On Jul. 1, 2020, InBios announced that it had 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 marked 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 in the 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.

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.

InBios International 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.