FDA's latest report: Tiki Bio-New Coronavirus Detection Products Are Among the Best.

According to a comparative conclusion from the FDA SARS-CoV-2 nucleic acid test kit released by the U.S. Food and Drug Administration (FDA) on September 15, QuantiVirus of DiaCarta (Tyki Bio) was among all FDA/EUA approved test kits that returned blind sample results. SARS-CoV-2 Test Kit and QuantiVirus SARS-CoV-2 Multiplex Test Kit are in the top three for detection sensitivity, with a lower detection limit (LoD) of 600NDU/ml.
FDA has approved 137 new crown manufacturers 400 companies 4000 to provide their new crown nucleic acid testing quality control plate and double-blind sample test assessment, and require each manufacturer to receive testing materials within two weeks after returning the test results.
to the deadline only 58 on time to return assessment data, the report shows that most manufacturers measured sensitivity is far worse than self-reported kit detection sensitivity.
DiaCarta (Diki Bio) these two test kits are 300 to 900 times more sensitive 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).
show that the DiaCarta kit is the only one that can maintain the high sensitivity originally declared by the assessment.
large amounts of data have shown that highly sensitive products are critical to fighting outbreaks and can effectively avoid false negative or false positive results.
(SCREENSHOT) https://The New Coronary Nucleic Acid Testing Panel (Reference Panel) was officially 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 and distribute them to 137 approved standardized test manufacturers by August 17.
approved domestic 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 significantly to the global fight against the epidemic and the reopening of the economy."
DiaCarta'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 DiaCarta (Diki Bio) DiaCarta has independent clinical testing centers (medical laboratories) in Both China and the United States.
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 U.S.-based Precision Medicine Molecular Diagnostics, based in Silicon Valley, California, has ISO13485 certification and CLIA certification and a number of unique technology platforms.
Headquarters 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.
focuses on the clinical application of molecular biology technology.
, on the other hand, actively promote the development of the new coronavirus testing kit, has now been launched QuantiVirus? SARS-Cov-2 Test Kit, QuantiVirus? SARS-CoV-2 Multiplex Test Kit and other test kits, on the other hand, DiaCarta (Tyki 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 Superb DNA technology platform launched around the world ColoScape? Early screening fluid testing for bowel cancer, and QuantiDNA? Radiotherapy monitors blood testing and other original products.
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