GaDia is developing rapid tests for hospital and healthcare centers in the field of infectiology.
Infections in hospital can quickly be life-threatening. Actual tests are mostly based on the microbial analysis and are time-consuming. With the solution developed by GaDia, physicians can rapidly select the right treatment and save time. Because time matters !
Rapid Test COVID-19
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by 2019-nCoV, a new strain of coronavirus that has not been previously identified in humans. The disease is primarily spread between people via respiratory droplets from infected individuals when they cough or sneeze. Time from exposure to onset of symptoms is generally between 2 and 14 days.
Detection of 2019-nCoV IgM and IgG antibodies in human blood can be used as an auxiliary means for early screening of COVID-19. 2019-nCoV IgM antibody could be detected in patient blood in 3-5 days after onset and IgG could be detected in 7 days after onset. However, the trend of IgM and IgG changes in different cases is not exactly the same. As it is a novel disease diagnosis and treatment of which are being explored, please refer to the latest guidelines for diagnosis and treatment of COVID-19.
The test uses mixed recombinant 2019-nCoV nucleocapsid protein (N protein) and spike protein (S protein) both conjugated with colloidal gold and anti-human IgM and IgG antibody coated on different test lines respectively. It is the unique test combining N and S protein to increase sensitivity. After the samples has been applied to the test strip, the gold-labelled recombinant 2019-nCoV N protein and S protein will bind with 2019-nCoV IgM and/or IgG antibody in sample and form marked antigen-antibody complexes. These complexes move to the test card detection zone by capillary action. Then marked antigen-antibody complexes will be captured on different test lines by anti-human IgM and IgG antibody resulting in purplish red streaks on the test lines. The color intensity of each test line increases in proportion to the amount of 2019-nCoV IgM and IgG antibody in sample.
This test has been co-developed by Augurix SA and its partner in Asia, based on previous project on MERS/SARS-CoV rapid diagnostic.
Clinical Result Summary_COVID19 IgG-IgM Short IFU leaflet_v3 06.20 University Hospital Geneva Clinical Study University Hospital Lausanne Clinical Study Clinical Evaluation Hes-so/Valais
Our first rapid test is intended to be used as first line screening test in hospital for patients with suspected infections.
Our patented test differentiates fungal infections from other causes of infection and gives a result in 15 minutes to start the right treatment.
Characteristics of the test
|Human Fluid||Blood, serum or plasma
Bronchoalveolar lavage (BAL)
|Test principle||IgG against a patented combination of fungal biomarkers|
(based on pre-clinical studies)
|Sensitivity: 85.5% (IC95: 82.9-88.2%)
Specificity: 67.0% (IC95: 58.8-75.2%)
|Availability||End of 2021|