CN113049819A - HSV1+2 type IgM antibody detection kit reference - Google Patents
HSV1+2 type IgM antibody detection kit reference Download PDFInfo
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- CN113049819A CN113049819A CN202110396387.7A CN202110396387A CN113049819A CN 113049819 A CN113049819 A CN 113049819A CN 202110396387 A CN202110396387 A CN 202110396387A CN 113049819 A CN113049819 A CN 113049819A
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- 238000001514 detection method Methods 0.000 title claims abstract description 68
- 241000700588 Human alphaherpesvirus 1 Species 0.000 title claims abstract description 23
- 239000013558 reference substance Substances 0.000 claims abstract description 68
- 210000002966 serum Anatomy 0.000 claims description 34
- 239000003755 preservative agent Substances 0.000 claims description 16
- 230000002335 preservative effect Effects 0.000 claims description 16
- 238000000034 method Methods 0.000 claims description 10
- 238000001914 filtration Methods 0.000 claims description 9
- 239000012528 membrane Substances 0.000 claims description 7
- 230000003252 repetitive effect Effects 0.000 claims description 7
- 239000011148 porous material Substances 0.000 claims description 2
- 238000003745 diagnosis Methods 0.000 abstract description 4
- 238000000338 in vitro Methods 0.000 abstract description 2
- 238000003908 quality control method Methods 0.000 abstract description 2
- 238000012360 testing method Methods 0.000 description 13
- 239000000523 sample Substances 0.000 description 9
- 241000700584 Simplexvirus Species 0.000 description 4
- 239000012482 calibration solution Substances 0.000 description 4
- 230000001154 acute effect Effects 0.000 description 3
- 208000015181 infectious disease Diseases 0.000 description 3
- 238000012797 qualification Methods 0.000 description 3
- XQFRJNBWHJMXHO-RRKCRQDMSA-N IDUR Chemical compound C1[C@H](O)[C@@H](CO)O[C@H]1N1C(=O)NC(=O)C(I)=C1 XQFRJNBWHJMXHO-RRKCRQDMSA-N 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 241001529453 unidentified herpesvirus Species 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 238000002965 ELISA Methods 0.000 description 1
- 241000282326 Felis catus Species 0.000 description 1
- 208000004898 Herpes Labialis Diseases 0.000 description 1
- 201000009906 Meningitis Diseases 0.000 description 1
- 206010067152 Oral herpes Diseases 0.000 description 1
- 230000000890 antigenic effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 230000000295 complement effect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000011841 epidemiological investigation Methods 0.000 description 1
- 210000004392 genitalia Anatomy 0.000 description 1
- 206010023332 keratitis Diseases 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000006386 neutralization reaction Methods 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 230000000750 progressive effect Effects 0.000 description 1
- 239000013074 reference sample Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000010561 standard procedure Methods 0.000 description 1
- 238000002054 transplantation Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
- G01N33/56983—Viruses
- G01N33/56994—Herpetoviridae, e.g. cytomegalovirus, Epstein-Barr virus
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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
- G01N33/96—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/005—Assays involving biological materials from specific organisms or of a specific nature from viruses
- G01N2333/01—DNA viruses
- G01N2333/03—Herpetoviridae, e.g. pseudorabies virus
- G01N2333/035—Herpes simplex virus I or II
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2469/00—Immunoassays for the detection of microorganisms
- G01N2469/20—Detection of antibodies in sample from host which are directed against antigens from microorganisms
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- Immunology (AREA)
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Abstract
The invention discloses a reference substance of an HSV1+2 type IgM antibody detection kit. Relates to the technical field of in vitro diagnosis and detection. The reference product comprises: a positive reference, a detection limit reference and a repeatability reference. The reference product provided by the invention is wide in application range of detection machine types, and the indexes of accelerated stability, real-time stability and bottle opening stability meet the standard requirements. The problem of random and uniform reference products in the prior art is solved, and the quality control of the HSV1+2IgM detection kit is facilitated.
Description
Technical Field
The invention relates to the technical field of in-vitro diagnosis and detection, in particular to a reference substance of an HSV1+2 type IgM antibody detection kit.
Background
Herpes Simplex Virus (HSV) belongs to the group of herpesviruses, and is classified into type I (HSV-1) and type II (HSV-2) based on antigenic differences. HSV-1 and HSV-2 both belong to the human herpes virus family and have high infection rate globally. Among them, HSV-1 can infect people of all ages, causing diseases such as herpes labialis, herpes meningitis and herpes keratitis, and the serious people can die. HSV-2 mainly infects genital parts and parts below the waist.
