15mins Reading One Step Covid POCT Covid-19 2019-NCoV Antigen Rapid Test Kit

Introduction

Covid-19 first emerged in December 2019 in Wuhan, China. The cause of the disease was confirmed as a new kind of coronavirus, this virus is transmitted through air from people to people. In two months, the infection has quickly spread in China and to a number of countries around the world.

Covid-19 virus causes over 2% mortality, there is 7 to 14 days incubation period. The current diagnostic method is majorly by PCR test, but its overall sensitivity is 50 to 60% and is limited by the user with the special trainning and special instruments. There is an urgent need to develop a simple and fast test to screen large population and unsymptomatic infected people. Infectious disease usually produces specific IgM antibody at 2 to 4 days after the infection, while specific IgG antibody appears after 5 to 7 days. Compared to other test, this test is more convenient with low cost, it can be performed in field, mobile hospital and laboratory.

Safety measure:

Covid-19 antibody test must be manipulated in a biosafety Level 3 facility, or with good personal protection, specimen deposit have to follow WHO or local health authority guidline .

Assay principle

The recombinant Covid-19 nuceloprotein antigen is used in the test, serum, plasma or whole blood from Covid-19 infected patient is loaded to the device, the specific Covid-19 antibodies in specimen will bind to gold-conjugated Covid-19 nucleoprotein antigens forming antibody – colloid gold-antigen complex. While the complex migrates along nitrocellulose membrane, the complex is captured on the test lines coated with anti-human IgM or IgG causing a pink to deep pink band at the IgG or IgM test line. The signal intensity is variable depending on the amount of specific antibody present in specimen. A red control line should always develop over control line indicating the proper performance.