Reagentless analysis of biological samples

• US 6,365,109 B1
• Filed: 09/28/1999
• Issued: 04/02/2002
• Est. Priority Date: 08/27/1998
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Shain, Eric B., Jeng, Tzyy-Wen, McDowell, Larry L., Oosta, Gary M., Pezzaniti, Joseph Larry
• Primary Examiner(s): SNAY, JEFFREY R
• Application Number:
  US09/407,397
• Time in Patent Office: 917 Days
• Field of Search: 422/99, 422/100, 356/72, 356/73, 356/246
• US Class Current: 422/547
• CPC Class Codes: G01N 21/05 Flow-through cuvettes G01N21/09 takes precedence; handling fluid samples G01N1/10
• CPC Class Codes: G01N 21/274 Calibration, base line adjustment, drift correction
• CPC Class Codes: G01N 21/4133 Refractometers, e.g. differential
• CPC Class Codes: Y10T 436/144444 Glucose
• CPC Class Codes: Y10T 436/146666 Bile pigment
• CPC Class Codes: Y10T 436/147777 Plural nitrogen in the same ring [e.g., barbituates, creatinine, etc.]
• CPC Class Codes: Y10T 436/171538 Urea or blood urea nitrogen
• CPC Class Codes: Y10T 436/200833 Carbonyl, ether, aldehyde or ketone containing

Abstract

Apparatus and method for determining at least one parameter, e.g., concentration, of at least one analyte, e.g., urea, of a biological sample, e.g., urine. A biological sample particularly suitable for the apparatus and method of this invention is urine. In general, spectroscopic measurements can be used to quantify the concentrations of one or more analytes in a biological sample. In order to obtain concentration values of certain analytes, such as hemoglobin and bilirubin, visible light absorption spectroscopy can be used. In order to obtain concentration values of other analytes, such as urea, creatinine, glucose, ketones, and protein, infrared light absorption spectroscopy can be used. The apparatus and method of this invention utilize one or more mathematical techniques to improve the accuracy of measurement of parameters of analytes in a biological sample. The invention also provides an apparatus and method for measuring the refractive index of a sample of biological fluid while making spectroscopic measurements substantially simultaneously.

Claims

1. A sample cell assembly for containing a biological sample to be used in determining concentration at least one analyte in said biological sample comprising:

(a) a port into which said biological sample can be introduced into the sample cell assembly;

(b) said port of (a) communicating with an expansion zone;

(c) said expansion zone communicating with a read zone;

(d) said read zone communicating with a contraction zone;

(e) said contraction zone communicating with a port from which said biological sample can be removed from said sample cell assembly;

(f) a first pair of windows; and

(g) a second pair of windows, said second pair of windows comprising

a first window having two major surfaces and a second window having two major surfaces, said major surfaces of said first window not being parallel to said major surfaces of said second window.

2. The sample cell assembly of claim 1, wherein said read zone has at least one dimension that is of sufficient size that a beam of light entering said read zone for making a spectroscopic measurement will not be truncated.

3. The sample cell assembly of claim 1, wherein said expansion zone has a first dimension where it communicates with said inlet port and a second dimension where it communicates with said read zone, said second dimension being greater than said first dimension.

4. The sample cell assembly of claim 1, wherein said contraction zone has a first dimension where it communicates with said port from which said biological sample can be removed from said sample cell assembly and a second dimension where it communicates with said read zone, said second dimension being greater than said first dimension.

5. The sample cell assembly of claim 1, wherein said first pair of windows are parallel to one another and are aligned with said read zone such that a beam of light for a spectroscopic measurement can be transmitted through said pair of windows and said sample.

6. The sample cell assembly of claim 1, wherein said second pair of windows defines a read zone for a refractive index measurement.

7. The sample cell assembly of claim 1, including a first port into which said biological sample can be introduced into the sample cell assembly and a second port from which said biological sample can be removed from said sample cell assembly.

8. The sample cell assembly of claim 1, wherein said expansion zone and said contraction zone are the same.

9. The sample cell assembly of claim 1, wherein said expansion zone and said contraction zone are different.

10. A sample cell assembly for containing a biological sample to be used in determining concentration at least one analyte in said biological sample comprising:

(a) a port into which said biological sample can be introduced into the sample cell assembly;

(b) said port of (a) communicating with an expansion zone;

(c) said expansion zone communicating with a read zone;

(d) said read zone communicating with a contraction zone;

(e) said contraction zone communicating with a port from which said biological sample can be removed from said sample cell assembly;

(f) a first pair of windows; and

(g) a second pair of windows, said second pair of windows defining a read zone for a refractive index measurement, wherein a beam of light entering said read zone for said spectroscopic measurement is not co-linear with a beam of light entering said read zone for said refractive index measurement, wherein said windows of said second pair of windows are positioned relative to one another such that a beam of light is capable of entering said first window of said second pair of windows, is capable of being transmitted through said read zone for refractive index measurement, is capable of emerging from said second window of said second pair of windows, wherein said beam of light entering said first window of said second pair of windows is not parallel to said beam of light emerging from said second window of said second pair of windows, and said beam of light capable of entering said first window of said second pair of windows is not capable of being oriented in a perpendicular direction to said first window of said second pair of windows.

11. The sample cell assembly of claim 10, wherein said read zone has at least one dimension that is of sufficient size that a beam of light entering said read zone for making a spectroscopic measurement will not be truncated.

12. The sample cell assembly of claim 10, wherein said expansion zone has a first dimension where it communicates with said inlet port and a second dimension where it communicates with said read zone, said second dimension being greater than said first dimension.

13. The sample cell assembly of claim 10, wherein said contraction zone has a first dimension where it communicates with said port from which said biological sample can be removed from said sample cell assembly and a second dimension where it communicates with said read zone, said second dimension being greater than said first dimension.

14. The sample cell assembly of claim 10, wherein said first pair of windows are parallel to one another and are aligned with said read zone such that a beam of light for a spectroscopic measurement can be transmitted through said pair of windows and said sample.

15. The sample cell assembly of claim 10, wherein said second pair of windows defines a read zone for a refractive index measurement.

16. The sample cell assembly of claim 10, including a first port into which said biological sample can be introduced into the sample cell assembly and a second port from which said biological sample can be removed from said sample cell assembly.

17. The sample cell assembly of claim 10, wherein said expansion zone and said contraction zone are the same.

18. The sample cell assembly of claim 10, wherein said expansion zone and said contraction zone are different.