U.S. patent application number 11/390104 was filed with the patent office on 2006-07-27 for handling method of body fluid sample and analysis apparatus using the same.
Invention is credited to Kyoko Imai, Shigeki Matsubara, Ryuji Tao.
Application Number | 20060165562 11/390104 |
Document ID | / |
Family ID | 26518186 |
Filed Date | 2006-07-27 |
United States Patent
Application |
20060165562 |
Kind Code |
A1 |
Matsubara; Shigeki ; et
al. |
July 27, 2006 |
Handling method of body fluid sample and analysis apparatus using
the same
Abstract
Sample sampling to an analysis apparatus 200 or 820 for
analyzing a biochemical analysis item is performed by a pipetting
device 202 or 840 which uses a repetitively used pipette nozzle,
and sample sampling to an analysis apparatus 100 or 810 for
analyzing an immune analysis item is performed by a pipetting
device 102 or 830 which uses a disposable nozzle tip. A sample
bottle containing a sample to be analyzed on both of a biochemical
analysis item and an immune analysis item is sample-pipetted by the
nozzle tip first, and then transported so as to be sample-pipetted
by the pipette nozzle.
Inventors: |
Matsubara; Shigeki;
(Hitachinaka-shi, JP) ; Imai; Kyoko;
(Hitachinaka-shi, JP) ; Tao; Ryuji;
(Hitachinaka-shi, JP) |
Correspondence
Address: |
MATTINGLY, STANGER, MALUR & BRUNDIDGE, P.C.
1800 DIAGONAL ROAD
SUITE 370
ALEXANDRIA
VA
22314
US
|
Family ID: |
26518186 |
Appl. No.: |
11/390104 |
Filed: |
March 28, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10103990 |
Mar 25, 2002 |
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11390104 |
Mar 28, 2006 |
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09965827 |
Oct 1, 2001 |
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10103990 |
Mar 25, 2002 |
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09360686 |
Jul 26, 1999 |
6319718 |
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09965827 |
Oct 1, 2001 |
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Current U.S.
Class: |
422/400 |
Current CPC
Class: |
Y10T 436/2575 20150115;
G01N 35/1065 20130101; Y10T 436/114165 20150115; G01N 2035/00326
20130101; G01N 2035/1076 20130101; G01N 35/025 20130101; G01N
35/1083 20130101; Y10T 436/114998 20150115; Y10T 436/113332
20150115; G01N 35/1009 20130101; Y10T 436/112499 20150115; G01N
35/026 20130101; Y10T 436/11 20150115; Y10T 436/12 20150115; G01N
35/02 20130101; G01N 2035/103 20130101; G01N 35/00603 20130101;
G01N 2035/1086 20130101 |
Class at
Publication: |
422/100 |
International
Class: |
B01L 3/00 20060101
B01L003/00 |
Foreign Application Data
Date |
Code |
Application Number |
Jul 27, 1998 |
JP |
10-210657 |
Aug 28, 1998 |
JP |
10-243203 |
Claims
1. An analysis apparatus for a body liquid sample comprising a rack
introducing unit for introducing a sample rack having a sample; a
plurality of analysis units for analysis processing the sample; and
a rack transporting apparatus for transporting the sample rack
coming out from said rack introducing unit to at least one of said
plurality of analysis units, which further comprises: a first
analysis unit a first pipetting device using a disposable nozzle
tip and a second analysis unit having a second pipetting device
using a repetitively used pipette nozzle, said first pipetting
device and said second pipetting device being included in said
plurality of analysis units; and a memory unit for storing a
specified analysis item necessary for sample sampling by said
nozzle tip, said sample rack having a sample to be analyzed on said
specified analysis item being transported to said first analysis
unit before being transported to the other analysis units to be
executed sample sampling for said specified analysis item using
said nozzle tip.
2. An analysis apparatus for a body liquid sample according to
claim 1, which further comprises: a display unit for displaying a
screen for specifying said specified analysis item; and a control
unit for recognizing a sample including said specified analysis
item among a plurality of analysis items instructed to be analyzed
and controlling said rack transporting apparatus so that a sample
rack having said recognized sample is transported to said first
analysis unit in first place of sample sampling processing.
24. An analysis apparatus for a body liquid sample according to
claim 2, wherein said screen displayed by said display unit
comprises an analysis item selecting section capable of selecting
one or more analysis items out of a plurality of analysis items;
and a level selecting section capable of instructing an avoiding
level of carry-over corresponding to the selected analysis
item.
4. An analysis apparatus for a body liquid sample according to
claim 1, wherein said plurality of analysis units are arranged
along a transporting path of said rack transporting apparatus, and
a sample rack having samples not requiring analysis of said
specified analysis item is transported so as to be let drop in at
said plurality of analysis units in arranging order depending on
necessity.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to a technology for analyzing
a body fluid sample, and particularly relates to a handling method
of a body fluid sample and an analysis apparatus using the handling
method which can sample the body fluid samples using a plurality of
pipetting devices.
[0003] 2. Description of the Prior Arts
[0004] Analysis of body fluid samples such as blood and urine
samples from patients is widely performed in order to diagnose
pathologies, and automated analysis apparatuses are used in
hospitals and clinical examination rooms.
[0005] In order to diagnose the pathologies, examination results
obtainable by only one automatic analyzer are insufficient in most
cases. In such a case, it is necessary to collect examination data
from a plurality of analysis units. Japanese Patent Application
Laid-Open Nos. 9-281113 and 9-304396 disclose an analysis system
which can analyze various kinds of analysis items by one
system.
[0006] These prior arts propose an analysis system in which a
plurality of analysis units for biochemical analysis are arranged
along a sample rack transportation line, and a sample rack from a
rack supply unit is dropped in at any one of the analysis units to
pipette a sample on the sample rack using a pipette nozzle.
[0007] The U.S. Pat. No. 5,470,534 discloses an analysis system in
which a biochemical analyzer, an immune analyzer and a nucleic acid
analyzer are arranged along a transportation path for a sample
bottle so that a single sample can be measured by each of the
analyzers. In this prior art, whether or not the sample should
proceed to a second measuring stage is determined depending on an
analysis result in a first measuring stage. A biochemical analysis
item is analyzed in the first measuring stage, and a sample
necessary to proceed to the second measuring stage in order to
identify a pathology is analyzed by the immune analyzer and/or the
nucleic acid analyzer in the second stage.
[0008] On the other hand, in the apparatus automatically analyzing
body fluid samples, many samples are successively pipetted usually
using one pipette nozzle. Therefore, there arises a contamination
problem of the following samples caused by residue of the preceding
sample on the pipette nozzle. A technology in regard to carry-over
of this kind is disclosed, for example, in Japanese Patent
Application Laid-Open No. 4-169851. In this example, analysis of a
biochemical analysis item such as measurement of components usually
contained in blood and analysis of an immune analysis item such as
detecting an antigen or an antibody utilizing cohesive reaction of
latex particles using a row of reaction containers formed in a
circular shape.
[0009] Further, Japanese Patent Application Laid-Open No. 4-169851
points out that useless consumption of washing solution can be
prevented by spending sufficient washing time in washing a reagent
pipette nozzle after pipetting a reagent for an immune analysis
item using a washing solution or by increasing a delivery flow rate
of the washing solution to wash the reagent pipette nozzle, and by
spending short washing time in washing a reagent pipette nozzle
after pipetting a reagent for a biochemical analysis item or by
decreasing a delivery flow rate of the washing solution to wash the
reagent pipette nozzle.
[0010] In addition, Japanese Patent Application Laid-Open No.
4-169851 also points out that in a case of a sample pipette nozzle
different from the reagent pipette nozzle, useless consumption of
washing solution can be prevented by controlling the flow rate of
the washing solution.
[0011] As an another type to pipette a body fluid sample, it is
widely known to use a disposable nozzle tip. For example, U.S. Pat.
No. 5,639,425 discloses a method comprising the steps of providing
a tip holder at a position within a movable range of a coupling
tube which can be coupled to a nozzle tip, transporting a nozzle
tip from a tip rack on which many nozzle tips are arranged to the
position of the tip holder, then coupling the nozzle tip with an
end portion of the coupling tube on the tip holder, discharging a
sample sucked inside the coupled nozzle tip into a reaction
container, and after discharging the sample, removing the nozzle
tip from the coupling tube at a tip detaching station.
[0012] Moreover, Japanese Patent Application Laid-Open No. 2-25755
discloses an analysis apparatus in which a plurality of reaction
parts are arranged near the transportation line for transporting
the sample rack, and a bypass line and a sample dilution part are
disposed between the transportation line and the respective
reaction parts.
[0013] This reference discloses further that the plurality of
reaction parts are constructed to analyze the sample by a
calorimathod, an ion selective electrode method and an immunity
method. In this example, the sample rack is moved from the
transportation line to the bypass line by a rack changer provided
in the transportation line, and a dilution arm pippetes the sample
from the sample rack on the bypass line to the sample dilution
part, and other pippetting arm having a different construction
pippetes the sample from the sample dilution part to the reaction
part. Furthermore, it is disclosed that it is preferable for the
plurality of the reaction parts to be arranged in a sequence to
prevent the mutual contamination between the samples.
[Discussion of the Prior Arts]
[0014] Many methods for measuring immune analysis items include an
operation for binding a label substance to solid phase utilizing an
antigen-antibody reaction (that is, an immune reaction).
