# US 2018/0024128 A1 · Immunoassay apparatus

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- Number: US 2018/0024128 A1
- Document ID: US20180024128A1
- Status: Published application
- Kind: A1
- Application number: 15/719,642
- Filed: 2017-09-29
- Published: 2018-01-25
- Earliest claimed: 2015-03-31
- Assignees: Sysmex Corporation
- Applicants: Sysmex Corporation
- Inventors: Toshiyuki SATO; Toshikatsu FUKUJU; Shuhei KANEKO; Atsushi AOKI; Tomohiro OKUZAKI; Yasuhiro TAKEUCHI; Yutaka KAWAMOTO
- Web page: https://patentgrep.com/patent/US20180024128A1

## CPC

- G01N 33/54386: {Analytical elements}
- G01N 35/04: Details of the conveyor system {(G01N35/021 - G01N35/028 take precedence)}
- G01N 33/543: with an insoluble carrier for immobilising immunochemicals
- G01N 33/54366: {Apparatus specially adapted for solid-phase testing}
- G01N 33/5764: {Hepatitis B surface antigen}
- G01N 35/0098: {involving analyte bound to insoluble magnetic carrier, e.g. using magnetic separation (magnetic particles used in immunoassays G01N33/54326; magnetic separation in general B03C)}
- G01N 35/025: {having a carousel or turntable for reaction cells or cuvettes}
- G01N 35/10: Devices for transferring samples {or any liquids} to, in, or from, the analysis apparatus, e.g. suction devices, injection devices {(G01N35/0099 takes precedence)}
- G01N 35/1002: {Reagent dispensers}
- G01N 2035/0441: {for samples}
- G01N 2035/103: {using disposable tips}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

An immunoassay apparatus may include: a sample dispenser part that dispenses a sample into a first reaction container; a reagent dispenser part that dispenses, into the first reaction container,: a solid-phase reagent containing a solid-phase carrier; a labeled reagent; and a releasing reagent that releases, from the solid-phase carrier, an immune complex including a target substance and a labeled substance; a measurement part that measures a signal based on the labeled substance in the immune complex in a second reaction container; a container supply part that stores a plurality of reaction containers; a transfer part that transfers the first reaction container so that the sample dispenser part and the reagent dispenser part perform a dispensing operation to the first reaction container, and that transfers the second reaction container so that the immune complex dispended from the first reaction container is dispensed into the second container.

## Claims

### Claim 1

An immunoassay apparatus comprising:
a sample dispenser part that dispenses a sample into a first reaction container;
a reagent dispenser part that dispenses, into the first reaction container:
a solid-phase reagent containing a solid-phase carrier;
a labeled reagent containing a labeled substance; and
a releasing reagent that releases, from the solid-phase carrier, an immune complex including a target substance included in the sample and the labeled substance;
a measurement part that measures a signal based on the labeled substance included in the immune complex in a second reaction container;
a container supply part that stores a plurality of reaction containers including the first reaction container and the second reaction container;
a transfer part that transfers the first reaction container supplied from the container supply part so that the sample dispenser part and the reagent dispenser part perform a dispensing operation to the first reaction container, and that transfers the second reaction container supplied from the container supply part so that the immune complex dispended from the first reaction container is dispensed into the second container.

### Claim 2 (depends on 1)

The immunoassay apparatus according to claim 1, wherein the sample dispenser part dispenses, from the first reaction container, the immune complex released from the solid-phase carrier by the releasing reagent into the second reaction container.

### Claim 3 (depends on 1)

The immunoassay apparatus according to claim 1, wherein the reagent dispenser part dispenses, from the first reaction container, the immune complex released from the solid-phase carrier by the releasing reagent into the second reaction container.

### Claim 4 (depends on 1)

The immunoassay apparatus according to claim 1, further comprising an immune-complex dispenser part that dispenses the released immune complex, wherein
the immune-complex dispenser part dispenses, from the first reaction container, the immune complex released from the solid-phase carrier by the releasing reagent into the second reaction container.

