CN201237594Y - Chemical luminescence immunity analysis reagent box for combined detection of multiple infectious disease items - Google Patents
Chemical luminescence immunity analysis reagent box for combined detection of multiple infectious disease items Download PDFInfo
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- CN201237594Y CN201237594Y CN 200820079990 CN200820079990U CN201237594Y CN 201237594 Y CN201237594 Y CN 201237594Y CN 200820079990 CN200820079990 CN 200820079990 CN 200820079990 U CN200820079990 U CN 200820079990U CN 201237594 Y CN201237594 Y CN 201237594Y
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Abstract
The utility model provides a chemiluminescence immunoassay kit for a joint detection of a plurality of infectious disease items, which consists of opaque demountable micropore laths; response holes are arranged on each of the opaque demountable micropore laths. Corresponding antigen or antibody is enveloped on each response hole. The utility model is characterized in that each 12 holes are a response lath; each response lath is loaded with uniform antigen or antibody to detect the same infectious disease item; combination of different response laths can jointly detect 4-8 infectious disease items. The chemiluminescence immunoassay kit for a joint detection of a plurality of infectious disease items can conveniently, handily and jointly detect a plurality of infectious disease items.
Description
Technical field
The chemical luminescence immune analysis reagent box that the utility model provides a kind of a plurality of infectious disease item association to detect.
Background technology
Acquired immune deficiency syndrome (AIDS), promptly (Acquired Immure Deficiency Syndrome AIDS), is by human immunodeficiency virus (human immunodeficiency virus, the serious disease that HIV) causes to aids.The propagation of AIDS passability, blood propagation and three kinds of approach of mother-to-baby transmission infect human.Detecting of HIV (1+2) antibody is the necessary condition of AIDS diagnosis, and present acquired immune deficiency syndrome (AIDS) etiological diagnosis technology comprises that mainly HIV virus is separated, the HIV virus load is measured, the HIV nucleic acid determination, and viral antigen detection and special viral antibody detection etc.Wherein antibody test is the conventional sense method, comprises that the detection technique of ELISA, CLIA, PA, IFA and Dot blot is used for screening experiment, and western blot test (WB) is used for confirming experiment, and the method beyond the antibody test is used for the detection of special circumstances.
Syphilis (Syphilis) is (to claim spirochaeta pallida again, one of common sexually transmitted disease that TP) causes by microspironema pallidum.Its clinical disease course is very long, and clinical manifestation is very complicated, almost can invade various tissues of whole body and organ, and produce the clinical symptoms and the Signs of varied complexity, can show effect repeatedly.Syphilis is a kind of disease of general, early stage main invades mucocutaneously, invades internal organs late period, and severe patient can cause the serious cardiovascular system nervous system damage of unifying.
Hepatitis B is a kind of serious common liver diseases, in the present global population, surpasses 2,000,000,000 people and has infected hepatitis type B virus (HBV) certain period in its life, and wherein, about 3.5 hundred million still are chronic infection person, become the carrier of virus.Whole world three quarters of the population is lived in the district occurred frequently of infection.The acute clinical case of annual HBV surpasses 400 ten thousand, and about 25% among the carrier, just annual 1000000 people die from chronic active hepatitis, cirrhosis or primary carcinoma of liver.China is the most serious country of hepatitis B virus infection in the world, and it is the hepatitis carrier that 1.2 hundred million people are arranged approximately, accounts for 1/3rd of the world.Wherein 3,000 ten thousand is chronic hepatitis, cirrhosis, primary carcinoma of liver, has every year 300000 people to die from chronic liver disease, and wherein about 130,000 people are Patients with Primary.
Hepatitis C is a kind of serious liver diseases of mainly propagating, being caused by hepatitis C virus through blood.The whole world has 100,000,000 hepatitis C virus carrier at present, and China accounts for 40,000,000 people.80% hepatitis C virus carrier can suffer from chronic hepatitis, and wherein the patient of about 10-30% will develop into cirrhosis, and the liver cirrhosis patient of 5-10% can develop into liver cancer.
