Validation of the test for detecting SARS--CoV-2 antigens in the Polish population in patients with suspected SARS-CoV-2 infection

Abstract

In December 2019, the World Health Organization (WHO) reported that China had accumulated pneumonia of unclear etiology in Wuhan. According to WHO recommendations, in strictly defined situations, antigen tests can be implemented into the diagnostic algorithm to reduce the number of molecular tests performed and support the rapid identification and treatment of COVID-19 patients. According to WHO recommendations, the antigen test for diagnostic use should have a sensitivity of ≥ 80% and a specificity of ≥ 97% compared to molecular tests (NAAT). Based on the comparative analysis, the sensitivity and specificity of the SARS-CoV-2 Antigen ELISA test were determined concerning the RT-PCR reference method. The sensitivity of the SARS-CoV-2 Antigen ELISA was 100% (51/51) and the specificity was 98.84%. The obtained data demonstrate that the analyzed antigen test meets both the WHO and the Ministry of Health criteria.

Diagnostic performance of a novel antigen-capture ELISA for the detection of SARS-CoV-2

“…Assessment of the established assay revealed an overall sensitivity of 70.72% (95% CI: 66.01–75.12) and specificity of 100% (95% CI: 97.57–100), regardless of Ct values and viral variants. The overall sensitivity was comparable to some other reports ( Table 4 ) [ 18 , [32] , [33] , [34] , [35] , [36] ]. The analytical sensitivity of our assay, regardless of SARS-CoV-2 variants, increased to 91.67% (95% CI: 87.76–94.64) for samples with Ct values below 25.…”

“…of positive samples No. of negative samples Overall sensitivity (%) Specificity (%) Humbert et al (2021) a [ 18 ] In-house 128 10 58.6 100 Humbert et al (2021)** [ 18 ] In-house 121 96 52.0 100 Adnan et al (2021) [ 32 ] In-house 147 192 61.9 99.0 Yamaoka et al (2021) [ 33 ] In-house 72 72 75 100 Gross et al (2021) [ 34 ] In-house 93 108 63.4 87 Mayanskiy et al (2021) [ 35 ] CoviNAg ELISA kit (XEMA, Russia) 164 18 90.1 75.8 Milosz et al (2022) [ 36 ] EUROIMMUN SARS-CoV-2 antigen ELISA kit 51 86 100 a 98.84 This Study (2022) In-house 403 150 70.72 100 (a) The assay sensitivity for this study was calculated for samples with Ct values ≤ 31. a T...…”