CN102226805A - Middle/low concentration positive quality control liquid for urine analysis - Google Patents
Middle/low concentration positive quality control liquid for urine analysis Download PDFInfo
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Abstract
The invention discloses a middle/low concentration positive quality control liquid for urine analysis. The positive quality control liquid comprises a buffer solution with a pH value of 4.5 to 8.5 and a concentration of 20 to 200 mmol/L, a surfactant with the concentration of 20 to 200 mmol/L, a carbohydrate protectant with the concentration of 20 to 200 mmol/L, a protein protectant with the concentration of 20 to 200 mmol/L, anhydrous glucose with the concentration of 300 to 990 mg/L, bovine serum albumin with the concentration of 100 to 1000 mg/L, bovine hemoglobin with the concentration of 0.6 to 5 mg/L, esterase with the concentration of 2 to 20 mg/L, acetone or lithium acetoacetate or sodium ethyl acetoacetate or ethyl acetoacetate with the concentration of 50 to 900 mg/L, and a direct bilirubin or naphthylamine salt with the concentration of 3 to 40 mg/L. Quality control objects of corresponding projects can be added as needed. Compared with the prior art, the quality control liquid has the advantages of good stability, high sensitivity, less toxicity of each component, wide source and low production cost.
Description
Technical field
The present invention relates to the control liquid that in the urine chemical analysis inspection technology urine chemical analysis system carried out quality control, be specifically related to a kind of positive quality control liquid that is used for the low concentration of urinalysis.
Background technology
In existing urine (dry chemical) analytical control, all the work quality state of urine chemical analysis system is carried out quality control clinically with control liquid, generally testing result is divided into N (normal, negative), ± (suspicious attitude) ,+1 (positive), + 2 (positives), + 3 (positives) ,+4 (positives) ,+5 (positives) etc.Existing control liquid, divide negative control liquid (contain the Quality Control thing of super low concentration or do not contain corresponding Quality Control thing), high positive quality control liquid or high concentration control liquid (the Quality Control thing that contains higher concentration), negative control liquid is the state that is lower than the detection limit of detection system, high positive quality control liquid then is in the upper end of sensing range, and the two control liquid is formed low high two Quality Control concentration.At the beginning of pathology, the variation of each material relevant with pathology is trickle in the urine, and the variation that this is trickle is presented as that in routine urinalysis check each monitoring recognizate presents by not having to the variation that has, and shows to the faint positive with feminine gender.And the insufficient sensitivity height that the low positive concentration of existing high positive quality control liquid centering (specifically finger ± (suspicious attitude) and positive grade are preceding two concentration ranges of+1 and+2) detects, testing result is not accurate enough.
At present, also less than the control liquid of the middle low concentration of being made up of a plurality of components, one or two component in comparatively commonly negative control liquid, high positive quality control liquid or the high concentration control liquid is the Quality Control thing of low concentration on the market.As State Intellectual Property Office's Chinese invention patent that January 2, disclosed publication number was CN 1329250A in 2002, a kind of quality control liquor for analysis of urine and compound method thereof are disclosed, described control liquid is made up of negative control liquid and positive quality control liquid, mainly contain in its middle-jiao yang, function of the spleen and stomach control liquid: PH is the 0.2M sodium phosphate buffer 1000ml of 6.0-7.0,2,4-dimethyl pyrrole-3,5-dicarboxylic acid sodium 50-1000mg, naphthalidine hydrochloride 10-100mg, anhydrous dextrose 0.99-1.98g, esterase 20mg, haemoglobin 22-30mg, human serum albumins 1-3g, bilirubin direct 120mg, sodium nitrite 31-50mg, acetoacetate magnesium 1.8mg.This control liquid can carry out Quality Control to potential of hydrogen (pH), albumin (PRO), glucose (GLU), occult blood (BLD), ketoboidies (KET), specific gravity of urine (SG), cholerythrin (BIL), urobilinogen (URO), nitrite (NIT), 10 projects of leucocyte (WBC).But the stability of above-mentioned control liquid is good inadequately, acetoacetate magnesium instability wherein, and degraded consumes easily under the effect of esterase; Esterase, albumin, haemoglobin etc. are subjected to the murder by poisoning of chemical substances such as nitrite and inactivation easily; Bilirubin direct in alkalescence dissolving better but is vulnerable to influence such as illumination and changes, and influences the Quality Control effect.Positive quality control liquid is under the situation of each Quality Control component low value, and less stable, especially haemoglobin, human serum albumins, acetoacetate magnesium are comparatively outstanding.In addition, the Quality Control thing source that above-mentioned control liquid is selected for use is wideless, costs an arm and a leg, and has higher biological pollution risk, as human serum albumins and human red cell in the invention, derives from human body; Acetoacetate magnesium is because preparation is difficult, and price is comparatively expensive.
