Fixative system, method and composition for biological testing

Abstract

A system, composition and method for the stabilization of biological specimens, which employs a chemical fixative.

What is claimed is:  
     
         1 . A method for preserving a biological test specimen, comprising the steps of: 
 a) contacting a biological test specimen with an effective amount of a fixative composition, said fixative composition including a generally non-coagulating chemical fixative dispersed in a solvent that is substantially free of water;    b) evaporating said solvent to yield a generally optically transparent fixative for preserving said biological test specimen.    
     
     
         2 . A method according to  claim 1  wherein said generally non-coagulating chemical fixative includes an effective amount of diazolidinyl urea.  
     
     
         3 . A method according to  claim 2  wherein said diazolidinyl urea is present in an amount up to about 5% of said composition.  
     
     
         4 . A method according to  claim 3  wherein said diazolidinyl urea is present in an amount of about 3% of said composition.  
     
     
         5 . A method according to  claim 1  wherein said composition further comprises a polyol.  
     
     
         6 . A method according to  claim 5  wherein said composition further comprises a glycol.  
     
     
         7 . A method according to  claim 6  wherein said composition further comprises polyethylene glycol.  
     
     
         8 . A method according to  claim 1  wherein said composition includes diazolidinyl urea in an amount up to about 5%, a glycol in an amount up to about 5%, and an alcohol.  
     
     
         9 . A method according to  claim 1  further comprising providing said gynecological test specimen from a pap smear test.  
     
     
         10 . A method according to  claim 1  further comprising conducting a pathological examination of said gynecological test specimen after it has been fixed with said composition.  
     
     
         11 . A method according to  claim 1  wherein said composition upon drying on a carrier is substantially free of crystallines to the naked eye.  
     
     
         12 . A method for preserving a gynecological test specimen, comprising the steps of: 
 a) contacting a gynecological test specimen with a composition including: 
 1) diazolidinyl urea; and  
 2) an alcohol solvent,  
   b) drying said solvent to yield a generally optically transparent fixative for preserving said gynecological test specimen.    
     
     
         13 . A method according to  claim 12  wherein said diazolidinyl urea is present in an amount up to about 5% of said composition.  
     
     
         14 . A method according to  claim 13  wherein said diazolidinyl urea is present in an amount of about 3% of said composition.  
     
     
         15 . A method according to  claim 12  wherein said composition further comprises a polyol.  
     
     
         16 . A method according to  claim 15  wherein said composition further comprises a glycol.  
     
     
         17 . A method according to  claim 16  wherein said composition further comprises polyethylene glycol.  
     
     
         18 . A method according to  claim 12  wherein said composition includes diazolidinyl urea in an amount up to about 5%, a glycol in an amount up to about 5%, and an alcohol solvent.  
     
     
         19 . A method according to  claim 12  further comprising providing said gynecological test specimen from a pap smear test.  
     
     
         20 . A method according to  claim 12  further comprising conducting at least one pathological examination of said gynecological test specimen after it has been fixed with said composition.  
     
     
         21 . A method according to  claim 12  wherein said composition upon drying on a substrate is substantially free of crystallines to the naked eye.  
     
     
         22 . A system for preserving a gynecological specimen for cytology testing, said system comprising: 
 a) a composition for preserving a gynecological test specimen, said composition comprising a chemical fixative dispersed in a liquid medium;    b) a substrate for said gynecological test specimen, onto which said composition is placed in contact with said gynecological test specimen;    c) an instrument for pathologically examining said gynecological test specimen.    
     
     
         23 . A system according to  claim 22  further comprising a kit including at least one item selected from stain, dye, immunostain, slide, coated glass slide, activated glass slide, scalpel, spatula, brush, swabbing, pipette, reference control, storage rack, storage container, data forms, labelers or coverslips.  
     
     
         24 . A system according to  claim 22  wherein said instrument is semi-automated.  
     
     
         25 . A system according to  claim 22  wherein said system is automated.  
     
     
         26 . A system according to  claim 22  further comprising an automated slide preparation instrument.  
     
     
         27 . A method according to  claim 1  or  12 , further comprising screening for HIV using said test specimen.  
     
     
         28 . A method according to  claim 1  or  12 , further comprising screening for HPV using said test specimen.  
     
     
         29 . A method according to  claim 1  or  12 , further comprising screening for hepatitis using said test specimen.  
     
     
         30 . A method according to  claim 1  or  12 , further comprising screening for cancer and for at least one disorder selected from HIV, HPV or hepatitis.  
     
     
         31 . A method for fixing biological specimens for cytological, immunocytochemical or molecular evaluation, comprising exposing said biological specimens to a fixative composition comprising a non-crosslinking agent.  
     
     
         32 . The method of  claim 31 , wherein said specimen is affixed to a slide either before or after exposure to said fixative composition.  
     
     
         33 . The method of  claim 31 , wherein said specimen is a gynecological specimen.  
     
     
         34 . A method for treating a biological specimen with reagents, said method comprising: 
 a) mounting said biological specimen onto a microscope slide,    b) fixing said specimen with a fixative composition comprising a non-crosslinking agent in a non-aqueous solvent to form an optically transparent medium including visible features of said biological specimen, and    c) screening said specimen for the presence of a disease.    
     
     
         35 . The method of  claim 34 , wherein said screening includes immunocytochemical staining.  
     
     
         36 . The method of  claim 34 , wherein screening includes in situ hybridization.  
     
     
         37 . The method of  claim 34 , wherein screening includes in situ amplification.  
     
     
         38 . The method of  claim 34 , wherein screening includes fluorescent in situ hybridization.  
     
     
         39 . The method of  claim 34 , wherein said fixing of said biological specimen takes place before mounting onto said slide.  
     
     
         40 . A biological fixative composition, consisting essentially of: 
 (a) a heterocyclic;    (b) polyol; and    (c) alcohol.    
     
     
         41 . The composition of  claim 40 , wherein said urea is diazolidinyl.  
     
     
         42 . The composition of  claim 40  wherein said polyol is a glycol.  
     
     
         43 . The composition of  claim 42  wherein said glycol is polyethylene glycol.  
     
     
         44 . The composition of  claim 40  wherein said alcohol is isopropyl alcohol.  
     
     
         45 . A biological fixative composition, comprising: 
 (a) diazolidinyl urea;    (b) glycol; and    (c) alcohol.    
     
     
         46 . The composition of  claim 45  wherein said glycol is polyethylene glycol.  
     
     
         47 . The composition of  claim 45  wherein said alcohol is isopropyl alcohol.