MDGen AB96-COVID-19 SP RBD IgG [ELISA]
MDGen AB96-COVID-19 SP RBD IgG Kit is an Indirect Enzyme Linked Immunosorbent Assay (ELISA) intended for qualitative detection of Spike Protein Multi-Domain IgG antibodies to SARS-CoV-2 in human serum or plasma samples.
MDGen AB96-COVID-19 SP RBD IgG employs synthetic peptides derived from the Spike(S) proteins of SARS-CoV-2 for the detection of IgG antibodies to SARS-CoV-2 in human serum or plasma.
This kit is for in vitro diagnostic use only and intended as an aid to diagnose SARS-CoV-2 infection in patients with clinical symptoms and may be used to test whether a patient that has received the COVID-19 Vaccine has developed IgG antibodies.
Content
Product Specification
Clinical Performance
RT-PCR |
Total | |||
Positive |
Negative | |||
MDGen® AB96-COVID-19 SP RBD IgG |
Positive |
163 |
1 |
164 |
Negative |
13 |
222 |
235 | |
Total |
176 |
223 |
399 |
Performance |
Percentage |
Sensitivity |
92.6% |
Specificity |
99.6% |
Positive Predictive Value |
99.4% |
Negative Predictive Value |
94.5% |
Cross Reactivity
Cross Reactivity Sample |
Results |
Cross Reactivity Sample |
Results | |
Influenza A IgG |
Negative |
Haemophilus influenza IgG antibody |
Negative | |
Influenza A IgM |
Negative |
Haemophilus influenza IgM antibody |
Negative | |
Influenza B IgG |
Negative |
COVID OC43 |
Negative | |
Influenza B IgM |
Negative |
Mycoplasma IgG positive plasma |
Negative | |
RSV IgG |
Negative |
Mycoplasma IgM positive plasma |
Negative | |
RSV IgM |
Negative |
Legionella pneumoniae IgG positive |
Negative | |
Parainfluenza IgG |
Negative |
Legionella pneumoniae IgM positive |
Negative | |
Parainfluenza IgM |
Negative |
Anti-RBD IgM human monoclonal antibody |
Negative | |
MERS coronavirus |
Negative |
Rhinovirus IgG positive |
Negative | |
SARS coronavirus |
Negative |
Rhinovirus IgM positive |
Negative | |
Human coronavirus 229E Antibody |
Negative |
Enterovirus IgG positive |
Negative | |
Human coronavirus NL63 Antibody |
Negative |
Enterovirus IgM positive |
Negative | |
COVID HKU1 |
Negative |
Adenovirus IgG positive |
Negative | |
Anti-HBV IgG/IgM |
Negative |
Adenovirus IgM positive |
Negative | |
Anti-HCV IgG/IgM |
Negative |
Bocavirus IgG positive |
Negative | |
Antinuclear antibody IgG/IgM |
Negative |
Metapneumovirus IgG positive |
Negative | |
Anti-HIV IgG/IgM |
Negative |
Metapneumovirus IgM positive |
Negative | |
Influenza A IgG |
Negative |
Haemophilus influenza IgG antibody |
Negative | |
Influenza A IgM |
Negative |
Haemophilus influenza IgM antibody |
Negative | |
Influenza B IgG |
Negative |
COVID OC43 |
Negative |
Kit Components
COVID-19 SP RBD Coated Microplate
QTY: 1 X 96 well microplate
Sample Diluent
QTY: 1 X 20 mL
Washing Buffer Concentrate (20X)
QTY: 1 X 20 mL
Stop Solution
QTY: 1 X 12 mL
TMB Substrate
QTY: 1 X 12 mL
Streptavidin Horseradish Peroxidase
QTY: 1 X 12 mL
Biotin Labeled Tracer Antibody
QTY: 1 X 6 mL
COVID-19 IgG Negative Control
QTY: 1 X 1 mL
COVID-19 IgG Positive Control
QTY: 1 X 0.5 mL
Plate Sealer
QTY: 1 ea
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