PHASE Scientific’s COVID-19 Accelerated Antigen Analysis Now Available Beyond the U.S.–Enabling Ease of Accumulation Sample Accumulating and Testing

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Garden Grove, CA /PRNewswire/ – PHASE Scientific All-embracing LTD (PHASE Scientific), a high-growth biotech aggregation founded by bioengineers from UCLA, today appear that its INDICAID™ COVID-19 Accelerated Antigen Analysis (INDICAID) accustomed Emergency Use Allotment (EUA) from the U.S. Food and Drug Administration (FDA) on July 29, 2021. The FDA accustomed the analysis for able use in point of affliction CLIA-waived settings in the U.S. The analysis is advised for the qualitative apprehension of SARS-CoV-2 antigen in individuals doubtable of application the virus aural bristles canicule of evidence onset. Anterior nasal besom specimens may be calm by a healthcare provider or self-collected (by individuals 18 years of age or older, beneath the administration of a healthcare professional). In regions alfresco of the U.S., such as Hong Kong, the analysis is accustomed as a customer self-test.

INDICAID is one of the aboriginal accelerated antigen tests to accredit accumulation sample accumulating and testing at the point of affliction due to its different sample accumulating canteen which protects the sample throughout the accumulating and staging process. The architecture gives healthcare professionals the advantage of accession a ample cardinal of samples accordingly and again bound testing the alone samples in batches aural a two-hour timeframe. INDICAID requires no appropriate chart and can be performed in 20 account on-site with a affable bank nasal swabbing vs. the added assimilation appropriate by added tests.

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“The advantages of INDICAID are capital for acceptance able testing workflows for point of affliction settings that crave aerial aggregate screening such as schools, astute and abiding healthcare accessories and association sites,” said Dr. Ricky Chiu, architect and arch controlling administrator of PHASE Scientific. “We’ve already supplied over two actor INDICAID kits beyond 30 countries worldwide—and are admiring to now activate administration into the United States pursuant to the Emergency Use Authorization.”

Earlier this month, the achievement of INDICAID was appear in a peer-reviewed commodity in the American Society for Microbiology’s journal, Microbiology Spectrum. The allotment shares abstracts from a -to-be multi-site U.S. analytic study, in which INDICAID approved able performance, accurately anecdotic 85% of those who were absolute (PPA) and 97% of those who were abrogating (NPA) for SARS-CoV-2 with self-collected specimens.

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“Our analysis has been globally adopted and activated to accommodated a array of emergency testing needs. From the Hong Kong government application INDICAID for healthcare worker’s account screenings to acceptance beyond arcade malls, supermarkets and schools worldwide, our accelerated analysis has accepted to be both able and efficient,” connected Chiu. “We see this U.S. emergency use allotment as acceptance of the accent of our technology and artefact affection and we are acquisitive to aggrandize our ability beyond the U.S. and into added all-embracing markets to do our allotment in allowance action the COVID-19 pandemic.”

To apprentice added about Phase Scientific and INDICAID, visit: https://us.phasescientific.com/.

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About the INDICAID™ COVID-19 Accelerated Antigen TestINDICAID has been accustomed by the FDA beneath an emergency use allotment for in vitro analytic and decree use only. INDICAID is alone accustomed for the continuance of the acknowledgment that affairs abide answer the allotment of emergency use of in vitro analytic tests for apprehension and/or analysis of COVID-19 beneath Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the allotment is concluded or revoked sooner. Testing is bound to laboratories certified beneath the Analytic Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that accommodated the requirements to accomplish abstinent complexity, aerial complexity, or waived tests. This analysis is accustomed for use at the point of care, i.e., in accommodating affliction settings operating beneath a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.

About Phase Scientific All-embracing LTDPHASE Scientific is a high-growth biotech aggregation founded by a aggregation of bioengineers from UCLA. The alignment is focused on architecture accoutrement that empower bodies by giving them bigger advice about their health. Headquartered in Hong Kong, its brand includes analysis and development, accomplishment and administration in Hong Kong and Southern California and added offices in acreage China. For added information, amuse appointment https://us.phasescientific.com/ or email info@phasesci.com.

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