[0015] In a case where there are needs to analyze both of an immune
analysis item through such a method and a biochemical analysis item
through a method of measuring an absorbance of a reaction solution
produced as a result of the chemical reaction, or there are needs
to analyze a DNA analysis item and biochemical analysis item, it is
convenient for handling samples that plurality of analysis units
are placed in an analysis system and a single sample bottle is
commonly used for each of the analysis units.
[0016] However in U.S. Pat. No. 5,470,534 in connection with the
analysis systems of such a type, there is no description on
measures for avoiding the carry-over between samples.
[0017] Furthermore, in Japanese Patent Application Laid-Open No.
9-281113 and Japanese Patent Application Laid-Open No. 9-304396,
plurality of analysis units are disclosed, however there is no
description to arrange both of a biochemical analysis unit and a
immune analysis unit, or to arrange both of the biochemical
analysis unit and a DNA analysis unit.
[0018] Japanese Patent Application Laid-Open No. 4-169851 proposes
that the carry-over is avoided only by washing operation using a
single pipette nozzle repetitively used for both of a biochemical
analysis item and an immune analysis item. However, since there is
a limitation in the actually applicable washing time or washing
flow rate, it is difficult to eliminate the effect of carry-over on
a measured value of an immune analysis item in which existence of
an extremely small amount of a residual sample causes a
problem.
[0019] According to the construction using the disposable nozzle
tip described in U.S. Pat. No. 5,637,425, there is no problem on
the effect of carry-over between samples since the nozzle tip is
exchanged for each sample. However, since there are the coupling
operation and the detaching operation of the nozzle tip for each
sample, the method has a disadvantage in that a sufficient
processing capacity can not be attained when a large volume of
analysis items such as biochemical analysis items must be processed
in a short time.
[0020] In a analysis apparatus described in Japanese Patent
Application Laid-Open No. 2-25755, there is not any difference
between the construction of the plurality of the reaction parts,
and it is intended to prevent the mutual contamination between the
samples only by changing the arranging sequence of the reaction
parts. However, the dilution arm and the pippeting arm are commonly
used for all of the samples repeatedly, therefore, it becomes
difficult to avoid the carry-over between the samples caused by
using these arms.
SUMMARY OF THE INVENTION
[Object of the Invention]
[0021] An object of the present invention is not to be affected by
carry-over between samples on a measured value of an immune
analysis item though a repetitively used pipette nozzle in sample
sampling for biochemical analysis items is employed.
[0022] Another object of the present invention is to provide a
method and an apparatus which can prevent deterioration of the
processing capacity in regard to biochemical analysis items and can
avoid the carry-over between samples in regard to immune analysis
items in a case where the biochemical analysis items and the immune
analysis items are analyzed using separate analysis units,
respectively.
[0023] A further object of the present invention is to make it
possible to avoid the carry-over between samples by using both of a
pipetting device of a type which samples a sample using a
repetitively used pipette nozzle and a pipetting device of a type
which samples a sample using a disposable nozzle.
[0024] A further object of the present invention is to provide a
method and an apparatus which can process a specified sample
without being affected by the carry-over between samples when being
ordered to analyze both of analysis item which should highly avoid
the carry-over and analysis item which does not need so much to
avoid the carry-over.
[0025] A further object of the present invention is to provide an
apparatus which can select a re-measurement logic and/or analysis
channel for the re-measurement automatically, before the
re-measurement of the sample is performed according to a
measurement result of the sample once measured.
[Statement of the Invention]
[0026] The present invention is characterized by an analysis
apparatus in which a sample is sampled from a single sample bottle
to a plurality of receiving containers using a plurality of sample
pipetting devices, and the each sample received in each of the
receiving containers is analyzed, wherein the plurality of sample
pipetting devices include first pipetting devices using a
disposable nozzle tip and second pipetting devices using a
repetitive used pipette nozzle, and operation of sampling the
sample from the single sample bottle is executed by the second
pipetting devices after executed by the first pipetting
devices.
[0027] It is preferable that the analysis apparatus comprises at
least two kinds of analysis units, and a first analysis unit has
the first pipetting device using a disposable nozzle tip and a
second analysis unit has the second pipetting device using a
repetitively used pipette nozzle. In this case, in regard to a
specified sample to be analysis measured in the first and the
second analysis unit, sample sampling is executed in the first
analysis unit in prior to sample sampling in the second analysis
unit, and the sample sampling in the second analysis unit is
executed after completing of sampling the specified sample by the
first analysis unit.
[0028] The analysis apparatus comprises a standby unit for letting
a sample rack which has been already executed sample sampling in
the first analysis unit but not yet executed sample sampling in the
second analysis unit stand by therein (the sample rack has the
specified sample). The specified sample is transported to the first
analysis unit from the standby unit to be sampled in the first
analysis unit for re-measurement before sampling the specified
sample in the second analysis unit when a measured result of the
first analysis unit in regard to the specified sample is necessary
to execute the re-measurement.
[0029] By constructing in such that the first analysis unit
measures an immune analysis item or a DNA analysis item, and the
second analysis unit measures a biochemical analysis item, the
immune analysis item or the DNA analysis item is sampled before
sampling relating to the biochemical analysis item.
[0030] In this case, whenever the samples are changed, the nozzle
tips are changed, and the analysis measured value of the immune
analysis item or the DNA analysis item is not affected by the
carry-over between samples.
[0031] Furthermore, the analysis measured value of the biochemical
analysis item does not receive the affection by the carry-over
between samples by washing the pipette nozzle repetitively used for
sampling the sample relating to the biochemical analysis item by a
well-known washing method whenever the samples are changed.
[0032] In the analysis apparatus, an analysis item which needs to
avoid the affection of very small carry-over between the samples,
that is, a specified analysis item requiring sample sampling by a
nozzle tip is pre-registered in the analysis apparatus. Such a
specified analysis item is stored in a memory unit in a control
unit, and if the specified analysis item is included among items to
be analyzed on many samples each of which is instructed by an
operator, the sample is transported initially to the first analysis
unit to be sampled using a nozzle tip before it is transported the
other analysis apparatus when sample sampling is performed on the
sample.
[0033] A specified sample rack having a specified sample required
to be analyzed in both of the first and the second analysis unit is
restricted in the transportation order or the transportation path
as described above, but a sample rack having only samples not
required to be sampled by the nozzle tip is transported so as to be
let drop in at the plurality of analysis units in arranging order
depending on necessity to be sampled. In this case, the sampling
process is efficiently performed.
[0034] In a case where the plurality of analysis units include a
first analysis unit having a pipetting device using a disposable
nozzle tip and a second and a third analysis apparatus having a
pipetting device using a repetitively used pipette nozzle and the
plurality of analysis units are arranged at positions in the order
of the third analysis apparatus, the first analysis unit and the
second analysis unit from the side near the rack supply unit, in
regard to a specified sample rack having a specified sample
necessary for analysis measurement in the first, the second and the
third analysis apparatus, the specified sample rack being
transported to the first analysis unit to execute sample sampling
using the nozzle tip first, then the specified sample rack being
let stand by in the standby unit, the specified sample rack on
standby in the standby unit being transferred to the rack
transporting apparatus through the returning line when
re-measurement of the specified sample by the first analysis unit
is determined to be necessary, then sample sampling for the
re-measurement in the first analysis unit being executed.
[0035] Then, in the first analysis unit, the specified sample rack
having the specified sample finished sampling of sample for
re-measurement is transferred to the rack transporting apparatus
through the returning line, and then the specified sample is
sampled in the third analysis apparatus and/or the second analysis
unit. On the other hand, when re-measurement of the specified
sample is determined to be unnecessary, the specified sample rack
on standby in the standby unit is transferred to the rack
transporting apparatus through the returning line and then the
specified sample is sampled in the third analysis apparatus and/or
the second analysis unit.
[0036] A method of handling a body fluid sample in accordance with
the present invention is characterized by that a sample rack having
a sample is positioned to at least one out of a plurality of
analysis units, and analysis of the sample sampled on the sample
rack is performed in the analysis apparatus, wherein the method
comprises the steps of processing the sample by an analyzer having
a first analysis unit having a first pipetting device using a
disposable nozzle tip and a second analysis unit having a second
pipetting device using a repetitively used pipette nozzle;
transporting a specified sample rack having a specified sample to
be analyzed in the first and the second analysis unit to the first
analysis unit to sample the specified sample in the first analysis
unit in prior to transferring the sample rack to the second
analysis unit; letting the specified sample rack finished sampling
of sample in the first analysis unit temporarily stand by in a
standby unit before transporting the specified sample rack to the
second analysis unit; judging whether or not re-measurement of the
specified sample by the first analysis unit is necessary;
transporting the specified sample rack from the standby unit to the
second analysis unit and sampling the specified sample by the
pipette nozzle if the result of judgment is that re-measurement of
the specified sample by the first analysis unit is not necessary;
transporting the specified sample rack from the standby unit to the
first analysis unit and sampling the specified sample for
re-measurement in said first analysis unit if the result of
judgment is that re-measurement of the specified sample by the
first analysis unit is necessary; and transporting the specified
sample rack finished sampling of the sample for re-measurement to
the second analysis unit and sampling the specified sample by the
pipette nozzle.
[0037] Furthermore, in the handling method of the biochemical
sample based on the present invention, an image plane to for
selecting the analysis items relating to the respective samples is
displayed on a display device, and an indication field to indicate
a necessity to avoid the carry-over between the sample relating to
the selected analysis item is displayed on the display device. When
the sample to be analyzed the analysis item which is indicated to
need to avoid the carry-over and the analysis item which is not
indicated to need to avoid the carry-over, are sampled in the
analysis part, the sampling relating to the analysis item which is
not indicated to need to avoid the carry-over is performed, after
the sampling relating to the analysis item which is indicated to
need to avoid the carry-over finishes.
