Absorbent paper and use thereof for breast cancer detection

Abstract

Biological samples of mammary fluid or components thereof are obtained using a breast pump device coupled with an absorbent paper or membrane, optionally facilitated by administering oxytocin to the subject. The breast pump device stimulates expression of mammary fluid and provides for collection of diagnostic samples on the absorbent paper or membrane to evaluate breast disease, including cancer. The biological sample may include fluid containing one or more of cells or cellular components, proteins, glycoproteins, peptides, nucleotides or other desired constituents comprising a breast disease marker. Absorbent paper or membrane, and methods relating to the paper or membrane, and a breast pump device are also provided.

1 .- 60 . (canceled) 
     
     
         61 . A system for analyzing a nipple aspirate fluid sample from an individual in need thereof, the system comprising:
 a nipple covering comprising an absorbent paper for absorbing the nipple aspirate fluid sample, the absorbent paper comprising microcellulose, mixed cellulose ester paper, or nitrocellulose, and having a diameter from about 1.0 to about 3.0 inches and a thickness from about 0.01 to about 0.1 inches, wherein the absorbent paper is sized to cover a nipple; and   a microscope for visualizing total protein of the nipple aspirate fluid sample, counting the number cells of the nipple aspirate fluid sample, or a combination thereof.   
     
     
         62 . The system of  claim 61 , further comprising a colloidal metal stain for determining the total protein of the nipple aspirate fluid sample. 
     
     
         63 . The system of  claim 62 , wherein the colloidal metal is colloidal gold or colloidal silver. 
     
     
         64 . The system of  claim 61 , further comprising: an optionally networked computer processing device configured to perform executable instructions; and a computer program, the computer program comprising a software module executed by the computer processing device to apply a model or algorithm for analyzing the total protein content of the nipple aspirate fluid sample, the number of cells of the nipple aspirate fluid sample, or a combination thereof. 
     
     
         65 . The system of  claim 64 , wherein the computer program further comprises a software module executed by the computer processing device to designate a treatment regimen for the individual. 
     
     
         66 . The system of  claim 64 , wherein the computer program further comprises a software module executed by the computer processing device to store photomicrograms in a database of photomicrograms. 
     
     
         67 . The system of  claim 64 , wherein the computer program further comprises a software module executed by the computer processing device to store analysis in a database of analyses. 
     
     
         68 . The system of  claim 64 , wherein the computer program further comprises a software module executed by the computer processing device to compare the total protein content or number of cells of the nipple aspirate fluid sample to a standard. 
     
     
         69 . The system of  claim 64 , wherein the computer program further comprises a software module executed by the computer processing device to transmit an analysis to a health care provider or the individual. 
     
     
         70 . The system of  claim 64 , wherein the computer program further comprises a software module executed by the computer processing device to transmit a diagnosis to a health care provider or the individual. 
     
     
         71 . The system of  claim 64 , wherein the computer program further comprises a software module executed by the computer processing device to generate a report comprising the analysis. 
     
     
         72 . The system of  claim 61 , wherein the absorbent paper is a device as shown in  FIG. 1 . 
     
     
         73 . The system of  claim 61 , further comprising an alcohol for cleaning a nipple and a periaureolar area of a breast. 
     
     
         74 . The system of  claim 61 , wherein the individual is identified as being at low risk for developing breast cancer where the nipple aspirate fluid sample contains protein and is acellular. 
     
     
         75 . The system of  claim 61 , wherein the individual is identified as being at low risk for breast cancer where the nipple aspirate fluid sample contains from about 1 pg to about 500 ng of protein and is acellular. 
     
     
         76 . The system of  claim 61 , wherein the individual is identified for further evaluation of breast cancer or diagnosed as at medium or high risk for breast cancer if the nipple aspirate fluid sample contains at least about 300 ng of protein and two or more cells. 
     
     
         77 . The system of  claim 61 , wherein the individual is identified for further evaluation of breast cancer or diagnosed as at medium or high risk for breast cancer if the nipple aspirate fluid sample contains between about 300 ng of protein to about 2 μg of protein and two or more cells. 
     
     
         78 . The system of  claim 61 , wherein the individual is identified for further evaluation of breast cancer or diagnosed as at medium or high risk for breast cancer if the nipple aspirate fluid sample contains between about 300 ng of protein to about 2 μg of protein, and between two and fifty cells. 
     
     
         79 . A system for analyzing a nipple aspirate fluid nipple aspirate fluid sample from an individual in need thereof, the system comprising:
 a nipple covering comprising an absorbent paper for absorbing the nipple aspirate fluid sample, the absorbent paper comprising microcellulose, mixed cellulose ester paper, or nitrocellulose, and having a diameter from about 1.0 to about 3.0 inches and a thickness from about 0.01 to about 0.1 inches, wherein the absorbent paper is sized to cover a nipple; and   a breast pump device.   
     
