2019-nCoV Antigen Rapid Test Kit

 

  

In 2020, Coronavirus (COVID-19) is raging around the world. In February, Diagreat successfully developed the Coronavirus Antigen kit, 2019-nCoV Antigen Rapid Test Kit, which is based on the Colloidal Gold Assay. 


Intended use

The rapid test kit is used for qualitative determination of novel coronavirus (SARS-CcV-2) antigen in human nasal swab and saliva samples in vitro.. This kit is offered to clinical laboratories and healthcare workers for point-of-care testing, and not for at home testing, in compliance with Section IV.D. of the FDA’s Policy for COVID-19 Diagnostic Test.


Principle

After an appropriate amount of sample is added to the detection well, the sample moves under the action of the capillary. The new coronavirus antigen in the sample will combine with colloidal gold-labeled new coronavirus N protein antibody to form a colloidal gold-antigen-antibody complex. The immune complex product is then chromatographed along the nitrocellulose membrane to the detection area (T), binds to the pre-coated N protein monoclonal antibody, and forms a purple line, indicating that the new coronavirus antigen is positive.

The quality control antibody-labeled colloidal gold particles are chromatographed to the quality control area (C) and combined with the pre-coated anti-quality control antibody to form a purple C line, indicating that the test is effective. If the QC line does not appear, the test result is invalid.


Applicable Department 

    Emergency Department

    ICU

    Pneumology Department

    Cardio-Pulmonary Function Department



2019-nCoV Antigen Rapid Test Kit (Colloidal gold Assay)2019-nCoV Antigen Rapid Test Kit



2019-nCoV Antigen Rapid Test Kit (Colloidal gold Assay)


Manual

2019-nCoV Antigen Rapid Test Kit6375467866149402768846799.pdf


Clinical Data

2019-nCoV Antigen Rapid Test Kit6375263086600395242507036.pdf

The latest clinic data report from Poland Centralne Laboratorium Kliniczne Uniwersyteckie Centrum Kliniczne (University Clinical Center)


2019-nCoV Antigen Rapid Test Kit6376307035069620295495053.pdf