Contemplations on preclinical validation of fluorescence in situ hybridization probe assay for paraffin-embedded tissues in hematologic disorders

Author:

Reddy Kavita S.,Tripodi Joseph

Publisher

Elsevier BV

Subject

Cancer Research,Genetics,Molecular Biology

Reference9 articles.

1. World Health Organization Classification of Tumors. Pathology and Genetics. Tumors of Haematopoietic and Lymphoid Tissues;Jaffe,2001

2. ACMG standards and guidelines for Clinical Genetic Laboratories. Section E: Clinical Cytogenetics. E9 metaphase FISH and E10 Interphase FISH. Available at: http://www.acmg.net/Pages/ACMG_Activities/stds-2002/e.htm#E10.3. Accessed on Dec 17, 2007.

3. College of American Pathologists Laboratory Accreditation Checklists. Available at: http://www.cap.org/apps/docs/laboratory_accreditation/standards/lapmanual_0707.pdf. Accessed on Dec. 17, 2007.

4. Clinical Laboratory Improvement Amendments. CLIA:42 CFR part 493-1253. Available at: http://www.phppo.cdc.gov/clia/regs/toc.aspx, http://wwwn.cdc.gov/clia/regs/toc.aspx CLIA:42 Laboratory requirements part 493.1253. Accessed on Dec. 17, 2007.

5. Food and Drug Administration. Guidelines on General Principle of Process Validation. Available at: http://www.fda.gov/cder/guidance/pv.htm. Accessed on Dec. 17, 2007.

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