Elisa and Rapid Test for SARS-CoV 2 serology
Both evaluated by French National Reference Center and 2 University Hospitals, serology testing kits were developed on antigen based on Protein S.
Their performances were demonstrated on several cohorts of patients and all report their diagnostic effectiveness.
Efficient ELISA tests
In accordance with French HAS (High Health Authority) recommendations, Theradiag offers you to carry out IgG and IgM assays directed against SARS CoV-2.
These ELISA kits did not show cross-reactions with coronavirus usually encountered (OC43, C229E, NL63, HKU1) or with other respiratory pathogens such as Influenza A/B, Legionella Pneumophila, C.Pneumoniae, M.Pneumonia, Haemophilus influenzae.
The antigens used are developped and produced in France thanks to an academic partnership. The assays are then produced, assembled and dispatched from our production facility based in Paris area.
Our IgG Assay offers a quantitative approach of Ig levels.
Based on a cohort of 169 samples and compared with another ELISA assay, results show a sensitivity and specificity of 99% for IgG anti-S and anti-N.
| Method | HM E-COVID02-G | ||
HM080 COVID19-LISA IgG | Positive | Negative | Total |
| Positive | 90 | 1 | 91 |
| Negative | 1 | 77 | 78 |
| Total | 91 | 78 | 169 |
An IgM anti-S ELISA kit
Based on a cohort of 166 samples and compared with another ELISA assay, results show a sensitivity and specificity of 99% for IgM anti-S.
| Method | HM E-COVID02-M | ||
Elisa Covid-9 THERA02 IgM | Positive | Negative | Total |
| Positive | 79 | 1 | 80 |
| Negative | 1 | 85 | 86 |
| Total | 80 | 86 | 166 |
A reliable Rapid Test
Based on an immunochromatography approach, the TDR Covid-19 IgG+IgM THERA brings you a reliable information in 15 minutes on whole blood, plasma or serum.
Based on this cohort, it shows a specificity of 100% and sensitivity of 93%
| Method | RT-PCR | ||
| TDR Covid-19 IgG+IgM THERA | Positive | Negative | Total |
| Positive | 14 | 0 | 14 |
| Negative | 1 | 15 | 16 |
| Total | 15 | 15 | 30 |