Interference control panel for evaluation of analytical assays for samples derived from blood

Abstract

The invention relates to quality control of analytical assays, particularly NAT assays of blood samples containing nucleic acids. A control panel containing quantified amounts of substances known to interfere with an analytical assay is used and compared with a reference sample in the analytical assay. A comparison of the assay results interference panel validates the assay and can serve as a periodic quality control check for the analytical assay as well as related methods and protocols. The use of the control panel of the invention can also determine whether interfering substances are present and establish under what conditions the analytical assay reliable.

I claim: 
     
         1 . A method for determining the presence of substances in an analytical assay comprising:
 adding a known amount of an analyte to two or more members of an inhibition panel, wherein each member of the inhibition panel contains a potentially inhibition of the analytical assay,   performing the assay to measure the analyte,   comparing a measurement of reference plasma sample with the measurement of at least one member of an inhibition panel, wherein the comparison indicates the presence an actual inhibition of the analytical assay.   
     
     
         2 . The method of  claim 1 , wherein the comparison detects more than one substance that inhibits the assay in the test sample. 
     
     
         3 . The method of  claim 1 , wherein the analytical assay amplifies nucleic acids. 
     
     
         4 . The method of  claim 3 , wherein the analytical assay is PCR. 
     
     
         5 . The method of  claim 1 , wherein the analyte is a nucleic acid. 
     
     
         6 . The method of  claim 1 , wherein the analyte is an antibody. 
     
     
         7 . The method of  claim 1 , wherein the analyte is an antigen. 
     
     
         8 . The method of  claim 1 , wherein the test sample is extracted from serum. 
     
     
         9 . The method of  claim 1 , wherein the test sample is extracted from plasma. 
     
     
         10 . The method of  claim 1 , wherein the test sample is extracted from plasma. 
     
     
         11 . The method of  claim 1 , wherein the inhibitory substance is selected from the group consisting of hemoglobin, lipids, bilirubin, and heparin. 
     
     
         12 . A kit for evaluating the performance of an analytical assay comprising:
 a panel comparing vials of a plurality of inhibitory substances wherein each substance is quantified to a known concentration and volume, and   analyte at a known concentration to be added to each panel member.   
     
     
         13 . The kit of  claim 12 , wherein the kit further comprises a reference sample free of inhibitory substance. 
     
     
         14 . The kit of  claim 12 , wherein an inhibitory substance is heparinzed. 
     
     
         15 . The kit of  claim 12 , wherein an inhibitory substance is lipemic plasma. 
     
     
         16 . The kit of  claim 12 , wherein an inhibitory substance is icteric plasma. 
     
     
         17 . The kit of  claim 12 , wherein an inhibitory substance is haemolytic blood. 
     
     
         18 . The kit of  claim 12 , wherein the analyte is an antibody. 
     
     
         19 . The kit of  claim 12 , wherein the analyte is an antigen. 
     
     
         20 . The kit of  claim 12 , wherein the analyte is selected from the group consisting of HIV, HBV, HCV, HSV-1, HSV-2, EBV or CMV.