SPADA Docs

(25) Bustin, S.A., Benes, V., Garson, J.A., Hellemans, J., Huggett, J., Kubista, M., Mueller, 1120 R., Nolan, T., Pfaffl, M.W., Shipley, G.L., Vandesompele, J., & Wittwer, C.T. (2009) 1121 Clin Chem 55 , 611-622; doi: 10.1373/clinchem.2008.112797 . 1122 (26) Boggy, G.J., & Woolf, P.J. (2010) PLoS One 5 , e12355; 1123 doi:10.1371/journal.pone.0012355. 1124 (27) Hartman, L.J., Heinrich, M.L., Zovanyi, A.M., Ingram, M.F., Hobson, J.P., Kulesh, 1125 D.A., Craw, P.D., Jaissle, J.G., Norwood, D.A., & Minogue, T.D. (2015) Clin Chem 61 , 1126 1391-1398; doi: 10.1373/clinchem.2015.242750 . 1127 (28) Saah, A.J., & Hoover, D.R. (1997) Ann. Intern. Med. 126 , 91-94; doi: 10.7326/0003- 1128 4819-126-1-199701010-00026 1129 (29) U.S. Food and Drug Administration (2018) Bioanalytical Method Validation Guidance for 1130 Industry. Center for Drug Evaluation and Research, U.S. Department of Health and Human 1131 Services, Silver Spring, MD; Available at: https://www.fda.gov/media/70858/download , 1132 accessed 30 May 2019. 1133 (30) Clinical and Laboratory Standards Institute (2008) User protocol for evaluation of 1134 qualitative test performance. Approved guideline, 2nd ed. CLSI document EP12-A2. 1135 Clinical and Laboratory Standards Institute, Wayne, PA. 1136 (31) ISO 17511:2003, In vitro diagnostic medical devices—measurement of quantities in 1137 biological samples. Metrological traceability of values assigned to calibrators and control 1138 materials. International Organization for Standardization, Geneva, Switzerland. 1139 (32) Koch, D.D., & and Peters, T. (1999) in Tietz Textbook of Clinical Chemistry , Third Edition, 1140 C.A. Burtis & E.R. Ashwood (Eds), Saunders Co., Philadelphia, PA. 1141

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