QUANTA Flash® SARS-CoV-2 IgG Receives Emergency Use Authorization from FDA
May 10, 2021 - San Diego
Inova Diagnostics, a world leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory, is pleased to announce the Emergency Use Authorization of QUANTA Flash SARS-CoV-2 IgG by the US Food and Drug Administration (FDA) for use on BIO-FLASH® random access chemiluminescent analyzer.
The QUANTA Flash SARS-CoV-2 IgG is a precise chemiluminescent immunoassay for the in vitro qualitative and semi-quantitative detection of IgG to the nucleocapsid and spike protein of SARS-CoV-2. This test has shown an excellent clinical performance with 100% specificity in patients with confounding conditions and a 100% sensitivity for COVID-19 in patients after ≥15 days of a positive RT-PCR result.
We are excited about the Emergency Use Authorization of our QUANTA Flash SARS-CoV-2 IgG. Based on the high performance of the assay and the high automation level of the BIO-FLASH system, QUANTA Flash SARS-CoV-2 IgG represents a promising solution to detect antibodies to SARS-CoV-2 said Dr. Michael Mahler, VP of Research and Development, Inova Diagnostics.
The QUANTA Flash SARS-CoV-2 IgG test is performed using human serum or citrated plasma on BIO-FLASH instrument which has a processing capacity of up to 60 samples per hour, STAT capability and time to first result of 30 min.
This test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detection IgG antibodies to SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked.
About Inova Diagnostics, Inc
Inova Diagnostics is a privately held company headquartered in San Diego, California, and is a part of Werfen, a global leader in IVD with a long-term commitment to providing innovative solutions for hospitals and clinical laboratories to improve patient care. Inova Diagnostics manufactures IVD systems, reagents for autoimmune disease and is a leader in the development and commercialization of new autoimmune technologies and diagnostic markers. Further information about Inova Diagnostics can be found at www.inovadx.com.
BIO-FLASH is a random access chemiluminescent instrument for the autoimmune laboratory which delivers results in as little as 30 minutes. BIO-FLASH offers a wide analytical measuring range and precise quantification for greater confidence in results, and is a progressive step forward to handle routine, specialized and STAT immunology tests. BIO-FLASH has a broad menu of QUANTA Flash assays that can be used to aid in the diagnosis of autoimmune diseases.
BIO-FLASH is a registered trademark of Biokit S.A. and QUANTA Flash is a registered trademark of Inova Diagnostics, Inc. © 2021 Inova Diagnostics, Inc. All rights reserved.