Multi-analyte diagnostic system and computer implemented process for same

• US 6,592,822 B1
• Filed: 05/13/1999
• Issued: 07/15/2003
• 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): Warden, Jill
• Assistant Examiner(s): Gordon, Brian R
• Application Number:
  US09/311,115
• Time in Patent Office: 1,524 Days
• Field of Search: 422/73, 422/100, 422/68, 422/158, 422/105, 422/82.05, 436/43, 436/171, 436/180, 702/19, 702/21-23, 702/25, 702/27-32, 702/45, 702/49, 702/50, 356/72, 356/73
• 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 system comprising:

a flow analyzer including a substantially co-planar optical assembly having a plurality of light sources and at least four optical detectors, said plurality of light sources including overlapping focal regions, and said flow analyzer being communicatable with the computer; and

a memory medium readable by the computer and storing computer software, the software including instructions for causing the computer to perform the steps of;

processing a biological sample using said flow analyzer, and

determining a presence and quantity of at least one analyte of interest in the biological sample substantially simultaneously to said processing step;

wherein said flow analyzer further includes a cuvette having a flat air-to-glass interface;

said cuvette includes a neck-up region having a hexagonal cross-section; and

two of the plurality of light sources are respectively configured to emit two distinct wavelengths of light.

2. The multi-analyte diagnostic system of claim 1, wherein said cuvette includes a neck-up region having a regular polygonal cross-section wherein opposite sides are parallel and have a flat air to surface interface relative to each of said light sources and said optical detectors and wherein the number of sides is at least 6.

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

a flow analyzer including a substantially co-planar optical assembly having a plurality of light sources and a plurality of optical detectors, said plurality of light sources including overlapping focal regions, and said flow analyzer being communicatable with the computer; and

a memory medium readable by the computer and storing computer software, the software including instructions for causing the computer to perform the steps of;

processing a biological sample using said flow analyzer, and

determining a presence and quantity of at least one analyte of interest in the biological sample substantially simultaneously to said processing step;

wherein said flow analyzer includes one of a multi-pass filter and a plurality of bandpass filters coupled in parallel to at least one of said plurality of optical detectors via a respective multi-mode cable.

4. The diagnostic system according to claim 3, wherein said flow analyzer includes, for each band-pass filter, an amplifying photo-detector and an analog-to-digital converter connected in series thereto.

5. The diagnostic system according to claim 4, wherein said amplifying photo-detector includes one of a photomultiplier tube, an avalanche photo-diode, and a p-i-n photo-diode.

6. The diagnostic system according to claim 4, wherein said flow analyzer includes for each band-pass filter, an inverting amplifier in series with a low pass Nyquist filter, connected between said amplifying photo-detector and said analog-to-digital converter.

7. The diagnostic system according to claim 3, further comprising a digital interface board connectable to the computer and to said flow analyzer.

8. The diagnostic system according to claim 7, wherein said digital interface board includes:

a microcontroller in communication with said flow analyzer, and

a digital signal processor in communication with said microcontroller and each analog-to-digital converter.

9. The diagnostic system according to claim 8, wherein said analog-to-digital converter includes a circular memory buffer having a first movable pointer, a second movable pointer, and a plurality of storage positions, said first pointer pointing to an oldest storage position into which new sample data may be stored, said second pointer pointing to a storage position from which said digital signal processor analyzes old sample data stored therein.

10. The diagnostic system according to claim 9 wherein said flow analyzer includes a cuvette, a sample pump communicating with said microcontroller and connected to said cuvette, and a sheath fluid reservoir communicating with said microcontroller and connected to said cuvette.

11. The diagnostic system according to claim 10, wherein said flow analyzer includes a waste receptacle, said microcontroller upon assay completion, communicating with said sample pump to one of halt sample fluid flow and to divert any remaining sample to said waste receptacle, and communicating with said sheath fluid reservoir to one of halt sheath fluid flow and divert any remaining sheath fluid to said waste receptacle.

12. The diagnostic system according to claim 4, wherein said flow analyzer includes a single-filter light path from each optical detector to each amplifying photo-detector.