DOI

Detection Principle

ImmunoAssay-Antibody

Target

Euroimmun: S1; Wantai: spike;

Testing Method Category

Other Immuno assay

Testing Method

Euroimmun SARS-CoV-2 IgA and IgG ELISAs (Euroimmun), Wantai SARS-CoV-2 IgM and total antibody ELISAs (Beijing Wantai Biological Pharmacy), Wantai SARS-CoV-2 Ab Rapid Test (Beijing Wantai), 2019-nCoV IgG/IgM Rapid Test (Hangzhou AllTest Biotech)

Testing Method - Additional Info

Comparison of performance among 2 ELISA: Euroimmun SARS-CoV-2 IgA and IgG ELISAs (Euroimmun), Wantai SARS-CoV-2 IgM and total antibody ELISAs (Beijing Wantai Biological Pharmacy); and 2 rapid tests the Wantai SARS-CoV-2 Ab Rapid Test (Beijing Wantai), and the 2019-nCoV IgG/IgM Rapid Test (Hangzhou AllTest Biotech)

Reported Performance

Sensitivity: the Euroimmun IgA and IgG ELISAs tested positive in 9 (30%) and 1 (3.3%) of the 30 individuals in group tested at < 5 d from symptoms, in 21 (84%) and 10 (40%) of the 25 at d 6-10, in all 22 patients (100%) at d>21. The Wantai IgM and total antibody ELISAs tested positive in 8 (26.7%) and 11 (36.7%) of the 30 individuals tested at <5d from symptoms. Both tests provided positive results in 23 of 25 patients (92%) at d 6-10 and in all 22 (100%) at d>21. The Wantai rapid test tested positive in 6 of 30 individuals (20%) tested at <5d from symptoms, in 20 of 25 (80%) at d 6-10, and in all 22 (100%) at d>21. The 2019-nCoV IgG/IgM Rapid Test tested 6 of the 30 (20%) patients positive IgM at < 5 d from symptoms and 4/30 (13.3%) a positive IgG band. At d 6-10 5 (20%) displayed weakly positive IgM and 12 (48%) clearly positive IgG bands. At d >21, 10 (45.5%) showed a weakly positive IgM band, and all 22 (100%) displayed a clearly positive IgG band. Specificity: Euroimmune IgA 83%; Euroimmune IgG 98%; Wantai IgM and total Ab: 97%; Wantai rapid test: 98%; 2019-nCoV IgG/IgM Rapid Test IgM 99%; IgG 100% .

Sample Size

77 positive. 100 negative

Peer-reviewed

yes