Immunoassay apparatus

Patent metadata

Field	Value
Publication number	US-10648973-B2
Application number	US-201715719642-A
Country	US
Kind code	B2
Filing date	Sep 29, 2017
Priority date	Mar 31, 2015
Publication date	May 12, 2020
Grant date	May 12, 2020

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.

First claim

The invention claimed is:

1. An immunoassay apparatus comprising:
a reaction container holder;
a supplying mechanism capable of accommodating a plurality of reaction containers and configured to supply one reaction container of the plurality of reaction containers to the reaction container holder, one at a time;
a first transferring mechanism configured to catch and transfer the one reaction container between the reaction container holder and a first position;
a sample dispenser comprising a movable arm with a tip end thereof;
a plurality of reagent dispenser units comprising respective pipettes each accessing the one reaction container at a corresponding one of reagent dispensing positions, wherein the plurality of reagent dispenser units is configured to dispense (A) a reagent comprising a solid phase carrier, (B) a reagent comprising a labeling substance and (C) a reagent comprising a releasing substance, with the respective pipettes;
a detector configured to detect a signal indicating an amount of the labeling substance bound to a target substance in the one reaction container which is transferred to the detector;
a second transferring mechanism comprising a plurality of holes each configured to hold the one reaction container therein, the second transferring mechanism configured to transfer the one reaction container between the first position and the detector via the reagent dispensing positions; and
a controller programmed to perform operations comprising:
(i) causing the sample dispenser to aspirate a sample and dispense the sample in a first reaction container at the reaction container holder;
(ii) causing the first transferring mechanism to transfer the first reaction container to the first position and then causing the second transferring mechanism to transfer the first reaction container to the reagent dispensing positions, along with causing the plurality of reagent dispenser units to dispense the reagents (A) to (C) in the first reaction container at the reagent dispensing positions, thereby preparing a mixture of the sample and the reagents (A) to (C);
(iii) causing the second transferring mechanism to transfer the first reaction container to the first position, causing the first transferring mechanism to transfer the first reaction container to the reaction container holder, and then causing the sample dispenser to aspirate a part of the mixture in the first reaction container and dispense the part of the mixture in a second reaction container, which is different from the first reaction container, at the reaction container holder;
(iv) causing the first transferring mechanism to transfer the second reaction container to the first position and then causing the second transferring mechanism to transfer the second reaction container to the detector; and
(v) causing the detector to detect a signal indicating an amount of a labeling substance bound to a target substance in the part of the mixture in the second reaction container.

2. The immunoassay apparatus according to claim 1 , wherein
a dispensing tip is detachably attached to the tip end of the movable arm of the sample dispenser,
the sample dispenser dispenses the sample into the first reaction container via a first dispensing tip, and
the sample dispenser aspirates, via a second dispensing tip which is different from the first dispensing tip, the part of the mixture in the first reaction container and dispense the part of the mixture in the second reaction container.

3. The immunoassay apparatus according to claim 2 , further comprising a dispensing tip supply unit configured to supply a dispensing tip to a tip attachment position, wherein the controller is programmed to perform operations further comprising causing the sample dispenser to move the tip end of the movable arm to the tip attachment position and attach a dispensing tip.

4. The immunoassay apparatus according to claim 3 , wherein the controller is programmed to perform operations further comprising causing the sample dispenser to replace a dispensing tip used in dispensing of the sample with an unused dispensing tip at the tip attachment position every time the sample dispenser dispenses the sample.

5. The immunoassay apparatus according to claim 1 , further comprising a BF (bound/free) separation unit comprising a magnet, the BF separation unit configured to remove an unreacted substance, which is not bound to an immune complex of a target substance and a solid phase, from the one reaction container, while applying magnetic force with the magnet to the one reaction container so that the solid phase is drawn to an inner side of the one reaction container.

6. The immunoassay apparatus according to claim 5 , wherein the BF separation unit comprises a tube through which washing solution is supplied and is configured to wash the immune complex in the one reaction container by supplying and aspirating washing solution.

7. The immunoassay apparatus according to claim 5 , wherein the controller is programmed to perform operations further comprising causing the BF separation unit to remove an reacted substance from the first reaction container after the reagents (A) and (B) are dispensed and before the reagent (C) is dispensed to the first reaction container.

8. The immunoassay apparatus according to claim 1 , wherein the controller is programmed to perform operations further comprising
performing one of a first test sequence and a second test sequence, and
performing, in the first test sequence, the operations (i) to (v).

9. The immunoassay apparatus according to claim 8 , wherein the controller is programmed to perform, in the second test sequence, operations comprising:
(a) causing the sample dispenser to aspirate a sample and dispense the sample in a third reaction container at the reaction container holder;
(b) causing the first transferring mechanism to transfer the third reaction container to the first position and then causing the second transferring mechanism to transfer the third reaction container to the reagent dispensing positions, along with causing the plurality of reagent dispenser units to dispense the reagents (A) and (B) in the third reaction container at the reagent dispensing positions; and
(c) causing the detector to detect a signal indicating an amount of a labeling substance bound to a target substance in the third reaction container.

10. The immunoassay apparatus according to claim 9 , wherein the controller is programmed to perform operations comprising:
receiving a selection of one of the first test sequence and the second test sequence from a user; and
performing the first test sequence or the second test sequence based on the selection.

11. The immunoassay apparatus according to claim 9 , wherein the controller is programmed to perform operations comprising:
receiving a designation of a measurement item to test on a sample, and
determining which of the first test sequence or the second test sequence to perform based on the received designation of the measurement item.

Assignees

• Sysmex Corp
• Sysmex Corproation

Inventors

• Sato Toshiyuki
• Fukuju Toshikatsu
• Kaneko Shuhei
• Aoki Atsushi
• Okuzaki Tomohiro
• Takeuchi Yasuhiro
• Kawamoto Yutaka

Classifications

• G01N33/5764

  Hepatitis B surface antigen · CPC title

• G01N35/025

  having a carousel or turntable for reaction cells or cuvettes · CPC title

• G01N2035/103

  using disposable tips · CPC title

• G01N35/10

  Devices for transferring samples {or any liquids} to, in, or from, the analysis apparatus, e.g. suction devices, injection devices {(G01N35/0099 takes precedence)} · CPC title

• G01N35/1002

  Reagent dispensers · CPC title