CN112362878A - Microalbumin detection freeze-drying reagent and reaction tube pre-stored with same - Google Patents
Microalbumin detection freeze-drying reagent and reaction tube pre-stored with same Download PDFInfo
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- CN112362878A CN112362878A CN202011207748.0A CN202011207748A CN112362878A CN 112362878 A CN112362878 A CN 112362878A CN 202011207748 A CN202011207748 A CN 202011207748A CN 112362878 A CN112362878 A CN 112362878A
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- 239000003153 chemical reaction reagent Substances 0.000 title claims abstract description 74
- 238000004108 freeze drying Methods 0.000 title claims abstract description 19
- 238000001514 detection method Methods 0.000 title abstract description 11
- 239000003085 diluting agent Substances 0.000 claims description 7
- 239000007853 buffer solution Substances 0.000 claims description 6
- 239000012528 membrane Substances 0.000 claims description 5
- 239000003755 preservative agent Substances 0.000 claims description 3
- 230000002335 preservative effect Effects 0.000 claims description 3
- 238000000034 method Methods 0.000 description 8
- 210000002700 urine Anatomy 0.000 description 5
- 208000007342 Diabetic Nephropathies Diseases 0.000 description 4
- 208000033679 diabetic kidney disease Diseases 0.000 description 4
- 201000010099 disease Diseases 0.000 description 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 4
- 238000011156 evaluation Methods 0.000 description 4
- 230000001684 chronic effect Effects 0.000 description 3
- 230000006378 damage Effects 0.000 description 3
- 206010012601 diabetes mellitus Diseases 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000007710 freezing Methods 0.000 description 3
- 230000008014 freezing Effects 0.000 description 3
- 208000017169 kidney disease Diseases 0.000 description 3
- 238000007789 sealing Methods 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000012545 processing Methods 0.000 description 2
- 230000035945 sensitivity Effects 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 210000002489 tectorial membrane Anatomy 0.000 description 2
- 102000009027 Albumins Human genes 0.000 description 1
- 108010088751 Albumins Proteins 0.000 description 1
- 208000002249 Diabetes Complications Diseases 0.000 description 1
- 206010012655 Diabetic complications Diseases 0.000 description 1
- 206010061481 Renal injury Diseases 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 208000020832 chronic kidney disease Diseases 0.000 description 1
- 208000028208 end stage renal disease Diseases 0.000 description 1
- 201000000523 end stage renal failure Diseases 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 230000002209 hydrophobic effect Effects 0.000 description 1
- 208000037806 kidney injury Diseases 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000002558 medical inspection Methods 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 239000013558 reference substance Substances 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000010257 thawing Methods 0.000 description 1
- 239000012780 transparent material Substances 0.000 description 1
- 238000009777 vacuum freeze-drying Methods 0.000 description 1
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
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- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Chemical & Material Sciences (AREA)
- Biomedical Technology (AREA)
- Urology & Nephrology (AREA)
- Hematology (AREA)
- Immunology (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Cell Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
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- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention provides a microalbumin detection freeze-drying reagent and a reaction tube pre-stored with the freeze-drying reagent, and relates to the technical field of medical examination, which comprises a reaction tube body, wherein the reaction tube body is of a cavity structure with an open end, a water-soluble film is arranged in the cavity of the reaction tube body, the inner cavity of the reaction tube body is divided into an upper cavity and a lower cavity by the water-soluble film, the lower cavity is filled with the freeze-drying reagent R1, the upper cavity is filled with the freeze-drying reagent R2, a detachable cover body is arranged on the reaction tube body at the top of the upper cavity, and when the cover body is not detached, the upper cavity is a closed cavity.
Description
Technical Field
The invention relates to the technical field of medical inspection, in particular to a freeze-drying reagent for detecting trace albumin and a reaction tube pre-stored with the freeze-drying reagent.
