InBios International, Inc. is a medical diagnostic company based in Seattle that specializes in the design, development, and manufacture of immunodiagnostic devices for infectious diseases. The company was founded in 1996 and, since its inception, has developed several technologies useful in designing rapid and ELISA based immunodiagnostic assays. InBios offers a number of life science reagents, along with a portfolio of more than 25 diagnostic products, including FDA Emergency Use Authorization for COVID-19 products 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.
In response to the COVID-19 pandemic, InBios developed a suite of diagnostic products in 2020, including a PCR kit  and ELISA tests that have been granted Emergency Use Authorization by the FDA. In October 2020, the Department of Defense, in coordination with the Department of Health and Human Services, awarded a $12.67 million contract to InBios to expand US based industrial production capacity of two point of care, rapid COVID-19 tests. 
In 2016, InBios received an EUA from the FDA for its ZIKV Detect™ IgM Capture ELISA, the first commercial serology diagnostic kit for Zika virus to receive an FDA EUA. In 2019, InBios announced that the FDA permitted marketing of its ZIKV Detect 2.0 IgM Capture ELISA, becoming the first commercial serology diagnostic kit to be granted market authorization from the FDA.
In 2011, InBios International announced the clearance of its IgM test for dengue fever, DENV Detect IgM Capture ELISA. It is the first test for the diagnosis of dengue infection approved in the United States. The technology is based on detecting dengue specific IgM antibodies in the serum of afflicted patients. The test is available internationally, especially in Southeast Asia, where dengue fever is particularly prevalent. The company also manufactures tests for other infectious diseases, including Leishmaniasis, Chagas disease, Scrub Typhus, Leptospirosis, Malaria, and West Nile.
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- ^"InBios Receives FDA EUA FOR COVID-19 Antibody Test." June 11, 2020. https://www.prweb.com/releases/inbios_receives_fda_emergency_use_authorization_for_covid_19_antibody_test/prweb17183541.htm
- ^"InBios Receives FDA EUA for Second COVID-19 Antibody Test." July 1, 2020. https://www.prweb.com/releases/inbios_receives_fda_emergency_use_authorization_for_second_covid_19_antibody_test/prweb17230805.htm
- ^"DoD Awards $12.67M Contract to InBios. Oct. 30, 2020. "https://www.defense.gov/Newsroom/Releases/Release/Article/2400993/dod-awards-1267-million-contract-action-to-inbios-international-inc-to-increase/
- ^"InBios Receives FDA EUA for Zika ELISA."Aug. 19, 2016. http://www.prweb.com/releases/2016/08/prweb13626657.htm
- ^"InBios Granted FDA Market Authorization." May 28, 2019. https://www.prweb.com/releases/inbios_receives_fda_market_authorization_for_its_zikv_detect_2_0_igm_capture_elisa_for_a_presumptive_diagnosis_of_zika_virus_infection/prweb16337876.htm
- ^"InBios Releases First FDA Cleared Dengue Fever Test in the US" PRWeb. April 22, 2011. http://www.prweb.com/releases/2011/4/prweb8334651.htm
- ^FDA permits marketing of first test to help diagnose dengue fever. April 8, 2011. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm250584.htm
- ^Design considerations for immunodiagnostics. "IVD Technology" April 1, 2006. http://www.ivdtechnology.com/article/design-considerations-immunodiagnostics?quicktabs_3=0Archived 2012-03-13 at the Wayback Machine
InBios Receives FDA Emergency Use Authorization for COVID-19 Antibody Test
SEATTLE, June 11, 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 IgG ELISA kit, which detects IgG antibodies to SARS-CoV-2 in human serum.
InBios' COVID-19 antibody test 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. 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.
Antibody testing for COVID-19 is needed to understand the pervasiveness of the disease within communities. The SCoV-2 Detect IgG ELISA kit, which is available to order now, includes all reagents and controls required to run 90 test specimens with results in approximately 2 hours. No specific analyzer is required for this assay, making it versatile and suitable for many qualified laboratories. In performance studies, the kit demonstrates 97.8% sensitivity and 98.9% specificity. InBios has a record of success in bringing high-quality ELISA kits to the world market. 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 kits are well established and continue to support accurate diagnostic testing in the US and worldwide.
Dr. Syamal Raychaudhuri, InBios' chief scientific officer, said, "InBios' long-term commitment to quality sets us apart as we worked to develop and validate this SARS-CoV-2 antibody test. While we all know speed is of the essence when it comes to diagnostics for emerging diseases like COVID-19, it is equally important to assure that quality and performance allow true insight into who might have an adaptive immune response to this virus."
InBios offers other products for COVID-19, including the Smart Detect SARS-CoV-2 rRT-PCR Kit, which received an FDA EUA in April. InBios is also developing an ELISA kit for SARS-CoV-2 IgM antibody detection, as well as the SCoV-2 Detect IgM/IgG Rapid Test.
In response to the worldwide pandemic, InBios has ramped up production of its COVID-19 diagnostic tests by increasing production capacity and automation in its state-of-the-art facility in South Lake Union area of Seattle, WA.
While the SCoV-2 Detect IgG 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 the FDA Emergency Use Authorized Smart Detect SARS-CoV-2 rRT-PCR Kit 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.
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