CN112617823A - Method for judging accuracy of noninvasive blood glucose detection - Google Patents
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Abstract
The invention relates to a blood sugar detection technology, in particular to a method for judging the accuracy of noninvasive blood sugar detection, which can realize a standard verification method, thereby being more accurate when judging a noninvasive blood sugar instrument, and comprises the following steps: the method comprises the following steps: establishing a test sample library, wherein the sample library comprises the following steps: a venous whole blood sample bank I; a venous whole blood sample bank II; a venous whole blood sample bank III; step two: the noninvasive glucometer measurement repeatability comprises the following steps: selecting a first venous whole blood sample bank for testing, placing the sample at the room temperature of 23 +/-5 ℃, and balancing for at least 30min to enable the temperature of the sample to reach the room temperature of +/-2 ℃; each sample was inverted and mixed well before testing; the test is repeated for 20 times on two noninvasive glucometers under the repetitive condition according to the measurement procedure in the use instruction; step three: the accuracy of the noninvasive glucometer system comprises a first method: comparative tests were used.
Description
Technical Field
The invention relates to a blood sugar detection technology, in particular to a method for judging the accuracy of non-invasive blood sugar detection.
Background
Diabetes mellitus is a common metabolic endocrine disease, is mainly characterized by hyperglycemia, has a remarkably rising trend in recent years, and is currently suffered by about 10 percent of adults all over the world. By 2019, about 4.63 hundred million diabetics exist in 20-79 years old worldwide, wherein the number of Chinese diabetics is the first rank, and the total number of Chinese diabetics is about 1.164 hundred million. The current treatment mode of the diabetes patient is mainly to regulate and control the glucose metabolism in the body of the patient, and the dosage is determined according to the glucose content in the blood of the patient in the clinical treatment, so that the blood glucose monitoring is very important for tracking and evaluating the control and curative effect of the diabetes.
The most direct and accurate method for detecting the blood sugar value at present is a method for detecting collected venous blood, namely a biochemical analyzer is used for analysis, which is the currently accepted 'gold standard' for measuring the blood sugar concentration, but the method has strong operation expertise and high cost, and brings pain and inconvenience to patients. The second type is a invasive blood glucose meter, which uses a blood sampling pen to prick a finger to collect fingertip blood, drops the blood into test paper, and then puts the test paper into a detection instrument to obtain blood glucose data. The pricking can cause the pain of the testee, and the test paper needs to be replaced every time of measurement; the measurement cost is high, the steps are complicated, and the operation is inconvenient in multiple links such as needle insertion, blood sampling and measurement. The third category is noninvasive blood glucose meters which are always considered as the blood glucose detection eosins, a large number of noninvasive blood glucose measurement methods have been researched in recent thirty years, but no method is approved by the national drug administration for production and application, the main reason is that the system accuracy and the measurement repeatability are not good, because the existing noninvasive glucometer adopts the spectrum detection or other photoelectric induction modes for detection, because the type selection of the sensor, the interference signal are complex and various, and the difference of various human bodies is too large, no method reaches the practical level so far, but the method is still a worthy direction, compared with the traditional glucose analyzer and the traditional glucometer which adopt a biological enzyme reaction method to obtain the content of the glucose in the blood, the system accuracy and the measurement repeatability are also obtained by repeatedly detecting samples with different concentrations prepared from collected whole blood samples by an enzyme reaction method for multiple times and obtaining accuracy and stability numerical values through statistical analysis.
In the current noninvasive blood glucose detection process, whether an algorithm and hardware have problems is judged, detection data of system accuracy and measurement repeatability of the noninvasive blood glucose meter needs to be provided, and a human body cannot be used as a data source at the moment, so that the detection methods of the system accuracy and the measurement repeatability of the noninvasive blood glucose meter are different from manufacturers at the moment, and because the detection methods are different, whether detection results have referential meanings are different, so that the noninvasive blood glucose meter does not have more accurate evaluation basis on the use effect.
Disclosure of Invention
Aiming at the problems mentioned in the background technology, the invention aims to provide a method for judging the accuracy of noninvasive blood glucose detection, which can realize a standard verification method, thereby being more accurate when judging a noninvasive blood glucose meter.