Background
The main harm of diabetes is various acute and chronic complications, which have great harm to the health of patients and even cause life threat in serious cases. Among them, Diabetic Nephropathy (DN) is a common chronic complication of diabetes and has also become an important cause of end-stage renal failure, so how to find early diabetic nephropathy earlier, faster and more conveniently has great significance for preventing and treating diabetic kidney injury. The research takes diabetic nephropathy in chronic diabetic complications as an entry point, and the occurrence of nephropathy is generally monitored by using a urine microalbumin index in clinic. The detection of urine microalbumin is a sensitive and reliable index for early detection of nephropathy. The disease condition can be accurately diagnosed by the numerical value of the urine microalbumin and the statement of the disease condition, symptoms and medical history. Therefore, the regular detection of microalbumin in urine can play an active role in preventing and treating nephropathy at an early stage.
At present, the microalbumin reagent is unstable to store at normal temperature, can be stored for about 12 months at the temperature of 2-8 ℃, brings inconvenience of repeated freeze thawing when stored at the temperature of-20 ℃, can cause adverse effects on the performance of the reagent, can well solve the problems after the freeze-drying technology is adopted, and can be stored at the temperature of 4 ℃ or normal temperature for 2 years or even longer.
The method for preserving the microalbumin freeze-dried reagent mainly adopts a vacuum sealing method, and the method has the advantages of high vacuum degree requirement, complex sealing process and inconvenient operation. If air leakage occurs during vacuum sealing, the freeze-dried reagent can be rehydrated, and the working time for storing the reagent is shortened.
Disclosure of Invention
The invention aims to provide a freeze-dried reagent for detecting microalbumin, which is used for accurately diagnosing disease conditions by combining the numerical value of microalbumin in urine and disease onset conditions, symptoms and medical history.
It is another object of the present invention to provide a reaction tube in which a lyophilized reagent is pre-stored.
The utility model provides a reaction tube that has freeze-drying reagent in advance, includes the reaction tube body, and the reaction tube body is one end open-ended cavity structure, is equipped with water-soluble membrane in the reaction tube body cavity, and cavity down are divided into to water-soluble membrane in with the reaction tube body cavity, and the cavity is filled with freeze-drying reagent R1 in the cavity down, and the cavity is filled with freeze-drying reagent R2 in going up, is equipped with the detachable lid on the reaction tube body of going up the cavity top, and when the lid was not dismantled, it was airtight cavity to go up.
A freeze-dried reagent for detecting microalbumin comprises a diluent, a reaction reagent R1 and a reaction reagent R2;
wherein the diluent consists of the following components:
buffer solution 0.01-1.0mol/L,
0.01-1.0mol/L of preservative,
wherein the reaction reagent R1 is composed of the following components:
wherein the reaction reagent R2 is composed of the following components:
wherein the pH value of the buffer solution is between 7.0 and 8.0.
The invention has the beneficial effects that:
the freeze-dried reagent has simple storage method, reliable performance of the freeze-dried reagent pre-stored in the tube and convenient storage and transportation. The freeze-drying reagent in the reaction tube can be isolated from air contact, so that the freeze-drying reagent can be stored at normal temperature, the coated film can be torn off, and the detection on the computer is very convenient and practical.
Drawings
Fig. 1 is a schematic structural view of the present invention.
Figure 2 is a cross-sectional view of the novel book.
Fig. 3 is a partially enlarged schematic view of a portion a of fig. 2.
FIG. 4 is a graph of data comparing clinical results of reaction tubes pre-stored with lyophilized reagents and commercially available aqueous reagents.
Detailed Description
Referring to fig. 1 to 4, a reaction tube with a pre-stored lyophilized reagent includes a reaction tube body 1, the reaction tube body 1 is a cavity structure with an open end, a water-soluble film 2 is disposed in the cavity of the reaction tube body 1, the water-soluble film 2 divides the cavity of the reaction tube body 1 into an upper cavity 4 and a lower cavity 5, the lower cavity 5 is filled with the lyophilized reagent R1, the upper cavity 4 is filled with the lyophilized reagent R2, a detachable cover 3 is disposed on the reaction tube body 1 at the top of the upper cavity 4, and the upper cavity 4 is a closed cavity when the cover 3 is not detached.
