CN1167920A - Safety human immunodeficiency virus antibody positive serum substitute - Google Patents
Safety human immunodeficiency virus antibody positive serum substitute Download PDFInfo
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- CN1167920A CN1167920A CN 97109106 CN97109106A CN1167920A CN 1167920 A CN1167920 A CN 1167920A CN 97109106 CN97109106 CN 97109106 CN 97109106 A CN97109106 A CN 97109106A CN 1167920 A CN1167920 A CN 1167920A
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- hiv
- antibody
- positive serum
- immunoglobulin
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Abstract
A safe substitute of HIV Ab positive serum is a cross-linked substance obtained by cross-linking reaction of non-human anti-HIV antibody or its processed liquid with human immunoglobulin or its processed liquid, and has the same reactivity, thermal stability and sensitivity as real HIV Ab positive serum, so avoiding the potential infection damage of positive serum at all. Said substitute can be used in production of HIV Ab EIA KIT.
Description
The present invention relates to a kind of positive serum substitute, specifically is exactly the substitute of a kind of human immune defect virus antibody (HIV Ab) positive serum, belongs to the immunological technique field.
Along with human immune defect virus antibody ELISA measuring reagent kit (HIV Ab EIA KIT) in the large-scale production in the whole nation be extensive use of, the latent infection of positive control serum can not be ignored in such kit.Though the positive control serum that is used for such kit is through inactivation treatment, but at present for not only keeping the activity of HIV antibody wherein but also the method for the thorough deactivation of HIV virus is not wherein come to a conclusion, therefore, both at home and abroad all adopt instructions in such kits of indirect ELISA methods (ELISA method) to indicate all that " the used HIV Ab of this kit positive control serum (or blood plasma) is inactivation treatment, but must be considered as infectious substance." in addition, because country is very strict to the management of HIV antibody positive blood plasma, not only link is many in the purchase of HIV antibody positive serum (or blood plasma), and the price height.
In order to overcome the deficiencies in the prior art, the object of the present invention is to provide a kind of substitute of safe HIV Ab positive serum, this substitute both performance with HIV Ab positive serum is suitable, can avoid the danger of the latent infection of positive serum again fully, and this substitute also should have the characteristics that the preparation of producing is simple, cost is low.In brief, the invention provides a kind of safe, reliable, HIV Ab positive serum substitute of being easy to get.
For realizing that the technical measures that purpose of the present invention is taked are:
A kind of safe anti-HIV Ab positive serum substitute, it is the cross-linking agent that inhuman anti-HIV antibody or its treating fluid and normal person's immunoglobulin (Ig) or its treating fluid are obtained by cross-linking reaction.Essence of the present invention is that the antigen active of the antibody activity of the inhuman anti-HIV Ab reactivity of HIV antigen (promptly with) and the normal person's immunoglobulin (Ig) reactivity of anti-human immunoglobulin(HIg) abzyme bond (promptly with) is combined, and eliminates reactive purpose that the danger that may have virulence factor in people's anti-virulence factor antibody positive serum (or blood plasma) possesses anti-virulence factor antibody positive serum again thereby reach.
Wherein, inhuman anti-HIV antibody can be the antibody that monoclonal antibody, genetic engineering antibody or HIV antigen (virolysis thing or synthetic peptide or gene engineering peptides) immune animal obtains.Can be the complete antibody or the fragment of tool antibody activity.Normal person's immunoglobulin (Ig) is meant the human immunoglobulin(HIg) of nonreactive HIV antibody activity, promptly detects the negative human immunoglobulin(HIg) of HIV Ab through enzyme immunoassay (EIA), can be complete human immunoglobulin(HIg) or its fragment.
Crosslinked method has multiple, as commonly used glutaraldehyde method, succinimide pyridine disulfide group propyl ester (SPDP) method, benzoquinones method etc. is arranged.
Compared with the prior art, adopt the obtained beneficial effect of technical measures of the present invention:
1. substitute of the present invention derives from inhuman anti-HIV Ab antibody and normal person's immunoglobulin (Ig), has therefore fundamentally avoided the danger of positive serum latent infection.
2.EIA testing result shows that substitute has good reactivity to two antienzymes; See that on the whole the reaction of many antienzymes is better than the monoclonal antibody enzyme, presents amplification effect.
3. through 37 ℃ of heat stabilization tests, the result shows that the thermal stability of substitute is suitable with real HIV Ab positive serum, promptly put 37 ℃ after, the reactivity of preceding 3 days samples all descends to some extent, then tends to be steady in back 4 days.
