منابع مشابه
Regulating laboratory-developed tests.
Disclaimer: The views expressed in this editorial are solely those of the author and should not be construed as reflecting the views of the Department of Veterans Affairs or the United States Government. As a molecular pathologist for more than 20 years, I have had the opportunity to develop laboratory tests and to assess the efforts of others to develop laboratory tests. As Editor of The Journ...
متن کاملRegulating laboratory-developed tests: devil will be in details.
For 2 days in January, the National Institutes of Health was the epicenter of the debate that has swirled around laboratory-developed tests (LDTs) since last July, when the U.S. Food and Drug Administration announced it would begin regulating them. More than 80 people—representing pathologists , clinicians, patients, and laborato-ries—spoke during FDA's unusually large and long public workshop....
متن کاملThe long and winding regulatory road for laboratory-developed tests.
"High complexity" clinical laboratories are approved under the Clinical Laboratory Improvement Amendments to develop, validate, and offer a laboratory-developed test (LDT) for clinical use. The Food and Drug Administration considers LDTs to be medical devices under their regulatory jurisdiction, and that at least certain LDTs should be subject to greater regulatory scrutiny. This review describ...
متن کاملInterference in laboratory tests
Interference in clinical laboratory testing can create discrepancies in test results which can lead to patient harm. In clinical chemistry, interference is defined as a cause of medically significant difference in the measurand test result due to another component or property of the sample. Interference by endogenous and exogenous substances with assays for clinical analytes is a common prob...
متن کاملEvaluation of Pollution of Newly Developed Biodegredable Fluid during Accelerated Laboratory Tests
Our study focused on evaluation of pollution from newly developed synthetic, biodegradable fluid MOL Farm UTTO Synt, produced by Slovnaft Company, member of MOL Group, Hungary. Fluid was subject of accelerated test in laboratories owned by Department of Transport and Handling, Faculty of Engineering, Slovak University of Agriculture in Nitra. Accelerated laboratory test was realized by cyclic p...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Nature Biotechnology
سال: 2009
ISSN: 1087-0156,1546-1696
DOI: 10.1038/nbt0509-419a