Sampling System

Abstract

A sampling system comprises a mailing package; a cell sampling device comprising a flexible shaft having a handle at one end, wherein the shaft is configured to allow an individual to self collect a cell sample from mucous tissue, and a sample collecting element removably connectable with the other end of the shaft and operable to collect a cell sample from mucous tissue of an individual; and a sealable unit, wherein the unit is configured to store the sample collecting element having a cell sample thereon and to be received within the mailing package in its sealed form. The system may optionally further include a transport package configured to receive the remaining components of the system for delivery to a user.

1 . A sampling system comprising:
 a) a mailing package;   b) a cell sampling device comprising:
 i) a flexible shaft having a handle at one end, wherein the shaft is configured to allow an individual to self collect a cell sample from mucous tissue, and 
 ii) a sample collecting element removably connectable with the other end of the shaft and operable to collect a cell sample from mucous tissue of an individual; and 
   c) a sealable unit, wherein the unit is configured to store the sample collecting element having a cell sample thereon and to be received within the mailing package in its sealed form.   
   
   
       2 . The system of  claim 1 , wherein the shaft is configured to allow an individual to self collect a cell sample from a cervix location. 
   
   
       3 . The system of  claim 1 , further comprising a transport package configured to receive components a)-c) for delivery to an individual for use of the system. 
   
   
       4 . The system of  claim 3 , wherein the transport package and the unit each have an identification element. 
   
   
       5 . The system of  claim 4 , wherein the identification element includes a bar code. 
   
   
       6 . The system of  claim 1 , wherein a portion of the shaft is rigid. 
   
   
       7 . The system of  claim 1 , wherein the shaft is formed of polymer comprising polypropylene, polyethylene, or a mixture thereof. 
   
   
       8 . The system of  claim 1 , wherein the sample collecting element is generally cylindrical and has a diameter of from about 2 to about 20 mm. 
   
   
       9 . The system of  claim 1 , wherein the sample collecting element comprises at least one raised portion. 
   
   
       10 . The system of  claim 1 , wherein the raised portion forms a plurality of cell and mucous collecting segments. 
   
   
       11 . The system of  claim 10 , wherein the sample collecting element further comprises at least one groove which is from about 0.01 to about 2 mm in width for maintaining a cell and mucous sample therein. 
   
   
       12 . The system of  claim 11 , wherein the raised portion forms an edge at the groove capable of scraping tissue to collect a sample. 
   
   
       13 . The system of  claim 12 , wherein the raised portion and grooves are configured to collect a sample by insertion in a body orifice and to hold a collected sample during withdrawal of the device from a body orifice. 
   
   
       14 . The system of  claim 1 , wherein the sample collecting element comprises an abrasive surface. 
   
   
       15 . The system of  claim 14 , wherein the abrasive surface has a surface roughness of from about 1 to about 100 μm. 
   
   
       16 . The system of  claim 1 , wherein the sealable unit comprise a unit cover for sealing the unit. 
   
   
       17 . The system of  claim 1 , wherein the sample collecting element, the shaft and the sealable unit are configured to allow the sample collecting element to be at least partially inserted within the sealable unit and separated from the shaft without contact of the sample collecting element by an individual. 
   
   
       18 . The system of  claim 17 , wherein the connection comprises a snap-fit mechanism. 
   
   
       19 . The system of  claim 16 , wherein the unit and the unit cover form an air-tight seal. 
   
   
       20 . The system of  claim 1 , further comprising an instruction sheet. 
   
   
       21 . A sampling system comprising:
 a) a preaddressed mailing package;   b) an instruction sheet;   c) a flexible shaft;   d) a sample collecting element removably connectable with an end of the shaft and having a plurality of raised portions and grooves;   e) a bar coded unit including an air tight unit cover and configured to receive the sample collecting element therein and to be received in the mailing package; and   f) a transport package configured to receive components a)-e) for delivery to a user.   
   
   
       22 . The sampling system of  claim 21 , wherein the sample collecting element is configured for snap-fit connection and removal with the shaft. 
   
   
       23 . The sampling system of  claim 22 , wherein the cell sampling device is configured to allow an individual to self collect a sample. 
   
   
       24 . The sampling system of  claim 23 , wherein the cell sampling device is configured to allow an individual to collect a sample from mucous tissue. 
   
   
       25 . The sampling system of  claim 24 , wherein the mucous tissue resides in the gynecological tract. 
   
   
       26 . The sampling system of  claim 24 , wherein the mucous tissue resides in the mouth.