The technical purpose of the invention is realized by the following technical scheme: a method for judging the accuracy of non-invasive blood sugar detection comprises the following steps:
the method comprises the following steps: establishing a test sample library, wherein the sample library comprises the following steps:
venous whole blood sample bank one:
the blood glucose concentrations were obtained as follows: 30-50 mg/dL; 51-110 mg/dL; 111-150 mg/dL; 151-250 mg/dL; 251-400mg/dL venous whole blood sample bank 1.
Venous whole blood sample bank two:
the blood glucose concentrations were obtained as follows: the concentration of 2 samples is less than 50 mg/dL; the concentration of 8 samples is less than 50-80 mg/dL; the concentration of 10 samples is 81-120 mg/dL; the concentration of 15 samples is 121-200 mg/dL; the concentration of 8 samples is 201-300 mg/dL; the concentration of 5 samples is 301-400 mg/dL; the concentration of 2 samples was > 400 mg/dL;
venous whole blood sample bank three: venous blood whole blood S1 supplemented with an anticoagulant;
a glucose physiological salt aqueous solution library: configuring 30-50 mg/dL; 51-110 mg/dL; 111-150 mg/dL; 151-250 mg/dL; 251-400 mg/dL; 500mg/dL of a physiological saline solution of glucose;
step two: the noninvasive glucometer measurement repeatability comprises the following steps: selecting a first venous whole blood sample bank for testing, placing the sample at the room temperature of 23 +/-5 ℃, and balancing for at least 30min to enable the temperature of the sample to reach the room temperature of +/-2 ℃; each sample was inverted and mixed well before testing; the test is repeated for 20 times on two noninvasive glucometers under the repetitive condition according to the measurement procedure in the use instruction;
1 aliquot should be taken from the sample immediately before the first test and after the last test in the blood glucose monitoring system and repeated tests are performed using the manufacturer's standard measurement procedure;
if the results show a drift effect: the difference between the first result and the last result is greater than 4mg/dL when the blood glucose concentration is less than or equal to 100mg/dL or greater than 4% when the blood glucose concentration is greater than 100mg/dL, the detection result of the sample is invalid, the sample needs to be detected again, and the standard deviation SD and the coefficient of variation CV of the effective detection result are calculated;
wherein, standard deviation
Coefficient of variation
Requiring SD < 7.7mg/dL when the glucose concentration is < 100 mg/dL; when the glucose concentration is not less than
When the CV is less than 7.5 percent at 100mg/dL, the measurement repeatability requirement is met;
step three: the accuracy of the noninvasive glucometer system comprises a first method: selecting a second venous whole blood sample bank by adopting a comparative test, inverting and uniformly mixing each sample before testing, and adjusting the oxygen partial pressure pO2 of each sample to 8.67kPa +/-0.67 kPa; dividing venous blood samples of each sample into 3 parts, testing the 1 st part by using a 1 st noninvasive glucometer, and testing the 2 nd part by using a 2 nd noninvasive glucometer; centrifuging at a high speed in the 3 rd part, taking out plasma, and then testing blood sugar by using a reference analyzer, wherein the difference between the venous plasma result tested by each noninvasive blood sugar analyzer and the venous plasma result tested by the reference analyzer is deviation;
95% of the deviation of the measurement result of the noninvasive glucometer should meet the following requirements: when the concentration of the glucose is less than or equal to 75mg/dL, the concentration is not more than +/-15 mg/dL; when the glucose concentration is more than 75mg/dL, the concentration is not more than +/-20 percent;
preferably, in the second step, the repeatability of the noninvasive glucometer measurement can be obtained by replacing the first venous whole blood sample library with a glucose physiological salt aqueous solution library.
Preferably, the third step further comprises a second method, wherein the second method adopts a recovery test, the third venous whole blood sample bank is selected, a sufficient amount of preservative which does not interfere with blood glucose detection is added into the S1 sample of the venous blood whole blood added with the anticoagulant, 7 equal parts of S1 with the volume of V1 are accurately sucked, standard glucose physiological saline solution with the known concentration and the volume of V2-V7 are respectively added into 6 parts of the S1 sample, and finally the glucose concentration of the 7 parts of the sample respectively corresponds to seven concentrations of the second venous whole blood sample bank; and adjusting the partial pressure of oxygen, pO2, of the venous blood sample to 8.67kPa + -0.67 kPa; respectively inverting and uniformly mixing each sample, respectively testing 7 samples by using 2 noninvasive glucometers for 10 times, and respectively calculating the glucose recovery rate of the noninvasive glucometers according to the formula (1) by using the average values of 10 measurements which are respectively marked as C1, C2, C3, C4, C5, C6 and C7;
r- - -recovery; n is 1,2,3,4,5, 6; 2,3,4,5,6, 7;
vi- -volume of physiological saline solution of glucose added between the S1 and Si samples;
v1- - -volume of S1 sample;
ci- - -measured concentration of Si sample;
c1- -concentration of S1 sample;
CS- - -concentration of glucose solution prepared;
wherein the recovery rate of the noninvasive glucose meter to the glucose is 80-120%.
