Serological COVID-19 kit

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
Using S1 and N protein as antigens for detecting both IgM and IgG type of anti-viral immunoglobulins ensures maximal sensitivity of the test.

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