CN1603820A - Instrument for separating biological sample and separation method therefor - Google Patents
Instrument for separating biological sample and separation method therefor Download PDFInfo
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- CN1603820A CN1603820A CN 03125586 CN03125586A CN1603820A CN 1603820 A CN1603820 A CN 1603820A CN 03125586 CN03125586 CN 03125586 CN 03125586 A CN03125586 A CN 03125586A CN 1603820 A CN1603820 A CN 1603820A
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Abstract
It is a biology sample collection apparatus, which comprises the following: a collection device to collect biology samples; a filter device to filter out the special component of collected biology sample; a separation device to contain the special component; an anti-reverse device to prevent the special component flow back through the filter device; and a device to prevent the closedown of the anti-reverse device after the special component goes through the filter device.
Description
Technical field
The present invention relates to a kind of instrument and separation method thereof of separation of biological samples, especially for collected blood system from the blood system of haematoblast and blood plasma or serum from instrument, and the method for separating collected blood.
Background technology
In general, in the Routine Test Lab check, personnel (for example doctor, nurse or clinical laboratory technology personnel) with certain license or professional technique come the collection of biological sample by for example blood sample collection method, are scheduled to check based on collected biological sample then.
But, for the collection of biological sample, the person under inspection must go to hospital or the clinical examination center of holding licensed people or professional and technical personnel (as doctor, nurse, clinical laboratory technology personnel or the like) place in the routine biochemistry method of inspection, or opposite, this people of license or the place that the professional and technical personnel must arrive the person under inspection place held.So the collection of biological sample is the increase that bothers very much and can cause inspection cost.
And, very fast because unprocessed blood changes in time, can fluctuate aspect the accuracy of check.So, need a kind of testing instruments that after collecting blood sample, can produce more accurate test findings of development by separating blood immediately.
In addition, in order to simplify the operation of collection of biological sample, although implemented the method by person under inspection's collection of biological sample, this method still has problems, because this method is only effective in some Interventions Requested, but can not be applied to other Interventions Requested.
Summary of the invention
Implement the present invention according to above-mentioned condition, it provides the instrument and the separation method thereof of separation of biological samples, and they can simplify the collection operation of biological sample, improves the accuracy of check and reduces inspection cost.
The present invention includes the biological specimen collection container that is used to receive collected biological sample, the filtrator that is used for making the predetermined component of collected biological sample to pass through, be used for receiving the predetermined component by filtrator and can be assembled to the separation component container of biological specimen collection container, prevent the predetermined component that received in the separation component container by filtrator reflux enter the biological specimen collection container prevent the adverse current part, in case wherein biological specimen collection is assembled in the biological specimen collection container in the collection of biological sampling receptacle and with the separation component container, with after the predetermined component in the biological sample is passed through filtrator, the parts that prevent adverse current are closed in flow channel between separation component container and the biological specimen collection container preventing the adverse current of predetermined component, and receive the predetermined component of biological sample in the separation component container respectively.
Preferably, the present invention includes and be used to receive the blood collection container of collecting blood, make to collect blood plasma in the blood or serum by and the filter membrane that stops haemocyte to pass through, can be assembled to the neutralization of blood collection container can receive by the blood plasma of filter membrane or the right cylinder of serum, preventing that the blood plasma that receives in right cylinder or serum from refluxing by filter membrane enters the sealing cap of blood collection container, in case wherein blood is collected in the blood collection container and with right cylinder and is assembled in the blood collection container, with when the blood plasma in the blood or serum by after the filter membrane, sealing cap is closed in the flow channel between right cylinder and the blood collection container in case hemostasis is starched or the adverse current of serum, and receives haemocyte and blood plasma or serum in blood collection container and right cylinder separately respectively.
More preferably, in the blood collection container, place dilute solution.
