CN117347618A - Colloid Jin Tiwai diagnostic reagent preservative with double effects - Google Patents
Colloid Jin Tiwai diagnostic reagent preservative with double effects Download PDFInfo
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- CN117347618A CN117347618A CN202311197826.7A CN202311197826A CN117347618A CN 117347618 A CN117347618 A CN 117347618A CN 202311197826 A CN202311197826 A CN 202311197826A CN 117347618 A CN117347618 A CN 117347618A
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- preservative
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- 239000003153 chemical reaction reagent Substances 0.000 title claims abstract description 100
- 239000003755 preservative agent Substances 0.000 title claims abstract description 61
- 230000002335 preservative effect Effects 0.000 title claims abstract description 57
- 230000000694 effects Effects 0.000 title claims abstract description 15
- 239000000084 colloidal system Substances 0.000 title claims abstract description 11
- 238000001514 detection method Methods 0.000 claims abstract description 50
- 238000000338 in vitro Methods 0.000 claims abstract description 46
- 235000017454 sodium diacetate Nutrition 0.000 claims abstract description 36
- OPGYRRGJRBEUFK-UHFFFAOYSA-L disodium;diacetate Chemical compound [Na+].[Na+].CC([O-])=O.CC([O-])=O OPGYRRGJRBEUFK-UHFFFAOYSA-L 0.000 claims abstract description 35
- 239000001632 sodium acetate Substances 0.000 claims abstract description 35
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 claims abstract description 25
- 239000000032 diagnostic agent Substances 0.000 claims description 19
- 229940039227 diagnostic agent Drugs 0.000 claims description 19
- 230000000747 cardiac effect Effects 0.000 claims description 11
- 239000003761 preservation solution Substances 0.000 claims description 6
- 238000012360 testing method Methods 0.000 claims description 5
- 208000035473 Communicable disease Diseases 0.000 claims description 2
- 208000027866 inflammatory disease Diseases 0.000 claims description 2
- 239000003550 marker Substances 0.000 claims description 2
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 230000003054 hormonal effect Effects 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 abstract description 9
- 238000006243 chemical reaction Methods 0.000 abstract description 8
- 238000003745 diagnosis Methods 0.000 abstract description 5
- 239000000126 substance Substances 0.000 abstract description 5
- 238000005260 corrosion Methods 0.000 abstract description 4
- 231100000252 nontoxic Toxicity 0.000 abstract description 2
- 230000003000 nontoxic effect Effects 0.000 abstract description 2
- 239000002253 acid Substances 0.000 abstract 1
- 239000013064 chemical raw material Substances 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- PXIPVTKHYLBLMZ-UHFFFAOYSA-N Sodium azide Chemical compound [Na+].[N-]=[N+]=[N-] PXIPVTKHYLBLMZ-UHFFFAOYSA-N 0.000 description 32
- 238000000034 method Methods 0.000 description 19
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 15
- 238000004458 analytical method Methods 0.000 description 7
- 238000003908 quality control method Methods 0.000 description 7
- 244000005700 microbiome Species 0.000 description 5
- 102000009151 Luteinizing Hormone Human genes 0.000 description 4
- 108010073521 Luteinizing Hormone Proteins 0.000 description 4
- 108010048233 Procalcitonin Proteins 0.000 description 4
- 239000003814 drug Substances 0.000 description 4
- 229940040129 luteinizing hormone Drugs 0.000 description 4
- 238000005259 measurement Methods 0.000 description 4
- 238000004806 packaging method and process Methods 0.000 description 4
- CWCXERYKLSEGEZ-KDKHKZEGSA-N procalcitonin Chemical compound C([C@@H](C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@H](C(=O)N[C@@H](C)C(=O)N[C@@H]([C@@H](C)CC)C(=O)NCC(=O)N[C@@H](C(C)C)C(=O)NCC(=O)N[C@@H](C)C(=O)N1[C@@H](CCC1)C(=O)NCC(O)=O)[C@@H](C)O)NC(=O)[C@@H](NC(=O)[C@H](CC=1NC=NC=1)NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCSC)NC(=O)[C@H]1NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)[C@@H](N)CSSC1)[C@@H](C)O)[C@@H](C)O)[C@@H](C)O)C1=CC=CC=C1 CWCXERYKLSEGEZ-KDKHKZEGSA-N 0.000 description 4
- 230000035484 reaction time Effects 0.000 description 4
