CN110926897A - Device and method for adjusting oxygen partial pressure in human blood sample - Google Patents

Device and method for adjusting oxygen partial pressure in human blood sample Download PDF

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Publication number
CN110926897A
CN110926897A CN201911241548.4A CN201911241548A CN110926897A CN 110926897 A CN110926897 A CN 110926897A CN 201911241548 A CN201911241548 A CN 201911241548A CN 110926897 A CN110926897 A CN 110926897A
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China
Prior art keywords
blood sample
partial pressure
oxygen
nitrogen
venous blood
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续勇
宋伟
李胜民
杨忠
王会如
张宏
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BEIJING INSTITUTE OF MEDICAL DEVICE TESTING
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BEIJING INSTITUTE OF MEDICAL DEVICE TESTING
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/28Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers

Abstract

The invention provides a device and a method for regulating oxygen partial pressure in a human blood sample, wherein the device comprises: a blood oxygen regulation workbench which comprises a gas-sealed box body, wherein the box body can accommodate a container filled with the human blood sample; a vacuum extractor in fluid communication with the tank capable of extracting gas from the tank; and a nitrogen filling device which is in fluid communication with the tank and is capable of filling nitrogen into the tank. The invention can adjust the oxygen partial pressure in the human blood sample so as to ensure the accuracy of the performance evaluation of the blood glucose monitoring system for self-test.

