CN203606366U - Joint detection kit for identifying and diagnosing benign and malignant ascites - Google Patents
Joint detection kit for identifying and diagnosing benign and malignant ascites Download PDFInfo
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- CN203606366U CN203606366U CN201320744040.8U CN201320744040U CN203606366U CN 203606366 U CN203606366 U CN 203606366U CN 201320744040 U CN201320744040 U CN 201320744040U CN 203606366 U CN203606366 U CN 203606366U
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Abstract
The utility model discloses a joint detection kit for identifying and diagnosing benign and malignant ascites. A first reagent bottle for measuring the activity of alpha-L-fucosidase, a second reagent bottle for measuring total cholesterol and a third reagent bottle for measuring glycyl praline dipeptide aminopeptidase are arranged in the kit, wherein partitioning bulges are arranged among the first reagent bottle, the second reagent bottle and the third reagent bottle; arced convex surfaces convenient for fingers to insert are formed in side surfaces of the partitioning bulges; the first reagent bottle is arranged in a position on the left side of the lower part of the kit; the second reagent bottle is arranged in a position on the right side of the lower part of the kit; the third regent bottle is arranged at the upper part of the kit; vent holes are formed in a part of the kit cover, corresponding to the third reagent bottle; vent holes are formed in the side surfaces of the kit; a buffer sponge pad layer is fixedly arranged on the inner side surface of the box cover. The joint detection kit is reasonable in structure, convenient and accurate in application, not easy to confuse, long in preservation time and good in preservation and transportation security.
Description
Technical field
The utility model relates to a kind of medical kit.
Background technology
Ascites is one of clinical common sympton, and tumor in digestive tract, tuberculosis, hepatic and kidney function obstacle and gynecological tumor etc. all can draw ascites, and conventional kit exists defect in inventions such as detecting performance, kit preservation, transportation.Therefore provide a kind of kit easy to use to become needing when business.
Summary of the invention
The purpose of this utility model be to provide a kind of rational in infrastructure, easy to use, facilitate storage and transport to combined detection kit good, malignant ascite antidiastole.
Technical solution of the present utility model is:
A kind of to combined detection kit good, malignant ascite antidiastole, comprise box body, lid, it is characterized in that: in box body, dress is measured the 3rd reagent bottle of the first reagent bottle of alpha-L-fucosidase activity, the second reagent bottle of measuring T-CHOL and mensuration glycylproline dipeptidyl aminopeptidase; Between the first reagent bottle, the second reagent bottle, the 3rd reagent bottle, arrange to separate and dash forward, and the arc-shaped concave that convenient finger inserts is set in the prominent side of each separation; The first reagent bottle is arranged on the lower left side position of box body, and the second kit is arranged on the lower right side position of box body, and the 3rd reagent bottle is arranged on the top of box body; On lid, with the 3rd reagent bottle corresponding position, air hole is set, in the side of box body, air hole is set; On the medial surface of lid, be fixedly installed buffering sponge bed course.
The utility model is rational in infrastructure, easy to usely is accurately difficult for obscuring, and the holding time is long, and preservation, Transport Safety are good.
Accompanying drawing explanation
Below in conjunction with drawings and Examples, the utility model is described in further detail.
Fig. 1 is the structural representation of an embodiment of the utility model.
Embodiment
A kind of to combined detection kit good, malignant ascite antidiastole, comprise box body 1, lid 2, in box body, dress is measured the 3rd reagent bottle 3 of the first reagent bottle 4 of alpha-L-fucosidase activity, the second reagent bottle 5 of measuring T-CHOL and mensuration glycylproline dipeptidyl aminopeptidase; Between the first reagent bottle, the second reagent bottle, the 3rd reagent bottle, arrange to separate and dash forward 6, and the arc-shaped concave 7 that convenient finger inserts is set in the prominent side of each separation, convenient taking-up reagent bottle; The first reagent bottle is arranged on the lower left side position of box body, and the second kit is arranged on the lower right side position of box body, and the 3rd reagent bottle is arranged on the top of box body; On lid, with the 3rd reagent bottle corresponding position, air hole 8 is set, in the side of box body, air hole 9 is set, form vent passages; On the medial surface of lid, be fixedly installed buffering sponge bed course 10, can effectively avoid the damage in preservation, transportation.