These communicable diseases serious threat human beings'health, tackle the effective method of infectious disease and cut off its route of transmission exactly, the detection of infectious disease mark is to finding the morning of disease, early treatment, prevention early show important especially, traditional detection method mainly is that single project detects, complex operation, and detection time is long, the cost height, and operating mistake appears easily.
Need detect several projects simultaneously to the usually all a sample of the detection of above-mentioned blood serum designated object clinically, modal test item combination has four of blood source examinations (HIV antibody, TP antibody, HCV antibody and HBsAg), liver five (HBsAg, HBsAb, HBeAg, HBeAb and HBcAb) and eight of infectious diseases (HIV antibody, TP antibody, HCV antibody, HBsAg, HBsAb, HBeAg, HBeAb and HBcAb).Four of blood source examinations are usually used in the conventional sense before blood donor and the corrective surgery; five indexes of hepatitis b is a domestic modal detection combination; be widely used in clinical detection at present; eight of infectious diseases are the test item before the corrective surgery usually also, has become the conventional sense of being admitted to hospital in a lot of medical institutions.
Compare with traditional detection method, the utility model adopts advanced microwell plate chemiluminescence immunoassay, can carry out the detection of a plurality of infectious disease projects simultaneously to a sample in single test, obtains testing result simultaneously; Have sensitivity and the specificity the same, but the operation ease for use improves greatly, shortened the running time, running program, can make up several different test items neatly with the conventional reagents box.Help large-scale promotion application.Reaction of the present utility model and traditional chemical luminescence method are about the same, the opaque 96 hole microwell plates of the standard of application surface special processing are as carrier, guaranteed the convenience and the agility of reaction, general all models are washed the board-like chemiluminescence immune assay of plate machine or complete/semi-automatic system on the compatible market; Problems such as other too much hand-manipulated and complicated operation, repeatability based on the biochip reaction step of slide or film etc. is poor, homogeneity difference have been solved.
Summary of the invention
That the purpose of this utility model has provided is easy, fast, the chemical luminescence immune analysis reagent box of a plurality of infectious disease projects of joint-detection accurately.
The utility model is made up of the bracing frame of position, 96 hole and the dismountable opaque micropore lath that is placed on it, wherein, per 12 holes are a reaction bar, identical antigen or the antibody of each reaction bar load, detect same infectious disease project, can joint-detection 4-8 kind infectious disease project.
The well-designed 96 orifice plate chemical luminescence immune analysis reagent boxes of the utility model, highly sensitive and special, easy and simple to handle quick, can in single test, detect 4-8 kind infectious disease project simultaneously and whether contain determinand, expense is cheap.It is easy fast, and a plurality of test items are application of sample simultaneously, washes plate simultaneously, reduce the application of sample time, misoperationes such as pollution of avoiding using sample to cause sample repeatedly and reversed order are comprehensively judged the person under inspection according to multinomial testing result, are convenient to the advantages such as processing of sample results.The utility model is particularly suitable for MEC, and clinical hospital promotes the use of, for clinical diagnosis and research work provide a kind of detection means very with practical value.
Description of drawings
The structural representation of Fig. 1,2 the utility model embodiment 1.
The structural representation of Fig. 3 the utility model embodiment 2.
The structural representation of Fig. 4 the utility model embodiment 3.
Embodiment
4 joint-detection chemical luminescence immune analysis reagent boxes of embodiment 1 preparation blood source examination
One, the preparation of enzyme labeling thing
Sodium periodate oxidizing process mark human immunodeficiency virus 1+2 type antigen, treponemal antigen, anti-human IgG, hepatitis B surface antibody with improvement.