Summary of the invention
The technical problem to be solved in the present invention provides a kind of positive quality control liquid of the low concentration that is used for urinalysis of highly sensitive, good stability.
The positive quality control liquid that is used for the low concentration of urinalysis of the present invention, it comprises:
PH value is 4.5～8.5 buffer solution, 20～200mmol/L;
Surfactant, 20～200mmol/L;
The carbohydrate protective agent, 20～200mmol/L;
The protide protective agent, 20～200mmol/L;
Anhydrous dextrose, 300～990mg/L;
Bovine serum albumin(BSA), 100～1000mg/L;
Bovine hemoglobin, 0.6～5mg/L;
Esterase, 2～20mg/L;
Acetone or acetoacetate lithium or oacetic acid sodium or ethyl acetoacetate, 50～900mg/L;
Bilirubin direct or naphthylamines salt, 3～40mg/L.
In the above-mentioned prescription:
Buffer solution can be citrate buffer, borate buffer solution, glycocoll-tris, methionine-amine damping fluid or GOOD ' S biological buffer; Wherein, GOOD ' S biological buffer can be selected from a kind of or two or more combination arbitrarily in PIPES, MOPSO, MOPS, BES and the HEPES damping fluid.Preferably select borate buffer solution, glycocoll-tris or methionine-amine damping fluid for use, concentration is between 40～150mmol/L, and PH is 5.7～7.3; More preferred, select methionine-amine damping fluid for use, concentration is 90～150mol/L, PH is 5.8～6.8.
Described surfactant is Tween-20, Tween-40, Tween-60, Tween-80, polyoxyethylene laurel ether (Brij35) or triton x-100.Preferably select Tween-20, Tween-40 or Brij35 for use, concentration is 25～120mmol/L.More preferred, select Brij35 for use, concentration is 60～90mmol/L.
Described carbohydrate protective agent is sucrose, lactose or trehalose.Be preferably trehalose or lactose, concentration is 50～130mmol/L; More preferred, select lactose for use, concentration is 80～110mmol/L.
Described protide protective agent is polyvinyl pyrrolidone (molecular formula is (C6H9NO) n, can be K30 or K90), gelatin or globulin.Preferably select K30 or gelatin for use, concentration is 40～160mmol/L; Gelatin more preferably, concentration is 80～120mmol/L.
Described naphthylamines salt is hydrochloride naphthodiamide or naphthalidine hydrochloride.
According to the project of Quality Control, positive quality control liquid of the present invention also can further comprise:
Pyrroles or 2,4-dimethyl pyrrole or 2,5-dimethyl pyrrole, 5～80mg/L;
Or comprise indole derivatives, 30～1000mg/L; Described indole derivatives is selected from 2,3-benzindole, 4-oxyindole, 5-oxyindole, 1-methyl indol, 2 methyl indole, 3-methyl indol, 4-methyl indol, 5-methyl indol, 6-methyl indol, 7-methyl indol, 1,2-dimethyl indole, 2, a kind of in 3-dimethyl indole, 5-amino-2-methyl indoles and the 1-methyl-6-skatoxyl.
On the basis of the above, positive quality control liquid of the present invention also can comprise:
Nitrite, 2～20mg/L; And/or
Creatinine, 300～2000mg/L; And/or
Ascorbic acid, 50～700mg/L; And/or
Urine calcium, 200～2000mg/L.
Compared with prior art, the invention has the advantages that:
1, by adding the protective agent of certain concentration range, effectively reduce phase mutual interference between each component, reduce the influence that individual components is caused by constraint such as illumination the Quality Control effect, make each component to coexist and good stability, highly sensitive.
2, each component toxicity, biological risk are less, and wide material sources, and production cost is low.
3, the quality control clearance of the centering low concentration positive carries out refinement on negative and positive basis, the urine system of quality control has been carried out effectively replenishing, control the p+ quality that detects on the other hand, meet and press close to the situation of clinical effectiveness more, for the doctor provides more accurate believable foundation to the observation of conditions of patients, diagnosis.