Preferably, the venous whole blood sample bank III can also be replaced by a 500mg/dL glucose physiological saline solution in a glucose physiological saline solution bank.
In summary, the invention mainly has the following beneficial effects: the method for judging the accuracy of noninvasive blood glucose detection is combined with a blood glucose monitoring system for self-testing, which is provided in the general technical conditions of a blood glucose monitoring system for self-testing of a GB/T19634-2005 in-vitro diagnosis and inspection system and is specially used for monitoring the concentration of glucose in capillary blood vessel whole blood and/or venous whole blood of a human body in vitro, usually comprises a portable blood glucose meter, a disposable test strip and a quality control substance, and provides a detection method for the measurement repeatability and the system accuracy of a noninvasive blood glucose meter for performing noninvasive detection on fingertip blood glucose by near infrared spectroscopy.
Detailed Description
The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the following embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
A method for judging the accuracy of non-invasive blood sugar detection comprises the following steps:
the method comprises the following steps: establishing a test sample library, wherein the sample library comprises the following steps:
venous whole blood sample bank one:
the blood glucose concentrations were obtained as follows: 30-50 mg/dL; 51-110 mg/dL; 111-150 mg/dL; 151-250 mg/dL; 251-400mg/dL venous whole blood sample bank 1.
Venous whole blood sample bank two:
the blood glucose concentrations were obtained as follows: the concentration of 2 samples is less than 50 mg/dL; the concentration of 8 samples is less than 50-80 mg/dL; the concentration of 10 samples is 81-120 mg/dL; the concentration of 15 samples is 121-200 mg/dL; the concentration of 8 samples is 201-300 mg/dL; the concentration of 5 samples is 301-400 mg/dL; the concentration of 2 samples was > 400 mg/dL;
venous whole blood sample bank three: venous blood whole blood S1 supplemented with an anticoagulant;
a glucose physiological salt aqueous solution library: configuring 30-50 mg/dL; 51-110 mg/dL; 111-150 mg/dL; 151-250 mg/dL; 251-400 mg/dL; 500mg/dL of a physiological saline solution of glucose;
step two: the noninvasive glucometer measurement repeatability comprises the following steps: selecting a first venous whole blood sample bank for testing, placing the sample at the room temperature of 23 +/-5 ℃, and balancing for at least 30min to enable the temperature of the sample to reach the room temperature of +/-2 ℃; each sample was inverted and mixed well before testing; the test is repeated for 20 times on two noninvasive glucometers under the repetitive condition according to the measurement procedure in the use instruction;
1 aliquot should be taken from the sample immediately before the first test and after the last test in the blood glucose monitoring system and repeated tests are performed using the manufacturer's standard measurement procedure;
if the results show a drift effect: the difference between the first result and the last result is greater than 4mg/dL when the blood glucose concentration is less than or equal to 100mg/dL or greater than 4% when the blood glucose concentration is greater than 100mg/dL, the detection result of the sample is invalid, the sample needs to be detected again, and the standard deviation SD and the coefficient of variation CV of the effective detection result are calculated;
wherein, standard deviation
Coefficient of variation
Requiring SD < 7.7mg/dL when the glucose concentration is < 100 mg/dL; when the glucose concentration is not less than
When the CV is less than 7.5 percent at 100mg/dL, the measurement repeatability requirement is met;
step three: the accuracy of the noninvasive glucometer system comprises a first method: adopting a contrast test, selecting a second venous whole blood sample bank, inverting and uniformly mixing each sample before testing, adjusting the oxygen partial pressure pO2 of each sample to 8.67kPa +/-0.67 kPa, dividing the venous blood sample of each sample into 3 parts, testing the 1 st part by using a 1 st noninvasive glucometer, and testing the 2 nd part by using a 2 nd noninvasive glucometer; centrifuging at a high speed in the 3 rd part, taking out plasma, and then testing blood sugar by using a reference analyzer, wherein the difference between the venous plasma result tested by each noninvasive blood sugar analyzer and the venous plasma result tested by the reference analyzer is deviation;
95% of the deviation of the measurement result of the noninvasive glucometer should meet the following requirements: when the concentration of the glucose is less than or equal to 75mg/dL, the concentration is not more than +/-15 mg/dL; when the glucose concentration is more than 75mg/dL, the concentration is not more than +/-20 percent;
and in the second step, the repeatability of the noninvasive glucometer measurement can be realized, and a glucose physiological salt aqueous solution library can be adopted to replace the venous whole blood sample library I.