4. substitute of the present invention and real HIV Ab positive serum have approximate consistent reactivity and susceptibility to two antienzymes of variable concentrations, and they and the human normal plasma's that compares reactivity has very big difference.
In a word, the thermal stability of HIV Ab positive serum substitute of the present invention, suitable to main performance index such as the reactivity of HIV antigen and two antienzymes and susceptibility with real HIV Ab positive serum, and fundamentally avoided the danger of the latent infection of positive serum, and the method that obtains this substitute is simple, cost is low.Therefore, this substitute has safety, reliable, the characteristics that are easy to get, and its application will be to the production of HIV Ab EIA KIT, use and produce greatly influence.Have important use value and social benefit.
The present invention is further illustrated below in conjunction with specific embodiment:
Embodiment 1:
1. 8mg anti-HIV-1 gp160 monoclonal antibody (McAb) is dissolved in 2ml 0.1M PH7.5PBS, under 23 ℃, stirs adding 0.2 μ mol SPDP, react after 30 minutes, the dress bag filter to 0.1M PH7.5PBS dialysis, changes liquid four times.
2. 16mg human gamma globulin (HGG) (anti-HIV antibody activity detects negative through EIA) is dissolved in 2ml 0.1M PH7.5PBS, under 23 ℃, stirs adding 0.4 μ mol SPDP, react after 30 minutes, the dress bag filter to the dialysis of 0.1M PH4.5 acetate buffer, changes liquid four times.The DTT (dithiothreitol (DTT)) that adds final concentration and be 25mM react 30 minutes under 23 ℃, and the dress bag filter is dialysed to 0.1M PH7.5PBS, changes liquid four times.
3. will be 1., the handled thing in 2. mixes, and in 23 ℃ of reactions 1 hour, in 4 ℃ of reactions 24 hours down, promptly get cross-linking agent, centrifugal going precipitated, supernatant is standby with normal human serum or diluted plasma, and it is anticorrosion to add ten thousand/thimerosal.
Embodiment 2:
This step is identical with embodiment 1, just among the embodiment 1 1. and the consumption of the SPDP 2. double.The crosslinked ratio of two kinds of albumen increases, and other characteristics are constant.
Claims (5)
1. the HIV Ab positive serum substitute of a safety, it is characterized in that: it is the cross-linking agent that is obtained by cross-linking reaction by inhuman anti-HIV antibody or its treating fluid and normal person's immunoglobulin (Ig) or its treating fluid, this product can react with HIV antigen and anti-human immunoglobulin(HIg) abzyme bond, and can be detected in HIV Ab EIA KIT.
2. by the described HIV Ab of claim 1 positive serum substitute, it is characterized in that described inhuman anti-HIV antibody is the antibody that monoclonal antibody, genetic engineering antibody or HIV antigen-immunized animal obtain.
3. by claim 1 or 2 described HIV Ab positive serum substitutes, it is characterized in that described inhuman anti-HIV antibody is complete antibody or the fragment with antibody activity.
4. by the described HIV Ab of claim 1 positive serum substitute, it is characterized in that described normal person's immunoglobulin (Ig) comes for detect the human serum or the blood plasma purification that turn out to be HIV Ab feminine gender through HIV Ab EIA KIT.
5. by claim 1 or 4 described HIV Ab positive serum substitutes, it is characterized in that described normal person's immunoglobulin (Ig) is the fragment of complete immunoglobulin (Ig) or tool antigen active.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 97109106 CN1068945C (en) | 1997-05-14 | 1997-05-14 | Safety human immunodeficiency virus antibody positive serum substitute |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 97109106 CN1068945C (en) | 1997-05-14 | 1997-05-14 | Safety human immunodeficiency virus antibody positive serum substitute |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1167920A true CN1167920A (en) | 1997-12-17 |
| CN1068945C CN1068945C (en) | 2001-07-25 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 97109106 Expired - Fee Related CN1068945C (en) | 1997-05-14 | 1997-05-14 | Safety human immunodeficiency virus antibody positive serum substitute |
Country Status (1)
| Country | Link |