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- 102000004190 Enzymes Human genes 0.000 description 3
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- 239000003242 anti bacterial agent Substances 0.000 description 3
- 230000000844 anti-bacterial effect Effects 0.000 description 3
- 230000002421 anti-septic effect Effects 0.000 description 3
- 210000002421 cell wall Anatomy 0.000 description 3
- 229960004407 chorionic gonadotrophin Drugs 0.000 description 3
- 230000000087 stabilizing effect Effects 0.000 description 3
- 108091003079 Bovine Serum Albumin Proteins 0.000 description 2
- 241000712431 Influenza A virus Species 0.000 description 2
- 241000701076 Macacine alphaherpesvirus 1 Species 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 2
- 239000000427 antigen Substances 0.000 description 2
- 102000036639 antigens Human genes 0.000 description 2
- 108091007433 antigens Proteins 0.000 description 2
- 229940098773 bovine serum albumin Drugs 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- HXQVQGWHFRNKMS-UHFFFAOYSA-M ethylmercurithiosalicylic acid Chemical compound CC[Hg]SC1=CC=CC=C1C(O)=O HXQVQGWHFRNKMS-UHFFFAOYSA-M 0.000 description 2
- 239000011888 foil Substances 0.000 description 2
- 239000010931 gold Substances 0.000 description 2
- 229910052737 gold Inorganic materials 0.000 description 2
- 208000037797 influenza A Diseases 0.000 description 2
- 230000002401 inhibitory effect Effects 0.000 description 2
- 230000000977 initiatory effect Effects 0.000 description 2
- 229910052751 metal Inorganic materials 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 230000000813 microbial effect Effects 0.000 description 2
- 239000012466 permeate Substances 0.000 description 2
- 230000036632 reaction speed Effects 0.000 description 2
- 238000005507 spraying Methods 0.000 description 2
- RTKIYNMVFMVABJ-UHFFFAOYSA-L thimerosal Chemical compound [Na+].CC[Hg]SC1=CC=CC=C1C([O-])=O RTKIYNMVFMVABJ-UHFFFAOYSA-L 0.000 description 2
- 231100000331 toxic Toxicity 0.000 description 2
- 230000002588 toxic effect Effects 0.000 description 2
- 231100000419 toxicity Toxicity 0.000 description 2
- 230000001988 toxicity Effects 0.000 description 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 108010077805 Bacterial Proteins Proteins 0.000 description 1
- 102000000634 Cytochrome c oxidase subunit IV Human genes 0.000 description 1
- 108050008072 Cytochrome c oxidase subunit IV Proteins 0.000 description 1
- 241000233866 Fungi Species 0.000 description 1
- CEAZRRDELHUEMR-URQXQFDESA-N Gentamicin Chemical compound O1[C@H](C(C)NC)CC[C@@H](N)[C@H]1O[C@H]1[C@H](O)[C@@H](O[C@@H]2[C@@H]([C@@H](NC)[C@@](C)(O)CO2)O)[C@H](N)C[C@@H]1N CEAZRRDELHUEMR-URQXQFDESA-N 0.000 description 1
- 229930182566 Gentamicin Natural products 0.000 description 1
- 206010019233 Headaches Diseases 0.000 description 1
- 206010019280 Heart failures Diseases 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 108010064719 Oxyhemoglobins Proteins 0.000 description 1
- 239000007983 Tris buffer Substances 0.000 description 1
- 231100000570 acute poisoning Toxicity 0.000 description 1
- 230000003276 anti-hypertensive effect Effects 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000036772 blood pressure Effects 0.000 description 1
- 230000032823 cell division Effects 0.000 description 1
- 210000000170 cell membrane Anatomy 0.000 description 1
- 231100000481 chemical toxicant Toxicity 0.000 description 1
- 238000009535 clinical urine test Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 238000005536 corrosion prevention Methods 0.000 description 1
- 230000002939 deleterious effect Effects 0.000 description 1
- 208000002173 dizziness Diseases 0.000 description 1
- 230000000816 effect on animals Effects 0.000 description 1
- 230000009982 effect on human Effects 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 238000003912 environmental pollution Methods 0.000 description 1
- 229960002518 gentamicin Drugs 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000002452 interceptive effect Effects 0.000 description 1
- 230000003834 intracellular effect Effects 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 230000002147 killing effect Effects 0.000 description 1
- QSHDDOUJBYECFT-UHFFFAOYSA-N mercury Chemical compound [Hg] QSHDDOUJBYECFT-UHFFFAOYSA-N 0.000 description 1
