Specimen Collection Container Having a Transitional Fill-Volume Indicator Indicating Extraction Method

Abstract

A specimen collection container having a transitional fill-volume indicator is disclosed. The specimen collection container includes an open top end, a closed bottom end, and a sidewall extending therebetween defining an interior. The specimen collection container includes a transitional fill-volume indicator adjacent the sidewall, such that the container defines a first volumetric interior defined by the sidewall between the closed bottom end and the transitional indicator. The specimen collection container also defines a second volumetric interior defined by the sidewall between the closed bottom end and a portion of the sidewall disposed above the transitional indicator. The first volumetric interior is adapted to allow extraction of a specimen therefrom by a first extraction process, and the second volumetric interior is adapted to allow extraction of a specimen therefrom by either the first extraction process or a second extraction process, the second extraction process being different than the first extraction process.

1 . A specimen collection container, comprising:
 a top end, a closed bottom end, and a sidewall extending therebetween defining an interior; and   a transitional fill-volume indicator adjacent the sidewall, wherein the container comprises a first volumetric interior defined by the sidewall between the closed bottom end and the transitional fill-volume indicator, and the container further comprises a second volumetric interior defined by the sidewall between the closed bottom end and a portion of the sidewall disposed above the transitional indicator,   wherein the first volumetric interior is adapted to allow extraction of a specimen therefrom by a first extraction process, and wherein the second volumetric interior is adapted to allow extraction of a specimen therefrom by either the first extraction process or a second extraction process, the second extraction process being different than the first extraction process.   
     
     
         2 . The specimen collection container of  claim 1 , further comprising an additive spray-dried to the interior, the additive provided in an appropriate amount to correspond to a volume of specimen designated by the transitional fill-volume indicator. 
     
     
         3 . The specimen collection container of  claim 1 , wherein the first extraction process is a manual extraction process, and the second extraction process is an automated extraction process. 
     
     
         4 . The specimen collection container of  claim 1 , wherein the transitional fill-volume indicator is integrally formed with the sidewall of the container. 
     
     
         5 . The specimen collection container of  claim 1 , wherein the transitional fill-volume indicator is at least partially raised with respect to a surface of the sidewall of the container. 
     
     
         6 . The specimen collection container of  claim 1 , wherein the transitional fill-volume indicator is at least partially recessed with respect to a surface of the sidewall of the container. 
     
     
         7 . The specimen collection container of  claim 1 , wherein the transitional fill-volume indicator is printed on a surface of the sidewall of the container. 
     
     
         8 . The specimen collection container of  claim 1 , wherein the transitional fill-volume indicator is at least partially textured with respect to a surface of the sidewall of the container. 
     
     
         9 . The specimen collection container of  claim 1 , wherein the transitional fill-volume indicator comprises a first colored portion and at least a portion of the sidewall of the container comprises a second colored portion, the second colored portion being different than the first colored portion. 
     
     
         10 . The specimen collection container of  claim 1 , further comprising a color contrast or visual effects contrast between at least a portion of the transitional fill-volume indicator and at least a portion of the sidewall of the container. 
     
     
         11 . The specimen collection container of  claim 1 , further comprising a label including the transitional fill-volume indicator disposed at least partially on a sidewall of the container. 
     
     
         12 . The specimen collection container of  claim 11 , wherein at least one of the label and the sidewall of the container includes first alignment symbology and the other of the label and the sidewall of the container includes second alignment symbology, wherein the first alignment symbology and the second alignment symbology provide corresponding alignment. 
     
     
         13 . The specimen collection container of  claim 1 , wherein the transitional fill-volume indicator further comprises information identifying at least one of the first extraction process and the second extraction process. 
     
     
         14 . The specimen collection container of  claim 1 , further comprising a closure disposed at least partially within the top end of the container. 
     
     
         15 . The specimen collection container of  claim 14 , wherein the closure comprises a pierceable portion capable of being pierced by a probe for automated extraction. 
     
     
         16 . A specimen collection container, comprising:
 a top end, a closed bottom end, and a sidewall extending therebetween defining an interior;   a first fill-volume indicator adjacent the sidewall corresponding to a first interior fill-volume;   a second fill-volume indicator adjacent the sidewall corresponding to a second interior fill-volume, wherein the first interior fill-volume is less than the second interior fill-volume; and   a transitional fill-volume indicator adjacent the sidewall and positioned between the first fill-volume indicator and the second fill-volume indicator, with the first fill-volume indicator, the second fill-volume indicator, and the transitional fill-volume indicator aligned about a longitudinal axis of the container,   wherein a sample may be extracted from within the interior of the container by a first extraction process if the volume of sample is below the transitional fill-volume indicator in a sampling orientation, and in which a sample may be extracted from within the interior of the container by the first extraction process or a second extraction process if the volume of sample is above the transitional fill-volume indicator in the sampling orientation, the second extraction process being different than the first extraction process.   
     
