CN105004360A - Analyzing and recording method used for in-vitro diagnostic reagent and analyzing and recording system used for in-vitro diagnostic reagent - Google Patents
Analyzing and recording method used for in-vitro diagnostic reagent and analyzing and recording system used for in-vitro diagnostic reagent Download PDFInfo
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- CN105004360A CN105004360A CN201510258923.1A CN201510258923A CN105004360A CN 105004360 A CN105004360 A CN 105004360A CN 201510258923 A CN201510258923 A CN 201510258923A CN 105004360 A CN105004360 A CN 105004360A
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Abstract
The present invention discloses an analyzing and recording method used for an in-vitro diagnostic reagent. The method comprises the following steps of (1) using a numerical value contrast card to read a reaction color numerical value of a colloidal gold detection result; (2) inputting the data read by the numerical value contrast card via an input module; (3) using the input module to transmit the data to a storage module to store; (4) using the storage module to transmit the data to an analyzing module, and using the analyzing module to analyze to obtain an analysis result according to the data; (5) using the analyzing module to transmit the analysis result to an output module.
Description
Technical field
The present invention relates to family planning technical field of tools, particularly a kind of analytic record method and system for external diagnosis reagent.
Background technology
Collaurum vitro diagnostic techniques is a kind of common labelling technique, be combined with colloid gold particle from Faulk and Taylon rabbit anti-salmonella antiserum in 1971, be prepared into the distribution of golden labeling antibody bacterial detection surface antigen, over 30 years, colloidal gold technique is constantly developed and maturation, period develops into scanning electron microscope, the research of transmission electron microscope and freeze-etching Electronic Speculum, the application of light microscopic level, silver development, Protein transfer electrophoresis, the fields such as colored immunogold silver staining, after be introduced into immunodiagnosis field, with other quick diagnosis technology (as ELISA, HPLC, RTA etc.) compare, colloidal gold technique is due to convenient and swift, special sensitivity, stability is strong, do not need specific installation and reagent, result judges the advantages such as directly perceived, just placed high hopes by industry at the beginning of birth.
But in recent years because its characteristic determines to be applicable to qualitative detection (being namely with or without), clinical diagnose is had little significance, clinical medicine demand cannot be met.How solving above demand is the important topic that current colloidal gold diagnosis reagent is studied in the industry.
For human chorionic gonadotrophin (HCG): human chorionic gonadotrophin (HCG) is a kind of glycoprotein hormones that woman gestationperiod is produced by placenta, HCG can check in the pregnant woman urine after becoming pregnant and arrive.In urine, human chorionic gonadotrophin Newborn is less than 25mIU/mL, within pregnant latter 40 days, is greater than 5000mIU/mL, within pregnant 60 ~ 70 days, is greater than the 4 power mIU/mL (early morning urine HCG level is the highest, close to serum levels) of (8 ~ 32) × 10.
And the inspection of HCG is significant to diagnosis of early gestation, there is certain values to the diagnosis of the disease such as pregnancy related disorder, trophoblastic tumor, discriminating and course of disease observation etc.
1. diagnose early pregnancy: after pregnant, 35 ~ 50 days HCG can rise to and be greater than 2500IU/L.Within 60 ~ 70 days, can reach 80000IU/L, multifetation person urinates HCG often higher than a tire gestation.
2. the judgement of abnormal pregnancy and placental function:
1. ectopic pregnancy: during as ectopic pregnancy, this test only has the positive rate of 60%, and in uterine hemorrhage after 3 days, HCG still can be the positive, therefore HCG checks the discriminating that can be used as it and other acute abdomen.HCG value is often 312 ~ 625IU/L.
2. to miscarry Clinics and Practices: incomplete abortion is as remaining in still there being placenta tissue in uterus, HCG checks and still can be positive; When complete abortion or stillborn foetus, HCG is turned negative by the positive, therefore can be used as the reference frame of preventing miscarriage or inhaling palace treatment.
3. threatened abortion: high level is many inevitable abortion can not occur as HCG in urine still maintains.If HCG is at below 2500IU/L, and decline gradually, then have miscarriage or stillborn foetus possibility, when being down to 600IU/L then inevitable abortion.Preventing miscarriage in treatment, preventing miscarriage invalid as HCG still continues decline explanation, as HCG constantly rises, illustrate and prevent miscarriage successfully.
3. trophoblastic tumor Clinics and Practices monitoring
1. in the Urinary such as vesicular mole, chorioadenoma, chorioepithelioma and teratoma of testis, HCG significantly raises, the right side can reach 100,000 to millions of IU/L, available dilution test is diagnosed as before pregnant 12 weeks, 1: 500 diluted urine is positive, after pregnant 12 weeks, 1: 250 diluted urine is positive, valuable to vesicular mole diagnosis.1: 100 ~ 1: 500 diluted urines are positive and also have diagnostic value to choriocarcinoma, as HCG in male urine raises, consider that orchioncus is as spermatogonium cancer, deformity and dystopy HCG knurl etc.