[0038] In this case, the information to show the necessity to avoid
the carry-over is stored in a memory device relating to the
analysis item which is indicated the necessity to avoid the
carry-over, after that, a memorized information may be output on
the display device when the same analysis items are selected.
BRIEF DESCRIPTION OF THE DRAWINGS
[0039] FIG. 1 is a plane view showing the outline of a
configuration of an embodiment in accordance with the present
invention.
[0040] FIG. 2 is an enlarged plane view showing an analysis unit
for the immune analysis items of the analysis apparatus shown in
FIG. 1.
[0041] FIG. 3 is a view for explaining operation of a pipetting
device in the analysis unit shown in FIG. 2.
[0042] FIG. 4 is an enlarged perspective view showing an analysis
unit for the biochemical analysis items of the analysis apparatus
shown in FIG. 1.
[0043] FIG. 5 is a view for explaining a screen for setting a
sample volume, a reagent volume and a carry-over avoiding
level.
[0044] FIG. 6 is a view for showing an example of a screen for
selecting a designated analysis item for each sample.
[0045] FIG. 7 is a view showing an example of the screen for
selecting a designated analysis item for the same sample as that in
FIG. 6.
[0046] FIG. 8 is an outline of a configuration of an another
embodiment in accordance with the present invention.
[0047] FIG. 9 is an outline of a configuration of the third
embodiment in accordance with the present invention.
[0048] FIG. 10 is a view for explaining an operating flow of the
analysis apparatus shown in FIG. 9.
[0049] FIGS. 11A and 11B respectively are views for showing a
process flow for transporting the sample rack of the analysis
apparatus shown in FIG. 9.
[0050] FIG. 12 is an outline of a configuration of the fourth
embodiment in accordance with the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0051] In a preferred embodiment of the present invention, a sample
bottle containing a body fluid sample such as blood, blood serum or
urine is handled in a state of being held in a sample rack as a
bottle holder. It is preferable that the sample rack can hold one
or more sample bottles, but in the following embodiment, an example
as that one sample rack can hold up to five sample bottles.
[0052] FIG. 1 is a plane view showing the outline of a
configuration of an embodiment of an automatic analysis apparatus
to which the present invention is applied. In FIG. 1, a rack supply
unit 10 is operated so as to supply a sample rack 2 to a rack
transportation line 60 of a rack transportation apparatus. The rack
supply unit 10 comprises an area capable of placing a tray on which
a plurality of sample racks are arranged and an identification read
unit 15. The rack supply unit 10 is sometimes called as a rack
loading unit because the rack supply unit is loaded with the sample
rack 2 having samples. The sample racks 2 supplied to the rack
supply unit are pushed to an entrance side of the rack
transportation line 60 one-by-one by a well-known rack pushing
mechanism. The pushed sample rack 2 is moved up to a reading
position of the identification read unit 15 by a mover such as a
movable hook.
[0053] The sample rack 2 is, for example, a rectangular
parallelepiped shaped holder, and can hold the plurality of sample
bottles 5 (Refer FIG. 2) in a row along the lateral direction of
the sample rack. To the sample rack 2 of this type, a bar-code
label having coded rack identification information including kind
of rack and rack number is attached. In each of the sample bottle
5, a bar-code label having coded sample information such as bottle
identification number, patient code, medical section number, sample
receipt number is attached.
[0054] The automatic analysis apparatus of FIG. 1 comprises a rack
stoker 30 orderly storing the sample racks transported by the rack
transportation line 60. A electrolyte item analysis unit 300, a
immune item or DNA item analysis unit 100, a biochemical analysis
unit 200 and a standby unit 20 as a standby unit are arranged in
this order from a position near the rack supply apparatus along the
rack transportation line 60 between the rack supply apparatus 10
and the rack stoker 30.
[0055] The electrolyte item analysis unit 300 comprises a pipetting
device 302 which pipettes a sample from a sample bottle on the
sample rack stopping at a sample pipetting position on the rack
transportation line 60 for the electrolyte item analysis unit 300
to a dilution container 305 contained in the electrolyte item
analysis unit 300.
[0056] The pipetting device 302 has a repetitively used pipette
nozzle, that is, a pippeting nozzle commonly used for the different
samples, sucks and holds a sample in a sample container on the
sample rack in the pipette nozzle, and discharges a predetermined
amount of the held sample into the dilution container 305.
[0057] The sample diluted with a diluent in the dilution container
305 is conducted to a flow cell by a sucking tube (not shown), and
electrolytic components contained in the sample such as sodium ion,
potassium ion, chlorine ion and so on are measured using an ion
selective electrode for each ion arranged in the flow cell. An
analysis unit control part 301 contained in the analysis unit 300
executes calculation to obtain a concentration of each of the
electrolytic components based on a detected signal of each ion, and
reports the obtained measured value to a total system control unit
50.
[0058] The immune item or DNA item analysis unit 100 uses a
disposable nozzle tip, as to be described later, and comprises a
pipetting device 102 which is operated so as to suck a sample from
a sample bottle on the sample rack positioned at a sample sampling
position on a bypass line 61 into the nozzle tip, hold the sucked
sample in the nozzle tip and then discharge the preset amount of
the held sample into a reaction container on a reaction disk
103.
[0059] The pipetting device 102 exchanges the nozzle tip every time
when the samples are changed. For example, in a case that there is
one analysis item to be analyzed in the analysis unit 100 relating
to a former sample, the pipetting device 102 removes the used
nozzle tip after one sampling operation is performed for the former
sample, and then a new nozzle tip is mounted.
[0060] On the other hand, in a case that there is three analysis
items to be analyzed in the analysis unit 100 relating to the
following next sample, the pipetting device 102 removes the used
nozzle tip after the tree times of the sampling to the three
reaction containers are performed, after that, the new nozzle tip
is mounted.
[0061] When the analysis unit 100 is that used to analyze the
immune analysis item, the sample pipetted in the reaction container
on the reaction disk 103 is mixed with a reagent for immune
reaction. After immune reaction between the sample and the reagent,
an analysis item is measured through further steps if necessary. In
this case, the word "immune reaction" is a synonym for
antigen-antibody reaction.
[0062] When the analysis unit 100 is that used to analyze the DNA
analysis item, the sample pippeted in the reaction container on the
reaction disk 103, is mixed with a reagent for nucleic acid
analysis, after hybridization reaction thereof, a portion combined
with a label is cut out with a restriction enzyme, and analysis
results of the DNA analysis items are obtained base on the
measurement of the label.
[0063] A feature for obtaining a measured value of an immune
analysis item utilizing an immune reaction between a sample and a
reagent is a method of measuring a label substance utilizing a sold
phase such as magnetic particles produced by an antibody. For
example, a substance to be analyzed in a sample and a solid phase
are bound by a immune reaction, and a reagent having a label
substance is bound to the first complex, and then the solid phase
is separated from liquid phase. The separated liquid phase is
conducted to a flow cell, and the label substance is measured
through fluorescence photometry or chemi-luminescence photometry.
Otherwise, the solid phase after liquid separation is introduced to
a photometric position, and a marker bound on the solid phase is
measured through a chemi-luminescence method or an electro-chemical
luminescence method. An analysis unit control part 101 contained in
the analysis unit 100 performs control of operation of each
mechanism units in the analysis unit 100 and calculation of
measured data on an analysis item.
[0064] The biochmical analysis unit 200 comprises a pipetting
device 202 for pipetting a sample using a repetitively used pipette
nozzle, as to be described later. The pipetting device 202 is
operated so as to suck a sample from a sample bottle on the sample
rack, which is positioned at a sample pipetting position on the
bypass line 62 through the rack transportation line 60, into a
portion near the end of the pipette nozzle, hold the sucked sample
in the pipette nozzle, and then discharge the preset amount of the
held sample into a reaction container on a reaction disk 203. A
chemical reaction between the sample and a reagent is progressed in
the reaction container, and a optical characteristic of the
produced reaction solution is measured. In this example, the
reaction solution is optically measured in a sate that the reaction
solution is contained in the reaction container to obtain a
measured value of a biochemical analysis item. An analysis unit
control part 201 contained in the analysis unit 200 performs
control of operation of each mechanism units in the analysis unit
200 and calculation of measured data on an analysis item.
[0065] In the analysis apparatus of FIG. 1, the rack transportation
apparatus for transporting the sample rack having samples includes
the rack transportation line 60, the bypass line 61 for the
analysis unit 100 and the bypass line 62 for the analysis unit 200.
Each of the bypass lines 61, 62 is formed nearly parallel to the
rack transportation line 60, and receives the sample rack in the
upstream side of the bypass line from the rack transportation line
60, and the sample rack finishing pipetting of the sample in the
downstream side of the bypass line is transfered to the rack
transportation line 60. The sample rack on the rack transportation
line 60 and the bypass line 61, 62 is transported to a preset
position by a well-known transporting means in which a belt
conveyer or a movable hook is driven by a motor.
