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Method for determining the quantity of an hba1c in a blood sample

A technology of blood samples and liquids, applied in the field of volume suits, can solve the problems of cost reduction and increase of ease

Active Publication Date: 2019-01-04
W HEALTH LP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Another challenge is to increase the ease of each analysis, preferably to the extent that the measurement of HbA1c in blood can be performed by the patient without the assistance of a medical practitioner
Also, reducing the cost to a level where consumers can afford each measurement is a challenge

Method used

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  • Method for determining the quantity of an hba1c in a blood sample
  • Method for determining the quantity of an hba1c in a blood sample
  • Method for determining the quantity of an hba1c in a blood sample

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0096] Example 1. HbA1c assay and calibration process

[0097] sample

[0098] Six calibrator samples (all representing different levels of HbAlc concentration in human blood) were purchased from the Lyphochek Hemoglobin Alc Linear Set (BIO-RAD). Six samples from this BIO-RAD kit were lysed according to the manufacturer's instructions.

[0099] The six linear samples and raw signal values ​​for TRACE measurements are reported in Table 1 below.

[0100] Table 1

[0101]

[0102] Table 1 shows the TRACE measurements of the six calibrators (BIO-RAD). In column 2, the TRACE fluorescence signal is shown. In column 3, the total hemoglobin signal is shown, while in column 4, the final TRACE HbA1c raw signal is shown. Column 1 shows six different levels of HbA1c, each level representing a specific HbA1c concentration. Column 2 shows the raw signal of HbAlc reported in the 510 nm fluorescence channel 20 seconds after the decrease in fluorescence was measured after the addition...

example 2

[0118] Example 2. HbA1c Accuracy Process

[0119] According to Example 1, a sample of 40 patients obtained from the Herlev Hospital was measured with respect to TRACE. Known values ​​reported in NGSP format were obtained from the Roche cobas c system (Tina-quant HbA1c assay) for each sample.

[0120] In Table 3, using Figure 4 The calibration algorithm shown in converts the TRACE raw signal for 40 patient samples into 40 NGSP values.

[0121] table 3

[0122]

[0123] Figure 5 The content of Table 3 is shown graphically, where the raw TRACE HbA1c signal from 40 patients is shown (x-axis) as a function of the final TRACE NGSP signal (y-axis).

[0124] In Table 4, samples from 40 patients run on TRACE are compared to samples from the same 40 patients run on the Roche cobas c system (Tina-quant HbA1c assay format).

[0125] Table 4

[0126]

[0127] Figure 6 The content of Table 4 is shown graphically, however, the TRACE HbA1c NGSP results from 40 patients are sho...

example 3

[0134] Example 3. HbA1c Accuracy Process

[0135] Liquichek diabetes control levels 1, 2 and 3 (BIO-RAD criteria) were measured on TRACE over five days. Each control was measured four times per day. A total of 3×4×5=60 measurements are performed according to examples 1 and 2.

[0136] Calibration was performed to the Tina-quant HbA1c assay format and values ​​were reported in NGSP units.

[0137] Table 6 shows the means as well as the within and between %CV displays.

[0138] Table 6

[0139]

[0140] According to the NGSP plan, the recommendation for the accuracy of the HbA1c assay should be less than 3.5%. As shown in Table 6, the method according to the present invention brings this standard into compliance with the NGSP recommendation for accuracy standards.

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Abstract

The present invention relates to methods and kits-of-parts for determining the quantity of HbA1c relative to the concentration of haemoglobin in a blood sample comprising less than 200Mul, the methodcomprising the steps of adding the fluorophore to the sample and measuring the fluorescence at one or more time points within the time interval, at which the change in fluorescence over time is >0, followed by measurements of haemoglobin by adding a haemoglobin-binding agent and measuring the change in transmission at approximately 570nm and comparing the obtained results with an internal standard.

Description

technical field [0001] The present invention relates to a method for determining the amount of HbA1c in a blood sample comprising less than 200 μl. Furthermore, the invention relates to a kit-of-parts for determining the amount of HbA1c in a sample. Background technique [0002] Glycated hemoglobin (HbA1c or hemoglobin A1c, HbA1c, A1C, or Hb1c) is a natural form of hemoglobin that is primarily measured to identify the average plasma glucose concentration in humans over long periods of time. HbA1c is formed along a nonenzymatic glycosylation pathway through exposure of hemoglobin to plasma glucose. As the mean amount of plasma glucose increases, the fraction of glycated hemoglobin increases in a predictable manner. Therefore, the blood level of HbA1c is used as a marker of the average glucose concentration in the patient's blood in the months preceding the measurement, and is sensitive to natural daily fluctuations in glucose levels (e.g., due to exercise, rest, meals, and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/72G01N33/542
CPCG01N33/542G01N33/723G01N21/6428G01N21/6486
Inventor P·瓦尔霍
Owner W HEALTH LP
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