The third step also comprises a second method, wherein a recovery test is adopted, a third venous whole blood sample bank is selected, a sufficient amount of preservative which does not interfere with blood glucose detection is added into a sample of venous blood whole blood S1 added with anticoagulant, 7 equal parts of S1 with the volume of V1 are accurately sucked, standard glucose physiological saline solution with the known concentration and the volume of V2-V7 is respectively added into 6 parts of the sample, and finally the glucose concentration of the 7 parts of the sample respectively corresponds to seven concentrations of the second venous whole blood sample bank; and adjusting the partial pressure of oxygen, pO2, of the venous blood sample to 8.67kPa + -0.67 kPa; respectively inverting and uniformly mixing each sample, respectively testing 7 samples by using 2 noninvasive glucometers for 10 times, and respectively calculating the glucose recovery rate of the noninvasive glucometers according to the formula (1) by using the average values of 10 measurements which are respectively marked as C1, C2, C3, C4, C5, C6 and C7;
r- - -recovery; n is 1,2,3,4,5, 6; 2,3,4,5,6, 7;
vi- -volume of physiological saline solution of glucose added between the S1 and Si samples;
v1- - -volume of S1 sample;
ci- - -measured concentration of Si sample;
c1- -concentration of S1 sample;
CS- - -concentration of glucose solution prepared;
wherein the recovery rate of the noninvasive glucose meter to the glucose is 80-120%.
The venous whole blood sample bank III can also be replaced by a 500mg/dL glucose physiological saline solution in a glucose physiological saline solution bank.
In the specific implementation of the invention, the following experimental materials are adopted:
1) a quartz glass cuvette; 2) a noninvasive blood glucose meter (at least 2 meters with the same specification); 3) a reference analyzer; 4) A retroactive glycemic reference substance; 5) venous or capillary blood samples, physiological saline; 6) a blood collection tube to which an appropriate anticoagulant is added; 7) a low speed centrifuge; 8) a straw; 9) a pipettor; 10) a water bath kettle.
Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (4)
1. A method for judging the accuracy of noninvasive blood glucose detection is characterized in that: the method comprises the following steps:
the method comprises the following steps: establishing a test sample library, wherein the sample library comprises the following steps:
venous whole blood sample bank one:
the blood glucose concentrations were obtained as follows: 30-50 mg/dL; 51-110 mg/dL; 111-150 mg/dL; 151-250 mg/dL; 251-400mg/dL venous whole blood sample bank 1.