The sensitivity of control liquid of the present invention below is described by test:
One, material
1, control liquid
1) positive quality control liquid (hereinafter to be referred as middle low concentration control liquid) of middle low concentration of the present invention is produced by the applicant, and lot number is 080085, the term of validity 090715.
2) the commercially available urine positive quality control liquid (this control liquid is high value positive quality control liquid, hereinafter to be referred as commercially available control liquid) of certain brand, lot number is 61271, the term of validity 20090731.
2, main equipment
Four kinds of different urine analysis systems (the supporting test strips that contains two lot numbers).
Wherein,
Urine analysis system 1: the Clinitek-500 of Siemens Company type Urine Analyzer (numbering 6470-1008405) and ten test paper (test paper 1: lot number 8B23D of Bayer Multistix 10SG urine; Test paper 2: lot number 8B31D);
8003086) and ten test strips (test paper 1: lot number 30975021 of Luo Shi Bao Lingman Junior urine urine analysis system 2: the German Urisys of Roche Holding Ag 1800 type Urine Analyzers (numbering:; Test paper 2: lot number 30975028);
Urine analysis system 3: love section comes the medical electronics Shanghai PU-4010 of company limited Urine Analyzer (numbering 40810217) and love section to come ARKRAY 10EA urine test paper bar (test paper 1: lot number OEA8G90; Test paper 2: lot number OEA8G93);
Urine analysis system 4: the Uritest-500B of Guilin Youlite Medical Treatment Electron Co., Ltd type Urine Analyzer (numbering: 50B01132) and Uritest 11G urine test paper bar (test paper 1: lot number G1309045; Test paper 2: lot number G1309051)
3, clinical sample
Take from the clinical sample of clinical laboratory of affiliated hospital of Medical Colleges Of Guilin.Take a sample and test in back 2 hours.
Two, experiment and method
1, analytic system test environment temperature is to the correspondence research (clinical sample is 90) of Quality Control result and clinical effectiveness
Adopt urine analysis system 1 to test.At first regulating the test environment temperature is 10 ± 2 degrees centigrade, place the environment that regulates temperature to stablize 30 minutes instrument, reagent and clinical urine sample, before the clinical urine sample of test, carry out five Quality Controls test, carry out the test of clinical urine sample behind the record Quality Control result again with commercially available control liquid and middle low concentration control liquid; Be 25 ± 2 degrees centigrade and 35 ± 2 degrees centigrade with the test environment adjustment respectively again, under different temperature, repeat test.At last, collection, disposal data, relatively whether the temperature variant situation of result of control liquid test and clinical urine sample has correlativity.Before all tests, with the supporting calibration lath of producer to instrument detect by after carry out the test of control liquid and clinical sample again.
2, the monitoring of analytic system change of sensitivity and clinical correspondence research (clinical sample is 100)
In the test environment temperature is under 25 ± 3 ℃ of conditions, places the environment that regulates temperature to stablize 30 minutes instrument, reagent and clinical urine sample.Before the clinical urine sample of test, carry out three Quality Controls test, carry out the test of clinical urine sample behind the record Quality Control result again with commercially available control liquid and middle low concentration control liquid.At last, collection, disposal data, relatively whether the temperature variant situation of result of control liquid test and clinical urine sample has correlativity.
Before all tests, with the supporting calibration lath of producer to instrument detect by after carry out the test of control liquid and clinical sample again.
Three, experimental result
1, different test environment Quality Control results and clinical effectiveness correlativity
1) commercially available control liquid test result
Commercially available control liquid carries out the Quality Control test under 10 ℃, 25 ℃, 35 ℃ three different environment temperatures, the Quality Control result is consistent (as shown in table 1), does not reflect the influence of environment temperature to analytic system.
Table 1:
Remarks: X
Y: X represents that the result that tests, Y represent the number of times that this result occurs.
2) low concentration control liquid test result in
Carry out Quality Control test with middle low concentration control liquid under 10 ℃, 25 ℃, 35 ℃ three different environment temperatures, the Quality Control result is difference to some extent.Its mesobilirubin (BIL), occult blood (BLD), protein (PRO), urobilinogen (URO), leucocyte (WBC) project result are linear relevant with temperature, and temperature is high more, and positive grade is high more, and the result is as shown in table 2.
Table 2:
Remarks: X
Y: X represents that the result that tests, Y represent the number of times that this result occurs.
