JP3109443U - Automatic analyzer - Google Patents

Abstract

Provided is an automatic analysis system that eliminates the effect of carryover between samples when a biochemical automatic analyzer using a chemical reaction and an immune serum item analyzer using an immune reaction are provided.
A sample for measuring a carry-over amount is installed, a carry-over rate between samples is measured, an arithmetic process is performed based on the measurement result, and it is determined whether the result of the arithmetic process is within a threshold value. When the threshold value is exceeded, the detergent is sucked and held for a certain period of time, and the detergent is washed.
[Selection] Figure 1

Description

  The present invention relates to an automatic analyzer that performs qualitative and quantitative analysis of biological components such as blood and urine, and more particularly to an automatic analyzer that includes a sample probe.

  The current automatic analyzer can analyze many samples and many items quickly and with high accuracy by introducing a computer, so it can be used not only for biochemical tests in hospitals and testing centers, but also for immunoserologic tests. , It is used for examinations in various fields, such as toxicity tests in pharmaceutical research institutes.

  Sample sampling of the automatic analyzer is performed by sucking and discharging the sample probe. The sample is discharged every time the sample is changed, and then washed by sucking and discharging water or detergent. Over is prevented.

  Patent Document 1 proposes a mechanism in which a detergent flows in from a branch path after a probe sucks and discharges a sample and a reagent, and water is washed after a predetermined time has passed in a state where the probe is filled with the detergent. .

  Also, in Patent Document 2, even when the same sample container is installed in both the biochemical analyzer and the immune serum item analyzer, the analysis is performed so that the analysis result of the immune serum item does not carry over between samples. A mechanism has been proposed in which carry-over avoidance levels are set for each item, and water cleaning and detergent cleaning are performed according to the levels.

  A general method for determining the carryover rate of a probe for a sample is to use a dye solution with a high absorbance or a standard solution with a high concentration and physiological saline or distilled water with a concentration of 0, and sample a dark sample. There is a method in which physiological saline or distilled water with an absorbance of 0 is sampled several times and a person inspects how much is brought in from the previous sample, but this work is not a routine work and normal biochemistry In the case of measuring only the analysis items, the level is not affected by carryover, so very few facilities regularly check.

  However, hospitals that use the same sample container for analysis by combining biochemical analysis item devices and immune serum item analysis devices that differ in measurement sensitivity by 10 to 1000 times or more are now increasing. Even if it was over, the measurement results were affected more than expected, and erroneous data such as false positive results could be reported to the clinic.

  Here, in the method of Patent Document 1, detergent cleaning is carried out every time a sample is sampled, so the carryover rate is greatly reduced and the influence on the measurement result is reduced, but washing with detergent and water is carried out in any sample. Therefore, there is a possibility that the processing speed of the analyzer is significantly reduced and the cost is increased due to an increase in the consumption of detergent. In the method of Patent Document 2, cleaning is enhanced only when measuring items that may carry over. However, depending on conditions such as when there are many measurement requests for the item, there is a possibility that the processing speed may be significantly reduced, that is, the result reporting time may be delayed.

  In addition, since Patent Documents 1 and 2 do not consider the accumulation of protein stains and scale stains on the inside and outside of the sample probe due to daily use, the current carryover is required for customers to use with peace of mind. There was a problem that the quantity had to be checked and overhaul such as probe replacement had to be done regularly, and labor and expensive parts had to be replaced.

JP-A-6-213907 JP 2001-91523 A

  When equipped with a biochemical automatic analyzer that uses a chemical reaction and an immune serum item analyzer that uses an immune reaction, it automatically measures and determines the carry-over rate between samples and, if necessary, performs washing with a detergent. To provide an analysis system.

  When the sample exceeds the threshold, with a means to set the sample for measuring the carryover amount, a means to perform arithmetic processing based on the measurement result, and a determination means to determine whether the result of the arithmetic processing is within the threshold Is solved by providing means for sucking the detergent, holding it for a certain period of time, and cleaning the detergent.

  In the present invention, sample preparation, measurement, calculation, and judgment are automatically performed in the measurement of carryover rate, and detergent cleaning is also performed. Therefore, even in simultaneous measurement of immune items and biochemical items that have the effect of carryover between samples Since reporting of positive results and the like can be prevented, there is an effect of maintaining the accuracy of the test result, that is, improving the patient service, and also reducing the frequency of exchanging the probe for the sample, which is an expensive part, and also reducing the cost.

  Examples of the present invention will be described below.

  FIG. 1 is an overall schematic configuration diagram of an automatic analyzer according to an embodiment of the present invention.