     
         17 . The specimen collection container of  claim 16 , wherein the first extraction process is a manual extraction process, and the second extraction process is an automated extraction process. 
     
     
         18 . The specimen collection container of  claim 16 , wherein at least one of the first fill-volume indicator, the second fill-volume indicator, and the transitional fill-volume indicator are integrally formed with the sidewall of the container. 
     
     
         19 . The specimen collection container of  claim 16 , wherein at least one of the first fill-volume indicator, the second fill-volume indicator, and the transitional fill-volume indicator are at least partially raised with respect to a surface of the sidewall of the container. 
     
     
         20 . The specimen collection container of  claim 16 , wherein at least one of the first fill-volume indicator, the second fill-volume indicator, and the transitional fill-volume indicator are at least partially recessed with respect to a surface of the sidewall of the container. 
     
     
         21 . The specimen collection container of  claim 16 , wherein at least one of the first fill-volume indicator, the second fill-volume indicator, and the transitional fill-volume indicator are printed on a surface of the sidewall of the container. 
     
     
         22 . The specimen collection container of  claim 16 , wherein at least one of the first fill-volume indicator, the second fill-volume indicator, and the transitional fill-volume indicator are at least partially textured with respect to a surface of the sidewall of the container. 
     
     
         23 . The specimen collection container of  claim 16 , wherein at least one of the first fill-volume indicator, the second fill-volume indicator, and the transitional fill-volume indicator comprises a color contrast or visual effects contrast with respect to at least one of a portion of the sidewall of the container and the other of the first fill-volume indicator, the second fill-volume indicator, and the transitional fill-volume indicator. 
     
     
         24 . The specimen collection container of  claim 16 , further comprising a label including at least one of the first fill-volume indicator, the second fill-volume indicator, and the transitional fill-volume indicator disposed at least partially on a sidewall of the container. 
     
     
         25 . The specimen collection container of  claim 16 , wherein at least one of the label and the sidewall of the container includes first alignment symbology and the other of the label and the sidewall of the container includes second alignment symbology, wherein the first alignment symbology and the second alignment symbology provide corresponding alignment. 
     
     
         26 . The specimen collection container of  claim 16 , wherein at least one of the first fill-volume indicator, the second fill-volume indicator, and the transitional fill-volume indicator further comprises identifying information. 
     
     
         27 . The specimen collection container of  claim 26 , wherein the identifying information identifies at least one of the first extraction process and the second extraction process. 
     
     
         28 . The specimen collection container of  claim 26 , wherein the identifying information identifies corresponding fill-volumes. 
     
     
         29 . The specimen collection container of  claim 26 , wherein at least one of the first fill-volume indicator, the second fill-volume indicator, and the transitional fill-volume indicator is a line disposed substantially perpendicular to a longitudinal axis of the container. 
     
     
         30 . The specimen collection container of  claim 26 , wherein at least one of the first fill-volume indicator, the second fill-volume indicator, and the transitional fill-volume indicator comprise a window through which a specimen may be viewed. 
     
     
         31 . The specimen collection container of  claim 26 , wherein at least one of a range extending between the first fill-volume indicator and the transitional fill-volume indicator, and a range extending between the transitional fill-volume indicator and the second fill-volume indicator comprises an indicator region. 
     
     
         32 . The specimen collection container of  claim 31 , wherein the indicator region comprises a color contrast or a visual effects contrast with at least a portion of the sidewall of the container. 
     
     
         33 . The specimen collection container of  claim 31 , wherein the indicator region comprises a first region corresponding to the range extending between the first fill-volume indicator and the transitional fill-volume indicator, and a second region corresponding to the range extending between the transitional fill-volume indicator and the second fill-volume indicator. 
     
     
         34 . The specimen collection container of  claim 16 , further comprising a closure disposed at least partially within the open top end of the container. 
     
     
         35 . A specimen collection container, comprising:
 an open top end, a closed bottom end, and a sidewall extending therebetween defining an interior;   a minimum fill-volume indicator adjacent the sidewall, wherein the sidewall defines a minimum functional volume between the closed bottom end and the minimum fill-volume indicator;   a maximum fill-volume indicator adjacent the sidewall, wherein the sidewall defines a maximum functional volume between the closed bottom end and the maximum fill-volume indicator; and   a transitional fill-volume indicator adjacent the sidewall and positioned between the minimum fill-volume indicator and the maximum fill-volume indicator, the sidewall defining a first extraction volume between the minimum fill-volume indicator and the transitional fill-volume indicator, wherein a sample may be extracted therefrom by a first extraction process,   wherein the sidewall further defines a second extraction volume between the transitional fill-volume indicator and the maximum fill-volume indicator, wherein a sample may be extracted therefrom by either the first extraction process or a second extraction process, the second extraction process being different than the first extraction process.   
     
