Cuvette for an automated analyzer

• US 20050266570A1
• Filed: 08/10/2005
• Published: 12/01/2005
• Est. Priority Date: 03/04/1991
• Status: Abandoned Application

• Current Assignee: Aluminium Pechiney (Rio Tinto Limited)
• Original Assignee: Bayer Corporation (Bayer AG)
• Inventors: Carey, Glen, Lewis, Scott C.
• Application Number:
  US11/200,905
• Publication Number:
  US 20050266570A1
• Time in Patent Office: Days
• US Class Current: 436/43
• CPC Class Codes: B01L 2300/0854 Double walls
• CPC Class Codes: B01L 3/508 rigid containers not provided for above
• CPC Class Codes: G01N 2035/00386 using fluid heat transfer medium
• CPC Class Codes: G01N 2035/00396 where the fluid is a liquid
• CPC Class Codes: G01N 2035/00524 Mixing by agitating sample carrier
• CPC Class Codes: G01N 2035/00752 bar codes
• CPC Class Codes: G01N 2035/0441 for samples
• CPC Class Codes: G01N 2035/0443 for reagents
• CPC Class Codes: G01N 2035/0465 Loading or unloading the conveyor
• CPC Class Codes: G01N 2035/0486 Gearing, cams
• CPC Class Codes: G01N 2035/1025 Fluid level sensing
• CPC Class Codes: G01N 21/76 Chemiluminescence; Bioluminescence
• CPC Class Codes: 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
• CPC Class Codes: G01N 35/021 having a flexible chain, e.g. "cartridge belt", conveyor for reaction cells or cuvettes
• CPC Class Codes: G01N 35/025 having a carousel or turntable for reaction cells or cuvettes
• CPC Class Codes: G01N 35/04 Details of the conveyor system G01N35/021 - G01N35/028 take precedence
• CPC Class Codes: G01N 35/1002 Reagent dispensers
• CPC Class Codes: G01N 35/1065 Multiple transfer devices
• CPC Class Codes: Y10T 436/11 Automated chemical analysis
• CPC Class Codes: Y10T 436/114165 with step of insertion or removal from test line
• CPC Class Codes: Y10T 436/114998 : with treatment or replacement of aspirator element [e.g., cleaning, etc.]
• CPC Class Codes: Y10T 436/115831 : Condition or time responsive

Abstract

An analyzer for performing automated assay testing. The analyzer includes a storage and conveyor system for conveying cuvettes to an incubation or processing conveyor, a storage and selection system for test sample containers, a storage and selection system for reagent containers, sample and reagent aspirating and dispensing probes, a separation system for separating bound from unbound tracer or labeled reagent, a detection system and date collection/processing system. All of the sub-units of the machine are controlled by a central processing unit to coordinate the activity of all of the subunits of the analyzer. The analyzer is specifically suited for performing heterogeneous binding assay protocols, particularly immunoassays.

Claims

1. A method of testing for the presence of one or more analytes in each of plural patient samples using a high throughput, high sensitivity, random access, automated magnetic particle chemiluminescence immunoassay analyzer, the method comprising the steps of:

(a) randomly loading sample containers into the analyzer, each sample container containing a patient sample and having coded indicia on an outer surface thereof usable for identifying at least a test to be performed on the patient sample;

(b) automatically detecting the coded indicia on each of the sample containers at least for identifying and storing, in association with an analyzer controller, the test to be performed on each patient sample contained therein;

(c) mounting a set of first reagent containers in a first circular array about a primary vertical axis of rotation, each of the first reagent containers

having a solid phase reagent, comprised of paramagnetic microparticles and a liquid, disposed therein,

being mounted for rotation about a respective secondary vertical axis of rotation, and

having an internal agitating feature formed therein for agitating the respective solid phase reagent and thereby suspending the paramagnetic microparticles in the liquid;

(d) mounting a set of second reagent containers in a second circular array concentric with the set of first reagent containers about the primary vertical axis of rotation, each of the second reagent containers having a chemiluminescence labeled reagent disposed therein and containers of at least one of the sets of first and second reagent containers having coded indicia on an outer surface thereof usable for identifying at least the reagent contained therein;

