PMC8522420
- DOI: 10.1093/ofid/ofab496
Abstract
Background: Seroprevalence studies are essential to understand the epidemiology of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Various technologies, including laboratory assays and point-of-care self-tests, are available for antibody testing. The interpretation of seroprevalence studies requires comparative data on the performance of antibody tests.
Methods: In June 2020, current and former members of the United Kingdom police forces and fire service performed a self-test lateral flow immunoassay (LFIA), had a nurse-performed LFIA, and provided a venous blood sample for enzyme-linked immunosorbent assay (ELISA). We present the prevalence of antibodies to SARS-CoV-2 and the acceptability and usability of self-test LFIAs, and we determine the sensitivity and specificity of LFIAs compared with laboratory ELISA.
Results: In this cohort of 5189 current and former members of the police service and 263 members of the fire service, 7.4% (396 of 5348; 95% confidence interval [CI], 6.7-8.1) were antibody positive. Seroprevalence was 8.9% (95% CI, 6.9-11.4) in those under 40 years, 11.5% (95% CI, 8.8-15.0) in those of nonwhite ethnicity, and 7.8% (95% CI, 7.1-8.7) in those currently working. Self-test LFIA had an acceptability of 97.7% and a usability of 90.0%. There was substantial agreement between within-participant LFIA results (kappa 0.80; 95% CI, 0.77-0.83). The LFIAs had a similar performance: compared with ELISA, sensitivity was 82.1% (95% CI, 77.7-86.0) self-test and 76.4% (95% CI, 71.9-80.5) nurse-performed with specificity of 97.8% (95% CI, 97.3-98.2) and 98.5% (95% CI, 98.1-98.8), respectively.
Conclusions: A greater proportion of this nonhealthcare key worker cohort showed evidence of previous infection with SARS-CoV-2 than the general population at 6.0% (95% CI, 5.8-6.1) after the first wave in England. The high acceptability and usability reported by participants and similar performance of self-test and nurse-performed LFIAs indicate that the self-test LFIA is fit for purpose for home testing in occupational and community prevalence studies.
Keywords: COVID-19 diagnostic testing; SARS-CoV-2; antibody testing; sensitivity and specificity.