Evaluating 10 Commercially Available SARS-CoV-2 Rapid Serological Tests by Use of the STARD (Standards for Reporting of Diagnostic Accuracy Studies) Method
Laurent Dortet, Jean‐Baptiste Ronat, Christelle Vauloup‐Fellous, Céline Langendorf, David-Alexis Mendels, Cécile Emeraud, Saoussen Oueslati, Delphine Girlich, Anthony Chauvin, Ali Afdjei, Sandrine Bernabeu, Samuel Le Pape, Rim Kallala, Alice Rochard, Céline Verstuyft, Nicolas Fortineau, Anne‐Marie Roque‐Afonso, Thierry Naas
Abstract
= 226). All samples were tested using rapid lateral flow immunoassays (LFIAs) from 10 manufacturers. Only four tests achieved ≥98% specificity, with the specificities ranging from 75.7% to 99.2%. The sensitivities varied by the day of sample collection after the onset of symptoms, from 31.7% to 55.4% (days 0 to 9), 65.9% to 92.9% (days 10 to 14), and 81.0% to 95.2% (>14 days). Only three of the tests evaluated met French health authorities' thresholds for SARS-CoV-2 serological tests (≥90% sensitivity and ≥98% specificity). Overall, the performances varied greatly between tests, with only one-third meeting acceptable specificity and sensitivity thresholds. Knowledge of the analytical performances of these tests will allow clinicians and, most importantly, laboratorians to use them with more confidence; could help determine the general population's immunological status; and may help diagnose some patients with false-negative real-time reverse transcription-PCR (RT-PCR) results.