The methods commonly used for detecting the herpes simplex virus antibody comprise complement fixation tests, neutralization tests, chemiluminescence tests, enzyme-linked immunosorbent assays and the like, and are clinically used for acute infection diagnosis, detection of organ transplantation patients and epidemiological investigation. For the diagnosis of acute infection, two serum samples of acute phase and convalescent phase should be collected, and IgG and IgM in the serum should be detected at the same time.
In the prior art, reference products of the herpes simplex virus 1+2 type IgM antibody detection kit are not unified, so that the quality of the herpes simplex virus 1+2 type IgM antibody detection kit is uneven, and the market is disordered.
Therefore, it is a problem to be solved by those skilled in the art to provide a reference for a (HSV) IgM antibody detection kit.
Disclosure of Invention
In view of the above, the invention provides a reference substance of an HSV1+2 type IgM antibody detection kit.
In order to achieve the purpose, the invention adopts the following technical scheme:
a HSV1+2 type IgM antibody detection kit reference comprises: a positive reference, a detection limit reference and a repeatability reference;
wherein the S/CO value of the positive reference substance is 1.5-5.0;
the detection limit reference substance comprises a plurality of L1-L5, the detection results of L1-L3 are positive, the detection result of L4 is positive or negative, and the detection result of L5 is negative;
the S/CO value of the repetitive reference substance is 1.5-3.0.
Preferably: also comprises a negative reference product; the negative reference substance, the positive reference substance, the detection limit reference substance and the repeatability reference substance all contain proclin300 with mass concentration of 0.05-0.1%.
The beneficial effects are that the reference product performance should satisfy:
(1) negative reference product compliance rate: and detecting a negative reference product, wherein the coincidence rate (-/-) of the negative reference product is N/N.
(2) Positive reference compliance rate: and detecting a positive reference substance, wherein the positive reference substance coincidence rate ((/ +)) is N/N.
(3) The lowest detection limit is: and detecting a reference substance with the lowest detection limit, wherein the detection results of L1-L3 are positive, L4 can be positive or negative, and the detection result of L5 is negative.
(4) Repeatability: and (5) detecting the repetitive reference substance, repeating for 10 times, wherein the coefficient of variation CV is less than or equal to 15%.
The invention also provides a preparation method of the HSV1+2 type IgM antibody detection kit reference, which comprises the following steps:
(1) mixing a plurality of positive serum samples into 1 group, adding a preservative, and filtering to obtain a plurality of groups of positive reference substances;
(2) mixing a plurality of positive serum samples into 1 group, adding a preservative, and filtering to obtain a plurality of groups of detection limit reference substances;
(3) mixing a plurality of positive serum samples, adding a preservative, and filtering to obtain a repetitive reference substance;
(4) each of a plurality of negative serum samples is mixed into 1 group, added with preservative and filtered to obtain a negative reference substance containing a plurality of groups.
Has the advantages that: by the preparation method, a set of reference substances for the HSV1+2 type IgM antibody detection kit is obtained.
Preferably: the positive reference substance in the step (1) is more than or equal to 5 groups.
Preferably: the detection limit reference substance in the step (2) comprises 3-5 groups; wherein the S/CO value is L1: 3.5 to 5.0; l2 is more than or equal to 2.0 and less than 3.5; l3 is more than 1.01 and less than or equal to 1.9; l4 is more than or equal to 0.9 and less than or equal to 1.1; l5: 0.1 to 0.9.
Further: the positive reference substances in the step (1) are 5-10 groups.
Has the advantages that: the number of positive reference levels should not be less than 5 groups; the detection limit reference substance comprises positive, weak positive and negative, and the number should not be less than 3 groups.
Preferably: the negative serum sample in the step (4) comprises 5-10 groups which are respectively marked as N1-N10.
Preferably: filtration was carried out using a filter having a pore size of 0.22. mu.m.
Has the advantages that: the number of negative reference products is not less than 5 groups; filtering with 0.22 μm filter membrane to remove bacteria, and storing conveniently.
According to the technical scheme, compared with the prior art, the invention discloses and provides the reference product of the HSV1+2IgM antibody detection kit, and the obtained technical effects are that the reference product provided by the invention is wide in application detection machine type, and indexes of accelerated stability (placed at 37 ℃ for 18 days), real-time stability (stored at 2-8 ℃ for 24 months) and bottle opening stability (stored at 2-8 ℃ for 35 days) meet the following requirements:
(1) negative reference product compliance rate: and detecting a negative reference product, wherein the coincidence rate (-/-) of the negative reference product is N/N.
