Background The accuracy and reliability of rapid diagnostic tests are critical for monitoring and diagnosing SARS-CoV-2 infection in the general population. This study aimed to evaluate the analytical performance of the BIOSYNEX COVID-19 Ag BSS (Biosynex Swiss SA, Fribourg, Switzerland) antigen rapid diagnostic test ( BIOSYNEX Ag-RDT), which targets the SARS-CoV-2 N-nucleocapsid protein for the diagnosis of COVID-19. The Ag-RDT was compared with a real-time RT-PCR (rtRT-PCR) as gold standard for performance measurement. Methods Two nasopharyngeal flocked swabs were prospectively collected simultaneously in March and April 2021 from 967 individuals aged ≥ 18 years tested for SARS-CoV-2 in two private laboratories, Paris, France. Results Overall, the Ag-RDT demonstrated high sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 81.8%, 99.6%, 96.6%, and 97.5%, respectively. The agreement (97.0%), reliability assessed using Cohen’s κ-coefficient (0.87), and accuracy evaluated using Youden index (J) (81.6%) in detecting SARS-CoV-2 were high. The analytical performance of the Ag-RDT remained high when there was significant viral shedding ( i.e. , N gene C t values ≤ 33 on reference RT-PCR). The sensitivity was only 55.2% in case of low or very low viral excretion (C t > 33). Conclusions The BIOSYNEX Ag-RDT is a promising, potentially simple diagnostic tool, especially in symptomatic COVID-19 patients with substantial viral excretion in the nasopharynx. Supplementary Information The online version contains supplementary material available at 10.1007/s15010-021-01723-5.
【저자키워드】 COVID-19, SARS-CoV-2, Antigen, lateral flow assay, Rapid diagnostic test, France, N-nucleocapsid protein, 【초록키워드】 reliability, SARS-COV-2 infection, diagnostic test, diagnostic, viral shedding, RT-PCR, Predictive value, Protein, sensitivity, specificity, Viral, Positive predictive value, Accuracy, nasopharyngeal, diagnostic tests, symptomatic, nasopharynx, France, gold, target, General population, Swab, N gene, real-time RT-PCR, Ag-RDT, Switzerland, Critical, COVID-19 patient, Negative predictive value, supplementary material, gold standard, individual, Paris, rtRT-PCR, diagnosing, Result, tested, collected, evaluate, remained, evaluated, demonstrated, BSS, diagnosis of COVID-19, NPV, PPV, 【제목키워드】 nucleocapsid protein, SARS‐CoV‐2, point-of-care, nasopharyngeal, BSS,