MicroDigital Co., Ltd.

IVD System and Kits

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.

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Content

Product Feature Product Specification

⊙ Total 75 minutes for maximum of 94 samples at once

⊙ Requires only a small amount of sample (1μl) and is much less intrusive than nasopharyngeal swabs

⊙ Does not require any complex, expansible or large machinery and is compatible with standard plate readers (450 nm)

⊙ May be used to test whether a vaccine recipient has developed IgG antibodies to SARS-CoV-2 through the vaccine

⊙ May also be used to determine whether the sample provider requires a booster shot

⊙ May be used to test all vaccines that include the SARS-CoV-2 Spike Protein

⊙ Not affected by variants as the product detects the whole Spike Protein (Both S1 and S2).

Product Specification

Clinical Performance

		RT-PCR		Total
		Positive	Negative	Total
MDGen® AB96-COVID-19 SP RBD IgG	Positive	163	1	164
MDGen® AB96-COVID-19 SP RBD IgG	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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