Chemistry: analytical and immunological testing – Automated chemical analysis – With a continuously flowing sample or carrier stream
Reexamination Certificate
1999-01-11
2003-09-23
Warden, Jill (Department: 1743)
Chemistry: analytical and immunological testing
Automated chemical analysis
With a continuously flowing sample or carrier stream
C436S043000, C436S180000, C436S172000, C422S068100, C422S082000, C422S082080, C422S082050, C422S105000
Reexamination Certificate
active
06623971
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a capsule chemistry sample liquid analysis system adapted for the automated clinical analysis of pluralities of human biological sample liquids, in particular to a method and apparatus for conducting a stat immunoassay analysis in such a system.
BACKGROUND
U.S. Pat. Nos. 5,268,147 (the “'147 patent”) and 5,399,497 (the “'497 patent”), owned by the assignee hereof, the disclosures of which are incorporated herein by reference, describe a capsule chemistry sample liquid analysis system which operates through repeated reversible, bi-directional flow of an appropriately configured stream of liquid test packages, each test package consisting of alternating segments of a liquid, such as a sample, reagent or buffer, and air, to enable repeated, precisely timed analysis of the sample of each of the test packages in the stream by one or more sample liquid analysis means. As described in the '147 and '497 patents, the system generally comprises a sample liquid test package metering and supply means which operates to meter successive test packages for reaction and analysis within the system; a reversible direction sample liquid test package displacement means which operates to bi-directionally displace the thusly metered and supplied test packages through the system; a test package transfer means which operates in conjunction with the test package metering and supply means and the test package displacement means to provide for the successive test package supply and bi-directional functions of the system; test package reaction and analysis means for analysis of the thusly supplied and displaced text packages; and detection means operatively associated with the reaction and analysis means to detect and quantify the successive sample liquid test package analysis results.
Such a system is particularly adapted to conduct automated clinical analysis of pluralities of human biological sample liquids and can be configured to perform various specific analyses, including a well known so called immunoassay analysis. An embodiment of the system just described configured for conducting an immunoassay analysis is shown in FIG.
1
.
As described in detail in the '147 and '497 patents, the system generally operates by creating a plurality of test packages and successively inserting the test packages into analytical line
30
shown in
FIG. 1
, which preferably comprises a flexible conduit made of transparent Teflon or like material. Co-pending U.S. application Ser. No. 09/111,162, owned by the assignee hereof, the disclosure of which is incorporated herein by reference, describes in detail how the apparatus shown in
FIG. 1
, which includes an aspirating probe
10
connected to a service loop
15
, a liquid supply
20
, an aspiration pump
25
, a transfer loop
35
, and a shear valve
40
, is able to create and subsequently insert the liquid test packages into the analytical line
30
for analysis. Accordingly, that discussion will not be repeated herein.
After insertion into the analytical line
30
, the test packages are repeatedly and bi-directionally flowed back and forth in the analytical line
30
, through operation of the stream pump
46
shown in
FIG. 1
, and ultimately past the appropriate test package reaction, analysis and detection means. Depending on the type of analysis being done, particular devices are disposed along the analytical line
30
so as to comprise the reaction, analysis and detection means. As shown in
FIG. 1
, a configuration appropriate for conducting an immunoassay analysis includes vanish zone
50
, first, second and third bubble detectors
55
, first and second magnets
60
and luminometer
65
. The functionality of these components is described in greater detail both below and in the '147 and '497 patents.
It will be apparent to one of skill in the art that a test package suitable for a so-called sandwich type magnetic particle-based heterogeneous immunoassay is as shown in FIG.
2
. In particular, this test package consists of six liquid segments: a magnetic particle suspension designated as MP, a mixture of sample and first and second reagents designated as S/R
1
/R
2
, a first wash designated as W
1
, a second wash designated as W
2
, a combination of a third reagent and a fourth reagent designated as R
3
/R
4
, and a marker dye designated as D. As illustrated in
FIG. 2
, each of these liquid segments is separated by an air segment It will also be apparent to one of skill in the art that additional suitable immunoassay protocols, and thus additional immunoassay test packages, exist, for example a test package containing eight liquid segments. In addition, the test package shown in
FIG. 2
, as well as the one described below and shown in
FIG. 3
, could include an additional buffer liquid segment as the first liquid segment.
As will be known by one of skill in the art, in a typical sandwich immunoassay analysis which utilizes the test package shown in
FIG. 2
, the sample S is allowed to react with first and second reagents R
1
and R
2
within the test package for a particular, fixed period of time as defined by the assay protocol. Then, the magnetic particles are transferred out of the magnetic particle suspension MP and into the S/R
1
/R
2
segment, where they are allowed to mix for an additional specified amount of time as defined by the assay protocol. Thereafter, the magnetic particles are separated from the S/R
1
/R
2
segment, are transferred to and washed in washes W
1
and W
1
, and are transferred to and reacted with a combination of third and fourth reagents R
3
/R
4
. The reaction between the magnetic particles and the combination of third and fourth reagents R
3
/R
4
generates a detectable response in the form of emitted photons which are in proportion to the analyte concentration in the sample S. The R
3
/R
4
segment which is emitting photons is commonly referred to as a glowing segment. As noted above, a suitable apparatus for carrying out such an immunoassay is shown in FIG.
1
and includes first and second magnets
60
, first, second and third bubble detectors
55
and luminometer
65
. The first magnet
60
is used to transfer the magnetic particles into the S/R
1
/R
2
segment after a specific amount of time, and the second magnet
60
is used to transfer the magnetic particles from the S/R
1
/R
2
segment into washes W
1
and W
2
and ultimately into the R
3
/R
4
segment. The luminometer
65
is used to detect and measure the photons emitted from the segment R
3
/R
4
containing the magnetic particles. Bubble detectors
55
are capable of sensing an interface between an air segment and a liquid segment in a flowing stream of air and liquid segments and thus are used to track the flow of the stream of test packages in the analytical line
30
. Bubble detectors are well known in the art, examples of which are described in U.S. Pat. No. 5,466,946 and U.S. application Ser. No. 08/995,738, both owned by the assignee hereof, the disclosures of which are incorporated herein by reference.
In the sandwich immunoassay analysis just described, the time that it takes for the reactions and various washes to be completed, and thus ultimately the time that it takes to yield a glowing segment that can be analyzed, is typically relatively long, for example, on the order of twenty minutes. It may, however, often be desirable to obtain analysis results for a particular sample S in a much shorter time period. A so-called stat immunoassay, which utilizes the test package shown in
FIG. 3
, has been developed for providing analysis results in a quicker fashion. As can be seen by comparing FIG.
2
and
FIG. 3
, the conventional immunoassay test package, i.e., a non-stat immunoassay test package, and the stat immunoassay test package differ in that for the stat immunoassay, the magnetic particular suspension MP is aspirated along with the sample S, the reagent R
1
and the reagent R
2
when the test package is created, rather than being separated therefrom by an air
Bayer Corporation
Gordon Brian R
Klawitter Andrew L.
Paolino John M.
Warden Jill
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