Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Sample mechanical transport means in or for automated...
Reexamination Certificate
1999-09-17
2003-11-18
Soderquist, Arlen (Department: 1743)
Chemical apparatus and process disinfecting, deodorizing, preser
Analyzer, structured indicator, or manipulative laboratory...
Sample mechanical transport means in or for automated...
C422S065000, C422S064000, C422S068100, C422S050000, C436S047000
Reexamination Certificate
active
06649128
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to an assay device processing instrument, for example for processing assay devices in the form of chips on which have been deposited an array of localised reactive sites containing different reactive species, for example different antibodies.
DESCRIPTION OF THE PRIOR ART
In this context, “assay” means the quantitative analysis of a substance to determine the proportion of some valuable or potent constituent e.g. the active constituent in a pharmaceutical.
An immunoassay is a technique which measures the presence of a substance (analyte) in a biological sample exploiting an immunological reaction between antibody and antigen.
In the fields of chemical/veterinary diagnosis or drug screening, it is necessary to analyse samples to determine the presence of certain analytes. Recently, it has been proposed to provide a set of different antibodies on respective reactive sites on a substrate such as a chip. The sample is deposited on the chip and following incubation and other processes, a chemiluminescence process is monitored to detect the presence or absence of the appropriate analyte at each site. This is described in more detail in EP-A-0902394.
The problem with analysis of such chips is that the processes are complex and require careful handling of the chips and thus significant manual intervention.
WO-A-93/23732 describes automatic staining apparatus for slide specimens but this is a histochemical process and has no relevance to assays.
SUMMARY OF THE INVENTION
In accordance with one aspect of the present invention, an assay device processing instrument comprises a plurality of assay device processing modules; a transport system including an assay device positioning assembly for transporting an assay device to each processing module, the assay device positioning assembly being adapted to transfer the assay device to each module to enable the assay device positioning assembly to transport another assay device while the transferred assay device(s) is processed; and a control system for controlling operation of the transport system such that each assay device is transferred between the modules in a predetermined sequence, and such that a number of assay devices can be processed in different modules simultaneously.
We have realised that it is possible to develop a sophisticated multi-tasking processing instrument by developing a transport system which can transport an assay device to a processing module and transfer the assay device to the module thus releasing the transport system to transport another assay device while the first is processed. Under computer control, a large number of assay devices could be processed simultaneously with such an instrument.
A variety of transport systems could be used. In one case a rotary transport system could be implemented which will be relatively compact. The simplest rotary system would involve a circular “shaft”, and an assay device positioning assembly mounted for movement about the shaft, the shaft rotating until the positioning assembly is aligned with the respective processing module entry point for input or extraction of the storage units.
More complex options would involve rotating concentric assemblies/modules. The inner module could act as an incubator/shaker with the outer ring being the transport system. Thus, for example the incubator/shaker could shake with small angular movements about the vertical axis/shaft. The incubator/shaker could be multi-level/stack.
The storage units may be pushed out/pulled in between the inner incubator/shaker and the outer transport system via e.g. a push/pull motor assembly located within the centre of the inner incubator “ring”.
In the preferred example, the transport system comprises a rail; an assay device positioning assembly mounted for movement along the rail; and a first motor responsive to the control system to move the assay device positioning assembly into alignment with the respective processing modules. Preferably, the rail is linear. This increases the simplicity and ease of design and modification of such a system over, for example, a rotary system.
In some cases, the transport system can be folded back on itself into a multi-plane system thus forming a more compact design than one which is based on a single plane.
In some cases, part of the transport system at each module could include means for transferring an assay device to and from the module. However, a simpler and preferred approach is to provide the transport system with a support movably mounted to the rail; an arm for engaging an assay device and movably mounted to the support for movement laterally relative to the rail; and a second motor on the support for causing lateral movement of the arm. In this case, the arm for moving the assay device moves with the support along the rail so that only a single such arm is required. Typically, the arm will move relative to the support substantially orthogonally to the rail although this is not essential.
Conveniently, the arm has means for gripping the assay device although in other cases, the arm could simply push the assay device to different positions or connect to it by other means such as a magnetic coupling.
Preferably, however, the assay device is supported in an assay device holder having a formation which cooperates releasably with the gripping means to enable the assay device to be positioned by the arm. Such an arrangement is described in more detail in EP Patent Application No. 98307732.2.
A variety of modules could be provided. Typically, they will include one or more of:
a) a buffer for storing more than one assay device or assay device holder;
b) an incubator;
c) a wash station; and,
d) an assay device imaging station.
The use of a buffer is helpful in that it allows reactions to take place which require a period of time during which other assay devices can be transported and subjected to other processes. Conveniently, however, the buffer is provided by the incubator. Since assay devices normally have to be retained within the incubator for a period of time, this provides a useful dual purpose as a buffer.
An imaging station is needed in order to view the reaction sites after processing and it is important to restrict the access of ambient light. It is therefore necessary for the imaging station to be closed during the imaging process. This could be achieved by separately operating a door through which the assay device passes. This process can be simplified when the imaging station includes an entrance door which is automatically activated during transfer of the assay device to and from the imaging station.
This automatic activation could be achieved using sensors and the like to monitor movement of the assay device and a system responsive to the sensors to open the door. However, preferably the door is pivoted about an upper, horizontal axis to a wall of the imaging station and is coupled to a movable platform of the imaging station by a link pivoted to both the platform and the door whereby movement of the platform towards the door from either side of the door, causes the door to open and thereafter close once the platform has passed through from one side to the other.
As mentioned above, an important module for use during an immunoassay process is an incubator. In addition, it is usually necessary to shake or vibrate the assay device to promote the chemical reactions which are to take place.
Some examples of incubators are described in “Environmental Shakers/Incubators” by Shane Beck, Aug. 17, 1998. However, these are relatively unsophisticated.
In accordance with a second aspect of the present invention, an assay device incubator comprises a housing and a set of assay device supports positioned within the housing; means for independently heating each assay device within the housing; and means for shaking the support relative to the housing.
Unlike other systems, this new incubator enables shaking, incubation and accurate, independent heating control to be carried out at the same time so that no transfer is required betwe
Cao Bailin
Fitzgerald Stephen Peter
Kansanaho Ahti Kalevi
Lamont John Victor
McConnell Robert Ivan
Gordon Brian R.
Oliff & Berridg,e PLC
Randox Laboratories LTD
Soderquist Arlen
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