Serological COVID-19 ELISA kit
Icosagen Covid-19 ELISA kit provides a rapid and easy method for semiquantitative determination of both IgG and IgM antibodies against SARS-CoV-2 (2019-nCoV) Spike and Nucleocapsid proteins in human sera and plasma.
APPLICATION
The kit includes reagents necessary to analyze SARS-CoV-2 specific antibodies in up to 46 samples using one kit. ELISA titers can be determined in 23 serum or plasma samples.|
Catalogue No
| Antibodies against
|
Detectable antibodies
|
Substrate |
Format
|
|
K5-001-096
|
SARS-Coronavirus-2 (SARS-CoV-2)
|
IgG, IgM
|
Antigen-coated (S1 and N) microplate wells
|
96-well plate
|
INTENDED USE
The enzyme-linked immunosorbent assay (ELISA) provides semiquantitative in vitro determination of human antibodies of the immunoglobulin class IgG and IgM against SARS-CoV-2 in human serum or plasma to support the diagnosis of SARS-CoV-2 infection and constitutes a supplement to the direct pathogen detection. Serological analysis can be applied to collect epidemiological data.CROSS-REACTIVITY
The Icosagen Covid-19 ELISA kit was evaluated for potential cross-reactivity from a total of 90 specimens representing 4 different groups. All 90 specimens showed no cross-reactivity.Condition | Group | Samples | Positive | Negative | False positive | False negative |
Physiological factors | Pregnancy | 33 | 0 | 33 | 0% | 0% |
Immunological factors | HIV+ (human immunodeficiency virus) | 29 | 0 | 29 | 0% | 0% |
| HCV+ (hepatitis C virus) | 19 | 0 | 19 | 0% | 0% |
| HBV+ (hepatitis B virus) | 9 | 0 | 9 | 0% | 0% |
CLINICAL PERFORMANCE
Total of 296 specimens were tested using the Icosagen Covid-19 ELISA kit, of which 123 specimens were from PCR-positive group for SARS-CoV-2, and 173 serum specimens from pre-Covid-19 period or PCR-negative samples were used as negative control.The sensitivity, specificity, accuracy, positive percent agreement (PPA) and negative percent agreement (NPA) values for the Icosagen Covid-19 ELISA kit are shown in Table 7.
The results are presented in the following Table:Sample dilution | Sensitivity | Specificity | Accuracy | PPA | NPA | False negative* | False positive** |
1:200 | 87.8% | 98.9% | 94.3% | 98.2% | 92% | 15 | 2 |