3) clinical effectiveness statistics (clinical sample is 90)
Clinical sample is tested under 10 ℃, 25 ℃, 35 ℃ three different environment temperatures, and the positive rate of each project is added up.Find that cholerythrin (BIL), occult blood (BLD), protein (PRO), urobilinogen (URO), leucocyte (WBC) project result are linear relevant with temperature, wherein typical with leucocyte (WBC) again.The trend of this project is the rising along with temperature, and positive rate is high more.The result is as shown in table 3.
Table 3
Remarks: X
Y: X represents that the result that tests, Y represent the number of times that this result occurs.Potential of hydrogen (PH), proportion (SG) can't be added up according to positive rate.
2, sensitivity of different test macro test paper and clinical correlation (clinical sample 100 examples)
1) urine analysis system 1 Quality Control and clinical effectiveness correlativity
Carry out the Quality Control test with urine analysis system 1 centering low concentration control liquid and commercially available control liquid.In two batches of different test paper (test paper 1 and test paper 2), middle low concentration control liquid prompting ketoboidies (KET), occult blood (BLD) and leucocyte (WBC) sensitivity has phenomenon on the low side, and the prompting of commercially available control liquid shows that normally, the result is as shown in table 4.
Table 4:
Remarks: X
Y: X represents that the result that tests, Y represent the number of times that this result occurs.
Under same condition, carry out clinical trial with same clinical urine specimen.Can find that by testing result two batches of different test paper are also variant with the urine analysis system of urine instrument composition to 100 examples.The positive rate of ketoboidies in the test paper 1 (KET), occult blood (BLD) is than the difference high 4% and 9% of test paper 2, and leucocyte (WBC) item is then low by 8%, and the result is as shown in table 5.
Table 5
Remarks: X
Y: X represents that the result that tests, Y represent the number of times that this result occurs.Potential of hydrogen (PH), proportion (SG) can't be added up according to positive rate.
2) urine analysis system 2 Quality Controls and clinical effectiveness correlativity
Carry out the Quality Control test with urine analysis system 2 centering low concentration control liquids and commercially available control liquid.In two batches of different test paper (test paper 1 and test paper 2), middle low concentration control liquid points out (BLD) sensitivity of occulting blood that higher phenomenon is arranged, and the prompting of commercially available control liquid shows that normally, the result is as shown in table 6.
Table 6:
Remarks: X
Y: X represents that the result that tests, Y represent the number of times that this result occurs.
Can find that by the testing result to 100 examples the positive rate of occult blood in the test paper 1 (BLD) is lower nearly 11% than test paper 2, the result is as shown in table 7.
Table 7:
Remarks: X
Y: X represents that the result that tests, Y represent the number of times that this result occurs.Potential of hydrogen (PH), proportion (SG) can't be added up according to positive rate.
3) urine analysis system 3 Quality Controls and clinical effectiveness correlativity
With middle low concentration control liquid and commercially available control liquid urine analysis system 3 is carried out the Quality Control test.In two batches of different test paper (test paper 1 and test paper 2), in low positive concentration urine quality-control product prompting glucose (GLU) sensitivity have on the low side and the higher phenomenon of leucocyte (WBC), and that the prompting of commercially available control liquid shows is normal, the result is as shown in table 8.
Table 8:
Remarks: X
Y: X represents that the result that tests, Y represent the number of times that this result occurs.
100 routine clinical effectivenesses show that the glucose that test paper is 1 group (GLU) positive rate is higher by 4% than test paper 2, and leucocyte (WBC) is then low by 11%, and the result is as shown in table 9.
Table 9:
Remarks: X
Y: X represents that the result that tests, Y represent the number of times that this result occurs.Potential of hydrogen (PH), proportion (SG) can't be added up according to positive rate.
4) urine analysis system 4 Quality Controls and clinical effectiveness correlativity
With middle low concentration control liquid and commercially available control liquid urine analysis system 4 is carried out the Quality Control test.In 2 groups on the ketoboidies (KET) of 1 group on low concentration control liquid prompting test paper and protein (PRO) remolding sensitivity test paper high slightly, and the prompting of commercially available control liquid shows that normally, the result is as shown in table 10.
Table 10:
Remarks: X
Y: X represents that the result that tests, Y represent the number of times that this result occurs.
100 routine clinical effectivenesses show that the ketoboidies that test paper is 1 group (KET) positive rate is higher by 5% than test paper 2, and protein (PRO) is then low by 5%, and the result is as shown in table 11.
