MicroDigital Co., Ltd.
IVD System and Kits

CL96-COVID-19 IgG [CLIA]

MDGen CL96-COVID-19 IgG 


MicroDigital's MDGen AB96-COVID-19 IgG kit is a fast and effective COVID-19 IgG qualitative kit based on Chemiluminescent immunoassay (CLIA)


MDGen's exceptional specificity and sensitivity provides reliability. 

Inquiry

Content

- COVID-19 specific IgG analysis

- Analyze maximum 94 samples within 30 minutes

- Only 1 microliter of sample required

- Zero invasiveness

- Larger result differences between the negative and positive controls: Easier determination of IgG presence

- No cross-reactivity demonstrated with other disease samples



Product Specification

 Method

 Qualitative Presumptive

 Packaging

 94 Tests/Kit

 Test Principle

 Chemiluminescent Immunoassay (CLIA)

 Testing Time

 30 Minutes

 Sample Material

 Serum or Plasma

 Sample Volume

 1 μl


Clinical Evaluation


RT-PCR

MDGen

Positive

Negative

Positive

Negative

Positive

53

0 

51

2

Negative

0

100

0

100



Sensitivity 96.2%

Specificity 100%


Cross Reactivity


Sample Type

Results

 Influenza A IgG Positive Plasma

Negative

 Influenza A IgM Positive Plasma

Negative

 Influenza B IgG Positive Plasma

Negative

 Influenza B IgM Positive Plasma

Negative

 RSV IgG Positive Plasma

Negative

 RSV IgM Positive Plasma

Negative

 Parainfluenza IgG Positive Plasma

Negative

 Parainfluenza IgM Positive Plasma

Negative

 MERS CoV Positive Plasma

Negative

 SARS CoV Positive Plasma

Negative

 Human CoV 229E Antibody Positive

Negative

 Human CoV NL63 Antibody Positive

Negative