Assay systems, kits and methods for detecting microorganisms

Abstract

The present invention relates to an assay system, kits and methods for detecting microorgansims (especially for M. tuberculosis ) of suspected patient. The present invention also relates to an apparatus for performing the integration of thermal and magnetic control in the same apparatus to largely reduce the whole process of M. tuberculosis detection is less than 5 hours.

1 - 7 . (canceled)  
     
     
         8 . An apparatus for performing the dissociation of nucleic acid double strands, hybridization, washing, the separation of magnetic beads and thermal control in the same apparatus, comprising: 
 (a) the means for fitting reaction containers;    (b) the means for controlling the temperature of the containers; and    (c) the means for controlling the magnetic force of the containers,    wherein the means for controlling the temperature of the containers are connected to the means for fitting reaction containers, and the means for controlling the magnetic force of the containers are connected to the means for fitting reaction containers.    
     
     
         9 . The apparatus of  claim 8 , wherein the means for controlling the temperature of the containers to heat the containers to perform the dissociation of nucleic acid double strands according to temperature change.  
     
     
         10 . The apparatus of  claim 8 , wherein the means for controlling the magnetic force of the containers to perform the magnetic change of magnetic bead to facilitate hybridization, washing and the separation of magnetic beads in the containers.  11 - 14 . (canceled)  
     
     
         15 . An assay system for detecting microorganisms, the system comprising: 
 (i) diagnostic kit for detecting microorganism cDNA comprising: 
 (a) a probe linked to magnetic bead;  
 (b) bioactive primers;  
 (c) avidin enzyme complex or streptavidin enzyme complex; and  
 (d) enzyme substrate  
   (ii) an apparatus for performing the dissociation of nucleic acid double strands, hybridization, washing, the separation of magnetic beads and thermal control in the same apparatus, comprising: 
 (a) the means for fitting reaction containers;  
 (b) the means for controlling the temperature of the containers; and  
 (c) the means for controlling the magnetic force of the containers,  
 wherein the means for controlling the temperature of the containers are connected to the means for fitting reaction containers, and the means for controlling the magnetic force of the containers are connected to the means for fitting reaction containers;  
   (iii) a magnetic rack to bind the magnetic bead on the wall of the containers; and 
 (iv) a detector.  
   
     
     
         16 . The assay system of  claim 15 , wherein the bioactive primers are made by reacting DNA labeling reagent with the primers.  
     
     
         17 . The assay system of  claim 15 , wherein the streptavidin enzyme complex in the kit is streptavidin horseradish peroxidase (SA-HRP).  
     
     
         18 . The assay system of  claim 15 , which can differentiate  M. tuberculosis  from  M. marinum, M. avium  and  M. intracellulare  19.  
     
     
         19 . The assay system of  claim 15 , wherein the detector is luminometer or spectrophotometer.  
     
     
         20 . The assay system of  claim 15  The kit of  claim 15 , wherein the DNA labeling reagent in the kit is 9-(4′-(Aminomethyl)-4′, 5″-Dimethyl-angelicin) acridinium carboxamide.