2. Test of Trophoblastic Tumor Patients postoperative 3 weeks rear urine HCG answer < 50IU/L, within 8 ~ 12 weeks, are negative; Do not decline as HCG or do not turn out cloudy, prompting may have residual disease, and this kind of case often easily recurs, therefore need make regular check on.
4. other climacteric, ovulation and bilateral oophorectomy all can cause lutropin rising, and the α peptide chain composition because of LH and HCG is identical and make the pregnancy tests of employing Anti-HCG antibody positive, now can differentiate with monoclonal 2 enzyme immunoassay (EIA)s of β ~ HCG.As pituitary disease, hyperthyroidism, gynecological disease such as the HCG such as ovarian cyst, the cancer of the uterus also can increase in endocrine system disease.
The main detection adopting collaurum method to carry out early pregnancy and ovulation at present, but the method cannot read the testing result on colloidal gold test paper card, therefore people cannot correct decision whether conceived or whether pregnancy period HCG numerical value reasonable, make the mistake and identify false negative and false positive results.
Summary of the invention
The object of the invention is to solve the problem, a kind of analytic record method and system for external diagnosis reagent are provided, by described testing result on the analytic record systematic analysis colloidal gold test paper card of external diagnosis reagent, avoid people cannot testing result on correct decision colloidal gold test paper card whether reasonable, effectively raise the accuracy identifying false negative and false positive results.
In order to achieve the above object, the analytic record method for external diagnosis reagent of the present invention comprises the steps:
(1) the reaction color numerical value of collaurum testing result is read by numerical value contrast card;
(2) data that described numerical value contrast card reads are inputted by load module;
(3) described data are transferred to memory module and store by load module;
(4) described data transfer in analysis module by described memory module, and described analysis module draws analysis result according to described data analysis;
(5) described analysis result is transferred to output module by described analysis module.
Analytic record system for external diagnosis reagent of the present invention comprises: numerical value contrast card, load module, memory module, analysis module, output module;
Numerical value contrast card, the reaction color numerical value of described numerical value contrast card for reading collaurum testing result;
Load module, described load module and described numerical value contrast card and are associated, and the data that described numerical value contrast card reads are inputted by load module;
Memory module, described memory module is electrically connected described load module, the data of described input is stored;
Analysis module, described analysis module is electrically connected described memory module, for analyzing the data in described memory module;
Output module, described output module is electrically connected described analysis module, for the result of data described in display analysis.
Preferably, described numerical value contrast card comprises: numerical value contrast district and color data contrast bar; Described numerical value contrast card is coated on above colloidal gold test paper card; Described numerical value contrast district is arranged on the middle part of described numerical value contrast card, described numerical value contrast district is hollow, the testing result region of described colloidal gold test paper card is arranged on below described numerical value contrast district, and shows the testing result of colloidal gold test paper card by described numerical value contrast district; The described detachable both sides being fixed on described numerical value contrast head of district limit of color data contrast bar.
Preferably, the top that described numerical value contrast card is coated on colloidal gold test paper card is
type body or yi word pattern body.
Preferably, the bottom of described numerical value contrast card is with two claws.
Preferably, described numerical value contrast card is made for papery or plastics.
Preferably, described color data contrast bar is pasted or is fastened on the both sides on described numerical value contrast head of district limit.
Preferably, the quantity of described color data contrast bar is more than or equal to 2.
Preferably, described memory module is electrically connected described load module by data line, wireless network or bluetooth.
Preferably, described output module is electrically connected described analysis module by data line, wireless network or bluetooth.
The invention provides a kind of analytic record method and system for external diagnosis reagent, by described testing result on the analytic record systematic analysis colloidal gold test paper card of external diagnosis reagent, avoid people cannot testing result on correct decision colloidal gold test paper card whether reasonable, effectively raise the accuracy identifying false negative and false positive results.
Accompanying drawing illustrates:
Fig. 1: the present invention is used for the structural representation of the analytic record system of external diagnosis reagent.
Embodiment:
For making object of the invention process, technical scheme and advantage clearly, below in conjunction with the accompanying drawing in the embodiment of the present invention, the technical scheme in the embodiment of the present invention is further described in more detail.In the accompanying drawings, same or similar label represents same or similar element or has element that is identical or similar functions from start to finish.Described embodiment is the present invention's part embodiment, instead of whole embodiments.Be exemplary below by the embodiment be described with reference to the drawings, be intended to for explaining the present invention, and can not limitation of the present invention be interpreted as.Based on the embodiment in the present invention, those of ordinary skill in the art, not making the every other embodiment obtained under creative work prerequisite, belong to the scope of protection of the invention.Below in conjunction with accompanying drawing, embodiments of the invention are described in detail.