Table 11:
Remarks: X
Y: X represents that the result that tests, Y represent the number of times that this result occurs.Potential of hydrogen (PH), proportion (SG) can't be added up according to positive rate.
Four, discuss
1, environment temperature is to the discussion of analytic system test control liquid and clinical effectiveness
1) commercially available control liquid test result temperature influence hardly.No matter be 10 ℃, 25 ℃ or 35 ℃, it is stable that the result of Quality Control keeps.This result does not have higher guiding significance for the state of prompting test macro under corresponding test environment.
2) temperature influence is more remarkable as a result in low concentration control liquid survey Quality Control in.With 25 ℃ of normal temperature is reference, and when temperature was reduced to 10 ℃, BIL, BLD, URO, WBC test result decreased, and be especially obvious with WBC.Wherein still within the Quality Control scope, WBC then has negative findings to occur to the result of BIL, BLD, URO, and there is risk out of control in prompt system; When probe temperature was elevated to 35 ℃, URO, WBC test result also raise, and be the most obvious with WBC equally, though the result yet within the Quality Control scope, has been in the high-end of Quality Control scope, prompting is under this test environment, and the test result of system is with higher.
3) from clinical effectiveness: with 25 ℃ of normal temperature is reference, and when temperature is reduced to 10 ℃ or temperature when being elevated to 35 ℃, the positive rate of GLU, BIL, KET, NIT item does not significantly change, and illustrate that test result is more stable reliably.This conforms to the Quality Control result of control liquid.But when probe temperature was 10 ℃, it was 0 that the URO item is pointed out suspicious urine sample sample number, and 25 ℃ is 3, increases sharply in the time of 35 ℃ to 16; The WBC item is in the time of 10 ℃, and positive sample is 9, is 22 in the time of 25 ℃, is 30 in the time of 35 ℃; The PRO item is in the time of 10 ℃, and positive sample is 15, is 21 in the time of 25 ℃, is 23 in the time of 35 ℃; The BLD item is in the time of 10 ℃, and positive sample is 32, is 39 in the time of 25 ℃, is 34 in the time of 35 ℃.By statistics as can be seen, from 10 ℃ to 25 ℃, along with the increase of temperature, positive rate raises; And these projects positive sample amounts at different levels are increase trend, and this trend shows, increase along with temperature, result's skew that the past positive grade that original positive grade is low is high, owing to detect the raising of sensitivity, this negative sample also tests out positive result simultaneously.
4) comprehensively all clinical effectiveness, it is remarkable to illustrate that clinical result is subjected to test environment temperature effect.Temperature is low, and positive rate is low, and the possibility of omission increases; The temperature height, positive rate height, the corresponding increase of false-positive risk.
5) just see on the trend that the Quality Control result's of middle low concentration control liquid the trend and the trend comparison of clinical results vary coincide, promptly middle low concentration control liquid Quality Control result is more approaching with commercially available control liquid with clinical effectiveness correlativity ratio.So on the susceptibility of the risk of pointing out test macro, middle low concentration control liquid has bigger advantage.
2, the monitoring of analytic system change of sensitivity and clinical effectiveness discussion
1) from four analytic systems, when change of sensitivity occurring, the Quality Control results suggest effect of middle low concentration control liquid all is better than commercially available control liquid, and is particularly evident when positive grade is 1+.
2) from clinical effectiveness, the positive rate of clinical sample increases or reduces all and is consistent with middle low concentration control liquid Quality Control result, and commercially available control liquid Quality Control result does not have big variation, and suggesting effect is not remarkable.
3) comprehensive above 2 points, the low concentration control liquid is better than commercially available control liquid Quality Control to the suggesting effect of system testing risk in can thinking.Promptly the correlativity with clinical is more obvious.
Embodiment
The invention will be further described with embodiment below, but the present invention is not limited to these embodiment.
Embodiment 1
PH is 5.7 borate buffer solution, 60mmol/L;
Tween-20,40mmol/L;
Trehalose, 50mmol/L;
K30，40mmol/L；
Glucose item: anhydrous dextrose, 500mg/L;
Albumin item: bovine serum albumin(BSA), 300mg/L;
The item of occulting blood: bovine hemoglobin, 1mg/L;
Leucocyte item: esterase, 12mg/L;
Ketoboidies item: acetone, 150mg/L;
Cholerythrin item: naphthalidine hydrochloride, 12mg/L;
The urobilinogen item: 2,5-dimethyl pyrrole, 15mg/L;
Nitrite item: nitrite, 12mg/L;
Creatinine item: creatinine, 500mg/L;
Urine calcium item: anhydrous calcium chloride, 500mg/L.
