SARS-CoV-2 Neutralizing Antibody ELISA kit

SARS-CoV-2 Neutralizing Antibody ELISA kit

Icosagen SARS-CoV-2 Neutralizing Antibody ELISA kit provides a rapid and easy method for qualitative in-vitro determination of neutralizing antibodies in human serum or plasma.

APPLICATION

The kit includes reagents necessary to analyze SARS-CoV-2 specific antibodies in up to 46 samples using one kit.
Catalogue No
Antibodies against
Ig class Substrate
Format
K5-002-096
SARS-Coronavirus-2 (SARS-CoV-2) trimeric spike protein
All classes Antigen-coated microtiter plate wells
96-well plate

INTENDED USE

The kit applies for detecting the presence of neutralizing anti-trimeric spike antibodies that have the capacity to neutralize the binding of trimeric spike protein to ACE2 (angiotensin-converting enzyme 2) receptor.

CROSS-REACTIVITY

The Icosagen Neutralizing antibody kit was evaluated for potential cross-reactivity from a total of 165 specimens representing different medical conditions. All 165 specimens showed no cross-reactivity.

Condition

Group

Samples

Positive

Negative

False positive

Physiological factors

Pregnancy

46

0

46

0%

Immunological factors

HIV+ (human immunodeficiency virus)

29

0

29

0%

HCV+ (hepatitis C virus)

10

0

10

0%

HSV+ (herpes simplex virus)

10

0

10

0%

ANA+ (anti-nuclear antibodies)

10

0

10

0%

EBV+ (Ebstein-Barr virus)

10

0

10

0%

CMV+ (cytomegalovirus)

10

0

10

0%

Lyme disease (anti-borrelia antibodies)

10

0

10

0%

Pneumonia (chlamydia infection)

10

0

10

0%

Pneumonia (mycoplasma infection)

10

0

10

0%

Rheumatoid arthritis (anti-rheumatoid factor antibodies)

10

0

10

0%


CLINICAL PERFORMANCE

Total of 735 specimens were tested using the Icosagen SARS-CoV-2 Neutralizing Antibody ELISA kit.

The sensitivity, specificity, accuracy, positive percent agreement (PPA) and negative percent agreement (NPA) values for the Icosagen Covid-19 ELISA kit are shown in the following table:

Sensitivity

Specificity

Accuracy

PPA

NPA

False negative*

False positive**

84.6%

96.6%

90.3%

92.0%

89.3%

48

23

It is important to note that not all anti-RBD antibodies have the capacity to neutralize the binding of the SARS-CoV-2 spike protein to ACE2,
as well as not all the antibodies which neutralize the binding of spike protein to ACE2 have epitopes in the RBD region.