Be used for dilute solution of the present invention, be not limited to special kind, can comprise, deionized water for example, distilled water and buffering solution preferably can be buffer solution.Buffering agent as buffer solution can be that any buffering agent is as long as it has surge capability, can comprise that pH for example is effective buffering agent of 1 to 11, as the lactic acid buffering agent, citric acid buffer agent, acetic acid buffer, succinic acid buffer agent, the phthalic acid buffering agent, phosphoric acid buffer agent, the triethanolamine buffering agent, the diethanolamine buffering agent, the lysine buffering agent, the barbiturates salt buffer agent, three (methylol) aminomethane buffer solution, the imidazole buffer agent, the hydroxysuccinic acid buffering agent, the oxalic acid buffering agent, glycine buffer, borate buffer, the carbonic acid buffering agent, glycine buffer, 3-morpholino-propionic acid (MOPS), 1,4-piperazinebis (ethyl sulfonic acid) (PIPES), 2-[4-(2-hydroxyethyl)-1-piperadinyl] ethyl sulfonic acid (HEPES).The concentration of buffer solution specifically is not defined as certain value, but preferable range be the 0.1-1000 mM/liter, be more preferably the 1-500 mM/liter.
And if desired, buffer solution can contain surfactant, antiseptic or the like.Surfactant can comprise for example cationic surfactant, anionic surfactant, amphoteric surfactant or non-ionic surfactant.Antiseptic can comprise, for example sodium azide, antiseptic or the like.
When whole blood is used as biological sample, because the expansion of haemocyte (for example red blood cell or the like) or the change of shrinking concentration of element in the serum that may cause, the preferred salt that not have to influence for the quantification for the treatment of quantitative element, sugar, buffer solution or the like of using is prepared into isotonic solution with dilute solution in order to prevent.
Kind for salt does not have particular determination, but can comprise alkali halide such as sodium chloride, potassium chloride etc.
Kind for sugar does not have particular determination, still can comprise sugar alcohol such as mannitol, D-sorbite or the like.
For the kind of buffer solution, can the comprising of foregoing description.
Being used for indication material of the present invention can be any material, if itself neither the secondary element undetermined in the biological sample neither biological sample in contained element, preferably the secondary element undetermined in the biological sample is not had the element that influences.Indicate material to be, for example pigment, chromogen, fluorescent material, luminescent material or the like, preferably pigment or chromogen.Preferred pigment is because its concentration can be passed through the colourimetry direct quantitative.
Pigment can comprise, for example quinoline yellow, acid yellow 23, Indian yellow 25, quinoline yellow 6, acid orange 5, acid orange 6, acid orange 7, acid orange 10, acid orange 19, acid orange 52, acid green 16, ACID GREEN 25, acid violet 43, acid blue 3, acid blue 9 (brilliant blue FCF), Acid Blue 40, acid blue 45, acid blue 47, acid blue 59, Acid Blue 74, Acid blue 113, Blue VRS 58, azogeramine, acid red 2, azogeramine 4, acid red 18, acid red 27, acid red 37, acid red 51, acid red 52, acid red 87, acid red 88, acid red 92, acid red 94, acid red 95, azogeramine 11, Food Red 17, food Huang 3, basic yellow 1, basic yellow 2, basic yellow 11, Basic Orange 1, alkaline orange 22, Viride Nitens 4 (peacock green), alkaline purple 3, alkalescence purple 4, alkaline purple 10, alkali blue 1, alkali blue 3, alkali blue 9, alkali blue 24, alkali red 1:1, alkalescence red 2, alkalescence red 5, alkalescence red 9, Basic Red 18.
For reduction colour pattern look source, wherein can comprise, for example 3-(4,5-dimethyl-2-thiazolyl)-2,5-diphenyl-2H-tetrazole bromide (MTT), 2-(4-iodine substituted phenyl)-3-(nitre phenyl)-5-(2,4-two sulfophenyls)-2H-tetrazole list sodium salt (WST-1), 2-(4-sulfophenyl)-3-(2,4-dinitro phenyl)-5-(2,4-two sulfophenyls)-2H-tetrazole list sodium salt (WST-3) or the like.
For oxidation colour pattern chromogen, wherein can comprise, for example with such as hydrogen oxide and peroxidase (hereinafter, be called the uncolored type chromogen) the condition of peroxide actives material coexistence under, itself can be converted into the chromogen of pigment, another kind is can chromatogenous chromogen (hereinafter, being called the coupling type chromogen) by the oxidative coupling of two compounds.