Furthermore, reaction body 1 include body 6 and upper tube body 7 down, upper tube body 7 threaded connection is inside body 6 down, and 6 inner wall upper portions of body are equipped with the internal thread down, and 7 outer wall lower parts of upper tube body are equipped with the external screw thread, and reaction body 1 divide into body 6 and upper tube body 7 down and is considered processing convenience and better sealed effect, especially water-soluble membrane 2 and the airtight connection process of upper tube body 7.
Furthermore, the upper tube body 7 is a cavity structure which penetrates through from top to bottom, the lower part of the upper tube body 7 is provided with a water-soluble film 2, and the top of the upper tube body 7 is hinged with a cover body 3.
More specifically, the lower tube 6 is a cavity structure with an open upper end.
Furthermore, the bottom of the cavity structure of the lower pipe body 6 is of a hemispherical structure.
Furthermore, a tearable covering film 8 is provided on the top of the upper tube 7 at the lower end of the lid 3.
Furthermore, a detachable tearing tongue 9 extends from one end of the covering film 8.
Furthermore, lid 3 one end articulate in last body 7, the other end joint is to the 7 opposite sides of last body, the effect of lid 3 is to prevent that tectorial membrane 8 from receiving the damage in the processing transportation, can break its leakproofness.
Furthermore, the inner wall of the upper end of the lower pipe body 6 is provided with a first chamfer structure, the lower end of the upper pipe body 7 is a thin opening section, the top of the thin opening section is provided with a second chamfer structure matched with the first chamfer structure of the inner wall of the upper end of the lower pipe body 6, and the lower pipe body 6 and the upper pipe body 7 are assembled conveniently.
Further, the lower tube 6 and the upper tube 7 are made of transparent material, preferably PVC plastic.
The working principle and the using process of the invention are as follows:
this reaction body 1 can be with freeze-dried reagent R1 and freeze-dried reagent R2 after freeze-drying put into reaction body 1 upper chamber 4 and lower chamber 5 inside to it is sealed to use tectorial membrane 8, can the normal atmospheric temperature preserve the transportation.
When in use, the film 8 is only required to be uncovered and the machine is used for detection.
A freeze-dried reagent for detecting microalbumin comprises a diluent, a reaction reagent R1 and a reaction reagent R2;
wherein the diluent consists of the following components:
buffer solution 0.01-1.0mol/L,
0.01-1.0mol/L of preservative,
wherein the reaction reagent R1 is composed of the following components:
wherein the reaction reagent R2 is composed of the following components:
wherein the pH value of the buffer solution is between 7.0 and 8.0.
The freeze-drying process of the microalbumin detection freeze-drying reagent comprises the following steps:
preparing a reaction reagent R1 and a reaction reagent R2 according to the proportion relation, then respectively adding the reaction reagent R1 and the reaction reagent R2 into a pit of a pre-freezing plate coated with a hydrophobic material layer, enabling the reaction reagent R1 and the reaction reagent R2 in the pit to be in a spherical liquid drop shape, finally immersing the pre-freezing plate into liquid nitrogen for pre-freezing for 2-5 minutes, collecting solidified spherical reaction reagent R1 and the reaction reagent R2, directly putting the spherical reaction reagent R1 and the reaction reagent R2 into a freeze dryer for vacuum freeze drying to obtain a freeze-dried reagent R1 and a freeze-dried reagent R2, putting the freeze-dried reagent R2 into an upper chamber 4, putting the freeze-dried reagent R1 into a lower chamber 5 for packaging, and pouring a separately packaged diluent into a reaction tube body 1 when a medical worker uses the reaction tube body, so that the freeze-dried reagent R1, the freeze-dried reagent R2 and a.