[0066] The sample rack 2 having the sample is positioned in at
least one of the plurality of analysis units, and the sample is
pipetted from the sample bottle on the sample rack by the
corresponding analysis unit, and then the sample rack is
transported to the standby unit 20. A sample rack having
possibility of re-examination is let stand by in the standby unit
20 until the control unit judges necessity of re-measurement. The
sample rack entering into the standby unit 20 is moved along a
U-shaped path. The sample rack having no samples judged to be
necessary to be re-measured from the measured results of the
corresponding analysis unit is immediately contained in a rack
stoker 30. However, the sample rack having any samples judged to be
necessary to be re-measured from the measured results of the
corresponding analysis unit is transferred from the standby unit 20
to the returning line 65, transported to the entrance side of the
rack transportation line 60 from the returning line 65, transferred
to the rack transportation line 60 again and transported to the
analysis unit for the re-measurement to be sampled.
[0067] As described above, the standby unit 20 lets the sample rack
finished sampling of sample in any one out of the plurality of
analysis units temporarily stand by therein, but the sample rack
finished sampling of sample in the analysis unit 100 for the immune
analysis item is specially handled. That is, letting a sample
instructed to be necessary for analysis and measurement by the
three analysis units 100, 200, 300 or by the two analysis units
100, 200 be called as a specified sample, and letting a sample rack
having the specified sample be called as a specified sample rack,
the specified sample rack is initially transported to the analysis
unit 100 for the immune analysis item to sample the specified
sample by a disposable nozzle tip coupled with the pipetting device
102 in prior to transported to the other analysis unit. The
specified sample rack is let enter into the standby unit 20 without
dropping in at any other analysis unit. Then, when it is judged
from a measured result of the analysis unit 100 in regard to the
specified sample that execution of the re-measurement to the
specified sample is necessary, the specified sample standing-by at
the standby unit 20 is transferred to the rack transportation
apparatus 60 through the returning line 65.
[0068] The specified sample rack to be re-measured is transported
to the analysis unit 100 for the immune analysis item by the rack
transportation apparatus without dropping in at any other analysis
unit to be sampled the specified sample for the re-measurement. At
that time, a new nozzle tip is coupled to the nozzle coupling tube
of the pipetting device 102. Such operation is performed only in a
case where one sample bottle is held on the sample rack. In a case
of a plurality of samples, the transporting operation of the sample
rack becomes complex because it is necessary to satisfy sampling of
all the samples.
[0069] Operations of the rack supply unit 10, the standby unit 20,
the rack stoker 30, the transportation apparatus including the
transportation line 60 and the returning line 65 are controlled by
the total system control unit 50. A read result by the bar code
reader 16 as an identification information reading unit for the
sample rack and the sample bottle is also transmitted to the total
system control unit 50. The total system control unit 50 comprises
a memory unit 51, and connected to an operating unit 52 with a key
board, a CRT 53 as a screen display unit, a printer 54 for output
an analysis result of each sample, and a floppy disk memory 55
storing an operating program of the analysis apparatus.
[0070] Since an item to be analyzed to each sample on each sample
rack is pre-instructed from the operating unit 52 before starting
analysis operation and stored in the memory unit 51, the total
system control unit 50 compares read information by the bar code
reader 16 with the stored analysis item information and can be
determine an analysis unit to which each sample rack should be
transported based on the comparison result.
[0071] In the example of FIG. 1, one set of the analysis unit 100
used for analysis measurement of an immune analysis item and one
set of the analysis unit 200 used for analysis measurement of a
biochemical analysis item are arranged. Two or more sets of these
analysis unit for each may be arranged along the rack
transportation line 60.
[0072] An example of the construction of the unit for the immune
analysis item will be described in detail below, referring to FIG.
2 and FIG. 3. The first analysis unit 100 comprises the pipetting
device 102 for pipetting a sample, a reaction disk 103 having a
constant temperature maintaining function and capable of
rotationally moving the mounted reaction containers 105, a
rotatable reagent disk 115 on which reagent bottles 117 are
arranged along the circumference combining a plural kinds of
reagents for each analysis item, a reagent pipetter 110 for
pipetting a reagent from the reagent bottle 117 to the reaction
container 105 on the reaction disk 103, a sipper mechanism 130 for
introducing a mixed solution of the sample and the reagent formed
on the reaction disk 103, an unused reaction container 105 placed
in a part supply area 135 and a carriage mechanism 120 for
transporting an unused nozzle tip 125 to a predetermined position
by a gripper.
[0073] The pipetting device 102 for sampling a sample has a
coupling tube 104 capable of detachably coupling with the
disposable nozzle tip 125 shown in FIG. 3. The coupling tube 104 is
connected to a pump system 109 having a sucking and discharging
mechanism, and supported to a movable arm 106 movable in the
vertical direction and rotatable in the horizontal direction.
[0074] When analysis operation is started, the transportation
mechanism 120 grips a disposable unused reaction container 105
placed in the part supply area 135 by the gripper 128 to transport
it to the reaction disk 103, and releases gripping at a position
121 to put the reaction container on the reaction disk. Then, the
transportation mechanism 120 grips the unused nozzle tip 125 placed
in the part supply area 135 by the gripper 128 and releases
gripping at a coupling position 107 to put the nozzle tip on the
coupling position.
[0075] The sample rack 2 transported from the rack supply unit 10
through rack transportation line 60 is transferred to the bypass
line 61 of the analysis unit 100, and moved to a sample sampling
position 111. The pipetting device 102 positions the movable arm
106 to the coupling position 107, and moves down the coupling tube
104 to engage the unused nozzle tip 125 with the end of the
coupling tube 104 (refer to FIG. 3). Then, the pipetting device 102
rotates the coupling tube 104 to the sampling position, and inserts
the end of the nozzle tip 125 up to slightly lower than the liquid
surface of the sample in the sample bottle 5 on the sample rack to
suck a preset amount of the sample in the nozzle tip 125 and hold
it there.
[0076] Since the unused reaction container 102 has been moved from
the position 121 to a discharging position 112, the pipetting
device 102 discharges the preset amount of the sample held in the
nozzle tip 125 to the reaction container 105 placed at the
discharging position 112. After the sampling is repeated necessary
times relating to the one sample, the pipetting device 102 moves
the coupling tube 104 to a detaching position 108 to remove the
used nozzle tip 125 from the coupling tube 104. The removing
operation of the nozzle tip is performed by bringing the upper end
surface of the nozzle tip in contact with a lower surface of a
split groove larger than an outer diameter of the coupling tube 104
and smaller than an outer diameter of the upper end of the nozzle
tip 125, and then moving the coupling tube 104 upward. The removed
nozzle tip is collected in a disposal box. In a case where there
are a plurality of analysis items to be analyzed by the analysis
unit 100 on a sample in a single sample bottle, one nozzle tip is
continuously used for sampling the samples of these analysis items.
After that, the nozzle tip is removed from the coupling tube 104.
By doing so, number of consumed nozzle tips can be reduced.
[0077] The reaction container receiving the sample is moved to a
reagent receiving position 113 by the reaction disk 103. The
reagent pipetter 110 sucks a dispersed solution of fine magnetic
particles as a solid phase into the pipette nozzle at a position
118, and discharges the dispersed solution to the reaction
container on the reagent receiving position 113. Thus, a first
immune reaction of binding a substance to be analyzed in the
sample, for example, an antigen to the solid phase is started.
After a predetermined time, a reagent containing a label substance
sucked into the pipette nozzle is discharged from the reagent
pipetter 110 at the position 119 into the reaction container again
positioned at the reagent receiving position 113. Thus, a second
immune reaction of binding the label substance to the substance to
be analyzed in the reaction container is started. The pipette
nozzle of the reagent pipetter 110 is used by washing every reagent
pipetting.
[0078] After that, the reaction container 105 containing the
reaction solution of the immune reaction is positioned at a sucking
position 114 by the reaction disk 103. The sipper mechanism 130
introduces the reaction solution to a detection unit 140 from the
reaction container at the sucking position 114 through a sucking
nozzle. In the detection unit 140, the liquid phase containing
substance not binding with the magnetic particles flows through
while the magnetic particles are being attached onto the wall
surface by a magnet. By doing so, the solid is separated from the
liquid phase. The separated liquid phase is conducted to a
measuring unit to measure fluorescence or chemi-luminescence of the
label substance contained in the liquid phase. Otherwise, the
separating position and the measuring unit are commonly used, and
measurement is performed by generating chemi-luminescence or
electro-chemical-luminescence from the label substance binding with
the magnetic particles through the substance to be analyzed. After
that, the sipper mechanism 130 sucks a washing solution from a
washing tank 131 through the sucking nozzle to wash the flow
passage of the detection unit 140. The used reaction container is
removed from the reaction disk 103 by the transportation mechanism
at the position 121.
[0079] An example of the construction of the analysis unit for the
biochemical analysis item in FIG. 1 will be described below in
detail, referring to FIG. 4. The analysis unit 200 for analyzing a
biochemical analysis item comprises a reaction disk 203 on which
transparent reaction containers 205 are concentrically arranged.
Water maintained at a preset temperature (for example, 37.degree.
C.) is supplied to a constant temperature bath of the reaction disk
203 from a constant temperature water supply unit 230. There are
two sets of reagent supply systems, and a reagent selected out of
many reagent bottles 217 arranged in the first reagent disk 215 is
pipetted to the reaction container 205 on the reaction disk 203 by
a reagent pipetter 210, and a reagent selected out of many reagent
bottles 218 arranged in the second reagent disk 216 is pipetted to
the reaction container 205 on the reaction disk by a reagent
pipetter 211. A mixer 219 mixes a mixture of the sample and the
reagent in the reaction container.
