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First CLIA Kits FDA Pre-EUA Accepted
      Date:2020-03-19
Alongside the spread of the novel coronavirus, U.S. Food & Drug Administration (FDA) introduced an emergency policy, “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency” on 2020-3-16.

Before that, YHLO were preparing the FDA register application. According to FDA policy guidelines, YHLO has completed the verification of SARS-CoV-2 CLIA kits and the application for Pre-EUA was accepted on 2020-3-18 officially, making YHLO the world’s first to have FDA PEUA submission numbers for SARS-CoV-2 kits using chemiluminescence method.

There are two YHLO’s items entering into FDA EUA: SARS-CoV-2 IgM CLIA kit, SARS-CoV-2 IgG CLIA kit and the matching devices for the kits——iFlash Automated Chemiluminescence Immunoassay Analyzer (iFlash 3000 & iFlash 1800). Based on “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency”, these kits are available to launch and sell in USA.

Besides, these two kits have obtained CE certificates on 2020-3-4.

Having a strong ability in protein engineering and immunoassay, YHLO developed the SARS-CoV-2 IgM/IgG kits by own R&D and have performed full clinical evaluation in many Chinese hospitals. Based on evaluation data from 13 designated hospitals for COVID-19, these kits demonstrated excellent performance for detection of SARS-CoV-2 IgG/IgM, the specificity and sensitivity for IgM are 98.3% and 86.6% respectively, and the specificity and sensitivity for IgM IgG are 97.4% and 96.3%. Antibody testing is a valuable supplementary tool for RT-PCR, and it is especially useful for patients with negative RT-PCR results to rule out false negative.

The novel coronavirus has been diagnosed in more than 100 countries and the number of infections is increasing rapidly day by day. At this critical period, we hope YHLO’s SARS-CoV-2 IgM/IgG kits can bring powerful support for hospitals around the world to fight the disease.

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