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 - 19 . (canceled) 
     
     
         20 . A quality control sample for formalin fixation and paraffin embedding (FFPE), comprising a defined amount of cellular material comprising a known amount of test cells admixed with a known amount of background cells admixed with a gelling polymer, wherein the cellular material is formalin-fixed, and further wherein the test cells include at least one pre-determined detectable genetic mutation and the background cells do not include said at least one pre-determined detectable genetic mutation. 
     
     
         21 . The quality control sample of  claim 20 , wherein the test cells are cancer cells. 
     
     
         22 . The quality control sample of  claim 20 , wherein the cellular material is subjected to formalin fixation before or after admixing with the gelling polymer. 
     
     
         23 . The quality control sample of  claim 20 , wherein the cellular material is embedded in paraffin. 
     
     
         24 . The quality control sample of  claim 20 , wherein the amount of test cells to background cells is between about 0.0001 and 100%. 
     
     
         25 . The quality control sample of  claim 23 , wherein the amount of test cells to background cells is between about 1 and 100%. 
     
     
         26 . The quality control sample of  claim 20 , wherein the amount of test cells is less than the amount of background cells. 
     
     
         27 . A kit for preparing samples for formalin fixation and paraffin embedding (FFPE), comprising:
 a quality control sample for FFPE, the sample comprising a defined amount of cellular material comprising a known amount of first test cells admixed with a known amount of background cells, wherein the cellular material is formalin-fixed, and further wherein the first test cells comprise a first pre-determined detectable genetic mutation and the background cells do not comprise the first pre-determined detectable genetic mutation.   
     
     
         28 . The kit of  claim 27 , further comprising a known amount of second test cells admixed with the first test cells and the background cells, wherein the second test cells comprise a second pre-determined detectable genetic mutation and the background cells do not comprise the second pre-determined detectable genetic mutation. 
     
     
         29 . The kit of  claim 27 , wherein the first test cells and/or the second test cells are cancer cells. 
     
     
         30 . The kit of  claim 27 , wherein the amount of first and second test cells to background cells is between about 0.0001 and 100%. 
     
     
         31 . The kit of  claim 27 , wherein the amount of first and second test cells to background cells is between about 1 and 100%. 
     
     
         32 . The kit of  claim 27 , wherein the amount of test cells is less than the amount of background cells. 
     
     
         33 . The kit of  claim 27 , wherein the cellular material is embedded in paraffin.