(2) Positive reference compliance rate: and detecting a positive reference substance, wherein the positive reference substance coincidence rate ((/ +)) is N/N.
(3) The lowest detection limit is: and detecting a reference substance with the lowest detection limit, wherein the detection results of L1-L3 are positive, L4 can be positive or negative, and the detection result of L5 is negative.
(4) Repeatability: and (5) detecting the repetitive reference substance, repeating for 10 times, wherein the coefficient of variation CV is less than or equal to 15%.
The problem of random and uniform reference substances in the prior art is solved, and the quality control of the HSV1+2IgM detection kit is facilitated.
Detailed Description
The following will clearly and completely describe the technical solutions in the 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 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.
The embodiment of the invention discloses a reference substance of an HSV1+2 type IgM antibody detection kit.
Example 1
A HSV1+2 type IgM antibody detection kit reference comprises: negative reference substance, positive reference substance, detection limit reference substance and repeatability reference substance.
200 serum samples for preparing reference substances are detected by using a herpes simplex virus 1+2IgM antibody detection kit (Soxhlet, cat # 310820), and 100 positive serum samples and 100 negative serum samples are preliminarily screened and confirmed.
Negative reference substance: the screened negative serum samples were mixed, and 10 negative serum samples were mixed into 1 group and 10 groups, each of which was labeled as N1-N10, and 0.1% proclin300 preservative was added thereto and filtered through a 0.22 μm filter (confirmed by using Soxhlet kit, cat. No. 310820).
A positive reference (S/CO value is 1.5-5.0): the screened positive serum samples were mixed, and 5 positive serum samples were mixed into 1 group and 5 groups, respectively labeled as P1-P5, and each of the groups was added with proclin300 preservative at a mass concentration of 0.1% and filtered through a 0.22 μm filter membrane for use (confirmed by using an external reagent kit, cat 310820).
Detection limit reference substance: the screened positive serum samples were mixed into 1 group per 5 positive serum samples (samples satisfying L1: S/CO value of 3.5 to 5.0 were mixed; samples satisfying 1.01< L3. ltoreq.1.9; L4: weakly positive serum samples were prepared using diluted part L1 of normal human negative mixed serum, S/CO value: 0.9. ltoreq.L 4. ltoreq.1.1), and 3 groups were blended and labeled L1, L3, and L4, respectively, and added with proclin300 preservative of 0.1% by mass concentration, and filtered with 0.22 μm filter membrane for use (confirmed using Soxhlet kit, cat # 310820).
A repeatability reference (S/CO value is 1.5-3.0): the remaining positive serum samples selected above were mixed and labeled as R, and proclin300 preservative was added at a mass concentration of 0.1%, and the mixture was filtered through a 0.22 μm filter (confirmed by using Soxhlet, Ex. kit, cat # 310820).
Example 2
A HSV1+2 type IgM antibody detection kit reference comprises: negative reference substance, positive reference substance, detection limit reference substance and repeatability reference substance.
200 serum samples for preparing reference substances are detected by using a herpes simplex virus 1+2IgM antibody detection kit (Soxhlet, cat # 310820), and 150 positive serum samples and 50 negative serum samples are preliminarily screened and confirmed.
Negative reference substance: the screened negative serum samples were mixed, and 10 negative serum samples were mixed into 1 group and 5 groups, each of which was labeled as N1-N5, and 0.1% proclin300 preservative was added thereto and filtered through a 0.22 μm filter (confirmed by using Soxhlet kit, cat. No. 310820).
A positive reference (S/CO value is 1.5-5.0): the screened positive serum samples were mixed, and 5 positive serum samples were mixed into 1 group and 10 groups were mixed, each of which was designated as P1-P10, and a proclin300 preservative was added at a mass concentration of 0.1% and filtered through a 0.22 μm filter membrane for use (confirmed by using Soxhlet kit, cat. No. 310820).
Detection limit reference substance: the screened positive serum samples were mixed into 1 group (samples satisfying L1: 3.5-5.0; L2<3.5 > 2.0 ≤ L3 ≤ 1.9; L4 ≤ 0.9; and L5: 0.1-0.9) per 5 positive serum samples, and the 5 groups were respectively labeled L1-L5, added with proclin300 preservative with a mass concentration of 0.1%, and filtered with a 0.22 μm filter membrane for use (confirmed by using Sorin, purchased from Ex-Spanish kit, cat # 310820).
