Kit and method for collecting body fluid for medical diagnosis

Abstract

A kit and method for collecting body fluid for medical diagnosis. In some embodiments, the method includes collecting a sufficient amount of body fluid and cells comprising nucleic acid, and applying a nucleic acid assay to detect pathogenic genomic material such as human papillomavirus mRNA and/or human papillomavirus DNA. In some embodiments, by testing fluid and cells, a sensitivity of the test is improved. In some embodiments, the method includes inserting an absorbing member into a body orifice, such as the vagina, for a time period such as 1-2 hours; retrieving the absorbing member and placing it in a sample container; extracting fluid from the absorbing member using a fluid extraction device, and testing the fluid. In some embodiments, the kit is a home use kit and the sample is self collected by a user.

What is claimed is: 
     
         1 . A kit comprising:
 an absorbing member configured for collecting fluid over time from the vagina, the absorbing member shaped and sized as a vaginal tampon including an attached bendable cord; and   a sample container at least partially filled with a preserving solution, said sample container comprising an elastically deformable wall portion, said wall portion forming a narrowing within said sample container; wherein said narrowing defines an aperture small enough to squeeze said absorbing member as said absorbing member passes through said aperture; and wherein said elastically deformable wall portion is configured to be pushed in a radially inwards direction by applying of external radial pressure, thereby applying radial pressure onto said absorbing member, and then to elastically return to a non-pushed form.   
     
     
         2 . The kit according to  claim 1 , wherein said elastically deformable portion is configured to be pushed in a radially inwards direction more than once. 
     
     
         3 . The kit according to  claim 1 , wherein said narrowing of said sample container is configured distally to an opening of said sample container; and wherein said sample container comprises a wider portion configured distally to said narrowing, said wider portion at least partially filled with said preserving solution. 
     
     
         4 . The kit according to  claim 1 , wherein said sample container comprises a cap threaded on said opening of said container. 
     
     
         5 . The kit according to  claim 1 , wherein said sample container comprises at least one curvature for channeling fluid extracted from said absorbing member into said preserving solution. 
     
     
         6 . The kit according to  claim 1 , wherein said sample container comprises a plurality of radially inward facing extracting elements which are arranged to reduce a size of said aperture. 
     
     
         7 . The kit according to  claim 1 , wherein said wall portion of said sample container is curved, forming an internally facing bulge within the sample container. 
     
     
         8 . The kit according to  claim 1 , wherein said sample container is formed of deformable plastics or rubber. 
     
     
         9 . The kit according to  claim 1 , wherein said sample container is formed of a transparent, non-breakable material. 
     
     
         10 . The kit according to  claim 1 , wherein said sample container, at said narrowing, is shaped and sized for manual applying of said external radial pressure by a user. 
     
     
         11 . The kit according to  claim 1 , further comprising a shipping box including a designated compartment for said sample container when sealed. 
     
     
         12 . The kit according to  claim 11 , wherein said is a home-use kit, and wherein said absorbing member is suitable for self-insertion into the body and for self-removal from the body. 
     
     
         13 . The kit according to  claim 12 , wherein said shipping box further comprises instructions for using said absorbing member and said sample container. 
     
     
         14 . The kit according to  claim 1 , wherein the absorbing member is expandable to a swollen state when fluid is collected therein. 
     
     
         15 . The kit according to  claim 1 , wherein said narrowing comprises a plurality of radially inward facing extracting elements which are arranged to reduce a size of said aperture. 
     
     
         16 . The kit according to  claim 1 , wherein said absorbing member is suitable for insertion into the vagina for a time period ranging between  15  minutes to  4  hours. 
     
     
         17 . The kit according to  claim 1 , further comprising a funnel shaped fluid extraction device configured to attach onto an opening of said sample container, wherein said fluid extraction device comprises an opening shaped and sized to scrape at least a portion of walls of said absorbing member as said absorbing member is passed through said fluid extraction device. 
     
     
         18 . The kit according to  claim 17 , wherein said fluid extraction device comprises a threaded edge for threading said fluid extraction device onto a rim of an opening of said sample container.