Korean Biopharmaceutical Firm Celltrion Launches Both Antigen and Antibody Testing Kits in the US

 | Post date: 2020/08/22 | 
 

Korean Biopharmaceutical Firm Celltrion Launches Both Antigen and Antibody Testing Kits in the US

By LabMedica International staff writers
Posted on 13 Aug 2020
  
SAMPINUTE™ COVID-19 Antigen MIA (left) and DiaTrust™ COVID-19 IgG/IgM Rapid Test (Photo courtesy of Celltrion)
SAMPINUTE™ COVID-19 Antigen MIA (left) and DiaTrust™ COVID-19 IgG/IgM Rapid Test (Photo courtesy of Celltrion)
Celltrion Group (Incheon, Korea) has launched two rapid COVID-19 testing kits, SAMPINUTE COVID-19 Antigen MIA for detection of SARS-CoV-2 antigen, and DiaTrust COVID-19 IgG/IgM Rapid Test for detection of SARS-CoV-2 IgG/IgM antibody in the US.

SAMPINUTE COVID-19 Antigen MIA is an electrochemical immunoassay test for detection of SARS-CoV-2 antigen from nasopharyngeal swab samples, composed of one time use test cartridges and a portable analyzer. DiaTrust 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. Both the rapid tests kits have shown a reliable performance and promising clinical trial results. SAMPINUTE COVID-19 Antigen MIA has a sensitivity of 94% and a specificity of 100%, with time to results within 10 minutes. DiaTrust COVID-19 IgG/IgM Rapid Test has also shown a reliable performance with 96% positive percent agreement and 98.67% negative percent agreement for IgM, 92% positive percent agreement and 100% negative percent agreement for IgG. The test has a turnaround time of 15 minutes.

“Celltrion has been striving to bring the tests into the US. The need for more accessible, affordable, and most importantly, rapid diagnostic testing will grow, as the daily activities are coming back, and the economy is opening up again,” a Celltrion representative stated. “With the short turnaround time and promising performance of the sensitivity and specificity results, Celltrion is confident that both SAMPINUTE COVID-19 Antigen MIA and DiaTrust COVID-19 IgG/IgM Rapid Test will add great value to healthcare providers in screening patients and keeping communities safe.”



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