Assay device

Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Calorimeter

Patent

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Details

422 61, 422102, 436 92, 436808, G01N 3122

Patent

active

056585314

DESCRIPTION:

BRIEF SUMMARY
This invention relates to an assay device and is more particularly concerned with a disposable assay device which is relatively safe and convenient to use and dispose of, and in which there is a reduced risk of operator contamination from either the assay reagents, or the sample to be analysed, or the resultant reaction mixture. This invention is particularly, but not exclusively, concerned with a disposable assay device for assaying for nicotine metabolites in samples of urine for the purpose of checking on recent smoking habit.


BACKGROUND OF THE INVENTION

The treatment of smoking-related disease is a major expenditure and there is a need for a convenient accurate determination of patient's smoking habit in order to determine appropriate and effective treatment of smoking-related diseases. There is also a demand for an assay device which can be used by non-chemists in extra-laboratory situations such as doctors surgeries, anti-natal clinics, industrial plants, water works, farms or the home. In order to be suitable for this, it is important for the assay device to be relatively easy and safe to use and to be relatively safely disposed of.


SUMMARY OF THE INVENTION

It is an object of the present invention to provide an assay device which meets the above-mentioned demand.
According to the present invention, there is provided a disposable assay device for assaying a sample, comprising a body including a reaction chamber which contains or is adapted to receive an assay reagent sensitive to a component being assayed for in the sample, a sample collector/dispenser for collecting a sample to be assayed and for dispensing a predetermined quantity of sample into the reaction chamber, said body and said collector/dispenser being non-detachably engaged or engageable together, and means for sealing the assembly of body and collector/dispenser to prevent leakage of the contents of the reaction chamber after use.
In a first series of embodiments, the sample collector/dispenser is adapted to be non-detachably engaged with said body after a sample has been collected, and the sealing means acts between the body and the collector/dispenser.
In this first series of embodiments, it is preferred for the sample collector/dispenser to include a sample collection cheer defined between two relatively moveable parts such that relative movement of the parts in one direction causes said predetermined quantity of the sample to be dispensed therefrom into the reaction chamber.
In one arrangement, the sample to be assayed is caused to enter a reservoir in which it is retained until being dispensed therefrom. In one aspect, the reservoir is defined by the cylinder of a piston and cylinder device so that the sample can be aspirated into the reservoir and then dispensed therefrom by relative movement of the piston and cylinder. In another aspect, the reservoir is filled by immersing it in the sample to be collected and causing the sample to be retained by closing the reservoir or designing the reservoir so that it retains the sample therein by surface tension. In the latter case, the surface tension effect can be achieved by providing the reservoir in a relatively narrow bore tube having a lower opening and having an upper opening which is openable to allow the sample to be collected and dispensed, but closed to retain the sample therein. In an alternative arrangement, the surface tension effect is achieved by filling the reservoir with a wicking element comprising an absorbent material which can be compressed to dispense sample absorbed therein.
The reaction chamber itself may be closed by a pierceable or moveable membrane.
The membrane may be a multi-layer construction and incorporate one or more reagents in order to enclose and separate it/them from other reagent(s). This multi-layer form of construction is useful for reagents which, when mixed together, can be unstable and must be kept separate prior to use.
In a second series of embodiments, the body and the collector/dispenser are permanently non-detachably engaged together and

REFERENCES:
patent: 2940448 (1960-06-01), Furlong
patent: 3715189 (1973-02-01), Nighohossian et al.
patent: 4663127 (1987-05-01), Jackson et al.
patent: 4812293 (1989-03-01), McLauren et al.
patent: 5013667 (1991-05-01), Lynn et al.
patent: 5179024 (1993-01-01), Dahms
Peach et al., "A Simple Inexpensive Urine Test of Smoking" Thorax 1985; 40:351-357.

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