Abstract
Purpose: In the context of the current COVID-19 pandemic, multiple serological assays for the detection of severe acute respiratory syndrome 2 (SARS-CoV-2) immune response are currently being developed. This study compares the FREND TM COVID-19 IgG/IgM Duo (NanoEntec) a point of care (POCT) assay with the automated Elecsys anti-SARS-CoV-2 electrochemiluminescent assay (Roche Diagnostics).
Methods: Serum samples ( n = 81) from PCR-confirmed SARS-CoV-2 positive patients at different time points after the onset of symptoms were analyzed with both assays. An additional 24 serum samples with cross reactivity potential were also included.
Results: The sensitivity of the COVID-19 IgG/IgM Duo assay was higher as compared to the Elecsys anti-SARS-CoV-2 assay, especially when using the combined IgM/IgG result in samples analyzed within 6 days after the onset of symptoms (46.2% vs. 15.4%). The sensitivity of both assays increased with increasing time interval after the onset of symptoms and reached 100% for the COVID-19 IgG/IgM Duo assay in samples taken 14 days or more after symptom onset. Specificity of the COVID-19 IgG/IgM Duo assay was 95.8% for IgM, 91.7% for IgG and 87.5% for the combination of both.
Conclusion: This study shows that the sensitivity of both assays was highly dependent on the time interval between the onset of the COVID-19 symptoms and serum sampling. Furthermore, rapid serological testing for SARS-CoV-2 antibodies by means of the FREND TM COVID-19 IgG/IgM Duo POCT assay showed a comparable diagnostic performance as the reference automated immunoassay.
Keywords: COVID-19; IgG/IgM; SARS-CoV-2; immunoassay; point-of-care testing.
【저자키워드】 COVID-19, SARS-CoV-2, immunoassay, Point-of-care testing., IgG/IgM, 【초록키워드】 IgG, IgM, immune response, COVID-19 pandemic, point of care, diagnostic, anti-SARS-CoV-2, Severe acute respiratory syndrome, immunoassay, point-of-care, serum, sensitivity, SARS-CoV-2 antibodies, SARS-CoV-2 antibody, Serological testing, IgM/IgG, POCT, automated, respiratory, COVID-19 symptoms, Cross reactivity, Combination, COVID-19 symptom, time interval, symptom onset, acute respiratory syndrome, PCR-confirmed, serum samples, different time points, Roche Diagnostics, serum sample, multiple serological assays, analyzed, assays, onset of symptom, dependent on, comparable, reached, different time point, Elecsy, multiple serological assay, SARS-CoV-2 positive patient, 【제목키워드】 point-of-care, SARS-CoV-2 antibody, performance,