Venous whole blood sample bank two:
the blood glucose concentrations were obtained as follows: the concentration of 2 samples is less than 50 mg/dL; the concentration of 8 samples is less than 50-80 mg/dL; the concentration of 10 samples is 81-120 mg/dL; the concentration of 15 samples is 121-200 mg/dL; the concentration of 8 samples is 201-300 mg/dL; the concentration of 5 samples is 301-400 mg/dL; the concentration of 2 samples was > 400 mg/dL;
venous whole blood sample bank three: venous blood whole blood S1 supplemented with an anticoagulant;
a glucose physiological salt aqueous solution library: configuring 30-50 mg/dL; 51-110 mg/dL; 111-150 mg/dL; 151-250 mg/dL; 251-400 mg/dL; 500mg/dL of a physiological saline solution of glucose;
step two: the noninvasive glucometer measurement repeatability comprises the following steps: selecting a first venous whole blood sample bank for testing, placing the sample at the room temperature of 23 +/-5 ℃, and balancing for at least 30min to enable the temperature of the sample to reach the room temperature of +/-2 ℃; each sample was inverted and mixed well before testing; the test is repeated for 20 times on two noninvasive glucometers under the repetitive condition according to the measurement procedure in the use instruction;
1 aliquot should be taken from the sample immediately before the first test and after the last test in the blood glucose monitoring system and repeated tests are performed using the manufacturer's standard measurement procedure;
if the results show a drift effect: the difference between the first result and the last result is greater than 4mg/dL when the blood glucose concentration is less than or equal to 100mg/dL or greater than 4% when the blood glucose concentration is greater than 100mg/dL, the detection result of the sample is invalid, the sample needs to be detected again, and the standard deviation SD and the coefficient of variation CV of the effective detection result are calculated;
wherein, standard deviation
Coefficient of variation
Requiring SD < 7.7mg/dL when the glucose concentration is < 100 mg/dL; when the glucose concentration is more than or equal to 100mg/dL, the CV is less than 7.5 percent, and the measurement repeatability requirement is met;
step three: the accuracy of the noninvasive glucometer system comprises a first method: selecting a second venous whole blood sample bank by adopting a comparative test, inverting and uniformly mixing each sample before testing, and adjusting the oxygen partial pressure pO2 of each sample to 8.67kPa +/-0.67 kPa; dividing venous blood samples of each sample into 3 parts, testing the 1 st part by using a 1 st noninvasive glucometer, and testing the 2 nd part by using a 2 nd noninvasive glucometer; centrifuging at a high speed in the 3 rd part, taking out plasma, and then testing blood sugar by using a reference analyzer, wherein the difference between the venous plasma result tested by each noninvasive blood sugar analyzer and the venous plasma result tested by the reference analyzer is deviation;
95% of the deviation of the measurement result of the noninvasive glucometer should meet the following requirements: when the concentration of the glucose is less than or equal to 75mg/dL, the concentration is not more than +/-15 mg/dL; when the glucose concentration is more than 75mg/dL, the glucose concentration is not more than +/-20 percent.
2. The method of determining the accuracy of non-invasive blood glucose measurement according to claim 1, wherein: and in the second step, the repeatability of the noninvasive glucometer measurement can be realized, and a glucose physiological salt aqueous solution library can be adopted to replace the venous whole blood sample library I.
3. The method of determining the accuracy of non-invasive blood glucose measurement according to claim 1, wherein: the third step also comprises a second method, wherein a recovery test is adopted, a third venous whole blood sample bank is selected, a sufficient amount of preservative which does not interfere with blood glucose detection is added into a sample of venous blood whole blood S1 added with anticoagulant, 7 equal parts of S1 with the volume of V1 are accurately sucked, standard glucose physiological saline solution with the known concentration and the volume of V2-V7 is respectively added into 6 parts of the sample, and finally the glucose concentration of the 7 parts of the sample respectively corresponds to seven concentrations of the second venous whole blood sample bank; and adjusting the partial pressure of oxygen, pO2, of the venous blood sample to 8.67kPa + -0.67 kPa; respectively inverting and uniformly mixing each sample, respectively testing 7 samples by using 2 noninvasive glucometers for 10 times, and respectively calculating the glucose recovery rate of the noninvasive glucometers according to the formula (1) by using the average values of 10 measurements which are respectively marked as C1, C2, C3, C4, C5, C6 and C7;
r- - -recovery; n is 1,2,3,4,5, 6; 2,3,4,5,6, 7;
vi- -volume of physiological saline solution of glucose added between the S1 and Si samples;
v1- - -volume of S1 sample;
ci- - -measured concentration of Si sample;
c1- -concentration of S1 sample;
CS- - -concentration of glucose solution prepared;
wherein the recovery rate of the noninvasive glucose meter to the glucose is 80-120%.
4. The method of determining the accuracy of non-invasive blood glucose measurement according to claim 3, wherein: the venous whole blood sample bank III can also be replaced by a 500mg/dL glucose physiological saline solution in a glucose physiological saline solution bank.
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| CN117373586A (en) * | 2023-08-28 | 2024-01-09 | 北京华益精点生物技术有限公司 | Blood glucose data comparison method and related equipment |
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| CN117373586A (en) * | 2023-08-28 | 2024-01-09 | 北京华益精点生物技术有限公司 | Blood glucose data comparison method and related equipment |
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