CN202421187U - Rapid detection test paper of tuberculosis IgM (Immunoglobulin M) antibody - Google Patents

Rapid detection test paper of tuberculosis IgM (Immunoglobulin M) antibody Download PDF

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Publication number
CN202421187U
CN202421187U CN2011205338548U CN201120533854U CN202421187U CN 202421187 U CN202421187 U CN 202421187U CN 2011205338548 U CN2011205338548 U CN 2011205338548U CN 201120533854 U CN201120533854 U CN 201120533854U CN 202421187 U CN202421187 U CN 202421187U
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China
Prior art keywords
pad
tuberculosis
antibody
test paper
line
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CN2011205338548U
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Chinese (zh)
Inventor
李洲
许俊艳
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Tianjin new torch bio pharmaceutical Limited by Share Ltd
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NEWSCEN COAST BIO-PHARMACEUTICAL Co Ltd
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Abstract

The utility model relates to rapid detection test paper of a tuberculosis IgM (Immunoglobulin M) antibody. The rapid detection test paper comprises a nitrocellulose membrane stuck on a plastic supporting plate, wherein the right end of the nitrocellulose membrane is connected with a sample adsorbing pad and the left end of the sample adsorbing pad is overlapped on the nitrocellulose membrane; the left end of the nitrocellulose membrane is connected with a colloidal gold pad containing a monoclonal antibody for marking an anti-human IgM mu chain; the right end of the colloidal gold pad is overlapped on the nitrocellulose membrane; the left end of the colloidal gold pad is connected with a sample feeding pad; the right end of the sample feeding pad is overlapped on the colloidal gold pad; the middle part of the nitrocellulose membrane is covered by a detection line of a mixed antigen and a quality control line of a goat anti-mouse IgG (Immunoglobulin G) antibody; and a sample feeding indication line further covers between the quality control line and the detection line. The test paper disclosed by the utility model can be conveniently and rapidly operated and can be used for judging a result by human eyes, and has the characteristics of good stability, convenience for popularization, no need of special precise instruments and the like; and the test paper can be used for overcoming the previous disadvantage that only a tuberculosis antibody IgG is detected, and providing important reference values for clinical early diagnosis of tuberculosis.

