Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples

Abstract

In the context of the coronavirus disease 2019 (COVID-19) pandemic, the development and validation of rapid and easy-to-perform diagnostic methods are of high priority. This study was performed to evaluate a novel rapid antigen detection test (RDT) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in respiratory samples. Methods: The fluorescence immunochromatographic SARS-CoV-2 antigen test (Bioeasy Biotechnology Co., Shenzhen, China) was evaluated using universal transport medium with nasopharyngeal (NP) and oropharyngeal (OP) swabs from suspected COVID-19 cases. Diagnostic accuracy was determined in comparison to SARS-CoV-2 real-time (RT)-PCR. Results: A total of 127 samples were included; 82 were RT-PCR-positive. The median patient age was 38 years, 53.5% were male, and 93.7% were from the first week after symptom onset. Overall sensitivity and specificity were 93.9% (95% confidence interval 86.5-97.4%) and 100% (95% confidence interval 92.1-100%), respectively, with a diagnostic accuracy of 96.1% and Kappa coefficient of 0.9. Sensitivity was significantly higher in samples with high viral loads. Conclusions: The RDT evaluated in this study showed a high sensitivity and specificity in samples mainly obtained during the first week of symptoms and with high viral loads, despite the use of a non-validated sample material. The assay has the potential to become an important tool for early diagnosis of SARS-CoV-2, particularly in situations with limited access to molecular methods.

Laboratory testing for the diagnosis of COVID-19

“…Users of these antigen tests should be aware that the sensitivity varies significantly with different assays. The average sensitivity was 56% with a range from 0% to 95% [ [48] , [49] , [50] , [51] ], False positive occurs infrequently. The specificity are reported to be high (>97%) [ 47 ] and are most commonly due to cross-reaction with proteins in other human coronaviruses.…”

Evaluation of the accuracy, ease of use and limit of detection of novel, rapid, antigen-detecting point-of-care diagnostics for SARS-CoV-2

“…12,13 Few peer-reviewed studies evaluating these novel assays have been published with only one small study, to our knowledge, performed independently of the manufacturer. 14,15 Here we present a manufacturer-independent validation of three novel, antigen-detecting, rapid POC diagnostics for SARS-CoV-2. Specifically, we performed a verification of analytical sensitivity, a large multi-centre clinical accuracy study, and an ease-of-use (EoU)assessment.…”

Molecular diagnosis of COVID‑19: Current situation and trend in China (Review)

“…Currently, several research teams have developed a variety of antigen detection kits, which are awaiting approval from the State Drug Administration (Table Ⅴ) (22). The biggest advantages of an antigen detection kit are short detection times and high detection sensitivity (as the detection of virus protein reaches pg levels), providing a simple and sensitive method for the early screening of viral infection (64). However, these kits are qualitative, not quantitative (65).…”