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COVID 19 Testing Kits

SARS-CoV-2 IgG / IgM Rapid Test Kit

Intended Use

The SARS-CoV-2 IgG/IgM Rapid Test Kit is used to qualitatively detect IgG and IgM antibodies of SARS-CoV-2 in human serum, plasma or whole blood. This device is intended to be used by professionals as a screening test and for SARS-CoV-2 research. Any reactive specimen with the SARS-CoV-2 IgG/IgM rapid test kit should be confirmed with alternative testing method(s). 

Click here for a introductory video on TBG's COVID-19 Testing Kits.

To report any adverse events, please see the section on "Regulations" shown below. 

 

Feature and Benefits

  • Easy to Use with only 3 steps
  • Fast Results within 15 minutes
  • High Sensitivity with both N and S antigen coated

Specifications

  • Kit Contents: Disposable test card, disposable plastic capillary tubes, lancet, sample diluent, instructions for Use. 

  • Storage: CE (2 to 30°C for 12 months). FDA-EUA (2 to 8C for 9 months)
     

Workflow

User Protocol



NOTE: The fingerstick image is only for CE-marked products. U.S. product has NOT been FDA EUA authorized for use with fingerstick sample type.

Data Analysis
Negative
IgM Positive
IgG Positive
IgG / IgM Positive

 
       
      
 

Ordering Information

Catalog. No. Package Sizes
No. 20010 25 tests/kit
No. 20010S 1 test/kit

Regulations

CE-IVD
FDA EUA

For reporting of adverse events related to this product, please send an email to COVID19@tbgbio.com and include the following within your email: 
- Product name and lot number. 
- Product operator and related testing facility. 
- Detailed description of the adverse event as well as the date of occurrence. 

All reported adverse events will be periodically updated and reported below. 
Currently Reported Adverse Events (Updated 8/12/2020): None Reported. 
 

Instruction Manuals

Name / Version Description Size
v1.5 User Manual (CE) 0.63MB
v1.2 User Manual (EUA) 2.63MB
v1.2 Control Set 0.13MB

Product Documents

Name / Version Description Size
v2.7 DM 2.01MB
v2.3 Introduction and Testing Strategies 10.31MB
8-31-2020 Fact Sheet for Health Care Professionals 0.14MB
8-31-2020 Fact Sheet for Recipients 0.13MB