[0080] The pipette unit 202 for pipetting a sample comprises a
pipette nozzle 225 capable of sucking and discharging liquid, and
can position the pipette nozzle at a sample pipetting position on
the bypass line 62, a sample discharging position 204 on the
reaction disk 203 and a probe washing tank 207. The pipette nozzle
225 finishing pipetting a sample on the sample rack 2 is washed in
an outer wall surface and an inner wall surface of the pipette
nozzle with a washing solution in the probe washing tank 207 before
pipetting another sample, and repetitively used for many
samples.
[0081] A reaction solution between the sample and the reagent
formed in the reaction container 205 on the reaction disk 203 is
irradiated with a light beam from a multi-wavelength light source
235 in a state of contained in the reaction container. The light
passed through the reaction container is converted to a spectrum by
a multi-wavelength photometer 240 to selectively detect a
wavelength corresponding to an analysis item, and the measured
light signal is digitized by an analogue-digital converter 245 and
input to an analysis unit control part 201 to be calculation
processed. The reaction container finishing photometrical measuring
is washed in a container washing unit (not shown) and moved to the
sample discharging position so as to receive a new sample.
[0082] In the analysis unit 200 of FIG. 4, the sample rack 2
transferred to the bypass line 62 through the rack transportation
line 60 is positioned at the sample sampling position on the bypass
line 62. The pipetting device 202 inserts the end of the pipette
nozzle 225 up to slightly lower than the liquid surface of the
sample in the sample bottle 5 at the sample pipetting position and
sucks a preset amount of the sample in to a portion near the end of
the probe and hold it there, and then moves the pipette nozzle 225
to the sample discharging position 204 of the row of the reaction
containers. After that, the sample held in the probe is discharged
into a washed reactor container placed at the discharge position
204.
[0083] The reaction container 205 receiving the sample is moved to
a first reagent adding position by the reaction disk 203, and the
first reagent corresponding to the analysis item is pipetted into
the reaction container by the reagent pipetter 210. Then, the
mixture in the reaction container is mixed by the mixing mechanism
219 to progress the chemical reaction between the sample and the
reagent. In a case of an analysis item requiring a second reagent,
the second reagent is further added to the reaction container at a
second reagent adding position by the reagent pipetter 211. The
reaction container containing the reaction solution is moved so as
to cross a light beam of a photometrical position 241, and an
absorbance of the reaction solution is measured based on the
transmitting light at that time, and a concentration of the
substance to be measured or an enzyme active value in the sample is
calculated by the analysis unit control part 201 and the measured
result is stored in the memory unit 51 of the total system control
unit 50.
[0084] An example of operation of the automatic analysis apparatus
in the embodiment of FIG. 1 will be described below, referring to
FIG. 5 to FIG. 7. Before starting analysis operation, analysis
items required for each sample from a patient are input through the
operating unit 52. Each of the sample is usually requested to
perform analytical examination on a plurality of analysis items. In
the automatic analysis apparatus, an analysis item having a high
necessity to avoid the carry-over is preset and stored in the
memory unit 51 of the total system control unit 50.
[0085] When setting of analysis condition is instructed from the
operating unit 52, an analysis condition setting screen 70 is
displayed on the CRT 53 as a screen display unit. This screen 70
comprises a button 71 for invoking a routine operation screen, a
button 72 for invoking a reagent control screen, a button 73 for
invoking a calibration screen, a button 74 for invoking an quality
control screen, and a button 75 for invoking a utility screen
arranged in an upper section, as shown in FIG. 5. By touching each
of the buttons with a finger by a touching panel method, or by
clicking each of the buttons with a pointer by operating a mouse,
the corresponding screen is displayed in the central portion. FIG.
5 shows an example of invoking a corresponding screen by touching
the utility screen invoking button 75. A help button 76 is arranged
below the analysis condition setting screen 70, and by touching
this button 76 an explanation sentence for screen operation is
displayed.
[0086] A button 81 for instructing stopping the analysis apparatus,
a button 82 for instructing stopping samplings-operation during
analysis operation, a button 83 for invoking an alarm screen, a
button 84 for invoking a screen showing states of each analysis
unit and rack transportation, a button 85 for instructing printing
to the printer 54, a button 86 for instructing starting the
analysis apparatus are arranged in an area in the right hand side
or the left hand side of the analysis condition setting screen 70.
Each of the above-mentioned buttons is always displayed when the
analysis condition setting screen 70 is displayed.
[0087] Here, when the utility screen invoking button 75 is
selected, screen invoking buttons for system 151, maintenance 152,
application 153, calculation item 154, carry-over 155, report 156
and unit configuration 157 appear in a display area 150, and a
button 161 for instructing adding, a button 162 for instructing
writing of data base to a floppy disk memory, a button 163 for
instructing deleting and a button 164 for instructing reading from
the floppy disk memory appear. When the button 153 for invoking an
application screen is selected in this state, a table of list 170
showing a plurality of analysis items and sample kinds appears, and
detailed screen invoking buttons 171 to 174 appear.
[0088] When the analysis button 171 out of the detailed screen
invoking buttons is further selected, a screen shown in FIG. 5
appears in a display area 180. That is, a section 181 for setting
an amount of sample, a section 182 for setting an amount of
pipetted reagent, a level setting section 183 for setting a
carry-over avoiding level and a button 184 for instructing storing
are displayed.
[0089] In the analysis items displayed in the table of list 170 in
the screen of FIG. 5, TSH means thyrotropin, T4 means thyroxine,
TF4 means free thyroxine, CEA means carcino-embryonic antigen, HCG
means human chorionic gonadotropin, TNT means troponin T, HBsAg
means hepatitis B surface antigen, and a-HBs means hepatitis B
surface antibody. All of these are immune analysis items.
[0090] Here, it is assumed that HBsAg out of the analysis items in
the table of list 170 is selected, and 30 .mu.l of sampling amount
of sample is input to the sample amount setting section 181, and 70
.mu.l of adding amount of the first reagent R1, 60 .mu.l of adding
amount of the second reagent R2 and 40 .mu.l of adding amount of
beads reagent are input to the reagent pipette amount setting
section 182. It is also assumed that in the carry-over avoiding
level setting section 183, a level "High" is selected between
"High" and "Low". The level selection of high and low can be
performed using a level selection button 187. Then, when the
storing instruction button 184 is selected, the sample amount and
the reagent pipetting amounts in regard to the analysis item of
HBsAg and the avoiding level of carry-over between samples
corresponding to the analysis item are instructed, and stored in
the memory unit 51.
[0091] Then, by selecting another analysis item displayed in the
table of list 170 and similarly setting a sample volume, a reagent
pipetting volume and a carry-over avoiding level corresponding to
the item, these conditions can be successively set. On the other
hand, by constructing so that a plurality of analysis items are
selected and a common carry-over avoiding level may be instructed,
the carry-over avoiding level can be instructed to the plurality of
analysis items at once.
[0092] The level "High" in the carry-over avoiding level setting
section 183 is for performing sample sampling under a condition of
no carry-over between samples and, in more detail, the total system
control unit 50 controls a transporting destination of a
corresponding sample rack so as to perform sampling of the sample
by a pipetting device using the disposable nozzle tip to be
exchanged by a new one for each sample. In a case where the "High"
level is instructed on a specified analysis item, the memory unit
51 stores the specified analysis item requiring pipetting using a
disposable nozzle tip. On the other hand, the level "Low" is an
instruction that sampling of the sample may be performed by a
pipetting device having the pipette nozzle repetitively used for
many samples by washing it, and an analysis item corresponding to
this case can be analyzed in the analysis unit 200 and/or the
analysis unit 300 in FIG. 1.
[0093] The analysis condition set through the setting screen as
shown in FIG. 5 is continuously used corresponding to each analysis
item unless the condition is changed after that. Therefore, when an
examination of a patient sample is requested, the analysis
condition set in FIG. 5 is automatically applied if an analysis
item to be described later is input.
[0094] In this way, in the analysis apparatus shown in FIG. 1, a
special method to avoid the carry-over between the samples, is
needed, that is, when the analysis item is indicated as being in a
level of "high", an indicated information thereof as being in a
level of "high" is stored in a memory device. After that, when the
same analysis item with that which is already indicated in order to
set a new analysis condition, is selected by referring the analysis
condition setting screen 70, the stored information, that is, the
information having a necessity to avoid the carry-over operates so
as to be output on the display device. In the case shown by FIG. 5,
when the analysis item is selected, information "high" is displayed
on the level setting section.
[0095] An operator work at starting routine analysis work will be
described below. By selecting the button 71 for invoking a routine
operating screen in the analysis condition setting screen 70, an
item selecting screen as shown in FIG. 6 is displayed in the large
display area 150 on the CRT 53. A section 251 for selecting a
sample kind, a section 252 for inputting a sample number, a section
253 for inputting a patient identification number, a section 254
for selecting a kind of sample cup, an area 255 for selecting an
analysis item, a button 256 for instructing a preceding sample, a
button 257 for instructing a following sample and a button 258 for
instructing registering are displayed in this screen. The analysis
item selecting area 255 among these has a reservation registering
function of 5-page capacity, and each of the pages has 24 item
inputting sections or analysis item selecting sections. When the
preceding sample instructing button 256 is selected, analysis item
information on a sample preceding a sample displayed at present by
one is displayed instead of the contents displayed at present. When
the following sample instructing button 257 is selected, analysis
item information on a sample following a sample displayed at
present by one is displayed.