Description

A kind of quick detection test paper of tuberculosis IgM antibody
Technical field
The utility model relates to a kind of quick detection test paper of tuberculosis IgM antibody.
Background technology
According to the World Health Organization (WHO), the population in the whole world existing nearly 1/3 has infected tulase, and annual neopathy number has 8,700,000, dies from tuberculosis and reaches 2,000,000 examples, and the whole world has tuberculosis 20,000,000 examples at present.China's tuberculosis number occupies second in the whole world, estimates that according to the Ministry of Public Health tuberculosis patient of China is 4,500,000 in 2004.According to the data presentation of Chinese prevention from suffering from the diseases and control center, the new cases number of 2005 2006 tuberculosis is respectively 1,250,000 113 ten thousand.The pulmonary tuberculosis patient age of China 75% causes serious financial burden for society, family between 15-54 year; 80% pulmonary tuberculosis patient is in the rural area.There are every year 130000 people to die from tuberculosis approximately, substantially exceed the summation of other infectious disease death tolls.Epidemic situation is the highest in central and west regions.
In the tuberculosis diagnostic techniques commonly used, main method is the sputum smear dyeing microscopy, in conjunction with x line chest film inspection, is aided with Much's bacillus and cultivates affirmation.Phlegm smear positive rate is low, and inspection susceptibility is poor, and separation and Culture tubercle bacillus excessive cycle, x ray examination be lack of specific often again, is difficult to meet clinical needs.
Generation lungy, develop and lapse to body's immunological function closely related.The tuberculosis antibody reaction is a kind of humoral immunity, is the immunoglobulin (Ig) that is produced by B cell in the body.Discover that the tuberculosis patient humoral immunity level raises, its degree that increases is directly proportional with the pathology active level.The state of an illness is heavy more, more for obviously, recovers with sb.'s illness took a favorable turn.According to immunoreactive universal law: behind the human infection bacterium, what at first produce is IgM antibody, is IgG then, and the IgM early antibody is as the index that infects recently in theory.Tuberculosis infection generally is different from other acute infections of respiratory tract, generally is chronic lysis, when clinical symptoms or x line occurring when unusual, detects tuberculosis antibody IgG, has also transferred the positive to and keeps and ask that this moment, IgM possibly transfer feminine gender to when long.Because the tuberculosis course of disease is different, produce the asynchronism(-nization) that IgM, IgG appear in humoral immunity in the body, therefore should confirm detect IgM or IgG according to the course of disease.In view of this, the detection of approach antibody IgM has important significance in the tuberculosis early diagnosis, can be used as a main diagnosis index, also can be used as the additional experiment of tuberculosis antibody IgG, improves the sensitivity that detects.
The utility model content
For solving the problems of the technologies described above; The utility model provide a kind of easy and simple to handle, quick, with the naked eye judged result, good stability, be convenient to promote, need not the quick detection test paper of the tuberculosis IgM antibody of special exact instrument; Filled up the deficiency of a detected activity property tuberculosis antibody IgG in the past, for clinical tuberculosis early diagnosis provides important value.
The quick detection test paper of the tuberculosis IgM antibody of the utility model; Comprise the nitrocellulose filter that sticks on the plastic support board; The right-hand member of nitrocellulose filter connects inhales the appearance pad; The left end overlap joint of inhaling the appearance pad is on nitrocellulose filter, and the left end of said nitrocellulose filter connects the collaurum pad that contains underlined anti-people IgM μ chain monoclonal antibody, and the right-hand member overlap joint of collaurum pad is on nitrocellulose filter; The left end of collaurum pad connects goes up the appearance pad; The right-hand member overlap joint of last appearance pad is on the collaurum pad, and the middle part on the said nitrocellulose filter is coated with the detection line of hybrid antigen and the nature controlling line of sheep anti-mouse igg antibody, also is provided with the application of sample index line that is used to identify the application of sample position between nature controlling line and the detection line.
The quick detection test paper of the tuberculosis IgM antibody of the utility model, the distance between said application of sample index line and the nature controlling line is 2.5-3mm.
Compared with prior art the beneficial effect of the utility model is: the quick detection test paper of the tuberculosis IgM antibody of the utility model is easy and simple to handle, quick, judged result with the naked eye; Have good stability, be convenient to promote, need not characteristics such as special exact instrument; Filled up the deficiency that in the past only detects tuberculosis antibody IgG, for clinical tuberculosis early diagnosis provides important value.
Description of drawings
