Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or...
Reexamination Certificate
1996-08-20
2001-05-01
Duffy, Patricia A. (Department: 1645)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
C435S007720, C435S007800, C435S007910, C435S007920, C435S961000, C435S975000, C435S283100, C436S518000, C436S536000, C436S538000, C436S541000
Reexamination Certificate
active
06225043
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a separation method, to a method for detection, to a sensor, and to a test-kit which find application in immunological detection.
SUMMARY OF THE INVENTION
According to one aspect of the present invention there is provided a separation method for separation of a primary species which separation method is suitable for use in an immunoassay method for the detection of an analyte species and includes the use of a first auxiliary species capable of being formed into a second auxiliary species which second auxiliary species is capable of interacting with a third species to facilitate separation.
In one embodiment of the present invention the separation method also includes the steps of forming the second auxiliary species from the first auxiliary species, and allowing the second auxiliary species and the third species to react so as to facilitate separation.
According to another aspect of the present invention there is provided a method for the detection of an analyte species by immunoassay which method includes a separation method for separation of a primary species which separation method includes the use of a first auxiliary species capable of being formed into a second auxiliary species which second auxiliary species is capable of interacting with a third species to facilitate separation.
In another embodiment of the present invention there is provided a method for the detection of an analyte species by immunoassay which method comprises allowing a primary immune reaction to take place, subsequently forming the first auxiliary species into the second auxiliary species and allowing the second auxiliary species to react with the third species to facilitate a separation step in the immunoassay.
According to a further aspect of the present invention there is provided a sensor suitable for use in the detection of an analyte species by immunological detection which sensor is constructed such as to permit the performance of a separation method for separation of a primary species, or a method for detection which method for detection includes a separation method for separation of a primary species, which includes the use of a first auxiliary species capable of being formed into a second auxiliary species which second auxiliary species is capable of interacting with a third species to facilitate separation.
According to yet a further aspect of the present invention there is provided a test-kit for performing a method of detection, which method includes a separation method for separation of a primary species, in accordance with the present invention which test-kit includes a first auxiliary species capable of being formed into a second auxiliary species which second auxiliary species is capable of interacting with a third species to effect a separation.
The second auxiliary species may be, for example, a ligand. Where the second auxiliary species is a ligand the third species may be, for example, a binder species for the ligand.
The first auxiliary species and the second auxiliary species may be considered to be “auxiliary” in the sense that neither of these species takes part in a primary immune reaction. Thus, the first auxiliary species and the second auxiliary species may be considered as not being primary species. It is to be understood that a primary species in accordance with the present invention is a species which may take part in a primary immune reaction.
By way of example, a primary immune reaction (which may also be described as a primary immune binding reaction) is one in which an analyte species undergoes a specific binding reaction or an authentic analyte species (as hereinafter defined) undergoes a specific binding reaction, or an analyte species and an authentic analyte species undergo specific binding reactions. (It will be appreciated that the analyte species and the authentic analyte species undergo specific binding reactions with other species and not with each other.)
By way of example, a primary species may be a primary antibody or a ligand (e.g. an antigen). It is to be understood that, for example, a primary species may be an antibody to an analyte species, or an antibody to an authentic analyte species; it will be appreciated that, for a given immunoassay, the antibody to the analyte species and the antibody to the authentic analyte species will be the same antibody.
It is also to be understood that a primary species may be, for example, an analyte species or an authentic analyte species.
By way of example, it is possible to choose a third species which is a species which does not take part in a primary immune reaction; such a third species may be regarded as a third auxiliary species. For example, a third species being a third auxiliary species may be associated with a primary species (as further disclosed hereinafter) or provided on a support material (as further disclosed hereinafter).
Alternatively, by way of example, a third species may be chosen such as to have a part which provides a species for interaction with the second auxiliary species and a part which provides a primary species being a binder for a primary species; an example of such a third species is an antibody having more than one function (e.g. a bifunctional antibody). It is to be understood that where, for example, a third species has a part which provides a species for interaction with the second auxiliary species, that part may be regarded as an “auxiliary function” in that it may interact with the second auxiliary species. It is also to be understood that where, for example, a third species is a species which has an auxiliary function and itself has a part which provides a primary species, the third species may be regarded as a primary species in that it has a part which provides a primary species.
By way of example, where the third species is an antibody to the second auxiliary species the third species may be considered, by way of example, to be an “anti-second auxiliary species agent”.
The first auxiliary species may be, for example, regarded as a precursor for the second auxiliary species. For example, the first auxiliary species may be formed into the second auxiliary species by means of chemical synthesis. Alternatively, by way of example, the first auxiliary species may be essentially similar to the second auxiliary species with the exception that the first auxiliary species carries a “blocking” entity which inhibits the capability of the second auxiliary species to interact (e.g. react) with the third species. On removal of the blocking entity (i.e. the “unblocking” of the second auxiliary entity) the first auxiliary species is formed into the second auxiliary species which is then capable of interacting (e.g. reacting) with the third species.
It is to be understood that the removal of a blocking entity may be considered to be “unmasking” of a “masked” auxiliary species or the “switching on” of an interacting (e.g. reacting) capability of an auxiliary species.
Also, for example, any suitable structural change may be utilised in accordance with the present invention to obtain the second auxiliary species from the first auxiliary species.
By way of example, any substance (e.g. an organic substance) which can act as a ligand, and which can exist in more than one stable form or structure may be suitable to provide a first auxiliary species and a second auxiliary species in accordance with the present invention.
Thus, by way of example, to obtain a second auxiliary species being a ligand any suitable first auxiliary species (which may be considered to be a pro-ligand) capable of forming the ligand may be utilised.
For example, an antigenic ligand (e.g. a hapten) may be selected as the second auxiliary species and antibodies (either monoclonal or polyclonal) to the ligand may be raised (e.g. in any suitable manner such as those known in the art) said antibodies being a binder species forming the third species for reacting with the second auxiliary species.
The second auxiliary species may be formed from the first auxiliary spec
Duffy Patricia A.
GEC--Marconi Limited
Kirschstein et al.
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