Repetitive reference substance: the remaining positive serum samples selected were mixed and labeled as R, and then added with proclin300 preservative at a mass concentration of 0.1% and filtered through a 0.22 μm filter membrane for use (confirmed by using the purchased kit Soxhlet, cat # 310820).
The test effect is as follows:
the full-automatic chemiluminescence determinator with all models produced by the company is operated according to the method of the specification to respectively test the negative reference product compliance rate, the positive reference product compliance rate, the minimum detection limit and the repeatability index.
The qualification standard is as follows:
(1) negative reference product compliance rate: and detecting a negative reference product, wherein the coincidence rate (-/-) of the negative reference product is N/N.
(2) Positive reference compliance rate: and detecting a positive reference substance, wherein the positive reference substance coincidence rate ((/ +)) is N/N.
(3) The lowest detection limit is: and detecting a reference substance with the lowest detection limit, wherein the detection results of L1-L3 are positive, L4 can be positive or negative, and the detection result of L5 is negative.
(4) Repeatability: and (5) detecting the repetitive reference substance, repeating for 10 times, wherein the coefficient of variation CV is less than or equal to 15%.
Accelerated stability: and subpackaging the prepared reference substance into 12 parts, storing one part in a refrigerator at 2-8 ℃, putting the other 11 parts in a water bath kettle at 37 ℃, and standing for 1 day, 3 days, 5 days, 7 days, 9 days, 11 days, 13 days, 15 days, 16 days, 17 days and 18 days respectively. The performance conditions of the reference products which are placed at 37 ℃ for 1 day, 3 days, 5 days, 7 days, 9 days, 11 days, 13 days, 15 days, 16 days, 17 days and 18 days are respectively detected, and the results are qualified.
Real-time stability: and (3) subpackaging 12 parts of the prepared reference product, storing the reference product in a refrigerator at the temperature of-20 ℃, respectively inspecting the reference product once at the 0 th month, the 3 rd month, the 6 th month, the 9 th month, the 12 th month, the 15 th month, the 18 th month, the 21 st month, the 24 th month, the 25 th month, the 26 th month and the 27 th month, tracking the performance condition of the reference product, and obtaining qualified results.
The bottle opening stability is as follows: the prepared reference substance is used by opening a bottle and placed at the temperature of 2-8 ℃ for 5 weeks (35 days), and the examination is carried out once on the 1 st day, the 2 nd day, the 3 rd day, the 4 th day, the 5 th day, the 6 th day, the 7 th day, the 14 th day, the 21 st day, the 28 th day and the 35 th day. And detecting the performance condition of the reference product, and obtaining qualified results.
Example 3
The CIA1200 type full-automatic chemiluminescence determinator is selected, three different batches of kits are used for detecting the reference substance in the example 1, and the results are as follows:
remarking: s is the luminous value of the sample, Cutoff (CO) value is the average value of the luminous values of the calibration solution, and the measuring instrument can automatically calculate the S/CO value of each sample.
As can be seen from the test results in the table above, the test results of the reference samples meet the qualification standards by using the kits of three different batches for detection by adopting the method required by the standards.
Example 4
One of the three batches of example 3 was randomly selected, and the reference sample of example 1 was tested using three different models (CIA600, CIA1200, CIA2800) with the following results:
remarking: s is the luminous value of the sample, Cutoff (CO) value is the average value of the luminous values of the calibration solution, and the measuring instrument can automatically calculate the S/CO value of each sample.
As can be seen from the test results in the table above, the reference products are detected by three different types of instruments by adopting a standard method, the test results of the reference products meet the qualified standards, and the detection instruments used for the reference products are wide.
Example 5
The CIA1200 type full-automatic chemiluminescence determinator is selected, three different batches of kits are used for detecting the reference substance in the example 2, and the results are as follows:
remarking: s is the luminous value of the sample, Cutoff (CO) value is the average value of the luminous values of the calibration solution, and the measuring instrument can automatically calculate the S/CO value of each sample.
As can be seen from the test results in the table above, the test results of the reference samples meet the qualification standards by using the kits of three different batches for detection by adopting the method required by the standards.
Example 6
The reference substance in example 2 was tested by randomly selecting one of the three batches in example 5 and using three different models (CIA600, CIA1200, CIA2800) and the results are as follows:
remarking: s is the luminous value of the sample, Cutoff (CO) value is the average value of the luminous values of the calibration solution, and the measuring instrument can automatically calculate the S/CO value of each sample.