The uncolored type chromogen can comprise; 10-N-methylol-carbamyl-3 for example; two (the dimethylamino)-10H-phenothiazine (CCAP) of 7-; 10-N-methyl carbamyl-3, two (the dimethylamino)-10H-phenothiazine (MCDP) of 7-, N-ethyloic-aminocarbonyl-4; 4 '-two (dimethylamino) diphenylamine sodium (DA-64); 4,4 ' two (dimethylamino) diphenylamine, two [two (4-chlorphenyl) methyl of 3--4-dimethylamino phenyl] amine (BCMA) or the like.
The coupling type chromogen can comprise, 4-amino-antipyrine (4-AA) for example, 3-methyl-2-[4-morpholinodithio quinoline hydrazine or the like and aniline such as N-ethyl-N-(3-aminomethyl phenyl)-N ' succinyl ethylethylenediamine (EMSE), N-(3, the 5-Dimethoxyphenyl)-N ' succinyl ethylethylenediamine sodium salt (DOSE) N-ethyl-N-(2-carboxyl-3-sulfopropyl)--toluidine, N-ethyl-N sulphur-propyl group-aniline, N-ethyl-N-sulfopropyl-3,5-dimethoxy-aniline, N-sulfopropyl-3,5-dimethoxy-aniline, N-ethyl-N sulfopropyl-3,5-dimethoxy-aniline, N-ethyl-N sulfopropyl--toluidine, N-ethyl-N-(2-hydroxyl-3-sulfopropyl)--anisidine, N-ethyl-N (2-hydroxyl-3-sulfopropyl) aniline, N-ethyl-N-(2-hydroxyl-3-sulfopropyl)-3-toluidine sodium salt 2 hydrates (TOOS), N-ethyl-N-(2-hydroxyl-3-sulfopropyl)-3, the 5-dimethoxyaniline, N-ethyl-N-(2-hydroxyl-3-sulfopropyl)-3,5-dimethoxyaniline sodium salt (HSDA), N-ethyl-N-(2-hydroxyl-3-sulfopropyl)-3, the 5-xylidin, N-sulfopropyl-aniline, N-ethyl-N-sulfopropyl-aniline-propyl group--methoxyl-aniline, N-ethyl-N (2-hydroxyl-3-sulfopropyl)-4-fluoro-3, the bond of 5-dimethoxy-aniline sodium salt (F-DAOS) or the like coupling agent, perhaps other bond of 4-AA and phenol or phenol such as 3-hydroxyl-2,4,6-triiodoacetic acid or the like.
Fluorescent material can comprise p-hydroxy phenyl-acetate, p-hydroxy phenyl propionic acid, cumarin or the like.
Luminescent material can comprise the compound such as luminol, isoluminol, lucigenin, bifurcation pyridine drone ester (acridiniumes ter) or the like.
Being used for biological sample of the present invention can be any sample, and for example whole blood, blood plasma, serum, celiolymph, saliva, urine, sweat or the like preferably use whole blood, blood plasma or serum.
And biological sample can be taken from any organism, and it is not limited to human body, but can be animal, fish, bird or the like.These animals can comprise horse, ox, pig, wild boar (wild bore), sheep, rabbit, racoon, fox, dog, cat, bear, panda or the like, fish can comprise big conger pile, sweetfish, sardine, torgoch, eel, stripped tuna, happiness flying fish (sillaginoid), salmon, mackerel, Xiao Huang tail, globe fish, tuna or the like, and bird can comprise chicken, dove or the like.
The solution formed by the biological sample of the dilute solution that contains ormal weight indication material of prescribed volume and unknown volume of the sample that is used to quantize of Shi Yonging in the present invention.At this sample that is used for quantizing, described dilute solution contains the indication material of biological sample that is used to dissolve unknown volume of ormal weight, and this dilute solution is known as reference solution hereinafter.