  In FIG. 1, a transport unit 102 is provided for transporting a rack by a belt conveyor from a sample loading unit 101 that can mount a plurality of racks 107 on which a plurality of sample containers 108 can be installed. An immune analysis unit 103 and a biochemical analysis unit 104 are arranged along the transport unit 102, and finally a rack recovery unit 109 is provided. In addition to the transport unit 102, re-inspection is required before transporting the rack 107 in which the sample container 108 containing the sample that needs to be re-inspected to the next analysis unit or the rack recovery unit 109. Re-examination transport having first standby buffer 110 and second standby buffer 111 that wait until it is determined whether or not rack 107 is transported from first standby buffer 110 or second standby buffer 111 to the analysis unit at the time of re-inspection A portion 105 is provided.

  The immunological analysis unit 103 and the biochemical analysis unit 104 each have a sample analysis pipetter 206 or 303 as a sample dispensing device, and the sample container 108 held by the rack 107 enters the rack from the transport unit 102. The sample is moved to the subline 113 or 115 of each analysis unit as it is, and the sample is collected at the sample suction position on the subline. The sample collected from the sample container by the sample dispensing pipetter 206 or 303 is discharged to the reaction container on the reaction disk 203 or 305 of each analysis unit.

  Each mechanism part which comprises an automatic analyzer is connected to the control part 312 which consists of computers, and receives operation control at a suitable timing. Further connected to the control unit 312 are an operation unit 106 having a keyboard, a printer 54 for printing analysis results, a floppy (registered trademark) disk drive 55 as an external storage unit storing analysis parameters, and the like. Has been.

  Items to be analyzed for a large number of samples set in the specimen loading unit 101 are input to the control unit 312 using the operation unit 106 and the screen display unit 53 for each sample. The control unit 312 determines to which analysis unit the corresponding rack is to stop depending on the analysis item instructed to analyze each sample, and the sample is transferred to at least one analysis unit based on the determination result. Transport. In the example of FIG. 1, only two analysis units are shown for convenience of explanation, but three or more analysis units may be arranged along the transport unit 102.

In the embodiment of FIG. 1, the rack 107 installed on the specimen loading unit 101 and transported on the transport unit 102 is first transported to the sample suction position of the immune analysis unit 103, and the immune analysis unit for the sample on the rack 107. After the sample dispensing at 103 is completed, the rack 107 is subjected to sample dispensing at the biochemical analysis unit 104. The rack 107 waits in the first standby buffer 110 or the second standby buffer 111 until it is determined whether reinspection is necessary. When reinspection is necessary, the rack 107 is transported to the analysis unit by the reinspection transport unit 105 and reinspected. To be served.

  At this time, since the same specimen container after dispensing by the biochemical analysis unit 104 is used for reexamination of immunological analysis items, the residue of other samples is mixed by contact with the sample probe of the biochemical analysis unit 104. Contamination or carryover occurs.

  Next, a configuration example of the immune analysis unit 103 will be described with reference to FIG. In FIG. 2, a plurality of reagent containers 201 containing reagent solutions corresponding to analysis items that can be analyzed by the immunological analysis unit are arranged on a reagent disk 202 that can be rotated as a reagent positioning device. The reaction disk 203 maintained at a constant temperature can be rotated, and there are a plurality of reaction positions along the circumference on the reaction disk 203, and the reaction container 205 from the reaction container storage position 219 is stored therein. The reaction disk 203 moves the reaction container 205 from the reaction container installation position 204 to the sample discharge position 221, the reagent addition position 222, and the reaction liquid suction position 212 by a rotating operation. The sample dispensing pipetter 206 can move the coupling tube coupling the disposable dispensing tip 210 in the horizontal direction from the upper part of the sample suction position 207 to the upper part of the sample discharge position 221 and can be moved up and down at each position. It has become. Prior to the suction of the sample, the disposable dispensing tip 210 is attached to the tip of the tip coupling tube of the sample dispensing pipetter 206 at the tip coupling position 218.

  The reagent dispensing pipettor 208 can move from the upper part of the reagent suction position 209 on the reagent disk 202 to the upper part of the reagent addition position 222, and can also move up and down at each position. The sipper 211 can move between the upper part of the reaction liquid suction position 212, the upper part of the buffer liquid suction position 213, and the upper part of the cleaning liquid suction position 214 for the flow cell, and can also move up and down at each position. Further, the shipper 211 has a function of sending the reaction liquid to the flow cell in the detection unit 215 through the tube. The tip and reaction vessel transfer mechanism 216 that can move the gripping part in the x and y directions has the disposable dispensing tip 210 from the tip storage position 217 to the tip coupling position 218 and the disposable reaction vessel 205 to the reaction vessel storage position 219. To the reaction vessel installation position 204. In the reagent dispensing pipettor 208 and the sipper 211, the outer wall of the nozzle is washed with water at each of the corresponding washing positions.

