Method and apparatus for collecting and preparing biological samples for testing
Inventors
Assignees
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Publication Number
US-11350913-B2
Publication Date
2022-06-07
Expiration Date
Abstract
A kit and a method are disclosed for collecting and preparing a biological sample for testing where the sample is to be mixed with a buffer prior to being tested.
Core Innovation
The invention provides a method for collecting and preparing a biological sample to be tested using a kit that includes a sterile swab separate and distinct from a dropper bottle assembly. The sterile swab has a stick with a sorbent fixed to one end and a weakened portion at a pre-selected location to facilitate breaking the stick. The dropper bottle assembly includes a dropper cap with a spout and a threaded base, a squeezable bottle with a threaded neck, and a cover that is manually removable from the dropper cap to expose the spout, with the bottle containing a liquid buffer.
In use, the sterile swab is inserted into the bottle and the stick is broken at the pre-selected location so that the sorbent and a portion of the stick are disposed inside the bottle and do not extend above the top of the bottle. The dropper bottle assembly is closed by re-screwing the dropper cap onto the threaded neck with the stick of the swab disengaged from the dropper cap. The bottle is agitated to mix the sample with the liquid buffer contained within the bottle, and the mixed sample and liquid buffer contents are then dispensed as at least one drop through the spout by rotating the bottle and squeezing it after the cover is removed.
The kit configuration includes a geometric relationship between the sterile swab length and the bottle height without the dropper cap, and positions the weakened portion at a distance from the end of the sorbent that is 90% to 100% of the height of the bottle without the dropper cap. The documented embodiments include providing the mixed sample and liquid buffer onto an immunoassay device, and a dual-path immunoassay configuration where a second buffer bottle can supply buffer solution to a second path/opening on the immunoassay device.
Claims Coverage
The document provides one independent claim defining the overall method, with multiple dependent claims narrowing operational details and expanding test-device specificity.
Sterile swab with breakable stick and sorbent at one end
A sterile swab separate and distinct from a dropper bottle assembly, the sterile swab having a stick with a sorbent fixed to the stick at one end and the stick having a weakened portion at a pre-selected location to facilitate breaking the stick.
Dropper bottle assembly with threaded coupling and manually removable cover
A dropper bottle assembly comprising a dropper cap having a spout and a threaded base, a squeezable bottle with a threaded neck, and a cover manually removable from the dropper cap to expose the spout, the bottle containing a liquid buffer and the dropper cap being coupled to the threaded neck.
Swab length and weakened-portion location relative to bottle height
Length of the sterile swab is greater than height of the bottle without the dropper cap, and the weakened portion of the stick is located a distance from the end of the sorbent, the distance being 90% to 100% of the height of the bottle without the dropper cap.
Breaking the stick inside the bottle so the sorbent is disposed below the top
Inserting the one end of the sterile swab with the sorbent fixed into the bottle, and breaking the stick at the pre-selected location leaving the sorbent and a portion of the stick disposed inside in the bottle and not extending above the top of the bottle.
Agitating mixed contents and dispensing at least one drop through the spout
Agitating the bottle to mix the sample with the liquid buffer, then after closing the dropper bottle assembly and agitating the bottle, removing the cover to expose the spout, rotating the bottle so the mixed sample and liquid buffer contents reach the spout, and squeezing the bottle to dispense at least one drop of the mixed sample and liquid buffer contents through the spout.
Overall, the claim coverage centers on a workflow that uses a breakable sterile swab inserted into a buffer-containing dropper bottle, followed by mixing through agitating and then dispensing at least one drop through a spout onto a test device, with dependent refinements covering cover removal and optional dual-path immunoassay using an additional buffer bottle.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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