### Claim 5 (depends on 2)

The immunoassay apparatus according to claim 2, wherein a dispensing tip is detachably attachable to an end of the sample dispenser part,
the sample dispenser part dispenses the sample into the first reaction container via a first dispensing tip, and
the sample dispenser part, via a second dispensing tip attached by replacing the first dispensing tip, aspirates the immune complex from the first reaction container and dispenses the immune complex into the second reaction container.

### Claim 6 (depends on 5)

The immunoassay apparatus according to claim 5, further comprising a dispensing-tip supply part that supplies the dispensing tip to a tip attachment position, wherein the first dispensing tip and the second dispensing tip are attached to the end of the sample dispenser part in the tip attachment position.

### Claim 7 (depends on 2)

The immunoassay apparatus according to claim 2, further comprising a reaction-container holding part including holding holes, each of which is configured to hold a reaction container, wherein
the transfer part transfers the first reaction container and the second reaction container to the holding holes of the reaction-container holding part, and
the sample dispenser part dispenses, into the second reaction container held by the reaction-container holding part, the immune complex in the first reaction container held by the reaction-container holding part.

### Claim 8 (depends on 5)

The immunoassay apparatus according to claim 5, wherein every time the sample dispenser part performs any of a dispensing operation using the first dispensing tip and a dispensing operation using the second dispensing tip, a used dispensing tip attached to the sample dispenser part is replaced with an unused dispensing tip.

### Claim 9 (depends on 1)

The immunoassay apparatus according to claim 1, further comprising a BF separation part that separates the solid-phase carrier on which the immune complex is formed and a liquid component, wherein
the reagent dispenser part dispenses a first solid-phase reagent containing a first solid-phase carrier into the first reaction container and dispenses a second solid-phase reagent containing a second solid-phase carrier into the second reaction container storing the dispensed immune complex, and
the BF separation part performs separation processing for the immune complex in the first reaction container storing the dispensed first solid-phase reagent and separation processing for the immune complex in the second reaction container storing the dispensed second solid-phase reagent.

### Claim 10 (depends on 1)

The immunoassay apparatus according to claim 1, further comprising a controller that switches a first test mode of measuring the signal based on the labeled substance included in the immune complex stored in the second reaction container and a second test mode of measuring a signal based on the labeled substance included in the immune complex stored in the first reaction container.

### Claim 11 (depends on 10)

The immunoassay apparatus according to claim 10, wherein the controller switches the first test mode and the second test mode according to selection by a user.

### Claim 12 (depends on 10)

The immunoassay apparatus according to claim 10, wherein the controller switches the first test mode and the second test mode according to a measurement item.

### Claim 13 (depends on 1)

The immunoassay apparatus according to claim 1, further comprising a controller that controls first test processing including:
first solid phasing processing of binding the immune complex and a first solid-phase carrier;
releasing processing of releasing the immune complex from the first solid-phase carrier;
second solid phasing processing of binding the immune complex and a second solid-phase carrier; and
measurement processing of measuring the signal, wherein
the controller allocates the first reaction container and the second reaction container to the first test processing for a measurement order.

### Claim 14 (depends on 13)

The immunoassay apparatus according to claim 13, wherein the controller allocates the second reaction container to the first reaction container before completion of the releasing processing.

### Claim 15 (depends on 13)

The immunoassay apparatus according to claim 13, wherein based on reception of the measurement order, the controller allocates the first reaction container and the second reaction container to the first test processing for the measurement order.

### Claim 16 (depends on 13)

The immunoassay apparatus according to claim 13, wherein the controller controls the first test processing in the first solid phasing processing such that after performing labeled substance binding processing of binding the target substance and the labeled substance, the first test processing performs first solid-phase carrier binding processing of binding the immune complex including the target substance and the labeled substance to the first solid-phase carrier.

### Claim 17 (depends on 16)

The immunoassay apparatus according to claim 16, further comprising a BF separation part that separates the solid-phase carrier on which the immune complex is formed and a liquid component, wherein
the controller controls the first test processing further including, after the first solid phasing processing, first BF separation processing of discarding a liquid phase separated in BF separation by the BF separation part and second BF separation processing of dispensing, into the second reaction container, the immune complex released from the solid-phase carrier by the releasing reagent.