- 229910052753 mercury Inorganic materials 0.000 description 1
- 230000002107 myocardial effect Effects 0.000 description 1
- 230000009972 noncorrosive effect Effects 0.000 description 1
- 231100000956 nontoxicity Toxicity 0.000 description 1
- 150000002894 organic compounds Chemical class 0.000 description 1
- 231100000572 poisoning Toxicity 0.000 description 1
- 230000000607 poisoning effect Effects 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 238000001243 protein synthesis Methods 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910001415 sodium ion Inorganic materials 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000007785 strong electrolyte Substances 0.000 description 1
- 239000003440 toxic substance Substances 0.000 description 1
- 230000014616 translation Effects 0.000 description 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 1
Classifications
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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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/5306—Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding
-
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- 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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54313—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
- G01N33/54346—Nanoparticles
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- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
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- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
- G01N33/56983—Viruses
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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
- G01N33/58—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
- G01N33/585—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances with a particulate label, e.g. coloured latex
- G01N33/587—Nanoparticles
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- 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
- G01N33/6887—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids from muscle, cartilage or connective tissue
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- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
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- G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
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Abstract
The invention provides a novel colloid Jin Tiwai diagnostic reagent preservative with double effects, which is characterized in that sodium diacetate is adopted as the preservative, and the dosage of the preservative is 0.01-0.5% of the total amount of reagent components in an in-vitro diagnostic reagent. The colloidal gold diagnostic reagent technology adopts sodium diacetate as a preservative for the first time, and is characterized by having the anti-corrosion effect, being nontoxic and harmless, being a recognized safe substance, being capable of being used as common chemical raw material management at normal temperature in the production process, and not needing to be specially used for the management of special dangerous chemicals; meanwhile, sodium diacetate is weak acid salt, so that the pH of reagent components in the in-vitro diagnostic reagent is more stable, a buffer effect can be achieved in the diagnosis specific reaction, and the detection result of the diagnostic reagent is more accurate and sensitive.
Description
Technical Field
The invention relates to the field of medical in-vitro diagnosis, in particular to a colloid Jin Tiwai diagnostic reagent preservative with double effects.
Background
Preservatives are chemicals capable of killing or inhibiting the growth of microorganisms, particularly bacteria and fungi. The preservative can destroy cell division, inhibit growth and reproduction of microorganisms by acting on multiple targets such as cell membranes, cell walls and enzymes of the microorganisms, and achieve the aim of preservation.
In vitro diagnostic reagents are required to maintain stable performance of the components within the reagent for a period of time, so that preservatives are required to ensure that the in vitro diagnostic reagent does not fail due to microbial growth.
