SPADA Draft Documents

(19) Vallone, P.M., & Butler, J.M. (2004) Biotechniques 37 , 226-231; doi:

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10.2144/04372ST03 . 1025 (20) Satterfield, B.C., (2014) J. Mol. Diagn. 16 , 163-173; doi: 10.1016/j.jmoldx.2013.10.004 . 1026 (21) Brownie, J., Shawcross, S., Theaker, J., Whitcombe, D., Ferrie, R., Newton C., & Little, 1027 S. (1997) Nucleic Acids Res. 25 , 3235-3241; doi: 10.1093/nar/25.16.3235 . 1028 (22) Altschul, S.F., Gish, W., Miller, W., Myers, E.W., & Lipman, D.J. (1990) J. Mol. Biol. 1029 215 , 403-410; doi: 10.1016/S0022-2836(05)80360-2 . 1030 (23) Gans, J.D., & Wolinsky, M. (2008) Nucleic Acids Res. 36 , e74; doi: 10.1093/nar/gkn301. 1031 (24) Plant, A.L., Becker, C.A., Hanisch, R.J., Boisvert, R.F., Possolo, A.M., & Elliott J.T. 1032 (2018) PLoS Biol. 16 , e2004299; doi: 10.1371/journal.pbio.2004299. 1033 (25) Boggy, G.J., & Woolf, P.J. (2010) PLoS One 5 , e12355; doi: 1034 10.1371/journal.pone.0012355. 1035 (26) Saah, A.J., & Hoover, D.R. (1997) Ann. Intern. Med. 126 , 9-94. 1036 (27) U.S. Food and Drug Administration (2018) Bioanalytical Method Validation Guidance for 1037 Industry. Center for Drug Evaluation and Research, U.S. Department of Health and Human 1038 Services, Silver Spring, MD; Available at: https://www.fda.gov/media/70858/download , 1039 accessed 30 May 2019. 1040 (28) Clinical and Laboratory Standards Institute (2008) User protocol for evaluation of 1041 qualitative test performance. Approved guideline, 2nd ed. CLSI document EP12-A2. 1042 Clinical and Laboratory Standards Institute, Wayne, PA. 1043 (29) ISO 17511:2003, In vitro diagnostic medical devices—measurement of quantities in 1044 biological samples. Metrological traceability of values assigned to calibrators and control 1045 materials. International Organization for Standardization, Geneva, Switzerland. 1046

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