Multi-analyte diagnostic system and computer implemented process for same

• US 7,267,798 B2
• Filed: 05/21/2003
• Issued: 09/11/2007
• Est. Priority Date: 05/14/1998
• Status: Expired due to Fees

• Current Assignee: Luminex Corporation (DiaSorin S.p.A.)
• Original Assignee: Luminex Corporation (DiaSorin S.p.A.)
• Inventors: Chandler, Van S.
• Primary Examiner(s): Gordon; Brian R.
• Application Number:
  US10/442,130
• Publication Number:
  US 20030235919A1
• Time in Patent Office: 1,574 Days
• Field of Search: 422/73, 422/82.05, 422/55, 422/63, 422/67, 422/68.1, 422/100, 422/105, 702/19, 702 21- 23, 702/45, 702/49, 702/50, 356 72- 73
• US Class Current: 422/82.05
• CPC Class Codes: G01N 15/1456 without spatial resolution of the texture or inner structure of the particle, e.g. processing of pulse signals
• CPC Class Codes: G01N 15/149 specially adapted for sorting particles, e.g. by their size or optical properties
• CPC Class Codes: G01N 2015/1477 Multiparameters
• CPC Class Codes: G01N 2015/1493 Particle size
• CPC Class Codes: G01N 2021/0346 Capillary cells; Microcells
• CPC Class Codes: G01N 2021/4707 Forward scatter; Low angle scatter
• CPC Class Codes: G01N 2021/4726 Detecting scatter at 90°
• CPC Class Codes: G01N 2021/6441 with two or more labels
• CPC Class Codes: G01N 2021/6482 Sample cells, cuvettes
• CPC Class Codes: G01N 21/05 Flow-through cuvettes G01N21/09 takes precedence; handling fluid samples G01N1/10
• CPC Class Codes: G01N 21/53 within a flowing fluid, e.g. smoke
• CPC Class Codes: G01N 21/645 Specially adapted constructive features of fluorimeters
• CPC Class Codes: Y10T 436/11 Automated chemical analysis
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

A multi-analyte diagnostic system for use with a computer. The diagnostic system includes a flow analyzer including a co-planar light source-optical detector array, the flow analyzer being communicatable with the computer. The diagnostic system also includes a memory medium readable by the computer and storing computer instructions. The instructions include the following steps. A biological sample is run through the flow analyzer. The identity and quantity of at least one analyte of interest in the biological fluid is determined substantially simultaneously to the sample-running step.

Claims

1. A multi-analyte diagnostic system for use with a computer, the diagnostic system comprising:

a flow analyzer including a substantially co-planar optical assembly having at least one light source and at least one optical detector, said flow analyzer being communicable with the computer; and

a memory medium readable by the computer and storing computer instructions, the instructions including;

processing a biological sample using said flow analyzer, wherein said processing instruction includes;

(a) exposing a pooled population of subsets of particles to the biological sample, the particles in each subset having (i) at least one classification parameter that distinguishes the particles of one subset from those of another subset, and (ii) a reactant specific for each of at least one analyte of interest; and

(b) passing the exposed pooled population of subsets of particles through an examination zone; and

determining a presence and quantity of each of said at least one analyte of interest in the biological sample substantially simultaneously to said processing step, wherein said determining instruction comprises assessing the identity and quantity of each of said at least one analyte of interest, if present, in the sample by substantially contemporaneously;

(a) collecting data relating to the at least one classification parameter, including particle subset data on fluorescence emission intensities;

(b) collecting data relating to a presence or absence of a complex formed between the reactant and an analyte of interest specific to the reactant, including analyte data on fluorescence emission intensities, wherein the particle subset data and the analyte data exhibit spectral overlap;

(c) classifying, without relying exclusively, if at all, on differences in particle size, each particle according to its subset, wherein said classifying step includes reducing the spectral overlap sufficiently to identify said each particle according to its subset; and

(d) quantifying an amount of complex associated with each subset.

2. The multi-analyte diagnostic system according to claim 1, wherein said flow analyzer further comprises:

a plurality of light sources and a plurality of optical detectors, said plurality of light sources including overlapping focal regions; and

a plurality of magnification lenses for magnification of light emissions or reflections detected by said at least one of the plurality of optical detectors each of the plurality of magnification lenses having a magnification factor of at least 15X.

3. The multi-analyte diagnostic system according to claim 2, wherein said plurality of light sources includes a plurality of laser diodes emitting continuous wave light.

4. The multi-analyte diagnostic system according to claim 3, wherein said plurality of laser diodes includes laser diodes emitting a plurality of wavelengths of continuous wave light.

5. The multi-analyte diagnostic system according to claim 1, wherein said flow analyzer includes a cuvette having a flat air-to-glass interface.

6. The multi-analyte diagnostic system according to claim 1, further comprising at least one of a vertically and horizontally moveable platform, wherein said flow analyzer further comprises a vertically moveable aspirator, said platform cooperating with said aspirator.

7. The multi-analyte diagnostic system according to claim 6, wherein said platform supports one of a microtiter plate and said flow analyzer.

8. The multi-analyte diagnostic system according to claim 1, wherein said flow analyzer further comprises an aspirator moveable in either one of vertical and horizontal directions.

9. The multi-analyte diagnostic system according to claim 1, further comprising a circular memory buffer communicable with said flow analyzer.

10. The multi-analyte diagnostic system according to claim 9, wherein said circular memory buffer includes a first movable pointer in operation, pointing to a storage position available for storing new data, and a second movable pointer, in operation, pointing to a storage position having unanalyzed data.

11. The multi-analyte diagnostic system according to claim 1, wherein the computer instructions further provides at least one of:

a main menu;

a results table;

a system monitor;

a dot plot display including at least one of a density dot plot and a decaying dot plot;

a histogram tab;

an optical amplifier control tab;

a color compensation control tab; and

a doublet discriminator control tab.

12. The multi-analyte diagnostic system according to claim 5, wherein said cuvette includes a substantially flat glass-to-fluid interface.

13. The multi-analyte diagnostic system according to claim 12, wherein said cuvette includes a neck region having one of an internal rectangular cross-section and an internal square cross-section.

14. The multi-analyte diagnostic system of claim 2, wherein at least one of the plurality of magnification lenses has a magnification factor substantially within a range between 20X and 40X.

15. The multi-analyte diagnostic system of claim 14, wherein two of the plurality of magnification lenses each has a magnification factor substantially equal to 25X.