The utility model service condition:
Object and method
1 research object case-data is all from inpatient in year July Hospital Attached to Nantong Univ. in July, 2004 to 2007.Wherein malignant ascite 101 examples: male 58 examples, female's 43 examples, comprise 30 Cases of Liver Cancer, cancer of the stomach 16 examples, peritonaeum, belly cavity tumor 16 examples, gynecological tumor 7 examples, cancer of pancreas 4 examples, cancer ascites 6 examples, intestinal cancer 2 examples, malignant mesothelioma 8 examples, carcinoma of gallbladder 3 examples, other primary lesions are failed to understand person's 9 examples, case all through Histopathology or cytology in conjunction with clinical definite; Benign ascites 112 examples: male 70 examples, female's 42 examples.Wherein ascites due to cirrhosis 84 examples, Xing Jishen source, heart source property ascites 10 examples, all the other 18 examples.
2 detection method ascites diagnostic kits are by GPDA determination of activity reagent (Hospital Attached to Nantong Univ. digests disease research department to be provided), alpha-L-fucosidase (AFU) determination of activity reagent (being provided by Shanghai INM biotechnology center) and T-CHOL (Tch) reagent (being provided by Wenzhou DongOu JinMa Biology Science Co., Ltd) are provided and are formed, and three all applies the manual semi-automatic biochemical analyzer of BA-88 and detects.According to preliminary experiment result, drawn by ROC curve: the GPDA positive: GPDA>35u/ml.The AFU positive: AFU>120 μ mol/Lh.The Tch positive: Tch>1.1mmol/L.Experimental implementation step is as follows:
1. ascites GPDA assay method: in experimentation, every part of sample all does own control (the μ l of unit, even numbers pipe is control tube)
Mix, manual semi-automatic biochemical analyzer 405nm detects
Ascites GPDA activity=(A
survey-A
right)/A
mark× 593.8
2. ascites AFU measurement operation method: in experimentation, every part of sample all does own control (the μ l of unit, even numbers pipe is control tube)
Mix, put 37 ℃ of water-baths 60 minutes
Mix, put 37 ℃ of water-baths 5 minutes, with control tube school zero, manual semi-automatic biochemical analyzer 546nm detects
Ascites total cholesterol level (mmol/L)=At/As × Cs
Three, statistical method experimental data adopt SPSS11.5 statistical software carry out statistical procedures, result with
represent, respectively organize data and relatively adopt between two t check, represent that with p<0.05 difference has statistical significance.And measurement result is calculated respectively to susceptibility and the specificity of diagnosis.
3 statistical procedures adopt the processing of SPSS13.0 statistical package, measurement data data with
represent, respectively organize data and relatively take between two t check; The relatively employing Χ of two groups of rates
2check, p<0.05 represents that difference has statistical significance.
4 results judge the Cutoff value drawing according to ROC curve, respectively with AFU >=120 μ mol/Lh, and Tch >=1.1mmol/L, GPDA >=35u/ml is as positive defining standard.Joint-detection is with wherein at least one the positive positive criteria that is judged to of ascites; Three equal feminine genders are judged to negative standard.Result is divided into true positives, true negative, false positive and false negative.Calculate susceptibility, specificity, positive predictive value, negative predictive value and the accuracy of individual event detection and joint-detection.
Result
Organize ascites GPDA, AFU and T ch measurement result comparison (in table 1) for 1 liang.Malignant ascite group AFU, Tch and GPDA measurement result are all higher than optimum group, and difference has conspicuousness (* P<0.01; * P<0.05).