In describing the invention; it will be appreciated that; term " " center ", " longitudinal direction ", " transverse direction ", "front", "rear", "left", "right", " vertically ", " level ", " top ", " end " " interior ", " outward " etc. instruction orientation or position relationship be based on orientation shown in the drawings or position relationship; be only the present invention for convenience of description and simplified characterization; instead of instruction or imply indication device or element must have specific orientation, with specific azimuth configuration and operation, therefore can not be interpreted as limiting the scope of the invention.
A kind of analytic record method for external diagnosis reagent according to the present invention one broad embodiment comprises the steps:
(1) the reaction color numerical value of collaurum testing result is read by numerical value contrast card;
(2) data that described numerical value contrast card reads are inputted by load module;
(3) described data are transferred to memory module and store by load module;
(4) described data transfer in analysis module by described memory module, and described analysis module draws analysis result according to described data analysis;
(5) described analysis result is transferred to output module by described analysis module.
A kind of analytic record system for external diagnosis reagent according to the present invention one broad embodiment comprises: numerical value contrast card, load module, memory module, analysis module, output module; Numerical value contrast card, the reaction color numerical value of described numerical value contrast card for reading collaurum testing result; Load module, described load module and described numerical value contrast card and are associated, and the data that described numerical value contrast card reads are inputted by load module; Memory module, described memory module is electrically connected described load module, the data of described input is stored; Analysis module, described analysis module is electrically connected described memory module, for analyzing the data in described memory module; Output module, described output module is electrically connected described analysis module, for the result of data described in display analysis.
As shown in Figure 1: the analytic record system for external diagnosis reagent comprises: numerical value contrast card 1, load module 4, memory module 5, analysis module 6 and output module 7, described numerical value contrast card 1 is for reading the reaction color numerical value of collaurum testing result, described load module 4 and described numerical value contrast card 1 and are associated, and the data that described numerical value contrast card 1 reads are inputted by load module 4.
Described memory module 5 connects described load module 4 by data line, the data inputted by load module 4 are stored by described memory module 5, but be understandable that, the connected mode of described memory module 5 and described load module 4 is not limited to diagramatic way, such as, in a not shown embodiment, described memory module 5 connects described load module 4 by wireless network; In another not shown embodiment, described memory module 5 connects described load module 4 by bluetooth.
Described analysis module 6 is electrically connected described memory module 5, for analyzing the data in described memory module.
Described output module 7 connects described analysis module 6 by data line, for data described in display analysis result but be understandable that, the connected mode of described output module 7 and described analysis module 6 is not limited to diagramatic way, such as, in a not shown embodiment, described output module 7 connects described analysis module 6 by wireless network; In another not shown embodiment, described output module 7 connects described analysis module 6 by bluetooth.
In a not shown embodiment, the analytic record method for external diagnosis reagent comprises the steps:
(1) the reaction color numerical value of collaurum testing result is read by numerical value contrast card;
(2) data that described numerical value contrast card reads are inputted by the input keyboard of intelligent terminal;
(3) described data transfer in the storer of intelligent terminal by input keyboard;
(4) described data transfer in the analysis module of intelligent terminal by described storer, and described analysis module draws analysis result according to described data analysis;
(5) described analysis result is transferred to the display screen of intelligent terminal by described analysis module.
In a not shown embodiment, the analytic record system for external diagnosis reagent comprises: numerical value contrast card and intelligent terminal, described intelligent terminal comprises: input keyboard, storer, analysis module and display screen.The reaction color numerical value of described numerical value contrast card for reading collaurum testing result, described input keyboard and described numerical value contrast card and are associated, the data that described numerical value contrast card reads are inputted by input keyboard, described input keyboard is electrically connected with described storer, described storer is electrically connected described analysis module and is passed in described analysis module by the data in storer, described analysis module is electrically connected described display screen, is shown by the analysis result of described analysis module by display screen.
Described numerical value contrast card 1 is
type body, and be coated on above colloidal gold test paper card.But be understandable that, the form of described numerical value contrast card is not limited to diagramatic way, such as, in a not shown embodiment, described numerical value contrast card is in yi word pattern body.
In a not shown embodiment, two bottoms of described numerical value contrast card, respectively with the claw be upturned, contrast the below of card for colloidal gold test paper card being fixed on relatively described numerical value.
In a not shown embodiment, described numerical value contrast blocks for papery is made.Such as, but be understandable that, the material of described numerical value contrast card is not limited to diagramatic way, and, in a not shown embodiment, described numerical value contrast blocks for plastics are made.