  Next, the flow of processing in the immune analysis unit 103 will be described. First, the chip and reaction container transfer mechanism 216 transfers the disposable dispensing chip 210 to the chip coupling position 218 and then the reaction container 205 to the reaction container installation position 204. The rack 107 holding the sample container 108 is transported on the sub-line 113 so that the sample container 108 containing the sample to be analyzed is positioned at the sample suction position 207. At the same time, the reagent disk 202 rotates so that the reagent container 201 containing the reagent used for the analysis is positioned at the reagent suction position 209. At the same time, the reagent dispensing pipettor 208 moves to the upper part of the reagent suction position 209. At the reagent aspirating position 209, the reagent dispensing pipettor 208 descends and aspirates the reagent into the pipette nozzle. Next, the reagent dispensing pipettor 208 moves up and moves to the nozzle cleaning position. When the pipette nozzle reaches the upper part of the nozzle cleaning position, cleaning water blows out from the cleaning tank, and the tip of the pipette nozzle is cleaned.

  On the other hand, the sample dispensing pipetter 206 moves the dispensing tip 210 to the upper part of the sample suction position 207, descends into the sample container 108 on the rack 107, and sucks a predetermined amount of sample. After the sample is aspirated, the dispensing tip rises and moves to the sample discharge position 221. Then, the dispensing tip is lowered and the sample sucked and held in the dispensing tip is discharged into the reaction container 205. After the sample is discharged, the dispensing tip is raised by the sample dispensing pipetter 206 and moved to the tip disposal position 220. At the tip disposal position 220, the sample dispensing pipetter 206 removes the disposable dispensing tip 210 from the coupling tube and discards it.

After a predetermined time required for the reaction has elapsed, the sipper 211 moves the suction nozzle to the upper part of the buffer solution suction position 213, lowers the nozzle, and sucks the buffer solution through the nozzle toward the flow cell. Thereafter, the tip of the nozzle of the sipper 211 is cleaned at the nozzle cleaning position.

Next, the reaction disk 203 transfers the reaction container 205 to the reaction liquid suction position 212. The sipper 211 sucks the reaction liquid through the nozzle toward the flow cell at the reaction liquid suction position 212. After sucking the reaction solution, the sipper 211 moves the nozzle to the buffer solution suction position 213 and sucks the buffer solution. The sucked buffer solution and reaction solution are sent to the flow cell in the detection unit 215 through the tube, and measurement is performed. Then, the sipper 211 moves the nozzle to the cleaning liquid suction position 214, sucks the cleaning liquid for the flow cell, and cleans the inside of the flow cell in the detection unit 215 with the cleaning liquid.

Next, a configuration example of the biochemical analysis unit 104 will be described with reference to FIG. In FIG. 3, the biochemical analysis unit 104 includes a reagent disk 301A for holding a large number of reagent containers 310,
310B, a reagent supply system including reagent dispensing pipettors 302A and 302B, a sample supply system including sample dispensing pipetter 303, a reaction unit including a reaction disk 305 holding a number of reaction vessels 304, A photometer 306 and a measurement system including an analog / digital converter 307 are provided.

  In FIG. 3, the rack 107 holding the sample container 108 is transported from the transport unit 102 to the sample suction position 308 on the subline 115. The sample dispensing pipetter 303 sucks a predetermined amount of the sample in the sample container 108 into the sample probe 303 and discharges the sample into the reaction container 304. The reaction container 304 into which the sample liquid has been discharged and dispensed is moved to the first reagent addition position by the rotation of the reaction disk 305 that is kept warm by the thermostat 309. At this time, the reagent disk 301A is also moved by the rotating operation so that the reagent container 310 corresponding to the analysis item of the sample coming to the reagent addition position is positioned at the reagent suction position. Then, the predetermined first reagent sucked by the pipette nozzle of the reagent dispensing pipetter 302A is added to the reaction container 304 moved to the first reagent addition position. The reaction vessel 304 after the addition of the first reagent is moved to the position of the stirring device 311 and the first stirring is performed. In the case of an analysis item that requires the addition of the second reagent, the second reagent is further added by the reagent dispensing pipette 302B, and the contents are stirred.

The reaction container 304 containing the reaction liquid in which the sample and the reagent are mixed is transferred so as to cross the light beam from the light source, and the light transmitted through the reaction container enters the multi-wavelength photometer 306. Then, the absorbance of the reaction liquid that is the contents of the reaction vessel 304 is detected by the multiwavelength photometer 306. The detected absorbance signal is supplied to the control unit 312 configured by a computer via an analog / digital (A / D) converter 307 and an interface, and is converted into the concentration of the analysis item to be measured in the sample. The reaction vessel 304 that has been subjected to the analytical measurement is moved to the position of the reaction vessel cleaning mechanism (not shown), and after the reaction liquid in the reaction vessel is discharged by the reaction vessel cleaning mechanism, the reaction vessel 304 is washed with water for the next analysis. To be served.

