LFA COVID -19 IgG & IgM Rapid
Test Device
Spartacus-Biomed a R&D Company
The world global market for in vitro diagnostic tests is predicted to reach a compound annual growth rate (CAGR) of 12 % over the next five-year period.
Spartacus-Biomed business model is focused on biomarkers which are estimated to peak annual turnovers of up to 800 M€ in Europe. Indeed, the biomarkers are being increasingly used to aid for diagnosis, to a much lesser extend for prognosis and to identify sub-populations with differing benefit-risk ratios.
Spartacus-Biomed is providing novel Biomarkers that will equip physicians with tools to improve the early diagnosis, to identify patients at risk of developing diseases, and to characterize patient subsets with a greater likelihood of response to preventive therapies.
This project is funded by Occitanie district.
© 2020.Spartacus-Biomed
In 2019, a new coronavirus disease was reported in Wuhan, China. This disease subsequently affected a majority of countries in the world causing significant lung damage and respiratory failure. The pathogen has been identified as a coronavirus similar to that of SARS and MERS. He was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Clinical manifestations are systemic symptoms such as fever and fatigue, accompanied by dry cough and dyspnea which can quickly develop into severe pneumonia and acute respiratory failure and can be fatal.
The diagnosis is currently carried out by RT-qPCR techniques which have variations depending on the country (https://www.who.int/fr) but which very strongly depend on the quality of the nasopharyngeal swab (low presence or absence of virus). According to the patients and to the period of infection, the virus is localized in the lungs and not in the nose or throat (https://pubs.rsna.org/doi/10.1148/radiol.2020200642). For various reasons, the RT-qPCR test is not very suitable for testing a large population:
- The quality of the sample easily compromised
- More than 30% false negatives in some studies in real situations
(https://pubs.rsna.org/doi/10.1148/radiol.2020200642).
- The technical heaviness (4 to 6 H) of the RT-qPCR COVID-19 assay.
- Its high cost (20 to 56 Euros per test in France and much more in other countries).
Containment strongly penalize economic and social life. It is difficult to maintain them over a long period. It is therefore essential to be able to estimate quickly and at lower cost:
- Infection rates in the population.
- Distinguish contagious asymptomatic individuals.
- People who have never had contact with the virus.
- People immunized against the virus.
This operation is made possible by the very recent development of the LFA COVID-19 IgG & IgM Rapid Test Device, an immunochromatographic test operating from a drop of blood at the fingertip (or plasma / serum) and a revelation cassette producing reliable screening. This test is based on the detection on the same cassette of the IgM and IgG antibodies directed against SARS-CoV-2 in patients who are sick or who have been in contact with the virus (asymptomatic). Indeed, this double assay makes it possible to visualize the appearance of the patient's first antibodies in response to SARS-CoV-2 infection (anti-COVID-19 IgM) and the antibodies making it possible to protect the patient (IgG). This test therefore makes it possible to detect the infection at various stages. Indeed, the classical kinetics of the immune response to a viral infection involves the production of early IgM and later anti-COVID-19 IgG. In the case of SARS-CoV-2, the production of measurable IgM is estimated to be approximately 5 days post-infection
(https://www.thelancet.com/action/showPdf?pii=S1473-3099%2820%2930196-1).
The onset of symptoms occurs almost simultaneously at an average of 4 days post-infection (https://doi.org/10.3201/eid2606.200357).
The concomitance between the appearance of symptoms and anti-COVID-19 IgM makes the LFA COVID-19 IgG & IgM Rapid Test Device suitable for screening patients infected with COVID-19. The anti-COVID-19 IgM test reveals whether a person is infected and could therefore transmit Covid-19 to other people.
In order to meet the growing demand for rapid and reliable detection solutions for SARS-CoV-2 coronavirus infection, Spartacus-Biomed presents the LFA COVID-19 IgG & IgM Rapid Test Device as a diagnostic aid. This lateral flow device can reliably detect antibodies to the new SARS-CoV-2 virus in serum, plasma or whole blood, in 10 min.
The LFA COVID-19 IgG & IgM Rapid Test Device test was compared to a standard commercial RT-PCR test using 100 clinical samples. The results show that the device has a specificity of 100% for IgG and for IgM and a sensitivity of 96% for IgG, 92% for IgM and 94% for combined IgG and IgM.