The Tris of enzyme labeling thing diluent preparing weighing 12.12g, 5g BSA and 1mL Proclin 300 put into clean container well with the mentioned reagent weighing, and adjust pH 7.0～7.5 adds distilled water to 1L, the dissolving mixing.
Adopt the working concentration of four kinds of enzyme labeling things of chessboard experimental selection respectively.One bottle of each product packing is divided into and adorns four bottles or four kinds of enzyme labeling things and be blended in one bottle.
Two, the preparation of the compound reference substance of infectious disease project
With human immune defect virus antibody (Anti-HIV), syphilis helicoid antibody (Anti-TP), antibody of HCV (Anti-HCV), hepatitis b virus s antigen (HBsAg) positive serum after deactivation, be mixed with 4 compound positive controls of blood source examination, be mixed with compound negative control with normal human serum or NBCS, the packing of 2mL/ bottle.
Three, the preparation of solid phase micropore lath
As shown in Figure 1, HIV1+2 type antigen on the bag quilt in the micropore on reaction bar A, B lath, bag is by last syphilis antigen (TP15 in the micropore on C and the D lath, TP17, TP47 albumen), C hepatitis virus antigen on the bag quilt in the micropore on E and F lath, anti-HBs on the bag quilt in the micropore on G and H lath.As it is less to detect sample size, can press the solid phase micropore lath of HIV, TP, HCV and HBsAg successively A～D row, as shown in Figure 2.Stick the little label that indicates " HIV, TP, HCV, sAg " respectively on four kinds of test item coated slab empennages.
Four, chemical luminous substrate liquid
A liquid is to add Tris and dense HCl in distilled water to be made into 0.1M pH be 8.5 Tris-HCl damping fluid, comprise the Luminol of 4.0mg/mL and 0.3mg/mL to iodophenol.Or buy other commercial chemical luminous substrate A liquid.
B liquid is to add trisodium citrate and citric acid in distilled water, is mixed with 0.1M pH value and is 4.6 citrate buffer solution, comprises the superoxol of 200mg/mL.Or buy other commercial chemical luminous substrate B liquid.
Five, 20 times of cleansing solutions
Weighing 9.9g NaH
2PO
42H
2O, the NaH of 56.0g
2PO
412H
2O, 116g NaCl add distilled water to 1L in clean container, the dissolving mixing is adjusted PH to 7.4.
Six, semi-manufacture and finished product are formed
The packing of above-mentioned steps products obtained therefrom is semi-manufacture.Extract three parts of process specificitys, accuracy, sensitivity and stable assay approvals out and just can be assembled into four joint-detection chemical luminescence immune analysis reagent boxes of blood source examination.Be assembled into and just can dispatch from the factory after needing behind the kit sampling observation qualified.
Embodiment 2 preparation five indexes of hepatitis b joint-detection chemical luminescence immune analysis reagent boxes
One, the preparation of enzyme labeling thing
Sodium periodate oxidizing process mark anti-HBs, hepatitis b virus s antigen, antihepatitis b e antibody, anti-HBc with improvement.
The Tris of enzyme labeling thing diluent preparing weighing 12.12g, 5g BSA and 1mL Proclin 300 put into clean container well with the mentioned reagent weighing, add distilled water to 1L, the dissolving mixing.
Adopt the working concentration of four kinds of enzyme labeling things of chessboard experimental selection respectively.One bottle of each product packing is divided into and adorns four bottles, and wherein enzyme mark antihepatitis b e antibody can be used for hepatitis B virus e antigen and e detection of antibodies simultaneously.
Two, the preparation of the compound calibration object of infectious disease project
Adopt genetic engineering HBsAg, genetic engineering HBeAg to be diluted to finite concentration with NBCS, be mixed with the compound positive control of hepatitis B antigen, be diluted to finite concentration with polyclone HBsAb, polyclone HBeAb and polyclone HBcAb with NBCS, be mixed with the compound standard items of hbv antibody, be mixed with the compound negative control of hepatitis B with complete negative normal human serum of five indexes of hepatitis b or NBCS, difference packing yin and yang attribute reference substance, the 2mL/ bottle.
