The Case for Laboratory Developed Procedures: Quality and Positive Impact on Patient Care

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.

Clinical laboratories must be highly vigilant for infectious disease outbreaks, since they are likely the first to recover the pathogen and recognize the potential for an outbreak. Recent examples of emerging or reemerging pathogens causing substantial human morbidity and mortality include avian influenza virus ("bird flu"), chikungunya virus, Ebola virus, Middle Eastern respiratory syndrome virus, severe acute respiratory syndrome virus, and Zika virus. 35, 36 At the time of their emergence, no FDA-approved tests were available to detect any of these pathogens. In response, many clinical laboratories developed, validated, and implemented the LDPs needed to care for patients at their institutions. 37, 38 These assays were based on extensive data sets and reported in peer-reviewed journals, supporting their quality claims. Since performance characteristics such as analytic sensitivity (limit of detection) may vary between different assay designs, 39 as was recently discussed for several different Zika virus tests, 40 these sorts of collaborative efforts are essential. In many cases, laboratories leading these efforts collaborated with one another to share validation materials, perform interlaboratory comparisons, and exchange blinded testing samples (http://www.usatoday.com/story/ news/2016/02/23/texas-hospitals-develop-rapid-zika-test/ 80776382/. Accessed April 27, 2017). While perhaps not ideal, there is an urgent need for a more integrated and coordinated mechanism for rapid diagnosis of novel infectious agents that incorporates both the public health and hospital laboratories.