Method and apparatus for performing automated analysis

• US 5,939,326 A
• Filed: 03/13/1997
• Issued: 08/17/1999
• Est. Priority Date: 08/01/1994
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories
• Original Assignee: Abbott Laboratories
• Inventors: Larue, Roderick Walton, Stuart, John Paul, Kim, Young Ran, Lobban, Peter E., Chupp, Vernon L.
• Primary Examiner(s): Le, Long V.
• Application Number:
  US08/816,712
• Time in Patent Office: 887 Days
• Field of Search: 436/8, 436/10, 436/17, 436/18, 436/522, 436/519, 436/523, 436/49, 436/54, 436/164, 436/165, 436/172, 436/174, 436/175, 436/179, 436/180, 436/63, 436/805, 422/58.1, 422/73, 422/63, 422/65, 422/67, 422/82.01, 422/82.02, 422/82.08, 422/82.09, 435/808, 435/767, 435/809, 435/973, 435/7.24, 356/39, 356/73, 356/335, 356/336, 364/413.07, 364/413.08
• US Class Current: 436/43
• CPC Class Codes: B01F 25/3132 by using two or more injector devices
• CPC Class Codes: B01F 25/31324 arranged concentrically
• CPC Class Codes: G01N 1/14 Suction devices, e.g. pumps; Ejector devices
• CPC Class Codes: G01N 15/14 Optical investigation techniques, e.g. flow cytometry
• CPC Class Codes: G01N 15/1404 Handling flow, e.g. hydrodynamic focusing
• CPC Class Codes: G01N 2015/011 with lysing, e.g. of erythrocytes
• CPC Class Codes: G01N 2015/014 Reticulocytes
• CPC Class Codes: G01N 2015/018 Platelets
• CPC Class Codes: G01N 2015/1413 Hydrodynamic focussing
• CPC Class Codes: G01N 2035/00356 Holding samples at elevated temperature (incubation)
• CPC Class Codes: G01N 2035/00524 Mixing by agitating sample carrier
• CPC Class Codes: G01N 2035/1032 Dilution or aliquotting
• CPC Class Codes: G01N 35/0092 Scheduling
• CPC Class Codes: G01N 35/10 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 Class Codes: G01N 35/1004 Cleaning sample transfer devices
• CPC Class Codes: G01N 35/109 with two horizontal degrees of freedom
• CPC Class Codes: G01N 35/1095 for supplying the samples to flow-through analysers for a specific analyser see relevant groups, e.g. under G01N15/00, G01N21/00, G01N27/00, G01N30/00, H01J49/00
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10T 436/11 Automated chemical analysis
• CPC Class Codes: Y10T 436/119163 with aspirator of claimed structure
• CPC Class Codes: Y10T 436/25 : including sample preparation
• CPC Class Codes: Y10T 436/25125 : Digestion or removing interfering materials
• CPC Class Codes: Y10T 436/2575 : Volumetric liquid transfer

Abstract

A device for analyzing a whole blood sample is provided. The device comprises a conventionl hematology analyzer integrated with a fluorescence cyometry analyzer. A controller is provided for controlling the analyzers, obtaining and utilizing data from both and reporting a quantitative result. Methods are also provided for analyzing a whole blood sample. One such method comprises the steps of performing on a single instrument an analysis of impedance associated with the blood sample, an analysis of light scatter associated with the blood sample, and an analysis of fluorescence associated with the blood sample. Data is collected and utilized. A result is reported.

Claims

1. An automated method for distinguishing and differentiating cells in a whole blood sample with an automated instrument system capable of performing both hematology analysis and fluorescent cytometry analysis to which a whole blood sample is provided, the automated method comprising the steps of:

(a) selecting a series of one or more tests to be performed on the whole blood sample by the automated instrument system;

(b) correlating the one or more tests to be performed on the whole blood sample by the automated instrument system;

(c) aspirating a volume of the whole blood sample;

(d) dispensing an aliquot of the whole blood sample into at least two sample receiving vessels;

(e) diluting a first aliquot of the whole blood sample with a diluent reagent thereby producing a diluted sample in one of the at least two sample receiving vessels;

(f) lysing a second aliquot of the whole blood sample with a lysing reagent thereby producing a lysed sample in another one of the at least two sample receiving vessels;

(g) transporting an aliquot of the diluted sample through a flow transducer of the automated instrument system;

(h) detecting and counting red blood cells in the aliquot of the diluted sample with the flow transducer;

(i) transporting an aliquot of the lysed sample through the flow transducer;

(j) detecting multi-angle light scatter from the aliquot of lysed sample and counting and differentiating white blood cells ("WBC") therein with the flow transducer;

(k) detecting multi-angle light scatter and fluorescence from the lysed sample or the diluted sample and counting and differentiating nucleated red blood cells or reticulocytes or both therein with the flow transducer;

(l) storing flow transducer detecting and differentiating data for the tests performed on the whole blood sample; and

(m) reporting results of each test performed on the whole blood sample,

wherein the automated instrument system automatedly performs method steps (b) through (m) without physically separating cells from the whole blood sample or an aliquot thereof and results of hematology analysis are utilized in at least reporting of the results of the fluorescent cytometry analysis.

2. The method of claim 1 further comprising the steps of:

(n) staining an aliquot of the diluted sample thereby producing a stained aliquot in one of the at least two sample receiving vessels;

(o) transporting the stained aliquot through the flow transducer, wherein reticulocytes in the stained aliquot are counted and differentiated.

3. The method of claim 1 wherein an aliquot of the diluted sample is transported by the automated instrument system through the flow transducer and multi-angle light scatter is detected to count and to differentiate platelets in the diluted sample.

4. The method of claim 1 wherein nucleated red blood cells and white blood cells are counted and are differentiated from the lysed sample.

5. The method of claim 1 wherein a third aliquot of whole blood sample is placed in at least one of the at least two sample receiving vessels by the automated instrument system and the method further comprising the steps of:

(n) combining the third aliquot with fluorescent-labelled monoclonal antibodies for a sufficient time to allow the fluorescent-labelled monoclonal antibodies to become attached to cell surface antigen on cells in the third aliquot, thereby producing a labelled sample in the at least one of the at least two sample receiving vessels;

(o) lysing the labelled sample with a lysing reagent without thereafter separating the unlysed cells in the third aliquot, thereby producing a lysed and labelled sample in the at least one of the at least two sample receiving vessels;

(p) transporting the lysed and labelled sample through the flow transducer; and

(q) detecting multi-angle light scatter and fluorescence and counting and differentiating sub-populations of lymphocytes in the lysed and labelled sample.

6. The automated method of claim 1 wherein a reported quantitative white blood cell result is obtained from multi-angle light scatter and fluorescent detected data.

7. The automated method of claim 6 wherein the white blood cell result comprises a five-part differential.

8. The automated method of claim 7 wherein the five part differential further comprises a percentage of nucleated red blood cells.