Description

Device and method for adjusting oxygen partial pressure in human blood sample
Technical Field
The present invention relates to a device and method for regulating the partial pressure of oxygen in a human blood sample, and more particularly to a device and method for regulating the partial pressure of oxygen in a human blood sample for testing a blood glucose monitoring system.
Background
The human blood is divided into arterial blood, venous blood and capillary blood, wherein the oxygen partial pressure of the venous blood is lower than that of the arterial blood and the capillary blood. The household blood glucose meter is used for measuring blood glucose in capillary blood, and when a performance index of the blood glucose meter is evaluated, a large amount of blood is needed, and the capillary blood is difficult to collect, so venous blood is usually adopted to replace the capillary blood to evaluate the performance condition (such as accuracy and the like) of the blood glucose meter.
In the prior art, venous blood is generally adopted to carry out accuracy detection of a blood glucose monitoring system for self-test. In conducting this test, we need to regulate the blood glucose concentration of venous blood. However, as long as the venous blood contacts with the air, the oxygen partial pressure in the venous blood will continuously rise until the oxygen partial pressure exceeds the range (65mmHg + -5 mmHg) of the national standard, even exceeds 100 mmHg. The oxygen partial pressure in blood greatly affects the test result of the blood glucose monitoring system for self-test using glucose oxidase methodology, and when the oxygen partial pressure in venous blood rises to 150mmHg, the maximum deviation can reach more than 30%, affecting the evaluation result. Therefore, when evaluating the performance of the blood glucose system by venous blood, the oxygen partial pressure in the venous blood needs to be adjusted to reach and stabilize at the level of the capillary oxygen partial pressure during testing so as to ensure the accuracy of the test result. When the partial pressure of venous blood oxygen is lower than the required range, the venous blood can be contacted with oxygen to increase the partial pressure of oxygen, but when the partial pressure of venous blood oxygen is higher than the required range, the partial pressure of oxygen in the venous blood is difficult to reduce.
Therefore, there is a need to develop a method for reducing the partial pressure of oxygen in venous blood to ensure accurate detection of a self-test blood glucose monitoring system.
Disclosure of Invention
The invention aims to provide a device and a method for regulating oxygen partial pressure in a human blood sample, which can regulate the oxygen partial pressure in the human blood sample to reach an expected range value and ensure the evaluation of the accuracy of a blood glucose monitoring system (a glucose oxidase method) for self-test.
The technical scheme of the invention is as follows.
In a first aspect, the present invention provides a device for regulating the partial pressure of oxygen in a human blood sample, comprising:
a blood oxygen regulation workbench which comprises a gas-sealed box body, wherein the box body can accommodate a container filled with the human blood sample;
a vacuum extractor in fluid communication with the tank capable of extracting gas from the tank;
and a nitrogen filling device which is in fluid communication with the tank and is capable of filling nitrogen into the tank.
Preferably, the box body is a glove box or an organic glass box.
Preferably, the tank includes an intake valve, an exhaust valve, and a pressure measuring device.
Preferably, the vacuum pumping device includes a vacuum pump and a connection pipe connected between the vacuum pump and the tank.
Preferably, the nitrogen filling device comprises a nitrogen pipe and a nitrogen bottle; the nitrogen pipe is connected between the nitrogen bottle and the box body and can fill nitrogen into the box body.
Preferably, the nitrogen filling device comprises a nitrogen needle and a nitrogen bottle; the nitrogen needle can be inserted into the container in the box body, and nitrogen is filled into the human blood sample.
Preferably, the human blood sample is a venous blood sample.
The invention provides a device for preparing a human blood sample for testing a blood sugar monitoring system, which comprises the device for adjusting the oxygen partial pressure in the human blood sample, the blood gas analysis device, consumables and reagents according to any one of the above technical schemes.
In a third aspect, the present invention provides a method of preparing a human blood sample for testing a blood glucose monitoring system, comprising the steps of:
step S11, stabilizing the operation environment temperature;
step S12, contacting the venous blood sample with oxygen to raise the oxygen partial pressure;
step S13, packaging the venous blood sample in containers;
step S14, testing the venous blood oxygen partial pressure of the venous blood sample in the container using a blood gas analysis device;
step S15, placing the container filled with the venous blood sample into a box body provided with the device for adjusting the oxygen partial pressure in the human blood sample according to any one of the above technical schemes, and opening the container;
step S16, forming negative pressure in the box body by using the vacuum pumping device of the device for adjusting the oxygen partial pressure in the human blood sample, and closing the vacuum pumping device and keeping the vacuum pumping device for a set time when the negative pressure reaches a set value;
step S17, filling nitrogen into the box body until the pressure in the box body returns to normal;
step S18 of repeating steps S16 and S17 a plurality of times, closing the container and taking it out of the case, testing and recording the partial pressure of oxygen of the venous blood sample with the blood gas analysis device;
