IP Library Granted Patent US 11,035,784
Granted Patent B2
US 11,035,784 · App. 16/679,728 · Granted Jun 15, 2021

Methods and systems for optical hemoglobin measurement

Inventors: Norman F. Sheppard, Jr. (New Ipswich, NH); Gary Conrad Jensen (Cambridge, MA)
Assignee: Magellan Diagnostics, Inc.
G01N21/31G01N21/474G01N33/49G01N2201/062G01N2201/0625G01N2201/0696
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Quick Facts
Patent No.
US 11,035,784
App. No.
16/679,728
Granted
Jun 15, 2021
Kind
B2
Abstract

A method for measuring hemoglobin concentration in a whole blood sample is disclosed. The method may include mixing a whole blood sample with a lysing agent, followed by manual agitation, flowing the whole blood or mixture into a reservoir of a sensor, the sensor comprising a transparent portion configured to allow an optical measurement of an absorbance or reflectance of the whole blood sample in the reservoir of the sensor; detecting, using an analyzer into which at least a portion of the sensor has been inserted, the whole blood sample in the reservoir of the sensor; upon detecting the liquid whole blood sample in the reservoir, optically measuring an absorbance or reflectance of the whole blood sample using a light source and a detector in the analyzer; and determining a concentration of hemoglobin in the whole blood sample based on the measured absorbance or reflectance and a calibration curve that relates the absorbance or reflectance to the concentration of hemoglobin in the whole blood sample.

Claims (32)

1. A method for measuring hemoglobin concentration in a whole blood sample, the method comprising:

mixing a whole blood sample with a reagent to form a prepared blood sample;

flowing the prepared blood sample into a reservoir of a sensor, the sensor comprising a transparent portion configured to allow an optical measurement of an absorbance or reflectance of the prepared blood sample in the reservoir of the sensor;

detecting, using an analyzer into which at least a portion of the sensor has been inserted, the prepared blood sample in the reservoir of the sensor;

upon detecting the liquid prepared blood sample in the reservoir, optically measuring an absorbance or reflectance of the prepared blood sample using a light source and a detector in the analyzer, wherein optically measuring the absorbance or reflectance of the prepared blood sample using the light source and the detector in the analyzer comprises:

emitting light with the light source in the detector such that the light passes through the transparent portion of the sensor and is reflected by a porous, reflective material within the reservoir that absorbs the prepared blood sample; and

measuring an intensity of the light reflected by the porous, reflective material using the detector; and

determining a concentration of hemoglobin in the prepared blood sample based on the measured absorbance or reflectance and a calibration curve that relates the absorbance or reflectance to the concentration of hemoglobin in the prepared blood sample.

2. The method of claim 1 , wherein the light source is configured to emit light at a specific wavelength and the calibration curve is determined based on the specific wavelength.

3. The method of claim 2 , wherein the detector is configured to measure light at the specific wavelength.

4. The method of claim 2 , wherein the specific wavelength is between 250 nm and 950 nm.

5. The method of claim 2 , wherein the specific wavelength is between 350 nm and 450 nm.

6. The method of claim 2 , wherein the specific wavelength comprises an isosbestic point of the prepared blood sample.

7. The method of claim 1 , wherein optically measuring the absorbance or reflectance of the prepared blood sample using the light source and the detector in the analyzer comprises:

emitting light with the light source in the detector such that the light passes through the transparent portion of the sensor and into the prepared blood sample in the reservoir; and

measuring an intensity of the light after the light passes through the prepared blood sample using the detector.

8. The method of claim 7 , measuring the intensity of the light after the light passes through the prepared blood sample using the detector comprises measuring the intensity of the light that is reflected from a reflective surface in the sensor.

9. The method of claim 8 , wherein the reflective surface is positioned within the reservoir on a first side of the reservoir that is opposite a second side of the reservoir that includes the transparent portion.

10. The method of claim 1 , wherein the porous, reflective material within the reservoir is positioned on an inner surface of the transparent portion of the sensor.

11. The method of claim 1 , wherein optically measuring the absorbance or reflectance of the prepared blood sample using the light source and the detector in the analyzer comprises comparing a measured an intensity of light detected by the sensor to a reference intensity.

12. The method of claim 11 , further comprising measuring the reference intensity by:

illuminating an empty sensor with the light source; and

measuring a reflectance of the empty sensor with the detector.

13. The method of claim 11 , further comprising:

measuring internally reflected stray light by detecting an intensity of light reflected from a light absorbing surface on the sensor;

subtracting the measured internally reflected stray light from the reference intensity and the measured intensity.

14. The method of claim 13 , wherein measuring the internally reflected stray light comprises measuring the internally reflected stray light by detecting the intensity of light reflected from a light absorbing surface on the sensor as the sensor is inserted into or withdrawn from an analyzer.

15. The method of claim 1 , where the reagent comprises at least a lysing agent.

16. The method of claim 1 , further comprising:

pulsing the light source at a first frequency; and

demodulating the detector at the first frequency.

17. The method of claim 16 , wherein demodulating the detector at the first frequency removes substantially any signal that does not correspond to light pulsed at the first frequency.

Assignments (6)
SECURITY INTEREST Recorded Feb 2, 2023
From: MAGELLAN DIAGNOSTICS, INC.; MERIDIAN BIOSCIENCE, INC.
To: STANDARD CHARTERED BANK, AS ADMINISTRATIVE AGENT
Reel/Frame 062569/0309 →
SECURITY INTEREST Recorded Feb 1, 2023
From: MAGELLAN DIAGNOSTICS, INC.; MERIDIAN BIOSCIENCE, INC.
To: PNC BANK, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT
Reel/Frame 062563/0616 →
CORRECTIVE ASSIGNMENT TO CORRECT THE RECEIVING PARTY NAME PREVIOUSLY RECORDED AT REEL: 52576 FRAME: 018. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded May 19, 2020
From: SHEPPARD, NORMAN F.
To: MAGELLAN DIAGNOSTICS, INC.
Reel/Frame 052702/0345 →
CORRECTIVE ASSIGNMENT TO CORRECT THE RECEIVING PARTY NAME PREVIOUSLY RECORDED AT REEL: 52576 FRAME: 057. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded May 19, 2020
From: JENSEN, GARY CONRAD
To: MAGELLAN DIAGNOSTICS, INC.
Reel/Frame 052705/0161 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 5, 2020
From: SHEPPARD, NORMAN F.
To: MAGELLAN DIAGNOSTIC, INC.
Reel/Frame 052576/0018 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 5, 2020
From: JENSEN, GARY CONRAD
To: MAGELLAN DIAGNOSTIC, INC.
Reel/Frame 052576/0057 →
Continuity (4)
Continuation 15701006 · Sep 11, 2017
Continuation 14978292 · Dec 22, 2015
Provisional Application 62096178 · Dec 23, 2014
Related Publication 20200249150A1 · Aug 6, 2020