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| CN (1) | CN1068945C (en) |
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007003090A1 (en) * | 2005-07-04 | 2007-01-11 | Shanghai Fuchun Zhongnan Biotech Co. , Ltd. | A composition instead of positive sera used as control in diagnostic agent and its application |
| CN103383393A (en) * | 2013-06-28 | 2013-11-06 | 英科隆生物技术（杭州）有限公司 | Quality control object for substituting patients' positive blood |
| CN104569402A (en) * | 2014-12-15 | 2015-04-29 | 新乡医学院 | Harmless positive reference substance for detection through indirect enzyme linked immunosorbent assay |
| CN104569447A (en) * | 2014-12-15 | 2015-04-29 | 新乡医学院 | Harmless positive reference substance for detecting animal pathogen |
| CN104569403A (en) * | 2014-12-15 | 2015-04-29 | 新乡医学院 | Harmless positive control for enzyme-linked immune diagnosis of hepatitis c |
| CN104650238A (en) * | 2013-06-28 | 2015-05-27 | 英科隆生物技术（杭州）有限公司 | Human cytomegalovirns cross-linking antibody and application thereof to immunoassay kit |
| CN104650236A (en) * | 2013-06-28 | 2015-05-27 | 英科隆生物技术（杭州）有限公司 | Heterogenous conjugate and application thereof to RV (rubella virus) assay |
| CN104650237A (en) * | 2013-06-28 | 2015-05-27 | 英科隆生物技术（杭州）有限公司 | Novel crosslinking antibody and application thereof to immunoassay |
| CN104650239A (en) * | 2013-06-28 | 2015-05-27 | 英科隆生物技术（杭州）有限公司 | Antibody and application thereof in immune detection of toxoplasma gondii |
| CN110483644A (en) * | 2019-09-10 | 2019-11-22 | 山东硕景生物科技有限公司 | Positive serum substitute of mycoplasma pneumoniae IgM antibody and preparation method thereof |
-
1997
- 1997-05-14 CN CN 97109106 patent/CN1068945C/en not_active Expired - Fee Related
Cited By (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007003090A1 (en) * | 2005-07-04 | 2007-01-11 | Shanghai Fuchun Zhongnan Biotech Co. , Ltd. | A composition instead of positive sera used as control in diagnostic agent and its application |
| CN104650238B (en) * | 2013-06-28 | 2018-03-06 | 艾康生物技术(杭州)有限公司 | Human cytomegalovirus cross-linking antibody and its application in immunity detection reagent |
| CN103383393B (en) * | 2013-06-28 | 2015-11-25 | 英科隆生物技术（杭州）有限公司 | A kind of quality-control product of alternative patient's positive blood |
| CN104650237B (en) * | 2013-06-28 | 2019-08-20 | 英科隆生物技术（杭州）有限公司 | It a kind of cross-linking antibody and its is applied in immune detection |
| CN104650239B (en) * | 2013-06-28 | 2018-08-07 | 英科隆生物技术（杭州）有限公司 | A kind of antibody and its application in Toxoplasma immune detection |
| CN104650238A (en) * | 2013-06-28 | 2015-05-27 | 英科隆生物技术（杭州）有限公司 | Human cytomegalovirns cross-linking antibody and application thereof to immunoassay kit |
| CN104650236A (en) * | 2013-06-28 | 2015-05-27 | 英科隆生物技术（杭州）有限公司 | Heterogenous conjugate and application thereof to RV (rubella virus) assay |
| CN103383393A (en) * | 2013-06-28 | 2013-11-06 | 英科隆生物技术（杭州）有限公司 | Quality control object for substituting patients' positive blood |
| CN104650239A (en) * | 2013-06-28 | 2015-05-27 | 英科隆生物技术（杭州）有限公司 | Antibody and application thereof in immune detection of toxoplasma gondii |
| CN104650237A (en) * | 2013-06-28 | 2015-05-27 | 英科隆生物技术（杭州）有限公司 | Novel crosslinking antibody and application thereof to immunoassay |
| CN104650236B (en) * | 2013-06-28 | 2018-02-23 | 英科隆生物技术（杭州）有限公司 | A kind of heterologous cross-linking agent and its application in rubella virus detects |
| CN104569403B (en) * | 2014-12-15 | 2016-08-24 | 新乡医学院 | Innoxious positive control for hepatitis C enzyme-linked immunologic diagnosis |
| CN104569402A (en) * | 2014-12-15 | 2015-04-29 | 新乡医学院 | Harmless positive reference substance for detection through indirect enzyme linked immunosorbent assay |
| CN104569403A (en) * | 2014-12-15 | 2015-04-29 | 新乡医学院 | Harmless positive control for enzyme-linked immune diagnosis of hepatitis c |
| CN104569447A (en) * | 2014-12-15 | 2015-04-29 | 新乡医学院 | Harmless positive reference substance for detecting animal pathogen |
| CN110483644A (en) * | 2019-09-10 | 2019-11-22 | 山东硕景生物科技有限公司 | Positive serum substitute of mycoplasma pneumoniae IgM antibody and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1068945C (en) | 2001-07-25 |
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