At present, most of the preservatives adopted by the in-vitro diagnostic reagents at home and abroad are sodium azide, merthiolate, antibiotics and ProClin series. The preservative has ideal preservative effect, but is extremely toxic, belongs to dangerous chemicals, is unfavorable for storage, and brings great difficulty to production enterprises in daily use and management.
Sodium azide is one of the most commonly used preservatives in vitro diagnostic reagents and can inhibit bacterial growth, and the dosage is generally 0.1% -0.5%. However, sodium azide belongs to a highly toxic chemical, has a half-lethal dose of 27mg/kg (rat, oral), has an inhibitory effect on cytochrome oxidase and other enzymes, can prevent the formation of oxyhemoglobin in vivo, and has a remarkable antihypertensive effect. Acute poisoning is manifested by dizziness, headache, general weakness, blood pressure drop, and heart failure. Besides the irritation to eyes and skin, the medicine can also be inhaled, taken orally or absorbed by skin to cause poisoning and death, and can be exploded strongly when encountering high heat or severe vibration, and the medicine should be very safe when in use.
Thiomerosal, sodium thiomerosal, is an organic compound containing mercury that has been widely used as a preservative for in vitro diagnostic reagents to prevent potential damage from contamination with harmful microorganisms. But are less and less practical because of their toxicity.
Gentamicin, an antibiotic that acts as a preservative, exerts an antibacterial effect by interfering with bacterial protein synthesis. However, the antibacterial agent cannot be effective against all microorganisms due to its small antibacterial range, and thus cannot achieve a complete preservative effect for a long time. So that the use in vitro diagnostic reagents is becoming smaller and smaller.
ProClin series has broad-spectrum antibacterial property, high action speed, good compatibility with enzyme, no influence on antigen-antibody reaction, much lower toxicity than merthiolate, and high price.
Thus, it is highly desirable to find an in vitro diagnostic agent preservative that is effective for a long period of time and that is free of deleterious effects.
Disclosure of Invention
The invention aims to provide an environment-friendly preservative which is nontoxic, noncorrosive, and suitable in price, and has a certain stabilizing effect on performance indexes of in-vitro diagnostic reagents. The preservative can replace the most commonly used preservative sodium azide and other medicines in the in-vitro diagnostic reagent, reduce the dangerous degree of the in-vitro diagnostic reagent production process and prevent environmental pollution.
Therefore, the invention adopts the following technical scheme: a colloid Jin Tiwai diagnostic reagent preservative with double effects adopts sodium diacetate, and the dosage of the preservative is 0.01% -0.5% of the total amount of reagents in an in-vitro diagnostic reagent, and most preferably 0.05% -0.2%.
Sodium diacetate of the formula: the C4H7NaO4, also called sodium diacetate and sodium diacetate, is a novel preservative with stable property and low price, has no toxic or side effect on human and animals, has no pollution on the environment, has been defined as a safe substance by the U.S. food and drug administration, and has the effects of high-efficiency mildew prevention, corrosion prevention and the like. The antiseptic and mildew-proof effects of sodium diacetate are derived from acetic acid, the compatibility of acetic acid molecules and lipoid compounds is good, and acetic acid can permeate cell walls (undissociated acetic acid can permeate cell walls of mould tissues more effectively than ionized acetic acid), so that intracellular proteins are denatured, and microbial growth and reproduction are inhibited, thereby achieving the sterilization effect.
The invention uses heart markers to detect the representative diagnostic reagent of the in vitro diagnostic reagent for the determination of the dosage of sodium diacetate as preservative, and the diagnostic reagent of cardiac troponin (colloidal gold method) is as follows:
the ratio of sodium diacetate to the reagent was 0.01%, 0.05%, 0.1%, 0.15%, 0.20%, 0.25%, 0.30%, 0.35%, 0.40%, 0.45%, 0.5% to prepare 11 colloid Jin Tiwai diagnostic reagents, provided that the amount of preservative used did not affect the effective components and performance index of the in vitro diagnostic reagents, and the results are shown in table 1 below:
TABLE 1 analysis of sodium diacetate consumption and diagnostic reagent Performance
The experimental data show that the dosage of the sodium diacetate is within the range of 0.01-0.5%, all technical indexes of the in-vitro diagnostic reagent for detecting the cardiac troponin are within the acceptable range, but all index measurement results within the range of 0.05-0.2% are optimal.
