The IRIS SARS-CoV-2 IgG / IgM rapid test has a very high sensitivity and specificity; has been successfully used in different settings, for monitoring and diagnosing patients (belonging to General Medicine, Emergency Dept or Internal Medicine) and for the periodic survey of industrial and healthcare personnel.
We consider this test valid and reliable in several sectors (food industry, hospitals and medical centres, other strategic industries) both for the high sensitivity and specificity (and therefore accuracy) and for the extreme ease of use and reading. In fact, over 900 tests carried out during the study and validation phase in Italy, no cases of difficulty / impossibility of execution were reported, even in non-specialist environments; in only one case was a doubt reported on reading the coloured band.
In our opinion, a test with such high sensitivity and specificity is also indicated for epidemiological purposes on large sections of the population (general population and/or high-risk groups). From a clinical point of view, it is indicated for the diagnosis of Covid19 infection and / or the differential diagnosis with respect to other diseases, according to good clinical practices, which require the doctor to consider all the diagnostic elements (clinic, instrumental, laboratory, included the RT-PCR). Furthermore, the use of the IRIS SARS CoV-2 test can reveal patients with false negative RT-PCR, as suggested by the WHO guidelines and the literature. It should be noted that the execution of the rapid serological test, while not replacing the use of swabs to identify viral RNA, is not operator-dependent and therefore very suitable for the setting of primary care2.
Coordinators of the Scientific Committee
Maurizio Cipolla MD, Pathologist
President of Digital Sit Calabria (Italian Society of Digital Health and Telemedicine Scientific director of the multicronicity plans Regione Calabria (Italy) Scientific director of Digitcal Srl
Prof. Antonio Vittorino Gaddi, MD, PhD
Research Doctor in Experimental Medicine and Atherosclerosis - Consultant: Cardiology, Geriatrics and Gerontology
Main Investigator of Health Research and Development SrL, IT -Scientific Director of Qi International Ltd, London, UK
Past President of the Medicine and Surgery undergraduate course of the Bologna University - Past Director, of Giancarlo Descovich Bologna Center of Atherosclerosis and Metabolic Diseases President of Digital SIT-EMR (Italian Society of Digital Health and Telemedicine, Emilia Romagna Region), Director of Scientific Board of EuroGenLab (BO) and Health-Lab, GT Foundation (MO).
Lugo Medica and Caravelli Lab & EuroGenLab, via Acquacalda 3 (Lugo, RA) and via Zamboni 8, Bologna,051 231531 -mobile+39 3341953354 https://www.researchgate.net/profile/Antonio_Gaddi- https://it.wikipedia.org/wiki/Antonio_Vittorino_Gaddi