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    Home > Active Ingredient News > Drugs Articles > Tiki Bio's new crown virus detection products are among the best

    Tiki Bio's new crown virus detection products are among the best

    • Last Update: 2021-03-01
    • Source: Internet
    • Author: User
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    The DiaCarta (Tyki Bio) kit is the only one that can maintain the high sensitivity originally declared by the assessment.Based on data comparison conclusions from the FDA SARS-CoV-2 nucleic acid testing kit released by the U.S. Food and Drug Administration (FDA) on September 15, DiaCarta (Diki Bio) was found in all FDA/EUA approved test kits that returned blind sample results. QuantiVirus™ SARS-CoV-2 Test Kit and QuantiVirus SARS-CoV-2 Multiplex Test Kit are in the top three with a detection lower limit (LoD) of 600NDU/ml. The FDA provides its new crown nucleic acid testing discs and double-blind sample tests to 137 new crown manufacturers available 447 companies 444 444, and requires each manufacturer to return the test results within two weeks of receiving the testing materials. To the deadline of only 58 on time return assessment data, the report shows that most manufacturers measured sensitivity is far worse than self-reported kit detection sensitivity. The sensitivity of the two test kits is 300 to 900 times higher than the approved new crown kits at the end of the report ranking (180,000 NDU/ml VTM swabs and 540,000 NDU/ml dry swabs). This suggests that the DiaCarta (Tyki Bio) kit is the only one that can maintain the high sensitivity originally declared by the assessment. A large amount of data has shown that highly sensitive products are critical to fighting outbreaks and can effectively avoid false negative or false positive results.Designed by the U.S. Food and Drug Administration (FDA) to compare the sensitivity and cross-reactivity of all FDA/EUA-approved SARS-CoV-2 nucleic acid test kits, the new reference panel was distributed to 137 approved standardized test manufacturers by August 17. Domestic approved manufacturers, including some well-known enterprises have not completed the assessment on time, the list is not named.Dr. Ram Vairavan, Senior Vice President of Commercial Operations at DiaCarta, said, "We are very grateful to the FDA for its tireless efforts to ensure that the market has a high-quality new crown test kit, and we are pleased to see that our two approved product tests have reached the top three, proving once again that the kits we offer for the in vitro diagnostics market are highly accurate and reliable testing products that actively contribute to the global fight against the epidemic and the reopening of the economy."Dia Carta's QuantiVirus SARS-CoV-2 Test Kit and QuantiVirus SARS-CoV-2 Multiplex Test Kit were granted FDA Emergency Use Authorization (EUA) in April and July, respectively. Two kits are currently used in testing laboratories in several countries around the world. In addition, DiaCarta's CLIA laboratory in the San Francisco Bay Area offers a wide range of rapid testing services for re-employment and personal travel, especially for domestic and international travelers who need to produce new crown test results on the same day or the next day.

    about Dia Carta (Tyki Creatures)DiaCarta has independent clinical testing centers (medical laboratories) in Both China and the United States. The company has also been approved by FDA/EUA LDT and has made a positive contribution to outbreak control by providing coronavirus testing services at the DiaCarta CLIA Lab Clinical Testing Center in the United States.DiaCarta ISO 13485 certification and CLIA certification and a number of unique technology platforms are available at Precision Medicine Molecular Diagnostics, a Silicon Valley, California-based precision medicine molecular diagnostic company. Headquartered in Nanjing, Jiangsu Province, China has an independent third-party inspection laboratory, ISO13485 and MDSAP system certified production workshop, built in line with diagnostic reagent development standards of research and development laboratory. The company focuses on the clinical application of molecular biology technology. On the one hand, we are actively promoting the development of new coronavirus test kits, which are now available in QuantiVirus™ SARS-Cov-2 Test Kit, QuantiVirus™ SARS-CoV-2 Multiplex Test Kit, and on the other hand, DiaCarta (Diki Bio) also focuses on cancer early screening and infectious disease diagnosis and treatment monitoring liquid biopsy, based on the company's own research and development of XNA and SuperbDNA technology platform worldwide launched ColoScape®intestinal cancer early screening fluid detection, as well as QuantiDNA® radiotherapy monitoring blood testing and other original products. (Biological exploration)
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