Method of Preparing Quality Control Material for FFPE

Abstract

This specification relates to Formalin-fixed embedded quality control material for use for validation, verification, and to run controls for molecular assays. The quality control material can be used for a variety of tissues and for a variety of molecular assays. The quality control material can be used in commercial labs for validation and limit-of-detection analyses.

1 . A method for preparing a sample for FFPE, comprising:
 obtaining a defined concentration of cellular material;   mixing the cellular material with a gelling polymer, creating a gel/cellular material;   adding the gel/cellular material to a mold with a defined shape until the gelling polymer solidifies; and   slicing the solidified material to a uniform and defined size.   
     
     
         2 . The method of  claim 1 , further comprising formalin fixing the cellular material before or after creating a gel/cellular material. 
     
     
         3 . The method of  claim 1 , further comprising embedding the material in paraffin. 
     
     
         4 . The method of  claim 1 , wherein the cellular material includes test cells and background cells. 
     
     
         5 . The method of  claim 1 , wherein the cellular material comprises a known number of test cells and a known number of background cells in a homogeneous mixture. 
     
     
         6 . The method of  claim 4 , wherein the test cells comprise at least one marker that is being tested for and the background cells do not have the marker. 
     
     
         7 . The method of  claim 4 , wherein the percentage of test cells to background cells is between 0.0001 and 100%. 
     
     
         8 . The method of  claim 7 , wherein the percentage of test cells to background cells is between 1 and 100%. 
     
     
         9 . A quality control sample for FFPE, comprising a defined concentration of test cells admixed with a defined concentration of background cells admixed with a gelling polymer, and formalin-fixed. 
     
     
         10 . The quality control sample of  claim 9 , wherein the test cells are positive for a test marker and the background cells are negative for the test marker. 
     
     
         11 . The quality control sample of  claim 9 , wherein the test cells are cancer cells. 
     
     
         12 . The quality control sample of  claim 9 , wherein the concentration of test cells to background cells is between about 0.0001 to 100%. 
     
     
         13 . The quality control sample of  claim 12 , wherein the concentration of test cells to background cells is between about 1 and 100%. 
     
     
         14 . A kit for preparing samples for FFPE, comprising:
 at one quality control sample for FFPE made by the method of  claim 1 , the sample comprising a first defined concentration of test cells admixed with background cells, wherein the test cells comprise at least a first marker and the background cells do not comprise the first marker.   
     
     
         15 . The kit of  claim 14 , wherein the test cells are cancer cells. 
     
     
         16 . The kit of  claim 14 , further comprising a second sample containing a second test cell comprising a second marker. 
     
     
         17 . The kit of  claim 14 , further comprising at least one other sample containing a second marker. 
     
     
         18 . The kit of  claim 14 , further comprising a second sample containing a second defined concentration of the test cell admixed with the background cell. 
     
     
         19 . The kit of  claim 14 , wherein the defined concentration of test cells to background cells is 0.0001 to 100%.