SPADA Meeting Book

(18) DiChiacchio, L., & Mathews, D.H. (2016) Methods Mol Biol. 1490 , 51-62; doi:

1047

1048

10.1007/978-1-4939-6433-8_4.

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

1049

10.2144/04372ST03 . 1050 (20) Satterfield, B.C., (2014) J. Mol. Diagn. 16 , 163-173; doi: 10.1016/j.jmoldx.2013.10.004 . 1051 (21) Brownie, J., Shawcross, S., Theaker, J., Whitcombe, D., Ferrie, R., Newton C., & Little, 1052 S. (1997) Nucleic Acids Res. 25 , 3235-3241; doi: 10.1093/nar/25.16.3235 . 1053 (22) Altschul, S.F., Gish, W., Miller, W., Myers, E.W., & Lipman, D.J. (1990) J. Mol. Biol. 1054 215 , 403-410; doi: 10.1016/S0022-2836(05)80360-2 . 1055 (23) Gans, J.D., & Wolinsky, M. (2008) Nucleic Acids Res. 36 , e74; doi: 10.1093/nar/gkn301. 1056 (24) Plant, A.L., Becker, C.A., Hanisch, R.J., Boisvert, R.F., Possolo, A.M., & Elliott J.T. 1057 (2018) PLoS Biol. 16 , e2004299; doi: 10.1371/journal.pbio.2004299. 1058 (25) Boggy, G.J., & Woolf, P.J. (2010) PLoS One 5 , e12355; doi: 1059 10.1371/journal.pone.0012355. 1060 (26) Saah, A.J., & Hoover, D.R. (1997) Ann. Intern. Med. 126 , 9-94. 1061 (27) U.S. Food and Drug Administration (2018) Bioanalytical Method Validation Guidance for 1062 Industry. Center for Drug Evaluation and Research, U.S. Department of Health and Human 1063 Services, Silver Spring, MD; Available at: https://www.fda.gov/media/70858/download , 1064 accessed 30 May 2019. 1065 (28) Clinical and Laboratory Standards Institute (2008) User protocol for evaluation of 1066 qualitative test performance. Approved guideline, 2nd ed. CLSI document EP12-A2. 1067 Clinical and Laboratory Standards Institute, Wayne, PA. 1068

54