GETEIN BIOTECH Novel Coronavirus (2019-nCoV) IgM-IgG Antibody Fast Test Kit

—— Quantitative detection of 2019-Novel Coronavirus IgM and IgG antibody

CE Marked

Basic Information

Intended Use

Novel Coronavirus (2019-nCoV) IgM/IgG antibody Fast Test Kit (Immunofluorescence Assay) is intended for the quantitative detection of 2019-Novel Coronavirus IgM and IgG antibody in serum, plasma or whole blood samples from patients suspected of COVID-19 infection by a healthcare provider.

 

Products Code for Getein 1100:  IF1084 

Products Code for Getein 1600:  IF2084

Detection Method: Immunofluorescence assay

Sample Type:  Serum, plasma or whole blood

Reaction Time:  Result comes out in about 10 min

 

Package

(1) For Getein 1100

A box package contains 25 tests:

Foil bag, which contains one test card and one desiccant	25
User manual	1
Sample diluent	25

 

(2) For Getein 1600

Sealed cartridge with Getein Novel Coronavirus (2019-nCoV) IgM/IgG antibody test cards	2×24 tests/kit, or 2×48 tests/kit
Sample diluent	1
Box with pipette tip	96 tips
Mixing plate	1
User Manual	1

 

Storage and Stability

For test card of Getein1100: Store the test card at 4-30℃  with a valid period of 24 months. Use the test card within 1 hour once the foil pouch is opened.
For test card of Getein1600: If the cartridge is opened, it could be stable within 24 hours once exposure to air. Please put the cartridge back to the foil pouch and reseal along the entire edge of zip-seal. The remaining test cards should be used up within 7 days.
Store the sample diluent at 0-30℃  with a valid period of 24 months.

Store the sample diluent at 2-8℃  for better results.

Applicable Devices

Getein1100 Immunofluorescence Quantitative Analyzer
Getein1600 Immunofluorescence Quantitative Analyzer

 

Clinical Application

The test kit is intended for the quantitative detection of 2019-Novel Coronavirus IgM and IgG and is only intended for professional and laboratory use, not for home testing. 

Results from the test should not be used as the sole basis for diagnosis and exclusion of 2019-nCoV infection.