14 August 2020 | News
Plans to launch two rapid COVID-19 testing kits, SAMPINUTETM COVID-19 Antigen MIA and DiaTrustTM COVID-19 IgG/IgM Rapid Test
Image credit: Businesswire
South Korea based Celltrion Group recently announced the launch of two rapid kits for SARS-CoV-2 in the US by the third week of August. SAMPINUTETM COVID-19 Antigen MIA is an electrochemical immunoassay test for the detection of SARS-CoV-2 antigen from nasopharyngeal swab samples, composed of one-time-use test cartridges and a portable analyzer developed in collaboration with BBB.
DiaTrustTM COVID-19 IgG/IgM Rapid Test is a one-step in-vitro diagnostic test based on immunochromatographic assay designed for the rapid detection of antibodies of the novel coronavirus in healthcare settings in collaboration with Humasis. Both SAMPINUTETM COVID-19 Antigen MIA (antigen test) and DiaTrustTM COVID-19 IgG/IgM Rapid Test (antibody test) have shown reliable performance and promising clinical trial results. SAMPINUTETM COVID-19 Antigen MIA has a sensitivity of 94% and a specificity of 100%, with time to results within 10 minutes.
Celltrion requested Emergency Use Authorization (EUA) for SAMPINUTETM COVID-19 Antigen MIA on July 24th, and for DiaTrustTM COVID-19 IgG/IgM Rapid Test on July 8th. The rapid tests kits are currently under the review of the US Food and Drug Administration’s Emergency Use Authorization. Celltrion anticipates the FDA EUA approval and subsequent commercialization in the US market by mid-August.
Celltrion plans to launch the second-generation antibody and antigen tests, in collaboration with the DiaTrustTM COVID-19 IgG/IgM Rapid Test’s manufacturer Humasis, for which Celltrion will apply its proprietary COVID-19 antibody-antiviral technology to enhance detection sensitivity during the second half of 2020.