Automatic liquid analytical reagent dispensing apparatus, analytical assay reaction cartridges and kits, and methods of use related thereto

Patent metadata

Field	Value
Publication number	US-12440834-B2
Application number	US-202117996669-A
Country	US
Kind code	B2
Filing date	Apr 20, 2021
Priority date	Apr 24, 2020
Publication date	Oct 14, 2025
Grant date	Oct 14, 2025

Abstract

Analytical assay reaction cartridges are disclosed that include a reagent tray containing a liquid reagent disposed therein and a flexible cover removably attached thereto. The flexible cover has a portion that extends beyond the reagent tray and that forms a tab portion extends through an opening in a lid member of the cartridge in order to facilitate removal of at least a portion of the cover and release of the liquid reagent. Also disclosed are analytical assay reaction kits that include the cartridges and diagnostic instruments for use with the analytical assay reaction cartridges/kits, as well as methods of making and using the cartridges/kits.

First claim

What is claimed is:

1. An analytical assay reaction cartridge, comprising:
a base comprising:
a back member;
a sidewall attached to the back member;
a reaction chamber defined by a lower portion of the base;
an inlet for introducing a liquid test sample into the reaction chamber;

a reagent tray disposed and retained within the base, the reagent tray having an upper end, a lower end, a cavity, and an upper edge that extends around a perimeter of the cavity, wherein the cavity is formed to contain a predetermined volume of liquid reagent;
a flexible cover removably attached to the upper edge of the reagent tray to seal the liquid reagent within the cavity and thereby form a sealed chamber between the cavity and the flexible cover, the flexible cover having a portion that extends beyond the upper end of the reagent tray to define a tab portion which can be pulled to remove at least a portion of the flexible cover from the reagent tray and thereby release the liquid reagent into the reaction chamber of the base;
a lid member disposed over the base and sealed to at least a portion of the sidewall of the base so as to seal the reagent tray within the base, the lid member comprising at least one opening through which the tab portion is threaded; and
a pivot member disposed between the reagent tray and the lid member, wherein the tab portion of the flexible cover is folded back upon itself around the pivot member so that the tab portion extends through the at least one opening in the lid member in order to facilitate removal of at least a portion of the flexible cover from the reagent tray for release of substantially all of the liquid reagent into the reaction chamber.

2. The analytical assay reaction cartridge of claim 1 , further comprising a sample read window in the lid member at a position that contacts a portion of the reaction chamber.

3. The analytical assay reaction cartridge of claim 1 , wherein the lid member comprises a second opening, and wherein the tab portion is threaded back through the second opening such that an end of the tab portion is disposed within the base of the cartridge, and wherein only the portion of the tab portion that extends between the two openings in the lid member is exposed outside of the analytical assay reaction cartridge.

4. The analytical assay reaction cartridge of claim 1 , further comprising a predetermined volume of liquid reagent disposed within the cavity of the reagent tray.

5. The analytical assay reaction cartridge of claim 1 , wherein the sidewall is formed of an upper perimeter side, a lower perimeter side, a first perimeter side, and a second perimeter side, and wherein the base further comprises:
a first inner sidewall that extends perpendicularly from the upper perimeter side and has a lower end positioned above the lower perimeter side; and
a second inner sidewall that extends perpendicularly from the upper perimeter side and has a lower end positioned above the lower perimeter side.

6. The analytical assay reaction cartridge of claim 5 , wherein the reagent tray is retained in place between the first and second inner side walls of the base.

7. The analytical assay reaction cartridge of claim 5 , wherein the at least one opening in the lid member is disposed between the first and second inner sidewalls.

8. The analytical assay reaction cartridge of claim 5 , wherein the base further comprises a flange extending from the upper perimeter side of the base.

9. The analytical assay reaction cartridge of claim 5 , further comprising at least a first guide member extending from the first inner sidewall and a second guide member extending from the second inner sidewall, wherein the guide members frictionally engage the reagent tray and maintain the reagent tray in position within the base of the analytical assay reaction cartridge.

10. The analytical assay reaction cartridge of claim 9 , wherein the first and second guide members extend beyond the reagent tray and frictionally engage the pivot member and maintain the pivot member in position within the base of the analytical assay reaction cartridge.

11. An analytical assay reaction kit, the kit comprising:
the analytical assay reaction cartridge of claim 1 ; and
a capillary holder at least partially inserted into the inlet of the analytical assay reaction cartridge.

12. The analytical assay reaction kit of claim 11 , wherein the analytical assay reaction cartridge further comprises a sample read window in the lid member at a position that contacts a portion of the reaction chamber.

13. The analytical assay reaction kit of claim 11 , wherein the lid member of the analytical assay reaction cartridge comprises a second opening, and wherein the tab portion is threaded back through the second opening such that an end of the tab portion is disposed within the base of the cartridge, and wherein only the portion of the tab portion that extends between the two openings in the lid member is exposed outside of the analytical assay reaction cartridge.

14. The analytical assay reaction kit of claim 11 , wherein the analytical assay reaction cartridge further comprises a predetermined volume of liquid reagent disposed within the cavity of the reagent tray.

15. The analytical assay reaction kit of claim 11 , wherein the capillary holder comprises a capillary into which a portion of the liquid test sample can be drawn.

16. The analytical assay reaction kit of claim 11 , wherein the sidewall of the analytical assay reaction cartridge is formed of an upper perimeter side, a lower perimeter side, a first perimeter side, and a second perimeter side, and wherein the base further comprises:
a first inner sidewall that extends perpendicularly from the upper perimeter side and has a lower end positioned above the lower perimeter side; and
a second inner sidewall that extends perpendicularly from the upper perimeter side and has a lower end positioned above the lower perimeter side.

17. The analytical assay reaction kit of claim 16 , wherein the reagent tray of the analytical assay reaction cartridge is retained in place between the first and second inner sidewalls of the base.

18. The analytical assay reaction kit of claim 16 , wherein the at least one opening in the lid member of the analytical assay reaction cartridge is disposed between the first and second inner sidewalls and is not in contact with the reaction chamber.

19. The analytical assay reaction kit of claim 16 , wherein the base of the analytical assay reaction cartridge further comprises a flange extending from the upper perimeter side of the base.

20. The analytical assay reaction kit of claim 16 , further comprising at least a first guide member extending from the first inner sidewall and a second guide member extending from the second inner sidewall, wherein the guide members frictionally engage the reagent tray and maintain the reagent tray in position within the base of the analytical assay reaction cartridge.

21. The analytical assay reaction kit of claim 20 , wherein the first and second guide members extend beyond the reagent tray and frictionally engage the pivot member and maintain the pivot member in position within the base of the analytical assay reaction cartridge.

22. A diagnostic assay instrument, comprising:
a housing that includes at least one cartridge compartment capable of receiving at least one of the analytical assay reaction cartridge of claim 1 or the analytical assay reaction cartridge kit of claim 11 ;
a

Assignees

• Siemens Healthcare Diagnostics Inc

Inventors

• Kauffmann Aaron

Classifications

• G01N33/721

  Haemoglobin · CPC title

• B01L2300/0858

  Side walls · CPC title

• B01L2300/0838

  Capillaries · CPC title

• B01L2300/0816

  Cards, e.g. flat sample carriers usually with flow in two horizontal directions · CPC title

• B01L2200/16

  Reagents, handling or storing thereof · CPC title