InBios Receives FDA Emergency Use Authorization for Second COVID-19 Antibody Test
SCoV-2 Detect IgM ELISA Kit to aid in diagnosing acute infection and identifying individuals with an adaptive immune response to SARS-CoV-2.
SEATTLE, July 1, 2020 /PRNewswire-PRWeb/ -- InBios International Inc., a leading developer of diagnostic tests for emerging infectious diseases, announced today that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its SCoV-2 Detect IgM ELISA kit, an in vitro diagnostic test for the qualitative detection of IgM antibodies to SARS-CoV-2, the virus that causes COVID-19, in human serum. This marks the first EUA granted for an ELISA that specifically detects IgM antibodies to SARS-CoV-2 and underscores InBios' success in developing and bringing to market high-quality ELISA kits for emerging infectious diseases.
Earlier this month, InBios received an FDA EUA for its SCoV-2 Detect IgG ELISA kit. In 2011, InBios was the first to be granted a 510(k) clearance from the FDA for its Dengue IgM ELISA kit and offered the first commercial Zika IgM ELISA under FDA's EUA in 2016.
"We know there is still much to learn about the virus that causes COVID-19 and the disease itself, and that's why accurate, high-quality antibody tests are so important," said Dr. Syamal Raychaudhuri, InBios' chief scientific officer. "InBios' expertise in emerging infectious diseases, as well as our prior success in developing and receiving authorization for ELISA tests, has enabled us to move quickly into development of much-needed products for COVID-19. Additionally, we've increased production capacity and automated some manufacturing capabilities to meet worldwide demand for COVID-19 diagnostics during this pandemic."
The specific and reliable detection of human IgM antibodies to SARS-CoV-2 may provide indication of recent infection, offering insight into the spread within communities. In performance studies, InBios' SCoV-2 Detect IgM ELISA kit demonstrated 92.50% sensitivity and 98.95% specificity. The SCoV-2 Detect IgM ELISA kit, which is available to order immediately, includes all reagents and controls required to run 90 test specimens with results in approximately 2 hours.
InBios's SCoV-2 Detect IgM ELISA kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, the virus that causes COVID-19, which may indicate recent or prior infection. At this time, it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Samples should be tested with this kit from individuals within 7-64 days post symptom onset to avoid false negative results. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
InBios offers other products for COVID-19, including the Smart Detect SARS-CoV-2 rRT-PCR Kit and the SCoV-2 Detect IgG ELISA kit, both of which received FDA EUAs this year. InBios is also developing the SCoV-2 Detect IgM/IgG Rapid Test.
While the SCoV-2 Detect IgM ELISA kit has not been FDA cleared or approved, it has been authorized for use by the FDA under an EUA, which permits use of certain medical products that may be effective during a public health emergency, which was declared for COVID-19 on Jan. 31, 2020. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
For more information about InBios COVID-19 tests, visit: http://www.inbios.com/covid-19/.
For more information on COVID-19, please visit http://www.cdc.gov or http://www.who.int.
About InBios: InBios International Inc. specializes in the design, development and manufacture of diagnostic assays for emerging infectious diseases and biothreats. Founded in 1996 in Seattle, WA, InBios offers superior quality products which are accurate, easy to use and cost effective. InBios offers an extensive catalog of life science reagents, along with a portfolio of more than 25 diagnostic products, including FDA Emergency Use Authorized COVID-19 tests and FDA-cleared ELISA kits for Zika, dengue, and West Nile and rapid test kits for Chagas and leishmaniasis. InBios is GMP compliant, FDA registered, USDA licensed and ISO 13485:2016 certified. For more information, visit http://www.inbios.com.
SOURCE InBios International, Inc.
Share this article