Author: Kaul, Karen L.; Sabatini, Linda M.; Tsongalis, Gregory J.; Caliendo, Angela M.; Olsen, Randall J.; Ashwood, Edward R.; Bale, Sherri; Benirschke, Robert; Carlow, Dean; Funke, Birgit H.; Grody, Wayne W.; Hayden, Randall T.; Hegde, Madhuri; Lyon, Elaine; Murata, Kazunori; Pessin, Melissa; Press, Richard D.; Thomson, Richard B.
Title: The Case for Laboratory Developed Procedures: Quality and Positive Impact on Patient Care Document date: 2017_7_16
ID: jzwwses4_13
Snippet: Although BK viral load testing has been the standard of care for several years and is used in transplant centers across the country, there is no FDA-cleared or FDA-approved test available. All testing is performed using LDPs. If these LDPs were not available, most cases of PVAN would not be identified promptly, leading to negative patient outcomes such as allograft loss or rejection......
Document: Although BK viral load testing has been the standard of care for several years and is used in transplant centers across the country, there is no FDA-cleared or FDA-approved test available. All testing is performed using LDPs. If these LDPs were not available, most cases of PVAN would not be identified promptly, leading to negative patient outcomes such as allograft loss or rejection.
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