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US 12,758,968 B2Granted
Unit device, method, and assembly
AssigneeCharm Sciences, Inc.
InventorsRobert S Salter, Robert J Markovsky, Meikel Brewster
Life of this patent
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Abstract
Sample collection and analysis devices, methods, and assemblies are shown and described. In one embodiment, an assembly includes a sample collection device and a removable vial having a penetrable barrier seal to prevent access to the vial until at least one penetrable activation. The result is improved efficient and effective sample collection and analysis.
Claims13
A system comprising:
- a. a housing body having at least one aperture;
- b. a sample collection device removably couplable to said housing;
- c. a sampling probe having a breakable sampling distal portion including a predefined weakened region forming a breaking location adapted to be separated along said defined breaking location and collect and retain a surface sample;
- d. a vial aligned in said housing in a first, sealed position and adapted to be separated from said housing to a second removed position, and having a penetrable barrier seal disposed at an entry region of the vial and preventing access to contents of said vial until at least one physical penetration of said breakable sampling distal portion of said probe, and wherein said vial comprises a buffer solution enclosed beneath said penetrable barrier seal and wherein said breakable sampling distal portion is received within said vial after penetration of said barrier seal;
- and
- e. a lateral flow test strip packaged separately from said vial within said system and removable from said sealed compartment and manually introducible into said vial only after said vial is in said second removed position, and wherein said lateral flow strip having at least one control line and at least one test line configured to undergo a detectable change when exposed to an analyte contained in said surface sample, when said analyte is present, within said removed vial, and
- wherein said system is adapted such that, upon penetration of said barrier seal by said breakable distal sampling portion and mixing with a reagent, said test strip when introduced into said vial develops a result indicative of a presence or absence of at least one said analyte in said second removed position, and
- wherein said system constitutes a single-use, self-contained assembly including said sample collection device, said vial, and said packaged lateral flow test strip, collectively supporting sample collection, transport, and analyte detection in said removed second position.
5 more elements
Dependencies are inferred from the claim text.