References
- Center for Devices and Radiological Health Draft guidance for industry, clinical laboratories, and FDA staff. In Vitro Diagnostic Multivariate Index Assays, 2007, 15 pp.
- Robinson AB, Pauling L. Techniques of orthomolecular diagnosis. Clin Chem 1974;20:961–5.
- Affymetrix. Manufacturing quality control and validation studies of GeneChip® arrays. Technical note, 2007, Available from: http://media.affymetrix.com/support/technical/technotes/manufacturing_quality_technote.pdf.
- Randox. Biochip Array Technology explained, 2014, Available from: http://www.randox.com/brochures/biochip/LT313.pdf.
- Illumina. Gene expression profiling with Sentrix® Focused Arrays, 2005, Available from: http://www.illumina.com/Documents/products/techbulletins/techbulletin_rna.pdf.
- Glas AM, Delahaye L, Krijgsman O. MammaPrint® translating research into a diagnostic test. In: Jorgensen JT, Winther H (eds), Molecular diagnostics: the key driver in personalized cancer medicine (pp. 139–64). Singapore: Pan Stanford, 2010.
- Hitachi Chemical Diagnostics, Inc. International package insert for OPTIGEN® assay, 2006, Available from: http://www.hcdiagnostics.com/International/Products/AllergyAssays/optigen-allergen-specific/index.html.
- Bio-Rad. BioPlex® 2200 ANA Screen with MDSS, 2012, Available from: http://www.bio-rad.com/webroot/web/pdf/cdg/literature/T-101_BioPlex-2200_ANA_Screen_%20MDSS_Brochure_%20DG12-0481.pdf.
- Chinnasamy T, Segerink LI, Nystrand M, Ganteliusa J, Svahn HA. A lateral flow paper microarray for rapid allergy point of care diagnostics. Analyst 2014;139:2348–54.
- Affymetrix. CustomExpress™ Arrays. Available from: http://www.affymetrix.com/support/help/faqs/custom_express/faq_4.jsp.
- Illumina. Analyzing standard and custom Infinium genotyping products training guide, 2012, Available from: https://support.illumina.com/content/dam/illumina-support/documents/myillumina/ff854be1-36f9-4f4b-8475-2bfe2487586d/infinium_controls_training_guide.pdf.
- Agilent Technologies. Learn about normalization and replicate probe groups. Available from: https://earray.chem.agilent.com/earray/helppages/index.htm#learn_about_normalization_and_replicate_probe_groups.htm.
- Master SR, Bierl C, Kricka LJ. Diagnostic challenges for multiplexed protein microarrays. Drug Discov Today 2006;11:1007–11.
- Tang W, Hu Z, Muallem H, Gulley ML. Quality assurance of RNA expression profiling in clinical laboratories. J Mol Diagn 2012;14:1–11.
- Sapino A, Roepman P, Linn SC, Snel MHJ, Delahaye LJMJ, van den AJ, Glas AM, Simon IM, Barth N, de Snoo FA, Vant Veer LJ, Molinaro L, Berns EMJJ, Wesseling J, Riley LB, Nguyen B, Cox CE. MammaPrint molecular diagnostics on formalin-fixed, paraffin-embedded tissue. J Mol Diagn 2014;16:190–7.
- AutoGenomics Inc. INFINITI CYP450 2D6I Assay. Directional package insert (DPI), 2012, Available from: www.autogenomics.com/pdf/EnglishPackageInsertforCYP4502D6I.pdf.
- Schrijver I, Aziz N, Jennings LJ, Richards CS, Voelkerding Weck KE. Methods-based proficiency testing in molecular genetic pathology. J Mol Diagn 2014;156:283–7.
- Wong RC, Tse HY. Quantitative, false positive, and false negative issues for lateral flow immunoassays as exemplified by onsite drug screens. In: Wong RC, Tse HY (eds), Lateral flow immunoassay (pp. 185–203). New York: Springer, 2009.
- Delahaye LJM, Wehkamp D, Floore AN, Bernards R, van’t Veer LJ, Glas AM. Performance characteristics of the MammaPrint® breast cancer diagnostic gene signature. Per Med 2013;10:801–11.
- Office of Public Health Strategy and Analysis. The public health evidence for FDA oversight of laboratory developed tests: 20 case studies, 2015. http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm472773.htm.
- Baggerly KA, Coombes KR. Deriving chemosensitivity from cell lines: forensic bioinformatics and reproducible research in high-throughput biology. Ann Appl Statistics 2009;3:1309–34.
- Gene Expression Omnibus. http://www.ncbi.nlm.nih.gov/geo/.
- MicroArray Quality Control (MAQC), 2016, Available from: http://www.fda.gov/ScienceResearch/BioinformaticsTools/MicroarrayQualityControlProject/.
- Patterson TA, Lobenhofer EK, Fulmer-Smentek B, Collins PJ, Chu T-M, Bao W, Fang H, Kawasaki ES, Hager J, Tikhonova IR, Walker SJ, Zhang L, Hurban P, de Longueville F, Fuscoe JC, Tong W, Shi L, Wolfinger RD. Performance comparison of one-color and two-color platforms within the MicroArray Quality Control (MAQC) project. Nat Biotechnol 2006;24:1140–50.
- Vujkovic M, Attiyeh EF, Ries RE, Horn M, Goodman EK, Ding Y, Kavcic M, Alonzo TA, Gerbing RB, Hirsch B, Raimondi S, Gamis AS, Meshinchi S, Aplenc R. Concordance of copy number alterations using a common analytic pipeline for genome-wide analysis of Illumina and Affymetrix genotyping data: a report from the Children’s Oncology Group. Cancer Genet 2015;208:408–13.