Table 1 is good, malignant ascite AFU, Tch and the comparison of GPDA measurement result
Note: with the comparison of benign ascites group, * P<0.01; * P<0.05
The 2 Cutoff values that draw according to ROC curve, formulate the recommended standard of good malignant ascite antidiastole, in table 2.(1) benign ascites, AFU<120 μ mol/Lh, Tch<1.1mmol/L, GPDA<35u/ml; (2) malignant ascite, AFU>120 μ mol/Lh, Tch>1.1mmol/L, GPDA>35u/ml.
Table 2 is good, malignant ascite antidiastole recommended standard
3 according to above-mentioned ascites antidiastole recommended standard, respectively with AFU >=120 μ mol/Lh, Tch >=1.1mmol/L, GPDA >=35u/ml is as positive defining standard, three indexs in good, malignant ascite separately and the comparison of joint inspection positive rate, as shown in table 3: malignant ascite group positive rate is all significantly higher than benign ascites group, difference has statistical significance (P<0.01).
Three indexs of table 3 in good, malignant ascite separately and joint inspection positive rate comparison (%)
Note: with the comparison of benign ascites group, * P<0.01
4GPDA, AFU and the evaluation of Tch joint-detection to ascites differential diagnosis value
Statistics is as shown in table 3: 1. individual event AFU, Tch, GPDA to the diagnostic sensitivity of good, malignant ascite between 65.3%～79.2%, and the diagnostic sensitivity of three index joint-detection significantly improves (90.1%), there is statistical significance (* P<0.01, * * P<0.05) with individual compare difference; 2. the negative predictive value of three index joint inspections is 88.5%, is significantly higher than individual event and detects (* P<0.01, * * P<0.05); 3. aspect specificity, accuracy and positive predictive value, have no the superiority of joint-detection diagnosis.
Three indexs of table 4 are to Diagnostic Value (%) good, malignant ascite
Note: with the comparison of joint-detection group, * P<0.01; * P<0.05
The formation mechanism of ascites is comparatively complicated, and general ascites routine or biochemical analysis are difficult for differentiating the character of ascites, although and the exfoliative cytology inspection specificity of ascites is high, positive rate is low.Therefore, there is for many years the different index joint inspection of many same provisional capitals trial application to improve the antidiastole rate of good malignant ascite, it is advantageous that joint-detection can reduce the limitation that single index detects, make up mutual deficiency, improve the accuracy of good malignant ascite antidiastole, and generally the specificity of joint detection results without obvious decline.
AFU is a kind of lysosomal acid hydrolytic enzyme, is extensively present in mammiferous cell and body fluid, and its main Physiological Function is the kalabolism participating in containing the bioactive macromolecule such as glycoprotein, the glycolipid material of fucosido.In recent years, serum AFU is progressively applied in clinical diagnosis and treatment as a new tumor markers
[3], there are many bibliographical information serum AFU to be determined at the meaning in PHC diagnosis both at home and abroad, the document of still inquiring into ascites AFU determination of activity value is few.This research data shows: malignant ascite group AFU level is apparently higher than benign ascites group (p<0.01); With the positive defining standard of AFU >=120 μ mol/Lh, its susceptibility, specificity and accuracy are respectively 65.3%, 78.6%, 71.6%.Ascites AFU level increases when mechanism may be tumour synthesizes with oncoprotein matter, AFU serum levels increases, containing glycoprotein and the glycolipid metabolism disorder of fucose, while there is ascites equally in morbid state, the AFU in serum and surrounding tissue can enter ascites and cause AFU level to increase.
In recent years, detect more to the bibliographical information of ascites diagnostic value about inquiring into ascites Tch
[4～6], be a more valuable index, but its clinical practice is not yet universal at present, may be to distinguish critical value good, malignant ascite to need further to be studied.Our research data shows: malignant ascite group Tch level is apparently higher than benign ascites group (p<0.01); Using Tch>=1.1mmol/L as positive defining standard, its susceptibility, specificity and accuracy are respectively 69.3%, 84.8%, 77.5%, conform to bibliographical information
[5], a little more than AFU index.The mechanism that in malignant ascite, cholesterol raises, Jungst etc.
