Methods, packaging and apparatus for collection of biological samples

A sample and packaging technology, applied in the field of self-collection of samples, can solve problems such as high unit structure cost and operational complexity

Inactive Publication Date: 2015-03-04
CYTOCORE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] None of the various devices and ancillary tools used for self-collection of clinical samples such as those described has been successful beca

Method used

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  • Methods, packaging and apparatus for collection of biological samples
  • Methods, packaging and apparatus for collection of biological samples
  • Methods, packaging and apparatus for collection of biological samples

Examples

Experimental program
Comparison scheme
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example 1

[0082] Example 1: Composition of supporting tools

[0083] Companion kits for self-collection of clinical samples will include, at a minimum: sample collection tools; preservatives to preserve collected samples during transport to the laboratory; instructions for use and other labeling as required by law or regulation; and packaging for these objects. The kit may additionally include items such as are appropriate for a particular sample collection. An example of such a companion tool is shown in figure 1 middle. This companion tool includes:

[0084] A sample collection tool (301). An interlabial pad of the type described by Brown is shown in this figure, but other forms of interlabial pads are also suitable. Tampons as described by way of cotton swabs; various forms of brushes or scrapers; and other such devices may also be used as appropriate to the specific intended use of the kit. Collection tools can be sterile or sterile as appropriate. The collection implement i...

example 2

[0092] Example 2: Sample Collection Tool

[0093] A preferred collection implement for routine self-collection of gynecological samples comprises a thin, approximately oval interlabial pad having a fluid absorbent core, a fluid permeable front panel, and a fluid impermeable back panel. Suitable interlabial pads of this type are described by Brown and are commercially available under "AlwaysActive" (Proctor & Gamble), "InSync" (A-FemMedical) and other trade names. Other forms of interlabial pads and tampons that generally have a higher capacity to absorb fluid than the preferred pads may also be suitable if the fluidity of the gynecological discharge is high. Suitable tampons are commercially available under "Always Active" (Proctor & Gamble), "Tampax" (Tampax), and other trade names. Samples collected using the adsorption tool contain material including cells, hormones, metabolites, microorganisms, or the like shed from the entire reproductive tract and can be tested for a ...

example 3

[0095] Example 3: Preservatives

[0096] The preferred preservative solution for use in the present invention is determined by the requirements of the particular test or tests to be performed on the collected sample. Preservative solutions suitable for use in the present invention and compatible with more relevant tests are commercially available from a number of suppliers, including but not limited to these: Cytyc (ThinPrep, PreservCyt), TriPath (SurePath), CellSolution (Synermed), Digene (STM) and others. Proprietary preservative solutions manufactured by specific suppliers specifically intended for specific tests are also commercially available and will be used if appropriate. Almost all suitable commercially available preservative solutions comprise one or more low molecular weight alcohols in buffered aqueous solution plus a variety of additives to impart specific characteristics to a particular product. The commercially available dosage form consists of about 25% eth...

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PUM

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Abstract

Methods, apparatus and compositions are disclosed for collection and transport of biological samples for testing and/or evaluation by a clinical laboratory. In particular, the disclosure relates to the self-collection of such samples by subjects providing the samples. Self-collection is necessary in some situations e.g. where a subject's religion prohibits being touched by a non-family member and subjects at great distance from medical facilities

Description

[0001] Related References to Cross-Applications [0002] This application claims priority to US Application 61 / 639,910, filed April 28, 2012, which is hereby incorporated by reference in its entirety. technical field [0003] Methods, devices and structures for the collection and transport of biological samples for use in clinical laboratory testing and / or evaluation are disclosed. In particular, the invention relates to the self-collection of such samples by the subject providing the samples. Background technique [0004] Tests performed by clinical laboratories are generally classified as "screening," "diagnostic," or "surveillance," based on the target population and intended use of the test results. Screening tests are performed on large asymptomatic populations to identify from this population relatively few individuals with the target disease or a precursor to the target disease. Screening tests for the development of the disease rather than the disease itself have r...

Claims

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Application Information

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IPC IPC(8): A61B10/00B65D77/06
CPCA61B2010/0074A61B10/0096A61B10/0045A61B10/00B65D77/06A61J1/14
Inventor R·A·多马尼克
Owner CYTOCORE
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