The method of mixing with the dilute solution of the prescribed volume that contains ormal weight indication material by the unknown volume biological sample that collected volume is not quantitative, perhaps the method for adding in the solution that the dilute solution of biological sample by the mixing unknown volume and prescribed volume makes by the dilute solution that will contain the prescribed volume of ormal weight chromogen prepares the sample that is used to quantize.So,, can easily prepare the sample that is used to quantize in the collection place of biological sample just since do not need to use the volume of the quantitative biological sample of container.And very small amount of biological sample just is enough to be used in preparing the sample that is used to quantize.
The method that reference solution can mix by the dilute solution with the indication material of ormal weight and prescribed volume or add in the prescribed volume dilute solution by the dilute solution that contains the ormal weight chromogen with prescribed volume prepares.
Adopt commonsense method not use specific process just can obtain biological sample, that is to say, for example whole blood is placed after a period of time, can from whole blood, be obtained serum by carrying out centrifugal treating, and by with the separating treatment technology (as divided thin film from) handle whole blood and can obtain serum.In the present invention, preferably adopt and self collect the method for blood, for example test the person under inspection and collect his/her blood in person by using blood taking needle.In addition, since do not need quantitative its volume just can carry out this operation, so do not need special technique to prepare the sample that is used to quantize, the test person under inspection can prepare the sample that is used to quantize in person.And, by whole blood is directly mixed the sample that is used to quantize for preparing with the dilute solution of prescribed volume, it can be used as a kind of sample, the concentration of secondary element undetermined in blood plasma of determining by the value of element undetermined in the quantitative quantification element or the serum, then, if desired, by separating treatment (as centrifuging and divided thin film from) the haemocyte element is separated, the dilution ratio of determining based on the dilution ratio computing method is described below.
The mode of mixing for the dilute solution with biological sample and prescribed volume does not have particular determination, and still the sample that obtains in said method can directly add or add by the separation equipment that is installed in the container indirectly.A kind of adding method in back can comprise, for example uses blood system of the present invention from instrument, adds the method for isolated blood plasma from whole blood.
Indicate the scope of the dilution ratio of material not have particular restriction for the sample that is used for quantizing, but preferred 2-10, more preferably 2-50 and most preferably 2-20.
Should be noted in the discussion above that if the dilute solution of prescribed volume does not contain the indication material of ormal weight, after biological sample is sneaked into wherein, can add the dilute solution of the prescribed volume that contains ormal weight indication material.Quantitatively the step that the method for secondary element undetermined comprises in the biological sample of unknown volume has: quantitatively the indication material concentration is indicated material concentration with the sample that is used for quantizing in the reference solution, determining the dilution ratio of biological sample, and quantitatively be used for the concentration of the sample secondary element undetermined that quantizes.
The concentration of secondary element undetermined (X) can be used as the concentration (Y) of the sample secondary element undetermined that is used for quantizing by method for preparing and the function of the dilution ratio (a) of the sample biological sample that is used for quantizing in the biological sample, determines by equation 1.
X=aY (equation 1)
In the present invention, as described belowly can determine dilution ratio.
C2=M1/ (V1+V2) (equation 2)
Wherein, C2 is that the sample that is used for quantizing is indicated concentration of material, V1 is the volume that is used to prepare the dilution of sample solution that is used to quantize, and M1 is the amount of wherein employed indication material and volume (note: need not measure V2) that V2 is wherein employed biological sample.
On the other hand, being used for preparing dilution of sample solution (=reference solution) the indication concentration of material C1 that is used to quantize can followingly represent:
C1=M1/V1 (equation 3)
Should be noted that the method at the sample that is used for quantizing by the biological sample preparation, reference solution is the solution that does not use the biological sample preparation.
