Friday 24 April 2020

Siena, April 24th 2020 -Diesse Diagnostica Sienese to begin supplying the patented and CE-marked IVD serological tests, as agreed with the Spallanzani Institute on March 18th. Production capacity will be 3000 kits per week, for about 1,200,000 tests per month.

"Upholding the commitment made to the Tuscany region, and all users of our tests, has been an extraordinary challenge for us,” says Massimiliano Boggetti, CEO of DIESSE, “which we managed to overcome thanks to the extraordinary nature of all my colleagues. First and foremost Research and Development, and of course the production team. But in general , everyone who has proudly worked so intensively over the past few months to make this test panel available.”

SARS-CoV-2 serological tests are very important for this next phase in the pandemic. The Diesse tests, developed in record timing for this type of test, are unique in the market thanks to their specific characteristics. As previously stated, the DIESSE serological tests were developed using the native antigen. By cultivating the virus in BSL3 high containment biological containment laboratories, we can ensure that the proteins of the virus maintain their natural shape. This in turn ensures both high levels of sensitivity and accuracy in diagnosis, as well as accurate identification of patient antibodies.

The kits have been developed to recognize the three types of antibody; IgG, IgM and IgA. As scientific research shows, a respiratory virus, including the coronavirus, triggers immune defences, first in the mucous membranes, later at a systematic level. By diagnosing the presence of the IgA antibodies in the mucous membranes at the early stages of this immune reaction, we can trace the many asymptomatic cases, or those who are in the initial stage of infection.

IgG antibodies are important for both testing the effectiveness of future vaccines, as well as to identify people who have been exposed to the virus and have developed a natural immunity.

EnzyWell SARS-CoV-2 serological tests are therefore an essential tool in following the evolution of COVID patients and help clinicians better understand how our body reacts to the infection.