[0096] Therein, the screen of FIG. 6 shows analysis items selected
by the first page of the analysis item selecting area 255. In the
displayed analysis items, AST means asparatate aminotransferase,
ATL means alanine aminotransferase, IP means inorganic phosphorus,
TP means total protein, Alb means albmin, LD means lactate
dehydrogenase, UA means uric acid, CRE means creatinine, Na means
sodium ion, and K means potassium ion.
[0097] FIG. 6 is an example of selecting 10 items of biochemical
analysis items to be analyzed in the first page in regard to a
blood serum sample of sample number 1. FIG. 7 is an example of
selecting 7 items of immune analysis items to be analyzed in the
second page in regard to the blood serum sample of the same sample
number. By selecting the registration instructing button 258 after
finishing inputting all the analysis items requested to examine on
the single sample, analysis measurement of the plurality of
analysis items on the sample is reserved and stored in the memory
unit 51. Since the screen of the display area 150 is updated by
this registering operation, analysis item selection on a sample of
the next sample number can be performed. Thus, the operator can
successively perform analysis item selecting work on all the
requested samples. In the example of FIG. 6 and FIG. 7, 17 analysis
items on the sample of sample number 1 are registered as a
result.
[0098] By selecting the reagent control screen invoking button 72
of the analysis condition setting screen, the screen for setting
analysis items to be analyzed and measured to each of the analysis
units in the analysis apparatus of FIG. 1 is displayed. Such
allocation of analysis items to each of the analysis units is
performed in prior to the inputting work of requested analysis
items for each sample as shown in FIG. 6. When a process of which
analysis item is allocated to which analysis units, the carry-over
avoiding level between samples set in FIG. 5 is reflected. That is,
an analysis item of "High" level is allocated to the analysis unit
100 having the pipetting device using the disposable nozzle
tip.
[0099] On the other hand, when items to be analyzed are instructed
for each sample in routine work, the relationship between analysis
item and carry-over avoiding level and the analysis items allocated
to each analysis unit are already registered in the control unit of
the automatic analysis apparatus. Therefore the control unit checks
a requested analysis item, for example, on a sample of sample
number 1, and judges which analysis unit among the plurality of
analysis units the sample is analyzed in. For example, since the
sample of sample number 1 is relates to the analysis unit 300 in
its electrolytic component, to the analysis unit 100 in its immune
analysis item and to the analysis unit 200 in its biochemical
analysis item, in the example of the construction of FIG. 1 the
sample is analyzed in all the analysis units.
[0100] In the cases that the analysis conditions for the respective
analysis items are set by using the screens shown in FIGS. 5 to 7,
the screen which is used to select the analysis item to be set the
analysis condition, is displayed on the display device, and the
indication field to be able to indicate the necessity to avoid
affection of the carry-over between the samples corresponding to
the analysis item selected on the screen, is displayed on the
display device.
[0101] After that, when the samples to be analyzed the analysis
items which is indicated the necessity to avoid the carry-over and
which is not indicated the necessity to avoid the carry-over
through the display device, are sampled in the analysis part such
as the analysis units 100, 200, 300 etc., the sampling of the
sample relating to the analysis item not indicated the necessity is
executed after the sampling of the sample relating to the analysis
item indicated the necessity is executed.
[0102] An example of handling a sample in the automatic analysis
apparatus of FIG. 1 will be described below. For the purpose of
convenience, it is assumed that a single sample analyzed on an
electrolytic substance analysis item and a biochemical analysis
item is held on the first sample rack firstly supplied from the
rack supply unit 10 to the rack transportation line 60, and a
single sample analyzed on an electrolytic substance analysis item,
a an immune analysis item and a biochemical analysis item is held
on the second sample rack secondarily supplied. In a case where a
plurality of samples are held on a single sample rack, the
transportation rout of the sample rack is determined so that sample
sampling of analysis items relating to all the samples is
performed.
[0103] The first sample rack pushed out from the rack supply unit
10 to the transportation apparatus side is positioned at the
reading position of the identification reading unit 15, and the bar
code label of sample information attached to the sample bottle is
read by the bar code reader 16. The total system control unit 50
determines analysis unit at which the first sample rack should drop
in by comparing the read information with analysis information
instructed to the samples, and recognizing based on the compared
result that there is no specified analysis item requiring sampling
by the nozzle tip, and recognizing requested analysis items
corresponding to analysis items allocated to each of the analysis
units.
[0104] Since the first sample rack has no samples requiring
analysis by the analysis unit 100 for the immune analysis item, the
total system control unit determines that the first sample rack is
transported so as to drop in at the analysis unit 300 for the
electrolytic analysis item placed in the position near the rack
supply unit 10, and then drop in at the analysis unit 200 for the
biochemical analysis item. That is, the sample racks in this case,
are transported to the plurality of the analysis units according to
the arranging order thereof and depending on the necessity. Both of
the second analysis unit 200 and the third analysis unit 300 are
analysis units having the pipetting device using the repetitively
used pipette nozzle.
[0105] The first sample rack of which the identification
information has been read is moved to the sample sampling position
of the analysis unit 300 for the electrolytic analysis item, and
the pipetting device 302 sucks a part of the sample on the sample
rack and discharge it to the diluting container 305 as a receiving
container. The first sample rack finishing sample sampling at the
analysis apparatus 300 is transported to the analysis unit 200 for
the biochemical analysis item without dropping in at the analysis
unit for the immune analysis item.
[0106] The first sample rack is once stopped at the entrance of the
bypass line 62 and then transferred to the bypass line 62, and
positioned at the sample sampling position on the bypass line 62.
The pipetting device 202 repeats operation of pipetting the sample
in the sample bottle on the first sample rack to a plurality of
reaction containers 205 number of which is corresponds to number of
items to be analyzed. After finishing sample sampling for a
predetermined number of analysis items, the first sample rack is
transferred to the rack transportation line 60, and then
transported to the standby unit 20.
[0107] If the control unit judges that the analysis result by each
of the analysis apparatus does not require any re-measurement, the
first sample rack goes out of the standby unit 20 and is stored in
the rack stoker 30. If the control unit judges that the analysis
results by the analysis unit requires re-measurement on one or more
analysis items, the first sample rack on standby in the standby
unit 20 is transferred to the returning line 65 to transported to
the entrance side of the rack transportation line 60, and then
transported to the analysis unit 200 again by the transportation
line 60. After plural times of sample sampling corresponding to
number of analysis items for re-measurement, the first sample rack
is stored in the rack stoker 30 through the transportation line 60.
The analysis results in regard to the sample on the first sample
rack by the units 200, 300 may be output to the CRT 53 and the
printer 54.
[0108] While the first sample rack is under processing, the second
sample rack may be supplied from the rack supply unit 10 to the
entrance side of the rack transportation apparatus. The second
sample rack is moved to the reading position of the identification
reading unit 15, and the sample information expressed by the bar
code on the outer wall of the sample bottle is read by the bar code
reader 16. The control unit determines analysis unit at which the
second sample rack should drop in by checking the analysis
condition set information and the instructed information input or
selected by the operating unit 52 and the read information in
regard to the sample on the second sample rack. Since the body
liquid sample held on the second sample rack is instructed so as to
be analyzed on an electrolytic analysis item, an immune analysis
item and a biochemical analysis item, it is determined that the
second sample rack drops in the analysis units 100, 200 and 300 in
the construction example of FIG. 1.
[0109] In this case, the control unit recognizes that the specified
analysis item requiring pipetting by the disposable nozzle tip is
included among the plurality of analysis items instructed to
perform analysis, and determines that the second sample rack is
transported firstly to the analysis unit 100 which can perform such
pipetting. Based on the determination, the control unit controls
operation of the rack transportation apparatus so that the second
rack is transported to the analysis unit 100 in prior to
transporting to the other analysis units. An analysis item
allocated to the first analysis unit is not limited to an immune
analysis item, but an analysis item set to "High" in the carry-over
avoiding level between samples as shown in FIG. 5 may be allocated
to the analysis unit 100 even if it is a biochemical analysis
item.
[0110] Based on the above-mentioned determination of the
transportation order, the second sample rack in the identification
reading unit 15 is transported to the bypass line 61 corresponding
to the analysis unit 100 arranged in the second order through the
rack transportation line 60 without dropping in at the analysis
unit 300 which is the closest to the rack supply unit, and
positioned at the sample sampling position on the bypass line 61.
The pipetting device 102 couples the unused disposable nozzle tip
125 with the coupling tube 104, and repeats operation of pipetting
the sample in the sample bottle on the second sample rack to a
plurality of reaction containers 105 number of which is corresponds
to number of items to be analyzed. The second sample rack after
finishing sampling is transferred from the bypass line 61 to the
rack transportation line 60, and then transported to the standby
unit 20 without dropping the analysis unit 200 arranged in the
third order.
[0111] While the second sample rack is temporally standing by at
the standby unit 20, analysis measured results of the sample by the
analysis unit 100 can be obtained. Based on the analysis measured
results by the analysis unit 100, the control unit judges necessity
of re-measurement on each of the measured analysis items is
necessary. If the judged result is that re-measurement is
unnecessary to any analysis items, the second sample rack on
standby in the standby unit 20 is transferred to the returning line
65, and transported to the entrance side of the rack transportation
line 60 by the returning line 65. Then, the second sample rack
drops in at the analysis unit 300 for the electrolytic analysis
item, and the pipetting device 302 pipettes the specified sample
using the pipette nozzle. After that, the second sample rack is
transported to the analysis unit 200 arranged in the third order
without dropping in at the analysis unit 100, and positioned at the
sample sampling position on the bypass line 62, and the pipetting
device 202 pipettes the specified sample using the pipette nozzle
225.
