Antibody testing for COVID-19: A report from the National COVID Scientific Advisory Panel [Supporting Data]

The materials presented here are a supporting dataset for a project to evaluate the performance of point of care (lateral flow) immunoassay test devices versus enzyme linked immunosorbent assay (ELISA) for the detection of antibodies to SARS-CoV-2.
Our work was undertaken with ethical approval from the National Health Service Blood and Transplant (NHSBT) ethics, providing donor consent for plasma use; NIHR Biobank REC agreement (REC 13/NW/0017; IRAS 87824); International Severe Acute Respiratory and Emerging Infection Consortium (‘ISARIC’) approval by the South Central (Oxford C) Research Ethics Committee in England (Ref: 13/SC/0149), and Scotland A Research Ethics Committee in Scotland (Ref: 20/SS/0028). The UK Government Department of Health and Social Care selected the lateral flow devices for testing. Otherwise, the funders had no role in study design or in the collection, analysis, and interpretation of data.

Material provided is as follows:
1. STARD checklist

2. Supplementary table S1. Metadata describing origin and characteristics of designated negative controls and individuals with confirmed SARS-CoV-2 infection (provided as a separate .xlsx file).

3. Supplementary material.pdf
- Supplementary Figure S1: Sensitivity and specificity of lateral flow devices compared with RT-PCR confirmed cases and pre-pandemic controls (panels A and B) and compared with ELISA results (panels C and D).

- Supplementary Figure S2: Comparison between ELISA and LFIA for SARS-CoV-2 designated negative and positive plasma.

- Supplementary table S2. Summary grid presenting the number of samples from each cohort tested using different assay platforms.

- Supplementary table S3. Multivariable regression models for relationship between ELISA IgM and IgG readings and covariates in RT-PCR positive cases.

- Supplementary Table S4. Results of nine lateral flow immunoassays (LFIA) devices and an ELISA assay, tested with plasma classified as positive (RT-PCR positive) obtained from patients ≥10 days after onset of symptoms.

- Supplementary Table S5. Results of nine lateral flow immunoassays (LFIA) devices, tested with plasma classified as positive and negative using ELISA as an alternative reference standard (n=81-90 per LFIA device). Different manufacturers are designated A-I. 95% confidence intervals (CI) are presented for each point estimate.

4. Supplementary table S6: Results of all assays performed and relevant metadata (provided as a separate .xlsx file).