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Abstract
Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) has become a global pandemic. Case identification is currently made by real-time polymerase chain reaction (PCR) during the acute phase and largely restricted to healthcare laboratories. Serological assays are emerging but independent validation is urgently required to assess their utility. We evaluated five different point-of-care (POC) SARS-CoV-2 antibody test kits against PCR, finding concordance across the assays (n = 15). We subsequently tested 200 patients using the OrientGene COVID-19 IgG/IgM Rapid Test Cassette and find a sensitivity of 74% in the early infection period (day 5–9 post symptom onset), with 100% sensitivity not seen until day 13, demonstrating inferiority to PCR testing in the infectious period. Negative rate was 96%, but in validating the serological tests uncovered potential false-negatives from PCR testing late-presenting cases. A positive predictive value (PPV) of 37% in the general population precludes any use for general screening. Where a case definition is applied however, the PPV is substantially improved (95.4%), supporting use of serology testing in carefully targeted, high-risk populations. Larger studies in specific patient cohorts, including those with mild infection are urgently required to inform on the applicability of POC serological assays to help control the spread of SARS-CoV-2 and improve case finding of patients that may experience late complications.
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1 Queen Elizabeth Hospital Birmingham, Centre of Defence Pathology, Royal Centre for Defence Medicine, Birmingham, UK (GRID:grid.415490.d) (ISNI:0000 0001 2177 007X); Chelsea and Westminster NHS Foundation Trust, Clinical Infection Department, London, UK (GRID:grid.428062.a) (ISNI:0000 0004 0497 2835)
2 Chelsea and Westminster NHS Foundation Trust, Clinical Infection Department, London, UK (GRID:grid.428062.a) (ISNI:0000 0004 0497 2835); North West London Pathology, London, UK (GRID:grid.428062.a)
3 Chelsea and Westminster NHS Foundation Trust, Clinical Infection Department, London, UK (GRID:grid.428062.a) (ISNI:0000 0004 0497 2835)
4 Imperial College London, Hammersmith Campus, NIHR Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, London, UK (GRID:grid.7445.2) (ISNI:0000 0001 2113 8111)
5 Chelsea and Westminster NHS Foundation Trust, Clinical Infection Department, London, UK (GRID:grid.428062.a) (ISNI:0000 0004 0497 2835); North West London Pathology, London, UK (GRID:grid.428062.a); Imperial College London, Hammersmith Campus, NIHR Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, London, UK (GRID:grid.7445.2) (ISNI:0000 0001 2113 8111)
6 Imperial College London, Hammersmith Campus, Department of Surgery and Cancer, London, UK (GRID:grid.7445.2) (ISNI:0000 0001 2113 8111)