Since the measurement results of each index in the range of 0.05% -0.2% are optimal, the in vitro diagnostic reagent for measuring HCG containing sodium diacetate in the serial concentration of 0.05%, 0.1%, 0.15% and 0.20% is prepared, and after the period of validity is 12 months, the technical index of the in vitro diagnostic reagent is observed until 13 months after the period of validity, and the results are as follows:
TABLE 2 Performance analysis of sodium diacetate and diagnostic reagents after 12 months of expiration date
The preservative effect of sodium diacetate as preservative was compared with that of sodium azide (cardiac troponin detection reagents were all near-expiration date batch numbers, month 12), and the results were as shown in table 3 below:
TABLE 3 Performance analysis of cardiac troponin detection reagents (colloidal gold method) different preservatives and diagnostic reagents
From the comparison data in the above tables, it can be seen that the application adopts sodium diacetate as the preservative, and the various technical indexes of the colloid Jin Tiwai diagnostic reagent are superior to those of the similar products which adopt sodium azide as the preservative in the market.
Sodium diacetate has an anti-corrosion function, and sodium diacetate is a strong electrolyte and is completely ionized into sodium ions and acetate ions in the solution, so that the pH of the gold mark preservation solution is more stable, and the reaction speed is accelerated.
The following table 4 is representative of hormone detection in vitro diagnostic reagents: the anti-corrosion effect of Luteinizing Hormone (LH) detection reagent (colloidal gold method) using sodium diacetate as preservative is compared with that of sodium azide (the reagent is semi-quantitative detection reagent, and the production time of the reagent is 10-12 months after production).
TABLE 4 Performance analysis Table of Luteinizing Hormone (LH) detection reagents (colloidal gold method) different preservatives and diagnostic reagents
Table 5 below shows reagents representative of the in vitro diagnostic reagents for the prenatal and postnatal tests: . The human chorionic gonadotrophin detection reagent (colloidal gold method) adopts sodium diacetate as preservative and compares the preservative effect with the preservative effect of sodium azide (the reagent is a qualitative detection reagent, and the reagent is 10-12 months after production).
TABLE 5 Performance analysis Table of human chorionic gonadotrophin detection reagents (colloidal gold method) different preservatives and diagnostic reagents
Table 6 below is representative of in vitro diagnostic reagents for the detection of inflammatory diseases: the Procalcitonin (PCT) detection reagent (colloidal gold method) adopts sodium diacetate as antiseptic and has antiseptic effect compared with sodium azide (the reagent is quantitative detection reagent, and the production time is 10-12 months after production).
TABLE 6 Procalcitonin (PCT) detection reagent (colloidal gold method) Performance analysis Table of different preservatives and diagnostic reagents
Table 7 below is representative of in vitro diagnostic reagents for detection of common infectious diseases: . The anti-corrosion effect of the influenza A/B virus antigen detection reagent (colloidal gold method) using sodium diacetate as a preservative is compared with that of sodium azide (the reagent is a qualitative detection reagent, and the reagent is 10-12 months after production).
TABLE 7 Performance analysis Table of influenza A/B Virus antigen detection reagents (colloidal gold method) for different preservatives and diagnostic reagents
The invention adopts sodium diacetate as the colloid Jin Tiwai diagnostic reagent preservative for the first time, which has the advantages of excellent preservative effect, no toxicity, no corrosiveness, proper price and environmental protection, and simultaneously has a certain stabilizing effect on the performance index of the in-vitro diagnostic reagent, thus being a novel ideal colloid Jin Tiwai diagnostic reagent preservative.
