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Method and apparatus for calibrating an analyte detection system with a calibration sample

a technology for analyte detection and calibration sample, which is applied in the field of method and apparatus for calibrating analyte detection system with a calibration sample, can solve the problems of affecting the health of patients, affecting the operation of certain currently known systems for analyte monitoring in hospitals or clinical settings,

Inactive Publication Date: 2006-09-07
OPTISCAN BIOMEDICAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The patent describes a fluid sampling and analysis system that includes a patient end, a sample analysis chamber, and a pump unit. The pump unit can deliver infusion fluid to the patient, draw a sample of bodily fluid from the patient, and supply calibration fluid to the sample analysis chamber. The system also includes a spectroscopic analyzer and a processor to analyze the contents of the sample. The technical effects of this invention include improved accuracy and efficiency in analyzing bodily fluids and the ability to calibrate the system using a calibration fluid."

Problems solved by technology

Often this is done in a hospital or clinical setting when there is a risk that the levels of certain analytes may move outside a desired range, which in turn can jeopardize the health of a patient.
Certain currently known systems for analyte monitoring in a hospital or clinical setting suffer from various drawbacks.

Method used

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  • Method and apparatus for calibrating an analyte detection system with a calibration sample
  • Method and apparatus for calibrating an analyte detection system with a calibration sample
  • Method and apparatus for calibrating an analyte detection system with a calibration sample

Examples

Experimental program
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example 1

[0410] One example of certain methods disclosed herein is illustrated with reference to the detection of glucose in blood using mid-IR absorption spectroscopy. Table 2 lists 10 Library Interferents (each having absorption features that overlap with glucose) and the corresponding maximum concentration of each Library Interferent. Table 2 also lists a Glucose Sensitivity to Interferent without and with training. The Glucose Sensitivity to Interferent is the calculated change in estimated glucose concentration for a unit change in interferent concentration. For a highly glucose selective analyte detection technique, this value is zero. The Glucose Sensitivity to Interferent without training is the Glucose Sensitivity to Interferent where the calibration has been determined using the methods above without any identified interferents. The Glucose Sensitivity to Interferent with training is the Glucose Sensitivity to Interferent where the calibration has been determined using the methods ...

example 2

[0411] Another example illustrates the effect of the methods for 18 interferents. Table 3 lists of 18 interferents and maximum concentrations that were modeled for this example, and the glucose sensitivity to the interferent without and with training. The table summarizes the results of a series of 1000 calibration and test simulations that were performed both in the absence of the interferents, and with all interferents present. FIG. 39 shows the distribution of the R.M.S. error in the glucose concentration estimation for 1000 trials. While a number of substances show significantly less sensitivity (sodium bicarbonate, magnesium sulfate, tolbutamide), others show increased sensitivity (ethanol, acetoacetate), as listed in Table 3. The curves in FIG. 39 are for calibration set and the test set both without any interferents and with all 18 interferents. The interferent produces a degradation of performance, as can be seen by comparing the calibration or test curves of FIG. 39. Thus, ...

example 3

[0412] In a third example, certain methods disclosed herein were tested for measuring glucose in blood using mid-IR absorption spectroscopy in the presence of four interferents not normally found in blood (Type-B interferents) and that may be common for patients in hospital intensive care units (ICUs). The four Type-B interferents are mannitol, dextran, n-acetyl L cysteine, and procainamide.

[0413] Of the four Type-B interferents, mannitol and dextran have the potential to interfere substantially with the estimation of glucose: both are spectrally similar to glucose (see FIG. 1), and the dosages employed in ICUs are very large in comparison to typical glucose levels. Mannitol, for example, may be present in the blood at concentrations of 2500 mg / dL, and dextran may be present at concentrations in excess of 5000 mg / dL. For comparison, typical plasma glucose levels are on the order of 100-200 mg / dL. The other Type-B interferents, n-acetyl L cysteine and procainamide, have spectra that...

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PUM

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Abstract

A fluid sampling and analysis system. The system comprises a fluid handling network including a patient end configured to maintain fluid communication with a bodily fluid of a patient; a sample analysis chamber accessible by the fluid handling network; and a pump unit in operative engagement with the fluid handling network. The pump unit has an infusion mode in which the pump unit is operable to deliver infusion fluid to the patient through the patient end; a sample draw mode in which the pump unit is operable to draw a sample of bodily fluid from the patient through the patient end, and provide a portion of the sample to the sample analysis chamber; and an optical calibration mode in which the pump unit is operable to supply calibration fluid to the sample analysis chamber. The system further comprises a spectroscopic analyzer configured to obtain spectra of the contents of the sample analysis chamber; a processor in communication with or incorporated into the spectroscopic analyzer; and stored program instructions executable by the processor to obtain a measurement of one or more analytes in the portion of the sample from the spectra.

Description

RELATED APPLICATIONS [0001] This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 60 / 652,660, filed Feb. 14, 2005, titled ANALYTE DETECTION SYSTEM; U.S. Provisional Application No. 60 / 658,001, filed Mar. 2, 2005, titled SEPARATING BLOOD SAMPLE FOR ANALYTE DETECTION SYSTEM; U.S. Provisional Application No. 60 / 673,551, filed Apr. 21, 2005, titled APPARATUS AND METHODS FOR SEPARATING SAMPLE FOR ANALYTE DETECTION SYSTEM; and of U.S. Provisional Application No. 60 / 724,199, filed Oct. 6, 2005, titled INTENSIVE CARE UNIT BLOOD ANALYSIS SYSTEM AND METHOD. The entire contents of each of the above-listed provisional applications are hereby incorporated by reference herein and made part of this specification.BACKGROUND [0002] 1. Field [0003] Certain embodiments disclosed herein relate to methods and apparatus for determining the concentration of an analyte in a sample, such as an analyte in a sample of bodily fluid, as well as methods and apparatus wh...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61M31/00A61B5/00
CPCA61B5/1427A61B5/14532A61B5/14546A61B5/14557A61B5/1495A61M5/14212A61M5/14232A61M5/16854A61M5/1723A61M2205/12A61M2230/20A61M2230/201G01N1/14G01N21/05G01N21/274G01N2021/0346G01N21/35A61B5/15003A61B5/150213A61B5/150221A61B5/150229A61B5/150755A61B5/150862A61B5/150992A61B5/153A61B5/155A61B5/157
Inventor CALLICOAT, DAVID N.GABLE, JENNIFER H.WITTE, KENNETH G.ZHENG, PENGKEENAN, RICHARDSTERLING, BERNHARD B.BRAIG, JAMES R.WECHSLER, MARKHALL, W. DALE
Owner OPTISCAN BIOMEDICAL
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