### Claim 18 (depends on 17)

The immunoassay apparatus according to claim 17, wherein the controller controls the first test processing such that the second BF separation processing is performed between the releasing processing and the second solid phasing processing.

### Claim 19 (depends on 17)

The immunoassay apparatus according to claim 17, wherein the sample dispenser part dispenses, from the first reaction container, the immune complex released by the second BF separation processing into the second reaction container.

### Claim 20 (depends on 17)

The immunoassay apparatus according to claim 17, wherein the controller controls the first test processing such that first reaction container discarding processing of discarding the first reaction container is performed between the second BF separation processing and the second solid phasing processing.

### Claim 21 (depends on 17)

The immunoassay apparatus according to claim 17, wherein the controller controls the first test processing such that third BF separation processing of discarding a liquid phase separated by the BF separation part is performed between the second solid phasing processing and the measurement processing.

### Claim 22 (depends on 13)

The immunoassay apparatus according to claim 13, wherein
the controller further controls second test processing including: third solid phasing processing of binding the immune complex and a third solid-phase carrier; and measurement processing of measuring the signal, and
in a condition in which measurement orders for the first test processing and the second test processing coexist, the controller performs control such that the first test processing for a first measurement order and the second test processing for a second measurement order are performed concurrently by allocating the first reaction container and the second reaction container to the first test processing, and allocating a first reaction container to the second test processing.

### Claim 23 (depends on 22)

The immunoassay apparatus according to claim 22, wherein the controller performs control such that processing timings of the first test processing and the second test processing at least partly overlap each other.

### Claim 24 (depends on 1)

The immunoassay apparatus according to claim 1, wherein the reagent dispenser part comprises:
a first reagent dispenser unit that dispenses, into the first reaction container, at least one of the solid-phase reagent and the labeled reagent; and
a second reagent dispenser unit that dispenses, into the first reaction container, the releasing reagent.

### Claim 25 (depends on 1)

The immunoassay apparatus according to claim 1, wherein the reagent dispenser part comprises a reagent dispenser unit that dispenses, into the first reaction container, at least one of the solid-phase reagent and the labeled reagent, and the releasing reagent.

### Claim 26

An immunoassay apparatus comprising:
a sample dispenser part that dispenses a sample into a first reaction container;
a reagent dispenser part that:
dispenses, into the first reaction container,:
a first solid-phase reagent containing a first solid-phase carrier;
a labeled reagent containing a labeled substance; and
a releasing reagent that releases, from the first solid-phase carrier,
an immune complex including a target substance included in the sample and the labeled substance; and
dispenses, into a second reaction container storing the immune complex dispensed from the first reaction container, the second solid-phase reagent containing a second solid-phase carrier,
a BF separation part that performs separation processing for the immune complex in the first reaction container storing the dispensed first solid-phase reagent and separation processing for the immune complex in the second reaction container storing the dispensed second solid-phase reagent;
a measurement part that measures a signal based on the labeled substance included in the immune complex in the second reaction container.

### Claim 27 (depends on 26)

The immunoassay apparatus according to claim 26, wherein the BF separation part comprises:
a first BF separation part that performs the separation processing for the immune complex in the first reaction container; and
a second BF separation part that performs the separation processing for the immune complex in the second reaction container.

### Claim 28 (depends on 26)

The immunoassay apparatus according to claim 26, wherein the sample dispenser part dispenses, from the first reaction container, the immune complex released from the first solid-phase carrier by the releasing reagent into the second reaction container.

### Claim 29 (depends on 26)

The immunoassay apparatus according to claim 26, wherein the reagent dispenser part comprises:
a first reagent dispenser unit that dispenses, into the first reaction container, at least one of the solid-phase reagent and the labeled reagent; and
a second reagent dispenser unit that dispenses, into the first reaction container, the releasing reagent.

### Claim 30 (depends on 26)

The immunoassay apparatus according to claim 26, wherein the reagent dispenser part comprises a reagent dispenser unit that dispenses, into the first reaction container, at least one of the solid-phase reagent and the labeled reagent, and the releasing reagent.