Detailed Description
Example 1:
in vitro diagnostic reagent for prenatal and postnatal care detection: human chorionic gonadotrophin detection reagent (colloidal gold method) (hereinafter abbreviated as HCG detection in vitro diagnostic reagent), gold label preservation solution formula:
pH：7.5
2.5g/L Tris
10g/L bovine serum albumin
Sodium diacetate 0.5g/L
The gold-labeled preservation solution described in the embodiment is suitable for an in-vitro diagnosis reagent for HCG detection, and the in-vitro diagnosis reagent for HCG detection is produced through the processes of subsequent metal spraying, film drawing, packaging and the like, and is a qualitative in-vitro diagnosis reagent, and the detection result is judged by naked eyes, and the operation process is as follows:
1. the reagent strips were removed from the original packaging aluminum foil bag and used as soon as possible within 1 hour.
2. The reagent strip is inserted into the urine sample in the direction of the arrow. Note that: the sample level cannot exceed the marking line of the reagent strip.
3. Waiting for the red band to appear, the urine test results should be read at 3 minutes. After 10 minutes, the test was not effective.
And (3) calculating results:
recording the time of appearance of the quality control line and the detection line respectively
Table 1 data of in vitro diagnostic reagent quality control line and detection line outlet time for HCG detection with sodium diacetate as preservative of the present application.
TABLE 8 quality control line and detection line appearance time for sodium diacetate as preservative
| First time of outgoing line | Time to complete outgoing line | |
| Quality control line | 40s | 49s |
| Detection line | 51s | 1min |
In Table 8, the reaction initiation time of urine with the reagent was 40s, and the complete reaction time was 1min.
Table 9 data of quality control line and detection line outlet time of HCG-promoted in vitro diagnostic reagent (other components of in vitro diagnostic reagent are the same as above) using sodium azide as preservative.
TABLE 9 quality control line and detection line appearance time for sodium azide as preservative
| First time of outgoing line | Time to complete outgoing line | |
| Quality control line | 43s | 55s |
| Detection line | 53s | 1min2s |
In Table 9, the reaction initiation time of urine with the reagent was 43s, and the complete reaction time was 1min2s. The reaction time was slightly slowed down compared to table 1.
The data of the reaction of the in vitro diagnostic reagent and the same urine sample are verified by adopting two different preservatives, and sodium diacetate is used as the preservative. The reaction time can be quickened, which means that the sodium diacetate can accelerate and stabilize the reaction process, and the sodium azide is adopted as a preservative, the reaction speed is slower, which means that the sodium azide only has the preservative effect and has no accelerating effect on the reaction.
Example 2:
cardiac marker detection in vitro diagnostic reagent: myocardial troponin detection reagent (colloidal gold method), gold-labeled preservation solution formula:
pH：7.5
5mol PBS
6g/L bovine serum albumin
Sodium diacetate 1.5g/L
The gold-labeled preservation solution described in the embodiment is suitable for a cardiac troponin detection reagent (a colloidal gold method), the cardiac troponin detection reagent (the colloidal gold method) is produced by the processes of subsequent metal spraying, film drawing, packaging and the like, the in-vitro diagnostic reagent is a quantitative detection in-vitro diagnostic reagent, and the detection result is interpreted by a colloidal gold instrument, and the operation process is as follows:
1. the reagent strips were removed from the original packaging aluminum foil bag and used as soon as possible within 1 hour.
2. Adding sample to reagent strip
After 3.10 minutes, the test strips were inserted into a colloidal gold instrument for detection.
4. Recording the detection result
And (3) calculating results:
the detection result is recorded and the accuracy (relative deviation B i )。
Wherein x is i For the test results, T is a sample indicator value.