in step S19, it is observed whether the value of the oxygen partial pressure reaches the expected range, and if it is higher than the expected range, the steps S15 to S18 are repeated until the oxygen partial pressure is adjusted to the expected range.
In a fourth aspect, the present invention provides a method of preparing a human blood sample for testing a blood glucose monitoring system, comprising the steps of:
step S21, stabilizing the operation environment temperature;
step S22, contacting the venous blood sample with oxygen to raise the oxygen partial pressure;
step S23, packaging the venous blood sample in containers;
step S24, testing the venous blood oxygen partial pressure of the venous blood sample in the container using a blood gas analysis device;
step S25, placing the container filled with the venous blood sample into a box body provided with the device for adjusting the oxygen partial pressure in the human blood sample according to any one of the above technical schemes, and opening the container;
step S26, inserting the nitrogen needle of the device for adjusting the oxygen partial pressure in the human blood sample into the container, directly filling nitrogen into the venous blood sample, and continuing for a set time;
step S27, closing the container and taking it out of the case, testing and recording the partial pressure of oxygen of the venous blood sample with the blood gas analyzer;
in step S28, it is observed whether the value of the oxygen partial pressure reaches the expected range, and if it is higher than the expected range, the steps S25 to S27 are repeated until the oxygen partial pressure is adjusted to the expected range.
With the above technical solutions, the present invention can achieve the following technical effects.
1. The device can adjust the oxygen partial pressure in the human blood sample so as to ensure the accuracy of performance evaluation of a blood glucose monitoring system (glucose oxidase method) for self-test, and the box body can adopt two specifications of a big box glove box and a small box organic glass box according to the amount of blood for test.
2. The blood oxygen adjusting workbench adopts a large-box glove box device, can adopt a method of extracting negative pressure and performing gas replacement, and can also adopt a method of directly filling nitrogen to adjust the oxygen partial pressure in the blood sample. The glove box of the big box is provided with a rubber sleeve, a blood gas analyzer can be placed in the glove box, and an experimenter can carry out on-site real-time blood oxygen measurement.
3. The invention adopts the direct nitrogen filling method to condition the oxygen partial pressure in the human blood sample, is simple and effective, has short time consumption, obviously reduces the oxygen partial pressure in the blood sample, and is suitable for processing a large amount of blood samples.
Drawings
FIGS. 1-3 are schematic views of the blood oxygen adjusting platform glove box structure of the present invention;
FIG. 4 is a schematic view of the organic glass box structure of the blood oxygen adjusting platform of the present invention;
FIG. 5 is a photograph of a vacuum pump of the present invention;
fig. 6 to 7 are photographs of the nitrogen filling apparatus of the present invention.
Detailed Description
Example 1
The present embodiment provides a device for regulating the partial pressure of oxygen in a human blood sample, comprising:
a blood oxygen regulation workbench which comprises a gas-sealed box body, wherein the box body can accommodate a container filled with the human blood sample;
a vacuum extractor in fluid communication with the tank capable of extracting gas from the tank;
and a nitrogen filling device which is in fluid communication with the tank and is capable of filling nitrogen into the tank.
Preferably, the box body is a glove box or an organic glass box.
Preferably, the tank includes an intake valve, an exhaust valve, and a pressure measuring device.
As shown in fig. 1-3, the glove box apparatus is a stainless steel vacuum glove box. In a preferred embodiment, the box is made of SUS304 stainless steel with a thickness of 6 mm; the box size was 800mm 600mm 650mm (length, width, height). The box body is provided with two 1/4 air inlet valves, a 1/4 air extraction valve and a standard pressure gauge, the vacuum degree of the box body is 0-0.1 MPa, the device can process samples with large blood volume, such as dozens of milliliters, and can be placed into a blood gas analyzer, an experimenter can measure blood gas in real time through rubber gloves, and the large-box glove box device can realize two blood oxygen adjusting methods of air replacement and direct nitrogen filling.
As shown in fig. 4, the plexiglas box device is a plexiglas vacuum box. In a preferred embodiment, the box body is made of organic glass and has the thickness of 20 mm; the internal dimensions of the box are 200mm by 200mm (length by width by height). The box has two 1/8 air inlet and outlet valves, a standard pressure gauge. The method is mainly used for processing samples with blood volume of a few milliliters, and only can realize the operation of a gas replacement method.
Preferably, the vacuum pumping means includes a vacuum pump and a connection pipe connected between the vacuum pump and the cabinet, as shown in fig. 5.
Preferably, the nitrogen filling device comprises a nitrogen pipe and a nitrogen bottle; the nitrogen gas pipe is connected between the nitrogen gas bottle and the box body, and can fill nitrogen gas into the box body, as shown in fig. 6.
Preferably, the nitrogen filling device comprises a nitrogen needle and a nitrogen bottle. As shown in fig. 7, the nitrogen needle can be inserted into the container in the case, and fills nitrogen gas into the human blood sample.
Preferably, the human blood sample is a venous blood sample.
Example 2
The present example provides an apparatus for preparing a human blood sample for testing a blood glucose monitoring system, comprising the apparatus for regulating partial pressure of oxygen in a human blood sample according to any one of examples 1, a blood gas analyzing apparatus, and consumables and reagents.
