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IVD System and Kits

MDGen AB96-COVID-19 IgG [ELISA]

MDGen AB96-COVID-19 IgG is MicroDigital’s diagnostic kit for presumptive qualitative testing of antibodies to the SARS-CoV-2 virus, responsible for the COVID-19 pandemic, through the indirect ELISA method.


With this kit, the user can determine whether a patient or specimen has developed antibodies against COVID-19 which would determine whether the patient is or was infected with the SARS-CoV-2 and whether the patient has developed immunity towards the virus.

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⊙ Total 75 minutes for maximum of 94 samples at once.
⊙ MDGen AB96-COVID-19 IgG is a test designed for the qualitative presumptive detection of specific Nucleocapsid Protein IgG to SARS-CoV-2.
⊙ MDGen AB96-COVID-19 IgG only requires a small amount of sample (1μl) from the testing individual.
⊙ MDGen AB96-COVID-19 IgG is much less intrusive than nasopharyngeal swabs.
⊙ MDGen AB96-COVID-19 IgG is compatible with standard plate readers (450nm)
⊙ Not affected by variants as MDGen AB96-COVID-19 IgG detects the Nucleocapsid Protein IgG where mutations rarely occur, if at all.

 

제품 사양

Clinical Performance

RT-PCR

Total

Positive

Negative

MDGen®

AB96-COVID-19 SP RBD IgG

Positive

52

1

53

Negative

0

100

100

Total

52

101

153


Performance

Percentage

Sensitivity

98.1%

Specificity

100.0%

Positive Predictive Value

100.0%

Negative Predictive Value

99.0%


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 Antigen 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