Linear range:
the linear results of the microalbumin are shown in fig. 4, which demonstrates that the reference substance is added in different concentrations for detection.
Statistical table for comparing clinical results with commercially available aqueous reagent
Precision evaluation result statistical table
Precision evaluation result statistical table
Sensitivity evaluation result statistical table
Accuracy evaluation result statistical table
From the detection results, the reagent has good precision, linear range, analysis sensitivity and accuracy, and can completely meet the requirements of clinical experiments.
Claims (10)
1. The reaction tube with the pre-stored freeze-dried reagent is characterized in that: including reaction tube body (1), reaction tube body (1) is one end open-ended cavity structure, be equipped with water-soluble membrane (2) in reaction tube body (1) cavity, cavity (4) and lower cavity (5) are gone into with reaction tube body (1) inner cavity to water-soluble membrane (2), be filled with freeze-drying reagent R1 in lower cavity (5), upward be filled with freeze-drying reagent R2 in cavity (4), upward be equipped with detachable lid (3) on cavity (4) top reaction tube body (1), when lid (3) are not dismantled, it is airtight cavity to go up cavity (4).
2. The reaction tube of claim 1, wherein the reaction tube is pre-stored with a lyophilized reagent, and further comprises: the reaction tube body (1) comprises a lower tube body (6) and an upper tube body (7), wherein the upper tube body (7) is in threaded connection with the inner part of the lower tube body (6).
3. The reaction tube pre-stored with lyophilized reagents according to claim 2, wherein: the upper pipe body (7) is of a cavity structure which penetrates through the upper pipe body and the lower pipe body (7), and a water-soluble film (2) is arranged on the lower portion of the upper pipe body (7).
4. The reaction tube pre-stored with lyophilized reagents according to claim 2, wherein: the lower pipe body (6) is of a cavity structure with an opening at the upper end.
5. The reaction tube pre-stored with lyophilized reagents according to claim 4, wherein: the bottom of the cavity structure of the lower pipe body (6) is of a hemispherical structure.
6. The reaction tube pre-stored with lyophilized reagents according to claim 2, wherein: the top of the upper pipe body (7) is positioned at the lower end of the cover body (3) and is provided with a film (8) which can be torn.
7. The reaction tube of claim 6, wherein the reaction tube is pre-stored with a lyophilized reagent, and further comprises: one end of the covering film (8) extends out of a detachable tearing tongue (9).
8. The reaction tube of claim 6, wherein the reaction tube is pre-stored with a lyophilized reagent, and further comprises: one end of the cover body (3) is hinged to the upper pipe body (7), and the other end of the cover body is clamped to the other side of the upper pipe body (7).
9. The reaction tube of claim 6, wherein the reaction tube is pre-stored with a lyophilized reagent, and further comprises: lower body (6) upper end inner wall be equipped with first chamfer structure, last body (7) lower extreme be the thin mouthful section, thin mouthful section top be equipped with lower body (6) upper end inner wall first chamfer structure matched with second chamfer structure.
