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 - 39 . (canceled) 
     
     
         40 . A kit for evaluating the performance of an analytical assay comprising:
 an interference panel comprising members, wherein each member comprises a known amount of a substance that may interfere with the analytical assay, wherein at least one member comprises a plurality of discrete concentrations of haemolyzed blood;   instructions for adding a known quantity of an analyte to the interference panel; and   instructions for performing the analytical assay on the members of the interference panel to obtain a measurement of the analyte in the members of the panel.   
     
     
         41 . The kit of  claim 40 , further comprising instructions for comparing the measurement of the analyte in the members of the panel with the known quantity of the analyte that was added to assess inhibition of the assay by the members of the interference panel. 
     
     
         42 . The kit of  claim 41 , wherein the level of interference is quantified by comparison of a measurement of a reference plasma sample with the measurement of members of the inhibition panel. 
     
     
         43 . The kit of  claim 40 , wherein the analyte is a blood derived analyte. 
     
     
         44 . The kit of  claim 40  wherein the analyte is a blood borne analyte. 
     
     
         45 . The kit of  claim 44 , wherein the blood borne analyte is a blood borne virus. 
     
     
         46 . The kit of  claim 45 , wherein the blood borne virus is HIV, HBV, HCV, HSV1, HSV-2, EBV or CMV. 
     
     
         47 . The kit of  claim 40 , wherein at least one of the members of the inhibition panel is comprised of a blood derivative. 
     
     
         48 . The kit of  claim 47 , wherein at least one of the members of the inhibition panel is comprised of a whole blood derivative. 
     
     
         49 . The kit of  claim 40 , wherein the substance that may interfere with the analytical assay is selected from the group consisting of hemoglobin, lipids, bilirubin, and heparin 
     
     
         50 . the kit of  claim 40 , further comprising reagents for amplifying nucleic acids.