As can be seen from the test results in the table above, the reference products are detected by three different types of instruments by adopting a standard requirement method, the test of each reference product meets the qualified standard, and the detection instruments used for the reference products are wide.
The embodiments in the present description are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments are referred to each other.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Claims (7)
1. The utility model provides a HSV1+2 type IgM antibody detection kit reference, which characterized in that includes: a positive reference, a detection limit reference and a repeatability reference;
wherein the S/CO value of the positive reference substance is 1.5-5.0;
the detection limit reference substance comprises a plurality of L1-L5, the detection results of L1-L3 are positive, the detection result of L4 is positive or negative, and the detection result of L5 is negative;
the S/CO value of the repeatability reference substance is 1.5-3.0.
2. The HSV type 1+2IgM antibody detection kit reference of claim 1, further comprising a negative reference; the negative reference substance, the positive reference substance, the detection limit reference substance and the repeatability reference substance all contain proclin300 with mass concentration of 0.05-0.1%.
3. The method for preparing the HSV1+2 type IgM antibody detection kit reference substance of claim 2, which comprises the following steps:
(1) mixing a plurality of positive serum samples into 1 group, adding a preservative, and filtering to obtain a plurality of groups of positive reference substances;
(2) mixing a plurality of positive serum samples into 1 group, adding a preservative, and filtering to obtain a plurality of groups of detection limit reference substances;
(3) mixing a plurality of positive serum samples, adding a preservative, and filtering to obtain a repetitive reference substance;
(4) each of a plurality of negative serum samples is mixed into 1 group, added with preservative and filtered to obtain a negative reference substance containing a plurality of groups.
4. The method for preparing a reference substance of the HSV1+2IgM antibody detection kit according to claim 3, wherein the positive reference substance in step (1) is not less than 5 groups.
5. The method of claim 3, wherein the detection limit reference of step (2) comprises 3-5 groups; wherein the S/CO value is L1: 3.5 to 5.0; l2 is more than or equal to 2.0 and less than 3.5; l3 is more than 1.01 and less than or equal to 1.9; l4 is more than or equal to 0.9 and less than or equal to 1.1; l5: 0.1 to 0.9.
6. The method of claim 3, wherein the negative serum sample of step (4) comprises 5-10 groups, labeled as N1-N10.
7. The method for preparing the HSV1+ 2-type IgM antibody detection kit reference substance according to claim 3 to 6, wherein the filtration is performed by using filter membranes with the pore size of 0.22 μm.
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CN108085391A (en) * | 2017-12-28 | 2018-05-29 | 广州市金圻睿生物科技有限责任公司 | A kind of RNA quality-control products for the lung cancer fusion detection kit for stablizing preservation |
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CN109916884A (en) * | 2019-03-14 | 2019-06-21 | 江苏泽成生物技术有限公司 | A kind of chemiluminescence class kit quality-control product method of inspection |
CN111007249A (en) * | 2019-11-27 | 2020-04-14 | 迪瑞医疗科技股份有限公司 | Herpes simplex virus antibody IgG chemiluminescence immunoassay kit and preparation method thereof |
CN111458498A (en) * | 2019-01-19 | 2020-07-28 | 艾维可生物科技有限公司 | Hand-foot-mouth EV71 antigen detection kit |
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2021
- 2021-04-13 CN CN202110396387.7A patent/CN113049819A/en active Pending
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
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CN103805714A (en) * | 2014-01-08 | 2014-05-21 | 厦门安普利生物工程有限公司 | Primers, probe, kit and detection method for type II nucleic acid quantitative detection of herpes simplex virus |
CN108593918A (en) * | 2017-12-21 | 2018-09-28 | 江苏泽成生物技术有限公司 | A kind of method of inspection for controlling hepatitis B surface antigen detection kit outgoing |
CN108085391A (en) * | 2017-12-28 | 2018-05-29 | 广州市金圻睿生物科技有限责任公司 | A kind of RNA quality-control products for the lung cancer fusion detection kit for stablizing preservation |
CN111458498A (en) * | 2019-01-19 | 2020-07-28 | 艾维可生物科技有限公司 | Hand-foot-mouth EV71 antigen detection kit |
CN109916884A (en) * | 2019-03-14 | 2019-06-21 | 江苏泽成生物技术有限公司 | A kind of chemiluminescence class kit quality-control product method of inspection |
CN111007249A (en) * | 2019-11-27 | 2020-04-14 | 迪瑞医疗科技股份有限公司 | Herpes simplex virus antibody IgG chemiluminescence immunoassay kit and preparation method thereof |
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