As shown in Figure 1, described numerical value contrast district 2 is arranged on the middle part of described numerical value contrast card 1, and described numerical value contrast district 2 is hollow, and described numerical value contrast district 2 is rectangle.But be understandable that, the form of described numerical value contrast district is not limited to diagramatic way, such as, in a not shown embodiment, numerical value contrast district is oval.The testing result region of described colloidal gold test paper card is arranged on below described numerical value contrast district 2, and shows the color of the testing result of colloidal gold test paper card by described numerical value contrast district 2.
Described color data contrast bar 3 is pasted and fixed on the both sides on long limit, described numerical value contrast district 2, and the quantity of described color data contrast bar 3 is 34.But be understandable that, the quantity of color data contrast bar is not limited to diagramatic way, in a not shown embodiment, the quantity of color data contrast bar is 20.
In a not shown embodiment, the both sides of described numerical value contrast card longer sides have draw-in groove, and described color data contrast bar is fastened in the draw-in groove of numerical value contrast card.
Obviously, the above embodiment of the present invention is only for example of the present invention is clearly described, and is not the restriction to embodiments of the present invention.For those of ordinary skill in the field, can also make other changes in different forms on the basis of the above description.Here exhaustive without the need to also giving all embodiments.And these belong to spirit institute's apparent change of extending out of the present invention or change and are still among protection scope of the present invention.
Claims (10)
1. for an analytic record method for external diagnosis reagent, it is characterized in that, the described analytic record method for external diagnosis reagent comprises the steps:
(1) the reaction color numerical value of collaurum testing result is read by numerical value contrast card;
(2) data that described numerical value contrast card reads are inputted by load module;
(3) described data are transferred to memory module and store by load module;
(4) described data transfer in analysis module by described memory module, and described analysis module draws analysis result according to described data analysis;
(5) described analysis result is transferred to output module by described analysis module.
2. application rights requires the analytic record system for external diagnosis reagent of the analytic record method for external diagnosis reagent described in 1, it is characterized in that: described analytic record system comprises: numerical value contrast card, load module, memory module, analysis module, output module;
Numerical value contrast card, the reaction color numerical value of described numerical value contrast card for reading collaurum testing result;
Load module, described load module and described numerical value contrast card and are associated, and the data that described numerical value contrast card reads are inputted by load module;
Memory module, described memory module is electrically connected described load module, the data of described input is stored;
Analysis module, described analysis module is electrically connected described memory module, for analyzing the data in described memory module;
Output module, described output module is electrically connected described analysis module, for the result of data described in display analysis.
3. the analytic record system for external diagnosis reagent according to claim 2, described numerical value contrast card comprises: numerical value contrast district and color data contrast bar; Described numerical value contrast card is coated on above colloidal gold test paper card; Described numerical value contrast district is arranged on the middle part of described numerical value contrast card, described numerical value contrast district is hollow, the testing result region of described colloidal gold test paper card is arranged on below described numerical value contrast district, and shows the testing result of colloidal gold test paper card by described numerical value contrast district; The described detachable both sides being fixed on described numerical value contrast head of district limit of color data contrast bar.
4. the analytic record system for external diagnosis reagent according to claim 3, is characterized in that: the top that described numerical value contrast card is coated on colloidal gold test paper card is
type body or yi word pattern body.
5. the analytic record system for external diagnosis reagent according to claim 4, is characterized in that: the bottom of described numerical value contrast card is with two claws.
6. the analytic record system for external diagnosis reagent according to claim 2, is characterized in that: described numerical value contrast card is made for papery or plastics.
7. the analytic record system for external diagnosis reagent according to claim 3, is characterized in that: described color data contrast bar is pasted or is fastened on the both sides on described numerical value contrast head of district limit.
8. the analytic record system for external diagnosis reagent according to claim 3, is characterized in that: the quantity of described color data contrast bar is more than or equal to 2.
9. the analytic record system for external diagnosis reagent according to claim 1, is characterized in that: described memory module is electrically connected described load module by data line, wireless network or bluetooth.
10. the analytic record system for external diagnosis reagent according to claim 1, is characterized in that: described output module is electrically connected described analysis module by data line, wireless network or bluetooth.
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| CN103248681A (en) * | 2013-04-27 | 2013-08-14 | 北京福乐云检测科技有限公司 | Colloidal gold method detection cloud platform based on mobile terminal reading |
| CN104569385A (en) * | 2014-12-29 | 2015-04-29 | 龙国亮 | Multifunctional test paper testing system |
| CN204718623U (en) * | 2015-05-13 | 2015-10-21 | 龙国亮 | A kind of analytic record system for external diagnosis reagent |
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| CN102007409A (en) * | 2007-10-26 | 2011-04-06 | 庄臣及庄臣株式会社 | Test strip ejection mechanism |
| CN102279263A (en) * | 2011-05-06 | 2011-12-14 | 杭州顿力医疗器械股份有限公司 | CCD-type quantitative analysis system of colloidal gold immunity chromatography diagnosis test papers |
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