[7]research thinks, is from due to blood plasma is transferred to the low selectivity peritonaeum process on the one hand by high-density lipoprotein (HDL) and low-density lipoprotein; In addition, the cholesterol splitting away off from cell membrane also can make the T-CHOL in ascites raise to a certain extent.
GPDA is a kind of dipeptides naphthoyl ammonia enzyme, is distributed in liver, kidney, salivary gland, connective tissue and lymph node, and main Physiological Function may be the polypeptide from collagen in hydrolysis blood.There is research to think that GPDA may play a role in tumor-infiltrated pathologic process
[8].Result of study herein show GPDA in malignant ascite group apparently higher than benign ascites group (P<0.05), using GPDA >=35u/ml as positive defining standard, its susceptibility, specificity and accuracy are respectively 79.2%, 70.5%, 74.6%.In malignant ascite, GPDA rising may infiltrate with the peritonaeum of tumour, shift relevant.
Statistical result showed AFU, Tch herein and the joint-detection of tri-indexs of GPDA have significantly improved diagnostic sensitivity (90.1%) and negative predictive value (88.5%) good, malignant ascite, embody the complementary advantage of joint-detection, but aspect specificity, accuracy and positive predictive value, have no the superiority of these three index joint-detection diagnosis.We think and may in these three indexs positive value of defining separately, need further research, and to obtaining more mutual supplement with each other's advantages, we are by for further study in statistics afterwards.
So far, there is no that generally acknowledged, special and responsive index is good in order to differentiate, malignant ascite both at home and abroad.Therefore, select a series of and good, malignant ascite differentiate relevant and sensitivity and specificity all good index carry out the joint-detection good method of can yet be regarded as.We think, to antidiastole good, malignant ascite, first should select the index of height negative predictive value to get rid of malignant ascite, secondly select the index of height positive predictive value to confirm malignant ascite.AFU, the Tch that we select and tri-index joint-detection of GPDA can improve the susceptibility of detection and identification, and specificity decline is not obvious, and have obtained higher negative predictive value, and antidiastole good, malignant ascite is had to positive meaning.
Claims (1)
1. one kind to combined detection kit good, malignant ascite antidiastole, comprise box body, lid, it is characterized in that: in box body, dress is measured the 3rd reagent bottle of the first reagent bottle of alpha-L-fucosidase activity, the second reagent bottle of measuring T-CHOL and mensuration glycylproline dipeptidyl aminopeptidase; Between the first reagent bottle, the second reagent bottle, the 3rd reagent bottle, arrange to separate and dash forward, and the arc-shaped concave that convenient finger inserts is set in the prominent side of each separation; The first reagent bottle is arranged on the lower left side position of box body, and the second kit is arranged on the lower right side position of box body, and the 3rd reagent bottle is arranged on the top of box body; On lid, with the 3rd reagent bottle corresponding position, air hole is set, in the side of box body, air hole is set; On the medial surface of lid, be fixedly installed buffering sponge bed course.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104880423A (en) * | 2015-05-08 | 2015-09-02 | 浙江蓝森生物科技有限公司 | Method, reagent and kit for quantitatively determining activity of glycylproline dipeptidyl aminopeptidase in human serum |
| CN105510572A (en) * | 2015-12-22 | 2016-04-20 | 山东博科生物产业有限公司 | Detection kit for glycylproline dipeptidyl aminopeptidase |
-
2013
- 2013-11-21 CN CN201320744040.8U patent/CN203606366U/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104880423A (en) * | 2015-05-08 | 2015-09-02 | 浙江蓝森生物科技有限公司 | Method, reagent and kit for quantitatively determining activity of glycylproline dipeptidyl aminopeptidase in human serum |
| CN105510572A (en) * | 2015-12-22 | 2016-04-20 | 山东博科生物产业有限公司 | Detection kit for glycylproline dipeptidyl aminopeptidase |
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Legal Events
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|---|---|---|---|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| 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: 20140521 Termination date: 20161121 |