[0112] The second sample rack finishing pipetting in the analysis
unit 300 and the analysis unit 200 is transported to the standby
unit 20 to temporally stand by at there. Then, necessity of
re-measurement is judged based on the analysis measured results by
the analysis units 200 and/or the analysis units 300. If
re-measurement is unnecessary, the second sample rack is stored in
the rack stoker 30. If re-measurement is necessary, the second
sample rack is transported to the third analysis unit 300 and/or
the second analysis unit 200 again to be sampled for the
re-measurement. After that, the second sample rack is transported
to and stored in the rack stoker 30.
[0113] On the other hand, when based on the analysis measured
result by the analysis unit 100 for the immune analysis item, it is
judged that re-measurement on any of the analysis items is
necessary, the control unit transports the second sample rack as
follows. That is, The second sample rack holding a specified sample
is transferred from the standby unit 20 to the returning line 65,
and transported to the entrance side of the rack transportation
line 60 by the returning line 65, and then transferred to the rack
transportation line. The rack transportation line 60 transports the
second sample rack to the bypass line 61 corresponding to the
analysis unit 100 without dropping in at the analysis unit 300. At
this time point, sample sampling of the second sample rack is not
performed by the other analysis units 200 and 300 yet.
[0114] The pipetting device 102 of the analysis unit 100 pipettes
the specified sample on the second sample rack positioned at the
sample sampling position on the bypass line to the reaction
container 105 on the reaction disk 103 using a new disposable
nozzle tip in order to measure the analysis item which is judged
that re-measurement is necessary.
[0115] The second sample rack finishing sample sampling for
re-measurement is once transferred to the rack transportation line
60, and immediately transported to bypass line 62 corresponding to
the analysis unit 200. Then, the first sample sampling of the
second sample rack by the pipette nozzle 225 of the pipetting
device 202 is performed. The second sample rack finishing sample
sampling in regard to the specified sample is transferred to the
returning line 65 through the rack transportation line 60, and then
transferred to the rack transportation line 60 to be transported to
the third analysis unit 300. After that, the first sample sampling
in regard to the specified sample by the pipette nozzle of the
pipetting device 302 is performed.
[0116] Otherwise, it is possible to control so that when sample
sampling for re-measurement in regard to the analysis unit 100 is
finished, the second sample rack is transferred to the rack
transportation line 60, successively transferred to the returning
line 65, transported from the entrance side of the rack
transportation line 60, and sample sampling is performed in the
analysis unit 300 and then in the analysis unit 200 in regard to
the specified samples, respectively. In any case, the second sample
rack finishing sample sampling in the analysis units 200 and 300 is
transported to the standby unit 20 to temporally stand by at there
until the judgment on necessity of the re-measurement is output.
The transporting operation in regard to the second sample rack
after judgment on necessity of the re-measurement is the same as
that described above.
[0117] Depending on a patient sample, there is a case where
analysis by only one analysis unit out of the three analysis units
shown in FIG. 1, analyses by the two analysis units for the immune
analysis item and the biochemical analysis item, or analysis by the
two analysis units for the immune analysis item and the electrolyte
analysis item is performed. In a case where a sample is analyzed by
the analysis unit 100 and the analysis unit 200 or 300, the system
is constructed so that the sample is initially sampled in the
analysis unit 100, then the sample sampling for re-measurement is
performed in the analysis unit 100, and then sampling operation of
the sample in the same sample bottle is performed in the other
analysis unit 200 or 300.
[0118] As described above, in the embodiment of the apparatus of
FIG. 1, since sample sampling is performed in the analysis unit
having the pipetting device using the disposable nozzle tip and
then sample sampling is performed in the analysis unit having the
pipetting device using the repetitively used pipette nozzle by
washing, an analysis item which must strictly avoid an effect of
carry-over between samples can be analyzed with keeping high
reliability. Further, since an analysis item which is not so
strongly affected by an effect of carry-over between samples is
sampled by the pipetting device using the repetitively used pipette
nozzle, the total processing capacity of the analysis apparatus is
not reduced so much. Because number of analysis items using the
pipette nozzle is much larger than number of items necessary to use
the disposable nozzle tip.
[0119] Another embodiment of the construction of an analysis
apparatus in accordance with the present invention will be
described below, referring to FIG. 8. The automatic analysis
apparatus for analyzing body fluid samples of FIG. 8 comprises a
sample bottle transportation apparatus 800, a first analysis unit
810 for analyzing the immune analysis item and a second analysis
unit 820 for analyzing the biochemical analysis item. The sample
bottle transportation apparatus 800 has a rotatable sample disk 801
capable of holding many sample bottles 802 in circular shape.
[0120] A first pipetting device 830 is a pipetting device using a
disposable nozzle tip by exchanging it for each sample. A second
pipetting device 840 is a pipetting device using a repetitively
used pipette nozzle by washing. The first analysis unit 810 has a
reaction container exchange apparatus 813 for exchanging a used
reaction container with a unused reaction container and capable of
exchangeably arranging many reaction containers 812 on a reaction
disk 811. A necessary reagent corresponding to an immune analysis
item is pipetted from a reagent supply unit 816 into the reaction
container 812 on the reaction disk 811.
[0121] The first pipetting device 830 can couples the unused
disposable nozzle tip to a tip coupling tube on a tip supplier 814.
The used nozzle tip is removed from the coupling tube to be
disposed to a disposal box 815. The first analysis unit 810 has a
measuring unit 815 for measuring a reaction solution or a solid
phase after immune reaction. A reaction disk 821 in the second
analysis unit 820 has a row of transparent reaction containers 822.
A necessary reagent corresponding to a biochemical analysis item is
pipetted from a reagent supplier 826 to these reaction containers
822. The second analysis unit 820 has a measuring unit for
measuring an optical characteristic of a reaction solution after
chemical reaction.
[0122] In the automatic analysis apparatus of FIG. 8, it is assumed
that a specified sample requiring to be analyzed on both of an
immune analysis item and a biochemical analysis item is contained
in one specified sample bottle 802. When analysis is started for
such a specified sample, the corresponding specified sample bottle
is positioned at a sample sampling position by the sample disk 801.
Then, the first pipetting device 830 coupled with the unused nozzle
tip sucks a part of the specified sample into the nozzle tip and
discharges it into the reaction container 812 on the reaction disk
811. An immune reaction between the sample and the reagent is
progressed in the reaction container, and then an immune analysis
item to be analyzed is measured.
[0123] The automatic analysis apparatus is programmed so that after
finishing sample sampling to the above-mentioned specified sample
bottle using the first pipetting device, the same sample bottle is
positioned at a sample sampling Position b, and sample sampling
using the second pipetting device 840 is performed. The specified
sample pipetted to the reaction container 822 on the reaction disk
821 by the pipette nozzle of the second pipetting device is
chemically reacted with the reagent in the reaction container, and
the biochemical analysis item is measured based on photometrical
measurement of the produced reaction solution.
[0124] Both of a biochemical analysis item and an immune analysis
item can be also measured by the embodiment of FIG. 8, and the
analysis measured value of the immune analysis item is not affected
by the effect of carry-over between samples.
[0125] In a case of measuring a biochemical analysis item and an
immune analysis item, the pipetting device using the disposable
nozzle tip and the pipetting device using the repetitively used
pipette nozzle are applied to a single sample bottle, and pipetting
operation by the disposable nozzle tip is performed in prior to
using the pipette nozzle. By doing so, the carry-over between
samples caused by the pipette nozzle is avoided relating to the
analysis item which should be extremely avoided, and the pipette
nozzle used commonly can be used for sampling the sample relating
to the biochemical analysis item.
[0126] Furthermore, the functions as shown in FIGS. 5 to 7 are
performed in the embodiment shown in FIG. 8. In this case, the
sampling processing effect becomes lower than that of the
embodiment shown in FIG. 1. The control part controls respective
mechanism of the analysis apparatus. In the analysis apparatus
shown in FIG. 8, when the re-measurement is directed to be executed
according to the measurement effect of the sample by the immune
analysis unit 810, it is controlled that the sampling of the same
sample is not performed by the second pipetting device 840 at the
sampling position b until the first measurement result is obtained
relating to the specified sample at the position a.
[0127] When the re-measurement is judged to need to be done, the
corresponding specified sample is returned to the sampling position
a by the sample disk 801, is sampled again by the first pipetting
device 830, and is analyzed again by the immune analysis unit
810.
[0128] After this second time sampling, the corresponding sample is
moved to the sampling position b, and is sampled by the second
pipetting device 840.
[0129] FIG. 9 shows an outline of a configuration of the third
embodiment based on the present invention. The same functions of
the elements in this embodiment as that in the former embodiment
are shown by attaching the same reference numerals.
[0130] In FIG. 9, the analysis units 100A, 100B for measuring the
immune analysis item and the analysis units 200A, 200B for
measuring the biochemical analysis item are arranged along the rack
transportation line 60. These analysis units are connected to be
able to be disconnected to the rack transportation line 60.
[0131] The sample rack 2 supplied from the rack supply unit 10 can
selectively drop in at the necessary analysis unit through the
bypass lines 61A, 61B, 62A, 62B attached on the respective analysis
units. The respective analysis units build in respective computers
101A, 101B, 201A, 201B as the analysis unit control parts.
