© ANSA
(ANSA) - ROME, MAY 07 - Siemens Healthineers has registered its SARS-CoV-2Assay Fast Track Diagnostics (FTD) molecular kit for diagnostic use at the Ministry of Health of Luxembourg. The registration of the kit, already released on April 2, 2020 for research use only (RUO), allows an immediate implementation for diagnostic use in Europe. Lorende noted the company in a statement explaining that "the test showed diagnostic sensitivity up to 100% (91.8-100.95% CI) and diagnostic specificity up to 100% (93.8-100.95% CI) The response time of the sample, including extraction and generation of the result, is 2-3 hours, depending on the molecular system used and the laboratory resources used.
Up to 32 samples per kit can be analyzed. "The company plans to ship over 1.3 million tests per month worldwide from May 2020, thanks to the increase in production capacity. The test can be performed in the laboratory at the same time with the test panels. Siemens Healthineers Syndromicidal Molecules, relating to Respiratory Pathogens FTD 21 and FTD FLU / HRSV, which identify a wide range of pathogens that can cause serious respiratory infections. Covid-19 in other areas of diagnostics. On April 23, it announced that it is developing a SARS-CoV-2 serological test to detect IgM and IgG antibodies in the blood, which helps to indicate whether a person has experienced an immune response against SARS-CoV- 2. A test that determines antibody is able to reveal whether a person has had the Covid-19, even s and asymptomatic or even if it has not had a diagnosis of the disease. (ANSA).