In a preferred embodiment, the consumable and reagent comprise: centrifuge tubes (CORNING, 2ml specification, 50ml), test tube racks, dust-free paper (KIMTECH), powder-free latex gloves, venous blood samples, blood gas analyzer reagent bags.
Example 3
The present embodiment provides a method for preparing a human blood sample for testing a blood glucose monitoring system, comprising the steps of:
step S11, stabilizing the operation environment temperature;
step S12, contacting the venous blood sample with oxygen to raise the oxygen partial pressure;
step S13, packaging the venous blood sample in containers;
step S14, testing the venous blood oxygen partial pressure of the venous blood sample in the container using a blood gas analysis device;
step S15, placing the container filled with the venous blood sample into a box body provided with the device for adjusting the oxygen partial pressure in the human blood sample according to any one of the above technical schemes, and opening the container;
step S16, forming negative pressure in the box body by using the vacuum pumping device of the device for adjusting the oxygen partial pressure in the human blood sample, and closing the vacuum pumping device and keeping the vacuum pumping device for a set time when the negative pressure reaches a set value;
step S17, filling nitrogen into the box body until the pressure in the box body returns to normal;
step S18 of repeating steps S16 and S17 a plurality of times, closing the container and taking it out of the case, testing and recording the partial pressure of oxygen of the venous blood sample with the blood gas analysis device;
in step S19, it is observed whether the value of the oxygen partial pressure reaches the expected range, and if it is higher than the expected range, the steps S15 to S18 are repeated until the oxygen partial pressure is adjusted to the expected range.
In a preferred embodiment, the container of step S13 is a 2.0ml centrifuge tube, with 1.0ml sample per centrifuge tube.
In a preferred embodiment, in the step S16, the sample is placed in an organic glass box or a glove box, the centrifuge tube cap is opened, the vacuum pump is started to extract air in the sealed tank, so that a negative pressure is formed in the sealed tank, and when the negative pressure is greater than 0.1MPa, the vacuum pump is closed and kept for several minutes; in a more preferred embodiment, the negative pressure is maintained for typically 2 minutes.
According to the above example, 10 venous blood samples, numbered 1 to 10 respectively, were taken and the method of adjusting the oxygen partial pressure was performed. Different negative pressure and maintenance time after negative pressure extraction are adopted for different venous blood samples respectively, and vacuum extraction is repeated for 3 times or 5 times, and finally obtained oxygen partial pressure test results are shown in table 1.
TABLE 1 test results of regulating partial pressure of oxygen in venous blood with blood oxygen regulating device
Figure BDA0002306383970000061
Example 4
The present embodiment provides a method for preparing a human blood sample for testing a blood glucose monitoring system, comprising the steps of:
step S21, stabilizing the operation environment temperature;
step S22, contacting the venous blood sample with oxygen to raise the oxygen partial pressure;
step S23, packaging the venous blood sample in containers;
step S24, testing the venous blood oxygen partial pressure of the venous blood sample in the container using a blood gas analysis device;
step S25, placing the container filled with the venous blood sample into a box body provided with the device for adjusting the oxygen partial pressure in the human blood sample according to any one of the above technical schemes, and opening the container;
step S26, inserting the nitrogen needle of the device for adjusting the oxygen partial pressure in the human blood sample into the container, directly filling nitrogen into the venous blood sample, and continuing for a set time;
step S27, closing the container and taking it out of the case, testing and recording the partial pressure of oxygen of the venous blood sample with the blood gas analyzer;
in step S28, it is observed whether the value of the oxygen partial pressure reaches the expected range, and if it is higher than the expected range, the steps S25 to S27 are repeated until the oxygen partial pressure is adjusted to the expected range.
In a preferred embodiment, in step S22, the partial pressure of oxygen in the venous blood sample is set to 90mmHg or more.
In a preferred embodiment, the containers in step S23 are 50ml centrifuge tubes, each of which is filled with approximately 30ml of venous blood sample.
According to the above example, 10 venous blood samples, numbered 1 to 10 respectively, were taken and the method of adjusting the oxygen partial pressure was performed. And different venous blood samples are respectively and directly filled with nitrogen to adjust the oxygen partial pressure in the venous blood, and the finally obtained oxygen partial pressure test results are shown in table 2.
TABLE 2 measurement of partial pressure of oxygen in venous blood by direct injection of nitrogen into venous blood
Figure BDA0002306383970000071
It is to be understood that the above-described embodiments of the present invention are merely illustrative of or explaining the principles of the invention and are not to be construed as limiting the invention. Therefore, any modification, equivalent replacement, improvement and the like made without departing from the spirit and scope of the present invention should be included in the protection scope of the present invention. Further, it is intended that the appended claims cover all such variations and modifications as fall within the scope and boundaries of the appended claims or the equivalents of such scope and boundaries.

