Evaluation of Two Rapid Antigen Tests for Detection of SARS-CoV-2 Virus

Abstract

Nucleic acid and antibody detection assays have been utilized in COVID-19 laboratory diagnosis. However, the use of viral antigenic proteins for diagnosis has not been successfully developed. Using viral antigen allows rapid direct viral detection earlier than production of antibodies. The present study was aimed at evaluating the performance of two COVID-19 rapid antigen detection tests, which are BIOCREDIT COVID-19 Ag (RapiGEN Inc., Korea) and Standard Q COVID-19 Ag (SD Biosensor, Korea), in comparison with RT-PCR. These tests were performed on 80 COVID-19 RT-PCR positive respiratory samples and 20 RT-PCR negative control samples. BIOCREDIT COVID-19 Ag and SD Biosensor RAD kits recorded total sensitivities of 52.5% and 68.7% and specificities of 46% and 96%, respectively. In high viral load samples, BIOCREDIT COVID-19 Ag and SD Biosensor RAD kits recorded higher sensitivities of 60% and 77%, compared to 45% and 60% in normal viral load samples, respectively. Sensitivity and specificity of the 2 antigen kits varied significantly with P values of <0.000001 and 0.0135, respectively. The evaluated RAD tests presented promising performance which was relatively better for SD-Biosensor than BIOCREDIT RAD tests, especially in high viral load samples. However, antigen tests are still considered substandard in comparison with RT-PCR in detecting SARS-CoV-2.

Rapid antigen test in diagnosis of SARS - COV-2 in a specialized care facility Urology and Nephrology center –Mansoura University

“…Also our results came in hand with Alemany et al [15] and Fenollar et al [16] (evaluated performance of the Panbio COVID-19 ag rapid test device assay Abbott) who reported a sensitivity ranging from 73.3-91.7% and specificity of 94.9 to 100%. [17] evaluated the performance of two COVID-19 rapid antigen tests, which are BIOCREDIT COVID-19 Ag (RapiGEN Inc., Korea) and Standard Q COVID-19 Ag (SD Biosensor, Korea), in comparison with RT-PCR.…”

Characteristic spatial scales of SARS-CoV-2 pandemics: lessons from mass rapid antigen testing in Slovakia

“…Round 0 was conducted in 235 testing stations in Bardejov, Dolný Kubín, Námestovo, and Tvrdošín counties with the highest current 7-day incidence of positive polymerase chain reaction (PCR) tests on October [23][24][25]2020. Three of these countries are located in proximity to the large observed geographical SARS-CoV-2 epidemic cluster in Poland and Czech Republic [15].…”

“…The manufacturer claims sensitivity 96.52% (95% CI 91.33-99.04%) and specificity 99.68% (95% CI 98.22 -99.99%) in the test package leaflet [18]. See Supplementary Material S1.3 for a further survey of 10 validation studies [20][21][22][23][24][25][26][27][28][29] with sensitivity median 78.1% and average 78.9%, and specificity median 99.4% and average 98.1%. The sample tested in the mass testing in Slovakia may significantly statistically differ from the validation studies samples.…”