     
         36 . The specimen collection container of  claim 35 , wherein the first extraction process is a manual extraction process, and the second extraction process is an automated extraction process. 
     
     
         37 . A method of filling a specimen collection container with a specimen, comprising:
 providing a collection container having an open top end, a closed bottom end, and a sidewall extending therebetween defining an interior, the sidewall including a transitional fill-volume indicator; and   providing a volume of specimen into the interior of the container such that the volume of specimen is disposed below the transitional fill-volume indicator if it is desired to remove the specimen therefrom by a first extraction process, or such that at least a portion of the volume of specimen is disposed at or above the transitional fill-volume indicator if it is desired to remove the specimen therefrom by the first extraction process or a second extraction process, the second extraction process being different than the first extraction process.   
     
     
         38 . The method of filling a specimen collection container with a specimen of  claim 37 , wherein the first extraction process is a manual extraction process, and the second extraction process is an automated extraction process. 
     
     
         39 . A method of extracting a sample from a specimen collection container, comprising:
 providing a collection container having an open top end, a closed bottom end, and a sidewall extending therebetween defining an interior, the sidewall including a transitional fill-volume indicator, and a specimen disposed within the interior; and   extracting the specimen from the interior by a first extraction process if the specimen is disposed below the transitional fill-volume indicator, or extracting the specimen from the interior by a second extraction process if at least a portion of the specimen is disposed at or above the transitional fill-volume indicator, the second extraction process being different than the first extraction process.   
     
     
         40 . The method of extracting a sample from a specimen collection container of  claim 39 , wherein the first extraction process is a manual extraction process, and the second extraction process is an automated extraction process. 
     
     
         41 . A method of producing a specimen collection container, comprising:
 providing a collection container having an open top end, a closed bottom end, and a sidewall extending therebetween defining an interior;   providing a first fill-volume indicator adjacent the sidewall; and   providing a second fill-volume indicator adjacent the sidewall,   wherein the first fill-volume indicator and the second fill-volume indicator are positioned to share at least one common surface.   
     
     
         42 . The method of  claim 41 , wherein the first fill-volume indicator and the second fill-volume indicator share at least one of a top surface and a bottom surface. 
     
     
         43 . The method of  claim 41 , further comprising providing a transitional fill-volume indicator adjacent the sidewall, wherein the transitional fill-volume indicator is co-extensive with at least one of the first fill-volume indicator and the second fill-volume indicator. 
     
     
         44 . The method of  claim 41 , further comprising providing a transitional fill-volume indicator adjacent the sidewall, wherein the transitional fill-volume indicator is provided between the first fill-volume indicator and the second-fill volume indicator. 
     
     
         45 . The method of  claim 41 , wherein the first fill-volume indicator defines a minimum functional volume from the closed bottom end, and wherein the second fill-volume indicator defines a maximum functional fill-volume from the closed bottom end. 
     
     
         46 . A specimen collection assembly, comprising:
 a container having an open top end, a closed bottom end, and a sidewall extending therebetween defining an interior adapted to receive a sample therein;   a dose-specific additive disposed within the interior; and   a transitional fill-volume indicator adjacent the sidewall, wherein the container defines a first volumetric interior defined by the sidewall between the closed bottom end and the transitional fill-volume indicator, and the container defines a second volumetric interior defined by the sidewall between the closed bottom end and a portion of the sidewall disposed above the transitional indicator,   wherein the transitional fill-volume indicator indicates the amount of sample to be introduced into the interior for a first process dependent on the dose-specific additive, and the transitional fill-volume indicator indicates the amount of sample to be introduced into the interior for a second process dependent on the dose-specific additive, the first process being different from the second process.   
     
     
         47 . The specimen collection assembly of  claim 46 , wherein the first process is an extraction procedure, diagnostic, qualitative, or quantitative test procedure, and the second process is a different extraction procedure, diagnostic, qualitative, or quantitative test procedure. 
     
     
         48 . The specimen collection assembly of  claim 46 , further comprising a minimum fill-volume indicator adjacent the sidewall, wherein the sidewall defines a minimum functional volume between the closed bottom end and the minimum fill-volume indicator; and
 a maximum fill-volume indicator adjacent the sidewall, wherein the sidewall defines a maximum functional volume between the closed bottom end and the maximum fill-volume indicator.