     
         80 . The system of  claim 79 , wherein the breast pump device is a MASCT™ device. 
     
     
         81 . The system of  claim 79 , wherein the absorbent paper is a device as shown in  FIG. 1 . 
     
     
         82 . The system of  claim 79 , further comprising: an optionally networked computer processing device configured to perform executable instructions; and a computer program, the computer program comprising a software module executed by the computer processing device to apply a model or algorithm for analyzing the total protein content of the nipple aspirate fluid sample, the number of cells of the nipple aspirate fluid sample, or a combination thereof. 
     
     
         83 . The system of  claim 82 , wherein the computer program further comprises a software module executed by the computer processing device to designate a treatment regimen for the individual. 
     
     
         84 . The system of  claim 82 , wherein the computer program further comprises a software module executed by the computer processing device to store photomicrograms in a database of photomicrograms. 
     
     
         85 . The system of  claim 82 , wherein the computer program further comprises a software module executed by the computer processing device to store analysis in a database of analyses. 
     
     
         86 . The system of  claim 82 , wherein the computer program further comprises a software module executed by the computer processing device to compare the total protein content or number of cells of the nipple aspirate fluid sample to a standard. 
     
     
         87 . The system of  claim 82 , wherein the computer program further comprises a software module executed by the computer processing device to transmit an analysis to a health care provider or the individual. 
     
     
         88 . The system of  claim 82 , wherein the computer program further comprises a software module executed by the computer processing device to transmit a diagnosis to a health care provider or the individual. 
     
     
         89 . The system of  claim 82 , wherein the computer program further comprises a software module executed by the computer processing device to generate a report comprising the analysis. 
     
     
         90 . The system of  claim 79 , wherein the absorbent paper comprises an L-shaped element  4  as illustrated in  FIG. 1 . 
     
     
         91 . The system of  claim 79 , further comprising an alcohol for cleaning a nipple and a periaureolar area of a breast. 
     
     
         92 . The system of  claim 79 , wherein the individual is identified as being at low risk for developing breast cancer where the nipple aspirate fluid sample contains protein and is acellular. 
     
     
         93 . The system of  claim 79 , wherein the individual is identified as being at low risk for breast cancer where the nipple aspirate fluid sample contains from about 1 pg to about 500 ng of protein and is acellular. 
     
     
         94 . The system of  claim 79 , wherein the individual is identified for further evaluation of breast cancer or diagnosed as at medium or high risk for breast cancer if the nipple aspirate fluid sample contains at least about 300 ng of protein and two or more cells. 
     
     
         95 . The system of  claim 79 , wherein the individual is identified for further evaluation of breast cancer or diagnosed as at medium or high risk for breast cancer if the nipple aspirate fluid sample contains between about 300 ng of protein to about 2 μg of protein and two or more cells. 
     
     
         96 . The system of  claim 79 , wherein the individual is identified for further evaluation of breast cancer or diagnosed as at medium or high risk for breast cancer if the nipple aspirate fluid sample contains between about 300 ng of protein to about 2 μg of protein, and between two and fifty cells. 
     
     
         97 . A system for analyzing a nipple aspirate fluid sample from an individual in need thereof, the system comprising:
 a. a nipple covering comprising an absorbent paper for absorbing the nipple aspirate fluid sample, the absorbent paper comprising microcellulose, mixed cellulose ester paper, or nitrocellulose, and having a diameter from about 1.0 to about 3.0 inches and a thickness from about 0.01 to about 0.1 inches, wherein the absorbent paper is sized to cover a nipple;
 an alcohol for cleaning a nipple and a periaureolar area of a breast; 
 a colloidal metal stain for determining the total protein of the nipple aspirate fluid sample; and 
 a microscope for visualizing total protein of the nipple aspirate fluid sample, counting the number cells of the nipple aspirate fluid sample, or a combination thereof; 
 wherein
 the individual is identified as being at low risk for developing breast cancer where the nipple aspirate fluid sample contains protein and is acellular; 
 the individual is identified as being at low risk for breast cancer where the nipple aspirate fluid sample contains from about 1 pg to about 500 ng of protein and is acellular; 
 the individual is identified for further evaluation of breast cancer or diagnosed as at medium or high risk for breast cancer if the nipple aspirate fluid sample contains at least about 300 ng of protein and two or more cells; 
 the individual is identified for further evaluation of breast cancer or diagnosed as at medium or high risk for breast cancer if the nipple aspirate fluid sample contains between about 300 ng of protein to about 2 μg of protein and two or more cells; or 
 the individual is identified for further evaluation of breast cancer or diagnosed as at medium or high risk for breast cancer if the nipple aspirate fluid sample contains between about 300 ng of protein to about 2 μg of protein, and between two and fifty cells.