Fig. 1 is the structural representation of the quick detection test paper of the described tuberculosis IgM antibody of the utility model embodiment.
Among the figure:
1, plastic support board; 2, nitrocellulose filter; 3, inhale the appearance pad; 4, collaurum pad; 5, go up the appearance pad; 6, detection line; 7, nature controlling line; 8, application of sample index line.
Embodiment
Below in conjunction with accompanying drawing and embodiment, the embodiment of the utility model is described in further detail.Following examples are used to explain the utility model, but are not used for limiting the scope of the utility model.
As shown in Figure 1; A kind of quick detection test paper of tuberculosis IgM antibody; Comprise the nitrocellulose filter 2 that sticks on the plastic support board 1, the right-hand member of nitrocellulose filter 2 connects inhales appearance pad 3, and the left end overlap joint of inhaling appearance pad 3 is on nitrocellulose filter 2; The left end of said nitrocellulose filter 2 connects the collaurum pad 4 that contains underlined anti-people IgM μ chain monoclonal antibody; The right-hand member overlap joint of collaurum pad 4 is on nitrocellulose filter 2, and the left end of collaurum pad 4 connects goes up appearance pad 5, and the right-hand member overlap joint of last appearance pad 5 is on collaurum pad 4; Middle part on the said nitrocellulose filter 2 is coated with the detection line 6 of hybrid antigen and the nature controlling line 7 of sheep anti-mouse igg antibody, also is provided with the application of sample index line 8 that is used to identify the application of sample position between nature controlling line 7 and the detection line 6.
The quick detection test paper of the tuberculosis IgM antibody of the utility model, the distance between said application of sample index line 8 and the nature controlling line 7 is 2.5-3mm.
The quick detection test paper of the tuberculosis IgM antibody of the utility model, said detection line 6 is for being coated on 38KD, the 16KDTB hybrid antigen on the nitrocellulose filter 2, and nature controlling line 7 is for being coated on the sheep anti-mouse igg antibody on the nitrocellulose filter 2.
When the quick detection test paper of the tuberculosis IgM antibody of the utility model was specifically used, the collaurum pad adopted following method to process: prepare the colloidal gold solution that diameter is 30-50nm, 0.2MK with gold chloride-trisodium citrate reduction method 2CO 3The pH that regulates colloidal gold solution is 8.5-9.5, places then on the magnetic stirring apparatus slowly to stir, and contains the anti-people IgM of 0.5mg-3mg μ chain monoclonal antibody by every 100ml solution and slowly drips said monoclonal antibody to colloidal gold solution; Stirring at room 1 hour adds BSA and PEG20000 sealing, and 12000rpm is centrifugal; Abandon supernatant; Deposition adds preservation liquid and is concentrated into 1/10 of original volume, will concentrate collaurum with gold mark dilution and be diluted to variable concentrations (5%, 10%, 15%, 20%), and the ratio of spreading 22cm2 in every milliliter of gold mark dilution is layered on the nonwoven fabrics respectively equably; Put drying shed (temperature 20-25 ℃, humidity less than 30%) drier 2-4 hour.Being cut into 6mm colloid gold bar is the collaurum pad.
Following mode is adopted in encapsulating of TB hybrid antigen: the PBS with 0.01M pH7.2 is diluted to variable concentrations respectively with TB antigen, and wherein 38KD antigen 0.4~0.6mg/ml and 16KD are 0.2~0.4mg/ml, carries out the seized survey line 6 of hybrid packet then; Encapsulate sheep anti-mouse igg antibody simultaneously as nature controlling line 7, encapsulate the application of sample index line that indicates the application of sample position.Encapsulate accomplish after dry NC film 3~4 hours.
The assembling of test paper: 20~25 ℃ of dry indoor temperatures; Humidity is less than 30%; Get plastic support board 1; Paste at the middle part that the nitrocellulose filter that has encapsulated 2 is placed on plastic support board 1, at the detection line 6 one sides overlap joint collaurum pad 4 of nitrocellulose filter 2, pastes appearance pad 5 at collaurum pad 4 opposite sides overlap joint; Nature controlling line 7 one sides at nitrocellulose filter 2 are inhaled appearance pad 3 apart from overlapping edges.With cutter the plastic plate that posts is cut into the test strips of proper width then.The test strips that cuts also can be packed in the plastic clip, forms the detectable card.
Clinical sample detects: the reagent strip for preparing is kept flat, add 3-5ul sample to be checked earlier in application of sample index line 8 positions, add an amount of dilution again, leave standstill and observed testing result in 15 minutes.Only have an aubergine band to occur in reagent strip nature controlling line 7 positions, then interpretation is negative; An aubergine band all occurs at detection line 6 and nature controlling line 7, then interpretation is positive; Detection line 6 the aubergine band all do not occur with nature controlling line 7 positions, then is null result.
The above only is the preferred implementation of the utility model; Should be understood that; For those skilled in the art; Under the prerequisite that does not break away from the utility model know-why, can also make some improvement and modification, these improvement and modification also should be regarded as the protection domain of the utility model.

