November 2010
Feature Story

Essential references

LAP Molecular Pathology Checklist. College of American Pathologists. June 17, 2010, Revision.

Molecular diagnostic methods for genetic diseases; approved guideline�2nd edition. CLSI document MM1-A2. Wayne, Pa.: CLSI. 2006.

Molecular diagnostic methods for infectious diseases; approved guideline�2nd edition. CLSI document MM3-A2. Wayne, Pa.: CLSI. 2006.

Nucleic acid amplification assays for molecular hematopathology; approved guideline. CLSI document MM5-A. Wayne, Pa.: CLSI. 2003.

Quantitative molecular methods for infectious diseases; approved guideline. CLSI document MM6-A. Wayne, Pa.: CLSI. 2003.

Fluorescence in situ hybridization (FISH) methods for medical genetics; approved guideline. CLSI document MM7-A. Wayne, Pa.: CLSI. 2004.

Collection, transport, preparation, and storage of specimens for molecular methods; approved guideline. CLSI document MM13-A. Wayne, Pa.: CLSI. 2005.

Proficiency testing (external quality assessment) for molecular methods; approved guideline. CLSI document MM14-A. Wayne, Pa.: CLSI. 2005.

Useful references

Seaton BL. Verification of molecular assays. In: Coleman WB, Tsongalis GJ, eds. Molecular Diagnostics for the Clinical Laboratorian. 2nd ed. Totowa, NJ: Humana Press; 2006.

Ferreira-Gonzalez A, Garrett CT. Laboratory developed tests in molecular diagnostics. In: Coleman WB, Tsongalis GJ, eds. Molecular Diagnostics for the Clinical Laboratorian. 2nd ed. Totowa, NJ: Humana Press; 2006.

Recommendations for in-house development and operation of molecular diagnostic tests (AMP statement). Am J Clin Pathol. 1999;111:449-463.

Gulley ML, Braziel RM, Halling KC, et al. Clinical laboratory reports in molecular pathology. Arch Pathol Lab Med. 2007;131:852-863.

Jennings L. Recommended principles and practices for validating clinical molecular tests. Arch Pathol Lab Med. 2009;133:743-755.

—List supplied by Dan Hyder, MD

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