Access Bio, Inc.'s CareStart™ COVID-19 Antigen Test Kit Using NanoAct™ Launched in the U.S
December 08, 2020 at 09:00 am EST
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Access Bio, Inc. announced that CareStart™ COVID-19 Antigen test kit developed by Access Bio, Inc., using Asahi Kasei's NanoAct™ cellulose nanobeads, received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), and its sale in the U.S. has begun. NanoAct™ colored cellulose nanobeads were developed by Asahi Kasei by utilizing its core technology of cellulose processing. They are currently used as labels for lateral flow immunochromatographic assays, mainly for influenza. NanoAct™ was adopted by Access Bio, Inc. for use in CareStart™ COVID-19 Ag as it is available in a wide range of colors and enables better visibility of test lines, which improves usability. The continuing spread of COVID-19 has raised the importance of rapid screening. Demand for rapid test kits is rising because unlike polymerase chain reaction (PCR) tests, they require no special equipment. Access Bio, Inc., the world's leading manufacturer of rapid test kits for malaria, developed CareStart™ COVID-19 Ag to rapidly detect antigens of SARS-CoV-2, the virus which causes COVID-19. Clinical evaluations indicate that CareStart™ COVID-19 Ag provides a sensitivity of 88.4% and specificity of 100%, which is comparable to reverse transcription (RT)-PCR testing. Furthermore, CareStart™ COVID-19 Ag provides results in 10 minutes while PCR generally takes 1 or 2 days. In addition, the availability of NanoAct™ in multi-color variation enables different colors to be shown, such as blue for the test line (T in the figure below) and red for the control line (C), which allows easier judgment as a user-friendly test kit. CareStart™ COVID-19 Ag has also obtained CE Mark certification, and it is scheduled to be launched in Europe, Southeast Asia, and Africa. In addition to various diagnostic test kits for COVID-19 and influenza, NanoAct™ is also expected to be used in multi-testing kits that enable simultaneous testing for several infectious diseases. Such kits are increasingly being developed by many diagnostic kit manufacturers in the U.S., Europe, and Asia. Asahi Kasei will continue to leverage NanoAct™ technology to help prevent the spread of COVID-19 and other infectious diseases.
Access Bio, Inc. is engaged in research, development and manufacturing of in vitro rapid diagnostic tests, biosensors and molecular diagnostic products. Its product list includes covid-19 detection kits, rapid diagnostic tests, analyzers and molecular diagnostics. Its covid-19 detection kits include CareStart COVID-19 Antigen Home Test, CareStart COVID-19 Antigen, CareStart COVID-19 MDx RT-PCR, CareStart COVID-19 lgM/lgG and CareStart EZ COVID-19 lgM/lgG. Its rapid diagnostic tests include CareStart EZ HIV, CareStart Flu A&B Plus+, CareStart G6PD RDT, CareStart Malaria RDT, CareStart Dengue RDT, care US HIV 1/2 and care US Syphilis. The analyzers include care SURE Analyzer 100, care SURE A1c Cartridge, care SURE ACR Cartridge, care SURE CRP Cartridge, care START S1 Analyzer and care START G6PD Biosensor. The molecular diagnostics include care GENE HPV Screening kit-H, care GENE Zika Virus RT-PCR kit, care GENE STD detection kit, care GENE Dengue Virus genotyping kit and others.