Because the dilution ratio (a) at the biological sample of the sample unknown volume that is used for quantizing can followingly be represented:
A=(V1+V2)/V2 (equation 4)
So, shown in equation 5, can use C1 and C2 to rewrite dilution ratio (a)
Dilution ratio (a)=(V1+V2)/V2=C1/ (C1-C2) (equation 5)
In this article, when the indication material is pigment or chromogen, indication concentration of material C1 and C2 can determine by measuring absorptivity, perhaps when the indication material is luminescent material, can determine, perhaps when the indication material is fluorescent material, can determine by measuring fluorescence intensity by measuring luminous intensity.When quantitatively indicating material, because concentration and absorptivity are proportional, so can write by absorptivity:
C2/C1=E2/E1 (equation 6)
Wherein, C1 and E1 are respectively the concentration and the absorptivities of reference solution, and C2 and E2 are respectively the concentration and the absorptivities of the sample that is used to quantize.So, also can determine dilution ratio by the equation of rewriting:
Dilution ratio (a)=C1/ (C1-C2)=E1/ (E1-E2) (equation 7)
As mentioned above, can calculate dilution ratio based on C1 and C2 value or based on E1 and E2 value.Although should be noted that and can set C1 in advance and E1 is a given value, because they can use the solution of preparation again quantitative, the amount of indication material can not be set at given value in advance in the reference solution.That is to say, in the present invention, the direct liquor capacity that mixes with biological sample, if and this solution contains the indication material, the amount of indication material or concentration and the volume that contains the solution of indicating material and the amount or the concentration that are used to prepare the indication material of the sample that is used to quantize, each is so long as constant can be unknown in them.
Quantitatively the method for indication material can be any method, as long as it can quantitatively indicate concentration of material.When indication material when being pigment, can quantitatively be used to the absorptivity of the sample self that quantizes.And, in other cases, can take out the sample of prescribed volume, then by quantitatively treating quantitatively to indicate quantitative its concentration of method of material from the sample that is used for quantizing.In case quantize, when using absorptivity, absorptivity need not be converted into the indication concentration of material, can directly use the value of absorptivity.
In the present invention, can use colourimetry, any one in luminescence method and the fluorescence method, wherein colourimetry most preferably.
The indication material that uses in colourimetry can comprise, for example above-mentioned pigment and chromogen.Chromogen can comprise reduction colour pattern chromogen and oxidation colour pattern chromogen.Use the colourimetry of reduction colour pattern chromogen can comprise a kind of method, wherein by operation such as NAD (p) H etc., dihydrolipoamide dehydrogenase, the electron carrier of the dihydrocoenzyme of 1-methoxyl-5-methyl phenaziummethylsulfate etc. will reduce the colour pattern chromogen and be converted into pigment, then by the chromatogenous absorptivity of spectrophotometer measurement.Use the colourimetry of oxidation colour pattern chromogen can comprise a kind of method, wherein the superoxide active material by operation such as hydrogen oxide, peroxidase or the like is converted into pigment with oxidation colour pattern chromogen, then by the chromatogenous absorptivity of spectrophotometer measurement.Under the situation of using chromogen, preferably use the method for oxidation colour pattern chromogen.
When using chromogen (chromogen) as the indication material, by following method chromogen is converted into pigment, measure chromatogenous absorptivity then.Under the situation of using reduction colour pattern chromogen, by operating such as NAD (p) H or the like, dihydrolipoamide dehydrogenase, the electron carrier of the dihydrocoenzyme of 1-methoxyl-5-methylphenaziummethylsulfate etc. will reduce the colour pattern chromogen and be converted into pigment, measure chromatogenous absorptivity then.Under the situation of using oxidation colour pattern chromogen, by the superoxide active material of operating such as hydrogen oxide, peroxidase or the like oxidation colour pattern chromogen is converted into pigment, measure chromatogenous absorptivity then.
Fluorescence method can comprise a kind of method, wherein measures the fluorescence of launching in the above-mentioned fluorescent material that is made by the superoxide active material such as hydrogen oxide, peroxidase or the like by fluorophotometer.
Fluorescence method can further comprise another kind of method, wherein the light of launching in the above-mentioned fluorescent material that is made by the superoxide active material such as hydrogen peroxide, peroxidase or the like by photometer measurement (photon).
Should be noted that using under the situation of coupling type chromogen as oxidation colour pattern chromogen as the contained indication material of the sample that is used for quantizing, any in two kinds of compounds relevant with colour developing separates preservation with other compound.