  This embodiment of the automatic analyzer as described above will be described using the flowchart of FIG. 4 and the screen examples of FIGS.

  First, as shown in 500 of FIG. 5 in the screen example, an item and density for checking the carryover rate are selected or input, and a start button 401 is pressed.

  Here, it is assumed that a sample with a high concentration uses a sample with a known concentration. However, in the case of a sample with an unknown concentration, after sampling the high concentration sample, use the dilution function of the device to measure the high concentration sample. Is calculated and reflected in the density of 500.

In step 402 in FIG. 4, the sample probe samples a high concentration sample, and then samples a zero concentration sample in step 403. If the item for measuring the carryover rate is a biochemical item such as LD or a dye solution such as orange G, the sampled zero concentration sample is measured by the biochemical unit 104, and if it is an immune item such as HBs, the immune unit In step 404, the carryover rate is calculated.

Here, the carryover rate is calculated by the following equation.
(Formula 1)
Carryover rate (%) = (measurement result of 0 concentration sample / measurement result of high concentration sample) × 100
In step 405, it is determined whether the carryover rate is within the threshold value. If the carryover rate is within the threshold value, a graph showing the calculation result and time series is displayed as shown in FIG.

  If the carryover rate exceeds the threshold value, alarm 1 is generated in step 407, the detergent is sampled in step 408, held for a predetermined time in step 409, and then washed with water.

The operation at this time will be described with reference to FIG. The detergent is sampled by the reagent probe 302 sampled on the reagent disk 301A or 301B of the biochemical unit 104, and the sample dispenser 303 samples the detergent dispensed in the reaction vessel 304 and holds it for a certain period of time. Water stains and protein stains adhering to the inner surface of the probe are removed, followed by washing with water.

  After cleaning, the carryover rate is measured and calculated again in step 410. In step 411, it is determined whether the carryover rate is within the threshold value. If it is within the threshold value, a graph showing the calculation result and time series is displayed as shown in FIG. Then, the process proceeds to step 412 and ends.

  If the carryover rate exceeds the threshold even after re-measurement, the sample probe may be severely scratched or dirty on the outer surface in step 413, and an alarm 2 is generated to prompt countermeasures such as parts replacement. End.

Schematic which showed the whole structure of the automatic analyzer to which this invention is applied. The block diagram of the immunoassay unit in the Example of FIG. The block diagram of the biochemical analysis unit in the Example of FIG. The flowchart in a present Example. The example of the setting screen which performs the carryover check between samples in a present Example. The example of a screen which displays the result of the carryover check between samples in a present Example.

Explanation of symbols

DESCRIPTION OF SYMBOLS 51 ... Memory | storage part, 53 ... Screen display apparatus, 54 ... Printer, 55 ... Floppy (trademark) disk drive, 101 ... Sample input part, 102 ... Conveyance part, 103 ... Immune analysis unit,
DESCRIPTION OF SYMBOLS 104 ... Biochemical analysis unit, 105 ... Reexamination conveyance part, 106 ... Operation part, 107 ... Rack, 108 ... Sample container, 109 ... Rack collection | recovery part, 110 ... First standby buffer, 111 ... Second standby buffer, 113, 115 ... subline, 201 ... reagent container, 202, 301A, 301B ... reagent disk, 203,305 ... reaction disk, 204 ... reaction container installation position, 205,304 ... reaction container, 206,303 ... sample dispensing pipettor, 207,308 Sample suction position, 208, 302A, 302B ... Reagent dispensing pipettor, 209 ... Reagent suction position, 210 ... Dispensing tip, 211 ... Shipper, 212 ... Reaction liquid suction position, 213 ... Buffer liquid suction position, 214 ... Washing liquid suction Position, 215 ... Detection unit, 216 ... Reaction vessel transfer mechanism, 217 ... Chip storage position, 218 ... Chip coupling Position, 219 ... Reaction container storage position, 220 ... Chip disposal position, 221 ... Sample discharge position, 222 ... Reagent addition position, 306 ... Multi-wavelength photometer, 307 ... Analog to digital converter, 309 ... Constant temperature bath, 310 ... Reagent container, 311: Stirrer,
312: Control unit.

Claims (2)

  An automatic analyzer for qualitative / quantitative analysis of biological components, characterized in that it has a system for automatically measuring the effect of carryover of a sample probe. 2. The automatic analyzer according to claim 1, wherein when the carryover rate exceeds a threshold value, an alarm is generated and the sample probe is automatically washed with a detergent.

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