Generic matrix for control nucleic acids

Abstract

The present invention belongs to the field of in-vitro diagnostics. Within this field, it particularly concerns the amplification of at least a first target nucleic acid that may be present in at least one fluid sample using an internal control nucleic acid for qualitative and/or quantitative purposes and at least one external control nucleic acid in an aqueous buffer. It further provides an analytical system comprising an internal control nucleic acid for qualitative and/or quantitative purposes and at least one external control nucleic acid in an aqueous buffer.

1 . A process for controlled amplification of a target nucleic acid, comprising:
 (a) providing in a reaction vessel an internal control nucleic acid and a fluid sample, wherein the fluid sample may comprise a target nucleic acid,   (b) providing a solid support material to the reaction vessel for a period of time and under conditions sufficient to permit nucleic acids comprising the target nucleic acid and the internal control nucleic acid to be immobilized on the solid support material,   (c) isolating the solid support material from other material present in the reaction vessel in a separation station,   (d) purifying the nucleic acids in the separation station and washing the solid support material one or more times with a wash buffer,   (e) providing in a first reaction vessel the purified nucleic acids and in a second reaction vessel an external control nucleic acid in an aqueous buffer, wherein the aqueous buffer lacks a fluid sample,   (f) adding identical amplification reagents to each of the first and second reaction vessels,   (g) incubating the first and second reaction vessels under identical conditions sufficient for amplification reactions to occur, and   (h) detecting results of the amplification reactions,   wherein the results of the amplification reactions are indicative of the presence or absence of amplification of the target nucleic acid, the internal control nucleic acid and the external control nucleic acid.   
     
     
         2 . The process of  claim 1 , wherein the aqueous buffer has a pH between 6.0 and 12.0 and comprises:
 1-100 mM Tris, 0.01-1 mM EDTA, 0.005-0.5% (w/v) Sodium Azide, and 1-200 mg/l Poly(rA) RNA.   
     
     
         3 . The process of  claim 2 , wherein the aqueous buffer has a pH of about 8 and comprises:
 10 mM Tris, 0.1 mM EDTA, 0.05% (w/v) Sodium Azide, and 20 mg/l Poly(rA) RNA.   
     
     
         4 . The process of  claim 1 , wherein a negative control is provided in a third reaction vessel and is subjected to steps b) through h). 
     
     
         5 . The process of  claim 1 , wherein the fluid sample is a clinical sample. 
     
     
         6 . The process of  claim 1 , further comprising:
 determining the quantity of the target nucleic acid.   
     
     
         7 . An analytical system ( 440 ) for controlled amplification of a target nucleic acid, the system comprising:
 an amplification station comprising reaction vessels, the reaction vessels comprising amplification reagents, purified target nucleic acid and a purified internal control nucleic acid, and at least one external control nucleic acid in an aqueous buffer, wherein the aqueous buffer lacks a fluid sample, and   wherein the at least one external control nucleic acid in an aqueous buffer is comprised in a different vessel than the purified target nucleic acid.   
     
     
         8 . The analytical system of  claim 7 , further comprising:
 a separation station comprising a solid support material, the separation station being constructed and arranged to separate and purify nucleic acids and comprised in at least one fluid sample.   
     
     
         9 . The analytical system of  claim 7 , wherein the reaction vessels are arranged in an integral arrangement. 
     
     
         10 . The analytical system of  claim 9 , wherein the integral arrangement is a multiwell plate and the at least one external control nucleic acid in an aqueous buffer is comprised in a different well than the purified target nucleic acid. 
     
     
         11 . The analytical system of  claim 7 , wherein the amplification station further comprises a negative control in a different vessel than the purified target nucleic acid and the external control nucleic acid in an aqueous buffer. 
     
     
         12 . The analytical system of  claim 11 , wherein the negative control is the aqueous buffer. 
     
     
         13 . The analytical system of  claim 7 , further comprising one or more elements selected from the group consisting of:
 a detection module for detecting signals evoked by an analyte,   a sealer,   a storage module for reagents and/or disposables, and   a control unit for controlling system components.   
     
     
         14 . The analytical system of  claim 7 , further comprising one or more elements selected from the group consisting of:
 a module for isolating and/or purifying an analyte, and   a module for analyzing an analyte to obtain a detectable signal.   
     
     
         15 . The analytical system of  claim 7 , further comprising both a module for isolating and/or purifying an analyte, and a module for analyzing the analyte to obtain a detectable signal. 
     
     
         16 . The analytical system of  claim 15 , wherein the two modules are autonomously controlled. 
     
     
         17 . The analytical system of  claim 15 , wherein control of the modules are shared with other modules. 
     
     
         18 . The analytical system of  claim 17 , wherein the modules are controlled centrally. 
     
     
         19 . The analytical system of  claim 7 , wherein the aqueous buffer is a synthetic buffer. 
     
     
         20 . The analytical system of  claim 7 , wherein the aqueous buffer is free of biological buffers derived from blood plasma. 
     
     
         21 . The analytical system of  claim 8 , wherein the fluid sample comprises blood. 
     
     
         22 . The analytical system of  claim 8 , wherein the fluid sample comprises blood plasma.