Three, the preparation of solid phase micropore lath
As shown in Figure 3, bag is by anti-HBs in the micropore of lath A, bag is by hepatitis b virus s antigen in lath B, bag is by antihepatitis b e antibody in lath C micropore, in lath D micropore, wrap earlier by antihepatitis b e antibody, wrap again by an amount of hepatitis B virus e antigen, bag is by hepatitis B virus core antigen in the micropore of lath E, lath A-E is respectively applied for and detects HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, and on the lath empennage, stamp label " sAg, sAb, eAg; eAb, cAb " respectively.
Four, chemical luminous substrate liquid
A liquid is to add Tris and dense HCl in distilled water to be made into 0.1M pH be 8.5 Tris-HCl damping fluid, comprise the Luminol of 4.0mg/mL and 0.3mg/mL to iodophenol.
B liquid is to add trisodium citrate and citric acid in distilled water, is mixed with 0.1M pH value and is 4.6 citrate buffer solution, comprises the superoxol of 200mg/mL.
Five, 20 times of cleansing solutions
Weighing 9.9g NaH
2PO
42H
2O, the NaH of 56.0g
2PO
412H
2O, 116g NaCl add distilled water to 1L in clean container, the dissolving mixing is adjusted PH to 7.4.
Six, semi-manufacture and finished product are formed
The packing of above-mentioned steps products obtained therefrom is semi-manufacture.Extract three parts of process specificitys, accuracy, sensitivity and stable assay approvals out and just can be assembled into joint-detection five indexes of hepatitis b chemical luminescence immune analysis reagent box.Be assembled into and just can dispatch from the factory after needing behind the kit sampling observation qualified.
Eight joint-detection chemical luminescence immune analysis reagent boxes of embodiment 3 preparation infectious diseases
Preparation HIV antibody, TP antibody, HCV, HBsAg, HBeAg mixing positive control are used for HIV, TP, HCV, HBsAg and HBeAg, and preparation HBsAb, HBeAb, HBcAb are hbv antibody mixing positive control, prepare negative control with NBCS.Difference packing yin and yang attribute reference substance, the 2mL/ bottle.
The preparation method of enzyme labeling thing and solid phase micropore lath is assigned bag on 96 hole bracing frame A～H rows, as Fig. 4 by HIV, TP, HCV, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb order by good micropore lath successively with embodiment 1 and 2.
The preparation method of all the other compositions is with embodiment 1 and 2 in the kit.
The using method of embodiment 4 combined detection kits
When sample need detect HIV antibody, TP antibody, HCV antibody and HBsAg simultaneously, use embodiment 1 kit.
When sample need detect HBsAg, HBsAb, HBeAg, HBeAb and HBcAb simultaneously, use embodiment 2 kits.
When sample need detect HIV antibody, TP antibody, HCV antibody, HBsAg, HBsAg, HBsAb, HBeAg, HBeAb and HBcAb simultaneously, use embodiment 3 kits.
The using method of embodiment 1～3 joint-detection chemical luminescence immune analysis reagent box is as follows:
Took out the kit equilibrium at room temperature 20～30 minutes, and took packing apart, take out used lath, the residue lath seals 4 ℃ of preservations with valve bag.
1, each test item is established negative control 1 hole, positive control 1 hole, getting every increment originally adds in the lath respective aperture respectively, every hole 50 μ l can not change the continuous application of sample of application of sample rifle head with a blood, need to change the rifle head between different samples, in negative control hole, add compound negative control 50 μ l again, add corresponding compound positive control 50 μ l in the positive control hole, behind the vibration mixing, inserted 37 ℃ of incubations 30 minutes.
