MicroDigital Co., Ltd.

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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Product Feature Product Specification

⊙ 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.

Product Specification

Clinical Performance

		RT-PCR		Total
		Positive	Negative	Total
MDGen® AB96-COVID-19 SP RBD IgG	Positive	52	1	53
MDGen® AB96-COVID-19 SP RBD IgG	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

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