Claims (10)

1. A device for regulating the partial pressure of oxygen in a human blood sample, comprising:
a blood oxygen regulation workbench which comprises a gas-sealed box body, wherein the box body can accommodate a container filled with the human blood sample;
a vacuum extractor in fluid communication with the tank capable of extracting gas from the tank;
and a nitrogen filling device which is in fluid communication with the tank and is capable of filling nitrogen into the tank.
2. The apparatus of claim 1, wherein the chamber is a glove box or a plexiglass chamber.
3. The apparatus of claim 1 or 2, wherein the tank comprises an inlet valve, an exhaust valve, and a pressure measuring device.
4. The apparatus of claim 1, wherein the evacuation device comprises a vacuum pump and a connection pipe connected between the vacuum pump and the tank.
5. The apparatus according to claim 1, wherein the nitrogen filling means comprises a nitrogen gas pipe and a nitrogen gas cylinder; the nitrogen pipe is connected between the nitrogen bottle and the box body and can fill nitrogen into the box body.
6. The apparatus of claim 1, wherein the nitrogen filling means comprises a nitrogen needle and a nitrogen cylinder; the nitrogen needle can be inserted into the container in the box body, and nitrogen is filled into the human blood sample.
7. The device of claim 1, wherein the human blood sample is a venous blood sample.
8. A device for preparing a human blood sample for testing a blood glucose monitoring system, comprising a device for regulating the partial pressure of oxygen in a human blood sample according to any one of claims 1 to 7, a blood gas analysis device, and consumables and reagents.
9. A method of preparing a human blood sample for testing a blood glucose monitoring system, comprising the steps of:
step S11, stabilizing the operation environment temperature;
step S12, contacting the venous blood sample with oxygen to raise the oxygen partial pressure;
step S13, packaging the venous blood sample in containers;
step S14, testing the venous blood oxygen partial pressure of the venous blood sample in the container using a blood gas analysis device;
a step S15 of putting the container containing the venous blood sample into a case provided with the apparatus for regulating partial pressure of oxygen in human blood sample according to any one of claims 1 to 6, and opening the container;
step S16, forming negative pressure in the box body by using the vacuum pumping device of the device for adjusting the oxygen partial pressure in the human blood sample, and closing the vacuum pumping device and keeping the vacuum pumping device for a set time when the negative pressure reaches a set value;
step S17, filling nitrogen into the box body until the pressure in the box body returns to normal;
step S18 of repeating steps S16 and S17 a plurality of times, closing the container and taking it out of the case, testing and recording the partial pressure of oxygen of the venous blood sample with the blood gas analysis device;
in step S19, it is observed whether the value of the oxygen partial pressure reaches the expected range, and if it is higher than the expected range, the steps S15 to S18 are repeated until the oxygen partial pressure is adjusted to the expected range.
10. A method of preparing a human blood sample for testing a blood glucose monitoring system, comprising the steps of:
step S21, stabilizing the operation environment temperature;
step S22, contacting the venous blood sample with oxygen to raise the oxygen partial pressure;
step S23, packaging the venous blood sample in containers;
step S24, testing the venous blood oxygen partial pressure of the venous blood sample in the container using a blood gas analysis device;
a step S25 of putting the container containing the venous blood sample into a case provided with the apparatus for regulating partial pressure of oxygen in human blood sample according to any one of claims 1 to 6, and opening the container;
step S26, inserting the nitrogen needle of the device for adjusting the oxygen partial pressure in the human blood sample into the container, directly filling nitrogen into the venous blood sample, and continuing for a set time;
step S27, closing the container and taking it out of the case, testing and recording the partial pressure of oxygen of the venous blood sample with the blood gas analyzer;
in step S28, it is observed whether the value of the oxygen partial pressure reaches the expected range, and if it is higher than the expected range, the steps S25 to S27 are repeated until the oxygen partial pressure is adjusted to the expected range.
CN201911241548.4A 2019-12-06 2019-12-06 Device and method for adjusting oxygen partial pressure in human blood sample Pending CN110926897A (en)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101158676A (en) * 2006-12-31 2008-04-09 重庆大学 Analysis method and device for evaluating blood and crucifixes oxygen carrying and oxygen releasing function thereof
RU2541142C1 (en) * 2013-10-01 2015-02-10 Федеральное государственное бюджетное учреждение науки Институт химии твердого тела и механохимии Сибирского отделения Российской академии наук (ИХТТМ СО РАН) Method of varying of initial oxygen partial pressure and maintaining of pre-set oxygen partial pressure
CN104492125A (en) * 2014-12-31 2015-04-08 大港油田集团有限责任公司 Method for removing dissolved oxygen in viscous liquid
GB201503805D0 (en) * 2015-03-06 2015-04-22 Spectrum Medical Ltd Blood analysis apparatus and method
CN107137699A (en) * 2017-06-15 2017-09-08 中国医学科学院输血研究所 The method of deoxidation and preparation technology of a kind of natural hemoglobin class blood substitute
CN209241772U (en) * 2018-11-19 2019-08-13 青海师范大学 A kind of special collection of specimens storage device

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101158676A (en) * 2006-12-31 2008-04-09 重庆大学 Analysis method and device for evaluating blood and crucifixes oxygen carrying and oxygen releasing function thereof
RU2541142C1 (en) * 2013-10-01 2015-02-10 Федеральное государственное бюджетное учреждение науки Институт химии твердого тела и механохимии Сибирского отделения Российской академии наук (ИХТТМ СО РАН) Method of varying of initial oxygen partial pressure and maintaining of pre-set oxygen partial pressure
CN104492125A (en) * 2014-12-31 2015-04-08 大港油田集团有限责任公司 Method for removing dissolved oxygen in viscous liquid
GB201503805D0 (en) * 2015-03-06 2015-04-22 Spectrum Medical Ltd Blood analysis apparatus and method
CN107137699A (en) * 2017-06-15 2017-09-08 中国医学科学院输血研究所 The method of deoxidation and preparation technology of a kind of natural hemoglobin class blood substitute
CN209241772U (en) * 2018-11-19 2019-08-13 青海师范大学 A kind of special collection of specimens storage device

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Application publication date: 20200327