2, wash plate with the cleansing solution after the dilution, can wash plate by hand, the also available plate machine of automatically washing is washed plate, and every hole adds cleansing solution 50 μ l, soaked at least 10 seconds, after abandon liquid or blot 3～5 times so repeatedly.
3, every hole adds corresponding enzyme working fluid 50 μ l, puts 37 ℃ of incubations 30 minutes.
4, wash plate 5 times as step 3
5, every hole adds the chemical luminous substrate liquid 50～100ul of 1:1 mixing, puts room temperature reaction 5 minutes.
6, carry out reading with the microwell plate chemiluminescent analyzer, according to whether also having determinand in the Cutoff value judgement sample.
Claims (1)
1, a kind of chemical luminescence immune analysis reagent box of a plurality of infectious disease item association detections, it is made up of the bracing frame of position, 96 hole and the dismountable opaque micropore lath that is placed on it, on each dismountable opaque reaction bar, reacting hole is set, on each reacting hole, be coated with corresponding antigen or antibody, it is characterized in that: per 12 holes are a reaction bar, identical antigen or the antibody of each reaction bar load.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200820079990 CN201237594Y (en) | 2008-04-16 | 2008-04-16 | Chemical luminescence immunity analysis reagent box for combined detection of multiple infectious disease items |
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| CN 200820079990 CN201237594Y (en) | 2008-04-16 | 2008-04-16 | Chemical luminescence immunity analysis reagent box for combined detection of multiple infectious disease items |
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| CN 200820079990 Expired - Fee Related CN201237594Y (en) | 2008-04-16 | 2008-04-16 | Chemical luminescence immunity analysis reagent box for combined detection of multiple infectious disease items |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102338806A (en) * | 2010-07-23 | 2012-02-01 | 南京英诺华科技有限公司 | Novel random multi-category full-automatic immunoassay system |
| CN103018434A (en) * | 2012-12-05 | 2013-04-03 | 北京鸿天志远科技有限公司 | Multi-index detecting device, kit and application thereof |
| CN106018768A (en) * | 2016-05-31 | 2016-10-12 | 四川金域医学检验中心有限公司 | Multi-project biochemical examination and analysis integrated kit |
-
2008
- 2008-04-16 CN CN 200820079990 patent/CN201237594Y/en not_active Expired - Fee Related
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102338806A (en) * | 2010-07-23 | 2012-02-01 | 南京英诺华科技有限公司 | Novel random multi-category full-automatic immunoassay system |
| CN102338806B (en) * | 2010-07-23 | 2013-09-04 | 江苏英诺华医疗技术有限公司 | Novel random multi-category full-automatic immunoassay system |
| CN103018434A (en) * | 2012-12-05 | 2013-04-03 | 北京鸿天志远科技有限公司 | Multi-index detecting device, kit and application thereof |
| CN103018434B (en) * | 2012-12-05 | 2016-01-20 | 博源诺信（北京）生物科技有限责任公司 | A kind of multiple determination device and a kind of kit, and application |
| CN106018768A (en) * | 2016-05-31 | 2016-10-12 | 四川金域医学检验中心有限公司 | Multi-project biochemical examination and analysis integrated kit |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| ASS | Succession or assignment of patent right |
Owner name: BEIJING KEMEI BIOLOGICAL TECHNOLOGY CO., LTD. Free format text: FORMER OWNER: KEMEI DONGYA BIOLOGICAL TECHNOLOGY CO., LTD., BEIJING Effective date: 20110519 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20110519 Address after: 100094 Beijing city Haidian District Yongfeng base Feng Xian Road No. 7 North Park Patentee after: Beijing Kemei Biological Technology Co., Ltd. Address before: 100094 Beijing city Haidian District Yongfeng base Feng Xian Road No. 7 North Park Patentee before: Kemei Dongya Biological Technology Co., Ltd., Beijing |
|
| CF01 | Termination of patent right due to non-payment of annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20090513 Termination date: 20170416 |