Validation Workshop Materials Last updated 8/26/05
For workshop presented at NFSTC on August 24-26, 2005 by Robyn Ragsdale (FDLE) and John Butler (NIST)
Handouts for PowerPoint presentations:
Inconsistencies in Validation Between Labs
Method Modifications and Performance Checks
Practical Exercises
Recommended articles to read:
Butler, J.M., Tomsey, C.S., Kline, M.C. (2004) Can the validation process in forensic DNA typing be standardized? Proceedings of the 15th International Symposium on Human Identification. Available at http://www.promega.com/geneticidproc/ussymp15proc/oralpresentations/butler.pdf or http://www.cstl.nist.gov/biotech/strbase/pub_pres/PromegaPaperOct2004.pdf.
Developmental Validation Papers (click on pdf link following reference to download article)
Collins PJ, Hennessy LK, Leibelt CS, Roby RK, Reeder DJ, Foxall PA. Developmental validation of a single-tube amplification of the 13 CODIS STR loci, D2S1338, D19S433, and amelogenin: the AmpFlSTR Identifiler PCR amplification kit. J. Forensic Sci. 2004; 49(6): 1265-1277. [pdf]
Cotton EA, Allsop RF, Guest JL, Frazier RR, Koumi P, Callow IP, Seager A, Sparkes RL. Validation of the AMPFlSTR SGM Plus system for use in forensic casework. Forensic Sci Int 2000; 112: 151-161. [pdf]
Fregeau CJ, Bowen KL, Fourney RM. Validation of highly polymorphic fluorescent multiplex short tandem repeat systems using two generations of DNA sequencers. J Forensic Sci 1999; 44(1):133-166. [ABI 377] [pdf]
Green RL, Roinestad IC, Boland C, Hennessy LK. Developmental validation of the Quantifiler real-time PCR kits for the quantification of human nuclear DNA samples. J. Forensic Sci. 2005; 50(4): 809-825. [pdf]
Greenspoon SA, Ban JD, Sykes K, Ballard EJ, Edler SS, Baisden M, Covington BL. Application of the BioMek 2000 Laboratory Automation Workstation and the DNA IQ System to the extraction of forensic casework samples. J Forensic Sci 2004; 49(1):29-39. [pdf]
Holt CL, Buoncristiani M, Wallin JM, Nguyen T, Lazaruk KD, Walsh PS. TWGDAM validation of AmpFlSTR PCR amplification kits for forensic DNA casework. J Forensic Sci 2002; 47(1): 66-96. [pdf]
Kadash K, Kozlowski BE, Biega LA, Duceman BW. Validation study of the TrueAllele automated data review system. J Forensic Sci 2004; 49(4):660-667. [pdf]
Koumi P, Green HE, Hartley S, Jordan D, Lahec S, Livett RJ, Tsang KW, Ward DM. Evaluation and validation of the ABI 3700, ABI 3100, and the MegaBACE 1000 capillary array electrophoresis instruments for use with short tandem repeat microsatellite typing in a forensic environment. Electrophoresis 2004; 25(14):2227-2241. [pdf]
Krenke BE, Tereba A, Anderson SJ, Buel E, Culhane S, Finis CJ, Tomsey CS, Zachetti JM, Masibay A, Rabbach DR, Amiott EA, Sprecher CJ. Validation of a 16-locus fluorescent multiplex system. J Forensic Sci 2002; 47(4): 773-785. [PowerPlex 16] [pdf]
Krenke BE, Viculis L, Richard ML, Prinz M, Milne SC, Ladd C, Gross AM, Gornall T, Frappier JRH, Eisenberg AJ, Barna C, Aranda XG, Adamowicz, Budowle B. Validation of a male-specific, 12-locus fluorescent short tandem repeat (STR) multiplex. Forensic Sci Int 2005; 148: 1-14. [PowerPlex Y kit] [pdf]
Lazaruk K, Walsh PS, Oaks F, Gilbert D, Rosenblum BB, Menchen S, Scheibler D, Wenz HM, Holt C, Wallin J. Genotyping of forensic short tandem repeat (STR) systems based on sizing precision in a capillary electrophoresis instrument. Electrophoresis 1998;19(1):86-93. [ABI 310] [no pdf available]
Nicklas JA, Buel E. Development of an Alu-based, real-time PCR method for quantitation of human DNA in forensic samples. J Forensic Sci 2003;48(5):936-944. [pdf]
Shewale JG, Nasir H, Schneida E, Gross AM, Budowle B, Sinha SK. Y-chromosome STR system, Y-PLEX 12, for forensic casework: development and validation. J Forensic Sci 2004;49(6): 1278-1290. [pdf]
Wilson MR, DiZinno JA, Polanskey D, Replogle J, Budowle B. Validation of mitochondrial DNA sequencing for forensic casework analysis. Int J Legal Med 1995; 108(2):68-74. [no pdf available]
Internal Validation Papers (click on pdf link following reference to download article)
Divne AM, Nilsson M, Calloway C, Reynolds R, Erlich H, Allen M. Forensic casework analysis using the HVI/HVII mtDNA Linear Array assay. J Forensic Sci 2005; 50(3): 548-554. [pdf]
Frank WE, Llewellyn BE, Fish PA, Riech AK, Marcacci TL, Gandor DW, Parker D, Carter RR, Thibault SM. Validation of the AmpFlSTR Profiler Plus PCR amplification kit for use in forensic casework. J Forensic Sci 2001; 46(3):642-646. [pdf]
Levedakou EN, Freeman DA, Budzynski MJ, Early BE, Damaso RC, Pollard AM, Townley AJ, Gombos JL, Lewis JL, Kist FG, Hockensmith ME, Terwilliger ML, Amiott E, McElfresh KC, Schumm JW, Ulery SR, Konotop F, Sessa TL, Sailus JS, Crouse CA, Tomsey CS, Ban JD, Nelson MS. Characterization and validation studies of PowerPlex 2.1, a nine-locus short tandem repeat (STR) multiplex system and penta D monoplex. J Forensic Sci 2002; 47(4):757-772. [pdf]
Montpetit SA, Fitch IT, O'Donnell PT. A simple automated instrument for DNA extraction in forensic casework. J Forensic Sci 2005; 50(3): 555-563. [pdf]
See also STRBase validation website: http://www.cstl.nist.gov/biotech/strbase/validation.htm and John M. Butler, Forensic DNA Typing: Biology, Technology, and Genetics of STR Markers, 2nd Edition (2005), Elsevier, Chapter 16 "Laboratory Validation", pp. 389-412.
Q2A Guideline for Industry: Text on Validation of Analytical Procedures http://www.fda.gov/cder/guidance/ichq2a.pdf
Q2B Guideline for Industry: Validation of Analytical Procedures: Methodology http://www.fda.gov/cder/guidance/1320fnl.pdf