(e) rotating the at least one set of first and second reagent containers having coded indicia about the primary vertical axis of rotation to position each respective container proximate a coded indicia detector and automatically detecting the coded indicia at least for identifying and storing, in association with the analyzer controller, the reagent contained therein;

(f) testing for the presence of one or more analytes in a first patient sample in one of the sample containers by

(1) automatically withdrawing at least a portion of the first patient sample from the sample container and depositing it into a cuvette,

(2) automatically and rotationally oscillating the set of first reagent containers about each respective secondary vertical axis of rotation, whereby the internal agitating feature within each first reagent container agitates the contents thereof for suspending the paramagnetic microparticles within the liquid,

(3) automatically rotating the set of first reagent containers about the primary vertical axis of rotation to position a selected first reagent container at a first reagent aspirating position at least on the basis of the test identified from the respective sample container coded indicia and stored in association with the analyzer controller,

(4) automatically aspirating a predetermined amount of solid phase reagent from the selected first reagent container, and automatically dispensing a predetermined amount of the aspirated solid phase reagent into the cuvette at a first reagent dispensing position,

(5) automatically rotating the set of second reagent containers about the primary vertical axis of rotation to position a selected second reagent container at a second reagent aspirating position at least on the basis of the test identified from the respective sample container and stored in association with the analyzer controller,

(6) automatically aspirating a predetermined amount of labeled reagent from the selected second reagent container, and automatically dispensing at least a portion of the predetermined amount of the aspirated labeled reagent into the cuvette at a second reagent dispensing position, and

(7) incubating the first patient sample in the cuvette whereby the paramagnetic microparticles in the solid phase reagent, the labeled reagent, and the analyte or analytes being tested for can form a complex,

(8) applying a magnetic field adjacent the cuvette to attract paramagnetic microparticles to an interior wall of the cuvette,

(9) washing the contents of the cuvette by dispensing a liquid into the cuvette then aspirating the liquid therefrom,

(10) generating a chemiluminescent reaction involving the labeled reagent within the cuvette, and

(11) automatically detecting a characteristic of the chemiluminescent reaction; and

(g) repeating step (f) for each successive patient sample using additional cuvettes.

2. The method of claim 1, wherein the coded indicia in steps (a) through (f) are bar codes and wherein the coded indicia detector of step (e) is a bar code reader.

3. The method of claim 1, wherein step (b) further comprises automatically detecting the coded indicia on each of the sample containers for identifying data relating to the respective patient.

4. The method of claim 1, wherein step (e) further comprises automatically detecting the coded indicia on each reagent container having coded indicia for identifying and storing the relative and absolute positions of each reagent container within the respective set.

5. The method of claim 1, wherein

step (c) further comprises mounting the set of first reagent containers, each having a pair of coplanar fins as the internal agitating feature, and

step (f)(2) further comprises automatically and rotationally oscillating the set of first reagent containers about each respective secondary vertical axis of rotation whereby the pair of coplanar fins agitates the contents of the respective first reagent container for suspending the paramagnetic microparticles within the liquid.

6. The method of claim 1, wherein the labeled reagent includes an acridinium ester.

7. The method of claim 1, wherein the chemiluminescent reaction is generated by addition of an acid solution followed by addition of a base solution.

8. The method of claim 7, wherein the acid solution is hydrogen peroxide and the base solution is sodium hydroxide.

9. The method of claim 1, wherein step (d) further comprises mounting the set of second reagent containers, wherein both of the sets of first and second reagent containers have coded indicia on an outer surface thereof.

10. The method of claim 9, wherein step (e) further comprises rotating the set of first reagent containers proximate the coded indicia detector and automatically detecting the coded indicia at least for identifying and storing, in association with the analyzer controller, the solid phase reagent contained within each container.

