Abstract
The SARS-CoV-2 pandemic, which started in December 2019, has been posing significant challenges to the health care system worldwide. As the pandemic spreads with rapidly increasing number of positive cases, early diagnosis of infected patients is crucial to successfully limit the spread of the virus. Although the real-time reverse-transcription polymerase chain reaction (RT-qPCR) is the recommended laboratory method to diagnose COVID-19 infection, many factors such as availability of laboratory equipment, reagents and trained personnel affect the use of time-consuming molecular techniques. To facilitate on-the-spot diagnosis of COVID-19, SARS-CoV-2 rapid antigen tests were developed by several different manufacturers. The evaluation of such rapid tests is particularly important due to the recent unanimous agreement by the European Commission Member States on a recommendation setting out a framework for the use of antigen rapid tests that contains a list of the mutually recognized assays and the basis of independent validation protocols. To evaluate the on-field performance of ten commercially available SARS-CoV-2 antigen rapid tests (CLINITEST Rapid COVID-19 Antigen Test, GenBody COVID-19 Antigen Test, GENEDIA W COVID-19 Ag Test, Healgen Coronavirus Antigen Rapid Test, Humasis COVID-19 Ag Test, VivaDiag SARS-CoV-2 Ag Rapid Test, Helix i-SARS-CoV-2 Ag Rapid Test, Roche SARS-CoV-2 Rapid Antigen Test, Abbot COVID-19 Ag Rapid Test and Vazyme SARS-CoV-2 Antigen Detection Kit) and compare with RT-qPCR as a reference method, the Hungarian National Public Health Center provided 1,597 antigen rapid tests to the National Ambulance Service, COVID-testing trucks and two hospitals treating COVID-19 patients. Sensitivity, specificity and accuracy were determined by performing the rapid test directly from nasopharyngeal swab samples of symptomatic individuals. For strongly positive samples (Ct < 25) sensitivities ranged between 66.7% and 100%, while for positive samples (Ct < 30) they gave a maximum sensitivity of 87.5%. The specificity of the tests was ranging between 79% to 100%. The results presented here are of high importance to the European Commission and also help governmental decision-making regarding the application of the proper rapid tests for screening different at-risk populations. Nonetheless, SARS-Cov-2 rapid tests play an important role in early and on-the-spot diagnosis of potentially infected individuals.
Highlights
At the end of 2019, a novel respiratory disease with unknown etiology appeared in Wuhan, China
Results of the antigen tests and the clinical specimens in viral transport medium (VTM) were transferred to the National Public Health Center (NPHC) COVID-19 laboratory where the RT-qPCR was performed
The outcome of the antigen-based rapid test devices (Ag-RTD) was unclear in the case of 4 cases, and RT-qPCR gave inconclusive result with 13 samples
Summary
At the end of 2019, a novel respiratory disease with unknown etiology appeared in Wuhan, China. To maintain and facilitate an adequate testing capacity, on-field diagnostic methods e.g., antigen-based rapid test devices (Ag-RTD) are indispensable tools beside the gold standard RT-qPCR. As Ag-RTDs are easy to perform and utilizing them allows to process a large number of different types of samples within a relatively short time, with the adequate sensitivity they are ideal for testing symptomatic patients and for on-field screening (e.g., in schools or university settings, employees in offices or factories). Negative Ag-RTD results should be strengthened by RT-qPCR, especially in the case of symptomatic cases; SARS-CoV-2 positivity within the recommended time interval means proven infection among asymptomatic carriers as well, considering false positivity is likely impossible using a properly inspected and certified (In Vitro Diagnostic–IVD) device [7]
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