New Changes in IVD Registration Process

How Does IVD Registration Process Change with New EU Regulations?   Manufacturing of in-vitro diagnostic devices (IVD) is set to change with new regulations set by the European Union (EU). According to the recent update in the EU Regulation 2017/746, medical device manufacturers are likely to face several changes in

Early diagnosis is early detection is better prognosis for COVID19

Antibody testing has emerged to be the most effective for presumptive diagnosis of COVID 19. In cases where molecular testing was negative but where there was a strong epidemiological link to COVID-19 infection and paired blood samples (acute and convalescent) showing rising antibody levels. From detecting effective mechanism to preventing

The Proven Benefits of Antibody Testing for Covid -19

The rapid spread of and severity of Covid-19, scientists and researchers have been aggressive in developing cheap and effective vaccine to combat the virus.       In the year gone by, companies across the globe have developed over 200 vaccines and 40 more are underway for consideration. The question

In Vitro Diagnostics: All that you need to know about it

Clinical diagnostics testing has entered a new phase with the availability of various tools to diagnose health conditions for effective treatment. Clinical tests such as in-vitro diagnostics (IVDs) are clinical tests that analyze the body conditions based on the samples taken from the human body. In contrast to other devices,

Antigen vs Antibody

An antigen is any substance or organism that is unrecognized by our immune system. Any foreign invaders, such as pathogens (bacteria and viruses), chemicals, toxins, and pollens, can be antigens. Under pathological conditions, normal cellular proteins can become self-antigens. An antigen contains distinct sites on its surface, which is called