11. The method of claim 10, wherein step (f)(3) further comprises automatically rotating the set of first reagent containers about the primary vertical axis of rotation to position the selected first reagent container at the first reagent aspirating position at least on the basis of the solid phase reagent identity detected from the coded indicia on each of the first reagent containers and stored in association with the analyzer controller and the test identity detected from the respective sample container coded indicia and stored in association with the analyzer controller.

12. The method of claim 1, wherein step (d) further comprises mounting the set of second reagent containers, wherein at least the set of first reagent containers has coded indicia on an outer surface of each first reagent container thereof, and wherein step (e) further comprises rotating each of the first reagent containers about the respective secondary vertical axis of rotation while proximate the coded indicia detector and while the coded indicia disposed thereon is detected by the coded indicia detector.

13. The method of claim 1, wherein step (c) further comprises randomly mounting the set of first reagent containers in the first circular array about the primary vertical axis of rotation, and wherein step (d) further comprises randomly mounting the set of second reagent containers in the second circular array concentric with the set of first reagent containers about the primary vertical axis of rotation.

14. The method of claim 1, wherein step (f)(2) is performed repeatedly during each iteration of step (f).

15. The method of claim 1, wherein step (f)(4) is performed before before step (f)(6).

16. The method of claim 1, wherein the step (f)(6) is performed before before step (f)(4).

17. The method of claim 1, wherein the complex is a sandwich assay.

18. The method of claim 1, wherein the first and second aspirating positions are noncoincident.

19. The method of claim 1, wherein the first and second dispensing positions are noncoincident.

20. A high throughput, high sensitivity, random access, automated magnetic particle chemiluminescence immunoassay analyzer having a reagent transport apparatus for testing patient samples for the presence of one or more analytes in each sample, comprising:

(a) an analyzer controller for controlling the apparatus according to data collected from containers removably associated with the analyzer;

(b) a sample module for receiving sample containers in a random, unordered fashion, each sample container containing a patient sample and having coded indicia on an outer surface thereof usable for identifying at least a test to be performed on the patient sample;

(c) a first coded indicia detector for automatically detecting the coded indicia on each of the sample containers at least for identifying and storing, in association with the analyzer controller, the test to be performed on each patient sample contained therein;

(d) a set of first reagent containers mounted in a first circular array about a primary vertical axis of rotation, each of the first reagent containers

having a solid phase reagent, comprised of paramagnetic microparticles and a liquid, disposed therein,

being mounted for rotation about a respective secondary vertical axis of rotation, and

having an internal agitating feature disposed therein for agitating the contents of the respective first reagent container to suspend the paramagnetic microparticles in the liquid;

(e) a set of second reagent containers mounted in a second circular array concentric with the set of first reagent containers about the primary vertical axis of rotation, each of the second reagent containers having a chemiluminescence labeled reagent disposed therein and containers of at least one of the sets of first and second reagent containers having coded indicia on an outer surface thereof usable at least for identifying the reagent contained therein;

(f) a second coded indicia detector for automatically detecting the coded indicia of the at least one of the sets of first and second reagent containers at least for identifying and storing, in association with the analyzer controller, the reagent contained therein;

(g) a translatable sample aspirating and dispensing probe for automatically aspirating and dispensing a portion of a patient sample from a first sample container into a cuvette;

(h) a conveyor for conveying plural cuvettes;

(i) a motor and linkage in communication with the set of first reagent containers for simultaneously, automatically, and rotationally oscillating all of the first reagent containers about the respective secondary vertical axes of rotation, whereby the internal agitating feature within each first reagent container agitates the contents thereof, thereby suspending the paramagnetic microparticles within the liquid;

(j) a first translatable reagent aspirating and dispensing probe for automatically aspirating a predetermined quantity of a solid phase reagent from a first reagent container at a first reagent aspirating position and for dispensing at least a portion thereof into a cuvette at a first reagent dispensing position;

(k) a second translatable reagent aspirating and dispensing probe for automatically aspirating a predetermined quantity of a labeled reagent from a second reagent container at a second reagent aspirating position and for dispensing at least a portion thereof into the cuvette at a second reagent dispensing position;

(l) a magnet array proximate the conveyor;