Claims (2)

1. the quick detection test paper of a tuberculosis IgM antibody; Comprise the nitrocellulose filter (2) that sticks on the plastic support board (1); It is characterized in that: the right-hand member of said nitrocellulose filter (2) connects inhales appearance pad (3); The left end overlap joint of inhaling appearance pad (3) is on nitrocellulose filter (2), and the left end of said nitrocellulose filter (2) connects the collaurum pad (4) that contains underlined anti-people IgM μ chain monoclonal antibody, and the right-hand member overlap joint of collaurum pad (4) is on nitrocellulose filter (2); The left end of collaurum pad (4) connects goes up appearance pad (5); The right-hand member overlap joint of last appearance pad (5) is on collaurum pad (4), and the middle part of said nitrocellulose filter (2) is coated with the detection line (6) of hybrid antigen and the nature controlling line (7) of sheep anti-mouse igg antibody, also is provided with the application of sample index line (8) that is used to identify the application of sample position between nature controlling line (7) and the detection line (6).
2. the quick detection test paper of tuberculosis IgM antibody according to claim 1 is characterized in that: the distance between said application of sample index line (8) and the nature controlling line (7) is 2.5-3mm.
CN2011205338548U 2011-12-19 2011-12-19 Rapid detection test paper of tuberculosis IgM (Immunoglobulin M) antibody Expired - Lifetime CN202421187U (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103575904A (en) * 2013-10-12 2014-02-12 北京健乃喜生物技术有限公司 Mycobacterium-tuberculosis antibody detection kit capable of respectively detecting IgG and IgM antibodies simultaneously
CN116087534A (en) * 2022-12-30 2023-05-09 天津德祥生物技术股份有限公司 Erythrocyte antigen detection method and detection kit
CN116087534B (en) * 2022-12-30 2024-05-10 天津德祥生物技术股份有限公司 Erythrocyte antigen detection method and detection kit

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103575904A (en) * 2013-10-12 2014-02-12 北京健乃喜生物技术有限公司 Mycobacterium-tuberculosis antibody detection kit capable of respectively detecting IgG and IgM antibodies simultaneously
CN116087534A (en) * 2022-12-30 2023-05-09 天津德祥生物技术股份有限公司 Erythrocyte antigen detection method and detection kit
CN116087534B (en) * 2022-12-30 2024-05-10 天津德祥生物技术股份有限公司 Erythrocyte antigen detection method and detection kit

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C14 Grant of patent or utility model
GR01 Patent grant
PE01 Entry into force of the registration of the contract for pledge of patent right

Denomination of utility model: Rapid detection test paper of tuberculosis IgM (Immunoglobulin M) antibody

Effective date of registration: 20121210

Granted publication date: 20120905

Pledgee: Tianjin TEDA Small Enterprise Credit Guarantee Center

Pledgor: Newscen Coast Bio-Pharmaceutical Co., Ltd.

Registration number: 2012990000773

PLDC Enforcement, change and cancellation of contracts on pledge of patent right or utility model
PC01 Cancellation of the registration of the contract for pledge of patent right

Date of cancellation: 20131224

Granted publication date: 20120905

Pledgee: Tianjin TEDA Small Enterprise Credit Guarantee Center

Pledgor: Newscen Coast Bio-Pharmaceutical Co., Ltd.

Registration number: 2012990000773

PLDC Enforcement, change and cancellation of contracts on pledge of patent right or utility model
PE01 Entry into force of the registration of the contract for pledge of patent right

Denomination of utility model: Rapid detection test paper of tuberculosis IgM (Immunoglobulin M) antibody

Effective date of registration: 20150204

Granted publication date: 20120905

Pledgee: Tianjin TEDA Small Enterprise Credit Guarantee Center

Pledgor: Newscen Coast Bio-Pharmaceutical Co., Ltd.

Registration number: 2015120000009

PC01 Cancellation of the registration of the contract for pledge of patent right

Date of cancellation: 20160307

Granted publication date: 20120905

Pledgee: Tianjin TEDA Small Enterprise Credit Guarantee Center

Pledgor: Newscen Coast Bio-Pharmaceutical Co., Ltd.

Registration number: 2015120000009

PLDC Enforcement, change and cancellation of contracts on pledge of patent right or utility model
CP01 Change in the name or title of a patent holder
CP01 Change in the name or title of a patent holder

Address after: 300457 Tianjin Development Zone, Sixth Street, No. 65

Patentee after: Tianjin new torch bio pharmaceutical Limited by Share Ltd

Address before: 300457 Tianjin Development Zone, Sixth Street, No. 65

Patentee before: Newscen Coast Bio-Pharmaceutical Co., Ltd.

CX01 Expiry of patent term
CX01 Expiry of patent term

Granted publication date: 20120905