10. The freeze-dried reagent for detecting microalbumin is characterized in that: comprises diluent, a reaction reagent R1 and a reaction reagent R2;
wherein the diluent consists of the following components:
buffer solution 0.01-1.0mol/L,
0.01-1.0mol/L of preservative,
wherein the reaction reagent R1 is composed of the following components:
wherein the reaction reagent R2 is composed of the following components:
wherein the pH value of the buffer solution is between 7.0 and 8.0.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011207748.0A CN112362878A (en) | 2020-11-03 | 2020-11-03 | Microalbumin detection freeze-drying reagent and reaction tube pre-stored with same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011207748.0A CN112362878A (en) | 2020-11-03 | 2020-11-03 | Microalbumin detection freeze-drying reagent and reaction tube pre-stored with same |
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| Publication Number | Publication Date |
|---|---|
| CN112362878A true CN112362878A (en) | 2021-02-12 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202011207748.0A Pending CN112362878A (en) | 2020-11-03 | 2020-11-03 | Microalbumin detection freeze-drying reagent and reaction tube pre-stored with same |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN112362878A (en) |
Citations (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0246760A2 (en) * | 1986-04-24 | 1987-11-25 | E-Y Laboratories, Inc. | Variable volume assay device and method |
| WO2001059159A2 (en) * | 2000-02-10 | 2001-08-16 | Instastain | Molecular biological kit apparatus and method |
| EP1975622A1 (en) * | 2007-03-28 | 2008-10-01 | Sysmex Corporation | Reagent for measuring clotting time and method for stabilizing tissue factor |
| CN103278648A (en) * | 2013-05-24 | 2013-09-04 | 宁波美康生物科技股份有限公司 | Albumin detection reagent |
| CN204958918U (en) * | 2015-08-25 | 2016-01-13 | 广州维伯鑫生物科技有限公司 | Reaction tube of pre -installation fluorescence PCR reagent |
| WO2016149972A1 (en) * | 2015-03-24 | 2016-09-29 | 深圳市贝沃德克生物技术研究院有限公司 | Diabetic nephropathy early screening reagent kit, biomarker testing method and applications |
| CN207227426U (en) * | 2017-05-17 | 2018-04-13 | 北京海普威生物技术有限公司 | Sample-adding gene amplification reaction pipe of exempting to uncap for mass production freeze-dried type reagent |
| CN207567206U (en) * | 2017-11-15 | 2018-07-03 | 郑州安图生物工程股份有限公司 | Prestore the reaction tube of freeze-dried reagent |
| US20190309344A1 (en) * | 2018-04-10 | 2019-10-10 | Stem Arts Projects, Llc | Capsule for lyophilized reagent storage and delivery |
| CN213715239U (en) * | 2020-11-03 | 2021-07-16 | 吉林省富生医疗器械有限公司 | Reaction tube with pre-stored freeze-drying reagent |
-
2020
- 2020-11-03 CN CN202011207748.0A patent/CN112362878A/en active Pending
Patent Citations (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0246760A2 (en) * | 1986-04-24 | 1987-11-25 | E-Y Laboratories, Inc. | Variable volume assay device and method |
| WO2001059159A2 (en) * | 2000-02-10 | 2001-08-16 | Instastain | Molecular biological kit apparatus and method |
| EP1975622A1 (en) * | 2007-03-28 | 2008-10-01 | Sysmex Corporation | Reagent for measuring clotting time and method for stabilizing tissue factor |
| CN103278648A (en) * | 2013-05-24 | 2013-09-04 | 宁波美康生物科技股份有限公司 | Albumin detection reagent |
| WO2016149972A1 (en) * | 2015-03-24 | 2016-09-29 | 深圳市贝沃德克生物技术研究院有限公司 | Diabetic nephropathy early screening reagent kit, biomarker testing method and applications |
| CN204958918U (en) * | 2015-08-25 | 2016-01-13 | 广州维伯鑫生物科技有限公司 | Reaction tube of pre -installation fluorescence PCR reagent |
| CN207227426U (en) * | 2017-05-17 | 2018-04-13 | 北京海普威生物技术有限公司 | Sample-adding gene amplification reaction pipe of exempting to uncap for mass production freeze-dried type reagent |
| CN207567206U (en) * | 2017-11-15 | 2018-07-03 | 郑州安图生物工程股份有限公司 | Prestore the reaction tube of freeze-dried reagent |
| US20190309344A1 (en) * | 2018-04-10 | 2019-10-10 | Stem Arts Projects, Llc | Capsule for lyophilized reagent storage and delivery |
| CN213715239U (en) * | 2020-11-03 | 2021-07-16 | 吉林省富生医疗器械有限公司 | Reaction tube with pre-stored freeze-drying reagent |
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