Positive quality control liquid of the present invention adopts the conventional method preparation.The control liquid that preparation obtains is a water white transparency.
For the effect of control liquid of the present invention is described, embodiment 1 and 3 contrast groups are compared experiment:
Do not add Tween-20, trehalose, K30 among contrast groups 1: the embodiment 1;
Do not add trehalose, K30 among contrast groups 2: the embodiment 1;
Do not add K30 among contrast groups 3: the embodiment 1.
Each contrast groups and embodiment 1 prepare simultaneously, keep in Dark Place under 2～8 ℃ of conditions in the preparation back.At quarterly intervals each contrast groups and embodiment 1 are compared observation test.(lot number: F1109012), test result is as shown in table 12 for 1500 type Urine Analyzers of the applicant production and supporting test strips in the system of test.
Table 12:
By data in the table 12 as can be known, contrast groups 1 preparation is after 3 months, and all items lost efficacy substantially except that creatinine, urine calcium and nitrite; The contrast groups 2 that on the basis of contrast groups 1, adds surfactant, then all events lost efficacy after 6 months in preparation, even nitrite, ketoboidies Quality Control item were to just inefficacy in the 9th, 12 month; Add the protectant contrast groups 3 of carbohydrate on the basis of contrast groups 2, then full item was to just inefficacy in 9th month, and the glucose item was to just inefficacy in 12nd month; Added the embodiment 1 of protein protective agent on the basis of contrast groups 3, each project can be saved in 12 months.As seen, the present invention in control liquid, increase surfactant, carbohydrate and protide protective agent can be to the stable obvious effects that plays of control liquid.
Embodiment 2
PH is 7.1 borate buffer solution, 135mmol/L;
Tween-20,100mmol/L;
Trehalose, 130mmol/L;
K30，160mmol/L；
Anhydrous dextrose, 990mg/L;
Bovine serum albumin(BSA), 800mg/L;
Bovine hemoglobin, 3mg/L;
Esterase, 18mg/L;
Ethyl acetoacetate, 150mg/L;
The naphthalidine hydrochloride, 20mg/L;
2,3-dimethyl indole, 40mg/L;
Nitrite, 20mg/L;
Creatinine, 1000mg/L;
Ascorbic acid, 250mg/L;
Anhydrous calcium chloride, 1500mg/L.
Embodiment 3
PH is glycocoll-tris damping fluid of 6.0,60mmol/L;
Brij35，60mmol/L；
Lactose, 80mmol/L;
Gelatin, 80mmol/L;
Anhydrous dextrose, 800mg/L;
Bovine serum albumin(BSA), 600mg/L;
Bovine hemoglobin, 2mg/L;
Esterase, 15mg/L;
Oacetic acid sodium, 150mg/L;
Bilirubin direct, 40mg/L;
The pyrroles, 40mg/L;
Nitrite, 10mg/L;
Creatinine, 1000mg/L;
Anhydrous calcium chloride, 1000mg/L.
For the stabilizing effect of control liquid of the present invention is described, embodiment 3 and 3 contrast groups are compared experiment:
Do not add Briji-35, lactose, gelatin among contrast groups 1: the embodiment 3;
Do not add lactose, gelatin among contrast groups 2: the embodiment 3;
Do not add gelatin among contrast groups 3: the embodiment 3.
Each contrast groups and embodiment 1 prepare simultaneously, keep in Dark Place under 2～8 ℃ of conditions in the preparation back.At quarterly intervals each contrast groups and embodiment 1 are compared observation test.(lot number: F1109012), test result is as shown in table 13 for 1500 type Urine Analyzers of the applicant production and supporting test strips in the system of test.
Table 13:
By data in the table 13 as can be known, though preparation the time has improved the concentration of some Quality Control thing, in preparation back 3 months, most of project all was the trend of reduction.After contrast groups 1,2,3 and embodiment 3 analyzed, can obtain the conclusion identical with embodiment 1: under the protectant effect of surfactant, carbohydrate and protide, the stability of control liquid was significantly improved.
