Portable disposable re-usable culture device for rapid diagnosis of infectious agents

Abstract

The present invention is directed to compositions, tools, methods and devices to culture microorganisms and, in particular, to compositions, tools, methods and devices for the detection of microorganisms in biological samples.

1 . A method of detecting a microorganism or group of microorganisms comprising:
 obtaining a biological sample with or without a collection tool;   placing the biological sample into an incubator containing culture medium for the proliferation and or stabilization of the microorganism;   sealing the incubator closed;   placing the closed incubator within or attached to an environmental chamber;   allowing the microorganism or group of microorganisms to proliferate and or stabilize in the incubator for a period of time; and   assessing proliferation and or stabilization of the microorganism or group of microorganisms to determine the presence or absence of the microorganism or group of microorganisms in the biological sample.   
     
     
         2 . The method of  claim 1 , wherein the biological sample is self-obtained. 
     
     
         3 . The method of  claim 1 , wherein the environmental chamber contains one or more environmental control elements. 
     
     
         4 . The method of  claim 3 , wherein the one or more environmental control elements comprise a heating element, a cooling element, a pH control element, a humidity control element, an oxygen control element, a carbon dioxide control element, a vibrator, or a light control element. 
     
     
         5 . The method of  claim 3 , wherein the environmental chamber contains a USB port that connects the one or more environmental control elements to an external processer containing software that controls the operation of the one or more environmental control elements and/or the environmental chamber contains a microprocessor that contains software to control the one or more environmental control elements. 
     
     
         6 . The method of  claim 1 , further determining a quantitative or relative concentration of the microorganism or group of microorganisms. 
     
     
         7 . The method of  claim 1 , wherein the period of time is from 1 hour to 7 days. 
     
     
         8 . The method of  claim 1 , wherein assessing comprising removing a sample from inside the incubator and determining the presence or absence of the microorganism. 
     
     
         9 . The method of  claim 1 , wherein assessing comprising performing a visual or chemical assessment, immunoassay, lateral flow assay, enzyme linked immunoassay, an immunochemistry assay, a polymerase chain reaction, a latex agglutination, other microbiologic assay or a combination thereof. 
     
     
         10 . The method of  claim 1 , wherein assessing comprising insertion of a device to perform an analysis. 
     
     
         11 . The method of  claim 10 , wherein the analysis comprises a visual analysis, a chemical analysis, an immunoassay, a lateral flow assay, an enzyme linked immunoassay, an immunochemistry assay, a polymerase chain reaction, a latex agglutination, other microbiologic assay or a combination thereof. 
     
     
         12 . The method of  claim 11 , wherein the analysis is a visual analysis and the method further comprises determining at least one of turbidity and color change with an optical reader. 
     
     
         13 . The method of  claim 1 , further comprising transmitting the assessment electronically to a physician, health care worker, a professional, an expert, a patient or another individual, or to a patient's medical or health care record. 
     
     
         14 . The method of  claim 13 , wherein the transmitting is accomplished by a WiFi.