(m) a wash liquid dispense and aspiration station;

(n) an acid dispensing probe;

(o) a base dispensing probe; and

(p) a luminometer,

whereby the analyzer is adapted for performing a chemiluminescence immunoassay test for detecting the presence of one or more analytes in a first patient sample by

(1) automatically detecting the coded indicia on the sample container containing the first patient sample at least for identifying and storing, in association with the analyzer controller, the test to be performed on the first patient sample,

(2) automatically aspirating at least a portion of the first patient sample from the sample container and depositing it into a cuvette using the sample aspirating and dispensing probe,

(3) using the motor and linkage, simultaneously, automatically, and rotationally oscillating the set of first reagent containers about each respective secondary vertical axis of rotation, whereby the internal agitating feature within each first reagent container agitates the contents thereof for suspending the paramagnetic microparticles within the liquid,

(4) automatically rotating the set of first reagent containers about the primary vertical axis of rotation to position a selected first reagent container at the first reagent aspirating position at least on the basis of the test identified from the respective sample container coded indicia and stored in association with the analyzer controller,

(5) automatically aspirating a predetermined amount of solid phase reagent from the selected first reagent container at the first reagent aspirating position using the first translatable reagent aspirating and dispensing probe, and automatically dispensing at least a portion of the predetermined amount of aspirated solid phase reagent into the cuvette at the first reagent dispensing position,

(6) automatically rotating the set of second reagent containers about the primary vertical axis of rotation to position a selected second reagent container at the second reagent aspirating position at least on the basis of the test identified from the respective sample container coded indicia and stored in association with the analyzer controller,

(7) automatically aspirating a predetermined amount of labeled reagent from the selected second reagent container at the second reagent aspirating position using the second translatable reagent aspirating and dispensing probe, and automatically dispensing at least a portion of the predetermined amount of aspirated labeled reagent into the cuvette at the second reagent dispensing position,

(8) incubating the first patient sample in the cuvette whereby the paramagnetic microparticles in the solid phase reagent, the labeled reagent, and the analyte or analytes being tested for form a complex,

(9) applying a magnetic field, using the magnet array, adjacent the cuvette to attract paramagnetic microparticles to an interior wall of the cuvette,

(10) washing the contents of the cuvette by dispensing a liquid into the cuvette then aspirating the liquid therefrom at the wash liquid dispense and aspiration station,

(11) generating a chemiluminescent reaction involving the labeled reagent within the cuvette, and

(12) automatically detecting a characteristic of the chemiluminescent reaction generated within the cuvette using the luminometer.

21. The analyzer of claim 20, wherein the sample container and reagent container coded indicia are bar codes and wherein the first and second coded indicia detectors are bar code readers.

22. The analyzer of claim 20, wherein the internal agitating feature in each of the first reagent containers is comprised of a pair of coplanar agitating fins.

23. The analyzer of claim 20, wherein the labeled reagent is an acridinium ester.

24. The analyzer of claim 20, wherein the chemiluminescent reaction is generated by addition of an acid solution followed by addition of a base solution.

25. The analyzer of claim 24 wherein the acid solution is hydrogen peroxide and the base solution is sodium hydroxide.

26. The analyzer of claim 25, wherein reagent containers of both of the sets of first and second reagent containers have coded indicia on an outer surface thereof.

27. The analyzer of claim 20, wherein containers of the set of first reagent containers have coded indicia on an outer surface thereof, and wherein the motor and linkage in communication with the set of first reagent containers are operative to automatically rotate all of the first reagent containers simultaneously about the respective secondary vertical axes of rotation while the second coded indicia detector automatically detects the coded indicia thereon.

28. The analyzer of claim 20, wherein step (5) is performed before step (7).

29. The analyzer of claim 20, wherein step (7) is performed before step (5).

30. The analyzer of claim 20, wherein the complex is a sandwich assay.

31. The analyzer of claim 20, wherein the first and second reagent aspirating positions are noncoincident.

32. The analyzer of claim 20, wherein the first and second reagent dispensing positions are noncoincident.