[0132] The computer 11 built in the rack supply unit 10 performs
necessary control of the rack supply unit 10, the rack
transportation line 60, the returning line 65, and the rack stoker
30. The computer 21 built in the standby unit 20 performs necessary
control in the standby unit 20. These computer and the bar code
reader 16 are connected to computer 50 as the integrated
controller. The computer 50 gives the necessary information to the
computer 11 and the computer of the analysis unit which is planed
to be dropped in by reading out the sample ID and the rack ID.
[0133] When the sample held by the sample rack is a sample which is
specified to perform automatic re-examination and has an immune
analysis item specified to perform automatic re-examination, after
finishing the sampling for immune analysis, the sample rack is
transported to the standby unit 20 by the transportation line 3 to
be temporarily let stand by. During that period, the computer 50
judges based on a preset algorithm or logic whether or not
re-examination is necessary. If the judged result is that the
re-examination is necessary, the sample rack is returned to the
entrance side of the rack transportation line 60 by the returning
line 65. The sample rack is further transported to the suitable
analysis unit by the rack transportation line 60, and the sample
held by the sample rack is re-sampled and re-examined, that is, the
immune analysis is performed on the sample again. After finishing
sampling of the sample for the re-examination of immune analysis in
the analysis unit, the sample rack is transported to the
biochemical analysis unit and the sample is sampled to perform
biochemical analysis. Then, the sample rack is transported to the
rack stoker 30 by the rack transportation line 60 to be collected
there without dropping in at the other analysis unit nor the
standby unit 20 when the sample held by the sample rack is not
specified to perform re-examination.
[0134] The analysis units 10A, 100B have the same construction with
that of the analysis unit 100 shown in FIG. 1, and the analysis
units 200A, 200B have the same construction with that of the
analysis unit 200 shown in FIG. 1.
[0135] FIG. 10 is a flow chart of the system operation of an
automatic analysis apparatus in accordance with the present
invention. An operator initially sets reagents at preset positions
in each analysis unit, and information which analysis unit each
reagent exists in and which analysis item each reagent is to be
used for is stored and registered in a memory unit in the computer
50 (S401). The registration may be performed by operating the
operating unit 18 by the operator, or by automatically reading a
reagent ID having each of the reagent bottles 217, 218.
[0136] Next, the operator operates the operating unit 52 to specify
whether or not the automatic re-examination logic function is put
in action and which re-examination logic is put in action if
re-examination logic is put in action (S402). This is for
automatically performing re-examination only on an analysis item
which really requires re-examination, and largely contributes to
suppress decrease in processing capacity of the whole apparatus. In
detail, the automatic re-examination logic is a logic showing, for
example, the following conditions. The conditions are pre-stored
and pre-registered in the memory unit 51 of the computer 50, and
the operator can select one by designating any one condition, and
the designation of the re-examination of the corresponding analysis
item can be cancelled. The automatic re-examination logic is
selected through the screen of the CRT 53.
[0137] (1) The automatic re-measurement is always performed without
any condition.
[0138] (2) The automatic re-measurement is performed when an
analysis result departs from an analysis (measurement) range preset
for each analysis item. For example, in regard to TSH (thyrotropin:
thyroid-stimulating hormone), when a first analysis result is above
0.27 IU/ml, but departs from a condition below 4.2 IU/ml, the
re-measurement is performed.
[0139] (3) The automatic re-measurement is performed when a
difference between an analysis value in this time and an analysis
value in the preceding time (or an analysis value before the
preceding time) on samples from a single person exceeds a preset
limit value (for example, when the analysis value in this time
differs from the analysis value in the preceding time by 50% or
more).
[0140] After that, the operator operates the operating unit 52 to
specify an analysis (measurement) channel using algorithm when the
re-examination is performed relating to the analysis item (S403).
In detail, the analysis channel using algorithm is a algorithm
showing, for example, the following conditions. The conditions are
pre-stored and pre-registered in the memory part 51 of the computer
50, and the operator can be specify and select one condition. The
one analysis channel means a combination of one reaction line and
one sensor.
[0141] (1) The same analysis (measurement) channel as an analysis
channel used for the analysis (measurement) in the time before the
re-examination is used.
[0142] (2) An analysis channel different from an analysis channel
used for the analysis in the time before the re-examination is
used. This condition is effective when the analysis channel used in
the time before the re-examination is abnormal.
[0143] (3) A plurality of analysis channels including the same
analysis channel used for the analysis in the time before the
re-examination are used. This condition is effective when a highly
reliable analysis result is attempted to be obtained.
[0144] (4) A plurality of analysis channels excluding the same
analysis channel used for the analysis in the time before the
re-examination are used. This condition is effective when the
analysis channel used in the time before the re-examination is
abnormal and a highly reliable analysis result is attempted to be
obtained.
[0145] Although each of the analysis units in the FIG. 1 and FIG. 9
has only one analysis (measuring) channel, each of the analysis
units may have a plurality of analysis channels. The plurality of
analysis channels in the above items (3) and (4) may have a
plurality of analysis channels in one analysis unit, or may have a
plurality of analysis channels extending over a plurality of
analysis units within a same immune analysis.
[0146] The automatic re-examination logic information and the
analysis channel using algorithm may be stored and registered not
in the memory part 51 in the computer 50 but in a memory unit 55
provided in the external.
[0147] Then, after the registration, the operator loading the
sample rack to the sample rack loading unit 1, and operates the
operating unit 52 to register to the computer 50 which sample is
analyzed on which analysis item, that is, register analysis item
request (S404). Successively, the operator operates the operating
unit 52 to specify for each sample whether or not the automatic
re-examination logic described above is executed by using the
screen of the CRT 53 (S405). This is effective for a small amount
of an important sample in that the unnecessary consumption of the
important sample can be prevented by omitting the automatic
re-examination. After finishing the above-mentioned operations by
the operator, analysis operation is started (S406), and a result of
the analysis is output (S407), and thus the analysis is completed
(S408).
[0148] FIGS. 11A and 11B are flow-charts of sample rack
transportation processing in accordance with the present invention.
A sample rack is loaded in the rack supply unit 10 (S501). When the
loaded sample rack is transported to the rack transportation line
60 (S502), the sample ID and the rack ID are read by the ID reading
unit 16 (S503) and the information is transmitted to the computer
50.
[0149] The computer 50 judges whether or not there is a sample
requested to analyze on an immune analysis item on the rack (S504).
If the result is "YES", the sample rack is transported to a
specified immune analysis unit by the rack transportation line 60
based on a command from the computer 50 to the computer 11 (S505).
The sample sampling is performed based on a command from the
computer 50 to the computer of the immune analysis unit, and immune
analysis is performed on the immune analysis item (S506).
[0150] After finishing the sampling, the computer 50 judges whether
or not the sampled sample is a sample specified automatic
re-examination in Step S405 of FIG. 10 (S507). If the result is
"YES", the computer 11 judges whether or not the immune analysis
item specified in Step S405 of FIG. 10 to perform automatic
re-examination is included in the sample (S508). If the result is
"YES", the rack is transported to the sample rack standby unit 9 by
the rack transportation line 60 based on a command from the
computer 50 to the computer 11 (S509) and the rack stands by there
until the analysis result is output (S510).
[0151] After outputting the result of the above analysis, the
computer 50 judges based on the re-examination logic specified in
Step S402 of FIG. 10 whether or not re-examination is necessary
(S511). If the result is "YES", the sample rack is transported to
an specified immune analysis unit by the returning line 65 and the
rack transportation line 60 according to the selected analysis
channel using algorithm based on a command from the computer 50 to
the computer 11 (S512). Pipetting is performed based on a command
from the computer 50 to the computer of the analysis unit (S513),
and thus, the immune analysis is completed (S514).
[0152] If the judged result in Step S507, S508 or S511 is "NO", the
flow proceeds to Step S514.
[0153] After finishing Step S514 or if the judged result in Step
S504 is "NO", Steps S515 to S525 of biochemical analysis
corresponding to Steps S504 to S514 of immune analysis are
similarly performed, respectively. After finishing the analysis or
when the analysis is necessary, the sample rack is collected to the
rack stoker 30 (S526).
[0154] FIG. 12 shows an example of a partial arrangement of another
embodiment of an automatic analysis apparatus in accordance with
the present invention. This embodiment is different from the
embodiment of FIGS. 1 and 9 in the point that each analysis unit
does not have any siding (by-pass line) as shown in FIGS. 1 and 9.
Therefore, in this embodiment, the sample rack is kept on the rack
transportation line 60 even during sample sampling.
[0155] In the analysis apparatus shown in FIG. 12, at respective
lower flow side of the analysis units 100a, 100B, 200A, 200B, the
standby units 20A, 20B, 20C, 20D are arranged corresponding to the
respective analysis units. The movement of the sample rack
transmitted to the standby units is little different from that of
the example shown in FIG. 1 or 9.
[0156] For example, in a case that the re-measurement by the same
analysis unit is needed relating to the sample rack in the standby
unit 20B attached to the analysis unit 100B, the sample rack is
moved from the standby unit 20B to the returning line 65, and is
moved to the rack transportation line 60 near the entrance of the
standby unit 20A, and again stops at the sample sampling position
of the analysis unit 100B (upper the transportation line 60) so as
to be sampled.
[0157] If the sample on the sample rack in the standby unit 20B
does not need to be re-measured, the sample rack is moved from the
standby unit 20B to the rack transportation line 60, and is
transferred to the sample sampling position of the biochemical
analysis unit 200A, for example. In this case, the sample rack does
not passes by the returning line 65.
* * * * *