Embodiment 4
PH is 7.5 BES damping fluid, 180mmol/L;
Tween-80,80mmol/L;
Sucrose, 20mmol/L;
Globulin, 30mmol/L;
Anhydrous dextrose, 300mg/L;
Bovine serum albumin(BSA), 1000mg/L;
Bovine hemoglobin, 4mg/L;
Esterase, 10mg/L;
Acetone, 80mg/L;
Hydrochloride naphthodiamide, 3mg/L.
Embodiment 5
PH is 5.1 citrate buffer, 150mmol/L;
Tween-60,20mmol/L;
Trehalose, 200mmol/L;
Gelatin, 120mmol/L;
Anhydrous dextrose, 600mg/L;
Bovine serum albumin(BSA), 100mg/L;
Bovine hemoglobin, 0.6mg/L;
Esterase, 5mg/L;
Acetone, 600mg/L;
The acetoacetate lithium, 25mg/L;
2,3-benzindole, 800mg/L.
Embodiment 6
PH is methionine-amine damping fluid of 6.5,90mmol/L;
Brij35，180mmol/L；
Lactose, 100mmol/L;
Gelatin, 100mmol/L;
Anhydrous dextrose, 400mg/L;
Bovine serum albumin(BSA), 750mg/L;
Bovine hemoglobin, 2.4mg/L;
Esterase, 17mg/L;
The acetoacetate lithium, 50mg/L;
The naphthalidine hydrochloride, 40mg/L;
2,5-dimethyl pyrrole, 80mg/L;
Nitrite, 12mg/L.
Claims (9)
1. positive quality control liquid that is used for the low concentration of urinalysis is characterized in that it comprises:
PH value is 4.5～8.5 buffer solution, 20～200mmol/L;
Surfactant, 20～200mmol/L;
The carbohydrate protective agent, 20～200mmol/L;
The protide protective agent, 20～200mmol/L;
Anhydrous dextrose, 300～990mg/L;
Bovine serum albumin(BSA), 100～1000mg/L;
Bovine hemoglobin, 0.6～5mg/L;
Esterase, 2～20mg/L;
Acetone or acetoacetate lithium or oacetic acid sodium or ethyl acetoacetate, 50～900mg/L;
Bilirubin direct or naphthylamines salt, 3～40mg/L.
2. the positive quality control liquid that is used for the low concentration of urinalysis according to claim 1 is characterized in that: described surfactant is Tween-20, Tween-40, Tween-60, Tween-80, polyoxyethylene laurel ether or triton x-100.
3. the positive quality control liquid that is used for the low concentration of urinalysis according to claim 1 is characterized in that: described carbohydrate protective agent is sucrose, lactose or trehalose.
4. the positive quality control liquid that is used for the low concentration of urinalysis according to claim 1 is characterized in that: described protide protective agent is polyvinyl pyrrolidone, gelatin or globulin.
5. the positive quality control liquid that is used for the low concentration of urinalysis according to claim 1 is characterized in that: this positive quality control liquid also comprises:
Pyrroles or 2,4-dimethyl pyrrole or 2,5-dimethyl pyrrole, 5～80mg/L.
6. the positive quality control liquid that is used for the low concentration of urinalysis according to claim 1 is characterized in that: this positive quality control liquid also comprises:
Indole derivatives, 30～1000mg/L.
7. the positive quality control liquid that is used for the low concentration of urinalysis according to claim 6, it is characterized in that: described indole derivatives is selected from 2,3-benzindole, 4-oxyindole, 5-oxyindole, 1-methyl indol, 2 methyl indole, 3-methyl indol, 4-methyl indol, 5-methyl indol, 6-methyl indol, 7-methyl indol, 1,2-dimethyl indole, 2, a kind of in 3-dimethyl indole, 5-amino-2-methyl indoles and the 1-methyl-6-skatoxyl.
8. according to claim 5 or the 6 described positive quality control liquids that are used for the low concentration of urinalysis, it is characterized in that: this positive quality control liquid also comprises:
Nitrite, 2～20mg/L; And/or
Creatinine, 300～2000mg/L; And/or
Ascorbic acid, 50～700mg/L; And/or
Urine calcium, 200～2000mg/L.
9. the positive quality control liquid that is used for the low concentration of urinalysis according to claim 1 is characterized in that: this positive quality control liquid also comprises:
Nitrite, 2～20mg/L; And/or
Creatinine, 300～2000mg/L; And/or
Ascorbic acid, 50～700mg/L; And/or
Urine calcium, 200～2000mg/L.
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