Table 10 data comparison of cardiac troponin assay diagnostic reagent with sodium diacetate as preservative of the present application with in vitro diagnostic reagent with sodium azide as preservative.
Table 10 comparison of the Performance of different preservatives for cardiac troponin detection diagnostic reagents
Comparing the two sets of measurement results in Table 10, it is shown that the measurement result of the cardiac troponin detection reagent (colloidal gold method) using sodium diacetate as a preservative is more accurate than the in vitro diagnostic reagent using sodium azide as a preservative, thus further demonstrating the effect of sodium diacetate on accelerating and stabilizing the reaction.
Claims (9)
1. A colloid Jin Tiwai diagnostic reagent preservative with double effects is characterized in that sodium diacetate is adopted as the preservative, and the dosage of the preservative is 0.01-0.5% of the total amount of reagents in an in-vitro diagnostic reagent.
2. The colloidal Jin Tiwai diagnostic agent preservative according to claim 1, characterized in that it is sodium diacetate in an amount of 0.05% to 0.2% of the total amount of the agent in the in vitro diagnostic agent.
3. The colloid Jin Tiwai diagnostic agent preservative as claimed in claim 1, wherein the preservative is sodium diacetate, and the pH of the gold standard preservation solution is 7.5+/-0.05.
4. A colloidal Jin Tiwai diagnostic agent preservative according to any of claims 1-3, characterized in that it is applied to colloidal gold immunochromatographic in vitro diagnostic agents, including qualitative detection colloidal Jin Tiwai diagnostic agents, semi-quantitative detection colloidal Jin Tiwai diagnostic agents and quantitative detection colloidal Jin Tiwai diagnostic agents.
5. A colloidal Jin Tiwai diagnostic agent preservative according to any of claims 1-3, characterized in that it is applied to a cardiac marker detection in vitro diagnostic agent.
6. A colloidal Jin Tiwai diagnostic agent preservative according to any of claims 1-3, characterized in that it is applied to hormonal detection in vitro diagnostic agents.
7. A colloidal Jin Tiwai diagnostic agent preservative according to any of claims 1-3, characterized in that it is applied to a prenatal and postnatal testing in vitro diagnostic agent.
8. A colloidal Jin Tiwai diagnostic agent preservative according to any of claims 1-3, characterized in that it is applied to an in vitro diagnostic agent for the detection of inflammatory diseases.
9. A colloidal Jin Tiwai diagnostic agent preservative according to any of claims 1-3, characterized in that it is applied in an in vitro diagnostic agent for the detection of common infectious diseases.
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Citations (4)
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| US20060246513A1 (en) * | 2005-05-02 | 2006-11-02 | Bohannon Robert C | Method and device to detect the presence of analytes in a sample |
| CN101849559A (en) * | 2010-05-25 | 2010-10-06 | 浙江康特生物科技有限公司 | In vitro diagnostic kit preservative with dual effects |
| CN113484258A (en) * | 2021-06-30 | 2021-10-08 | 重庆东渝中能实业有限公司 | C-reactive protein detection reagent freeze-dried microsphere and preparation method thereof |
| CN114966049A (en) * | 2022-05-13 | 2022-08-30 | 武汉市长立生物技术有限责任公司 | Alpha 1-antitrypsin assay kit |
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| US20060246513A1 (en) * | 2005-05-02 | 2006-11-02 | Bohannon Robert C | Method and device to detect the presence of analytes in a sample |
| CN101849559A (en) * | 2010-05-25 | 2010-10-06 | 浙江康特生物科技有限公司 | In vitro diagnostic kit preservative with dual effects |
| CN113484258A (en) * | 2021-06-30 | 2021-10-08 | 重庆东渝中能实业有限公司 | C-reactive protein detection reagent freeze-dried microsphere and preparation method thereof |
| CN114966049A (en) * | 2022-05-13 | 2022-08-30 | 武汉市长立生物技术有限责任公司 | Alpha 1-antitrypsin assay kit |
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