When using oxidation colour pattern chromogen as the indication material, the molal quantity of this oxidation colour pattern chromogen should be controlled at the molal quantity that is less than hydrogen peroxide.When using the coupling type chromogen as the indication material, the molal quantity of this chromogen should be controlled at and be less than in hydrogen peroxide and described other compound every kind molal quantity.
The hydrogen peroxide that is used for oxidation colour pattern chromogen is converted into pigment can be a hydrogen peroxide itself, also can be by using enzyme directly or indirectly from other material production.The bond that directly or indirectly produces hydrogen peroxidase and material can comprise following material: cholesterol and cholesterol oxidase; Uric acid and uricase; Triglyceride and Zhi Danbaizhifangmei ﹠amp; The glycerine oxidase; Free fatty acid and Xian JifumeiAHe Chengmei ﹠amp; ACOD; Glucose and pyranose oxidase; Phosphatide and Lin ZhimeiD ﹠amp; Choline oxidase; Creatine and Ji Suanmei ﹠amp; Sarcosine oxidase; Kreatinin and kreatinin oxidase, Ji Suanganmei ﹠amp; Sarcosine oxidase; Lactic acid and lactose oxidase; Phos and purine nucleosides acidic group phosphorylase; Xanthine oxidase; 2,4-dimethoxy-benzoyl choline and Dan Jianzhimei ﹠amp; Choline oxidase; Allylamine (allyllamine) and monoamine oxidase; Or the like.
The chemical reagent that will be converted into pigment as the oxidation colour pattern chromogen of the sample indication material that is used for quantizing is preserved as the single agents system or as many reagent systems.Preferably preserve, more preferably preserve as two reagent systems as many reagent systems.Under the situation of using hydrogen peroxide itself, preferred two reagent systems, it can avoid the coexistence of hydrogen peroxide and superoxide active material (as peroxidase).Using enzyme from other material, directly or indirectly to produce under the situation of hydrogen peroxide, preferred two reagent systems, its enzyme that can avoid coexisting directly reacts with material or material itself.The concrete preferred embodiment of preserving type of chemical reagent that preferably oxidation colour pattern chromogen is converted into pigment is as described below.But, be appreciated that preserving type is not limited to following specific embodiments.
The chromogen of the sample that is used for quantizing: N-(2-hydroxyl-3-sulfopropyl)-3,5-dimethoxyaniline sodium salt (HSDA)
First reagent:, add glucose by from first reagent of determinative CL-E (measuring the reagent of glucose: provide), removing the reagent of HSDA preparation by Kyowa-medexCorp..
Second reagent of second reagent: determinative GL-E.
For treating that quantitative element does not have specific limited, in the element in the still preferred serum is included in.And, although the quantization operation of secondary element undetermined is not limited to ad hoc fashion, can adopt the quantization method of conventional method as secondary element undetermined, preferably do not indicated this quantization method of the influence of material basically.
The assay method of secondary element undetermined and specific embodiment is described with method indicated in the bracket of back below.Tot Prot (Biuret Method), GOT (JSCC method), GPT (JSCC method), L-lactate dehydrogenase (SSCC method), γ-GTP (JSCC method), kreatinin activating enzymes (IFCC method), cholinesterase (p-HBC method), HDL cholesterol (enzyme process), LDL cholesterol (pure method), triglyceride (enzyme process), urea nitrogen (enzyme process), kreatinin (enzyme process), uric acid (enzyme process), glucose (enzyme process), alkaline phosphatase (GSCC method), ammonium (enzyme process), sialic acid (enzyme process), ceruloplasmin (colourimetry), free cholesterol (enzyme process), free fatty acid (enzyme process), lactic acid (enzyme process), fatty acid (enzyme process), Phos (enzyme process), and monoamine oxidase (enzyme process).
Be used for biological sample is added and contains exactly the above-mentioned dilute solution of prescribed volume inside, the container that is equipped with closable opening/closing device can be used as the sampling receptacle that collection and preservation biological sample or preparation are used to quantize.So, the test person under inspection can be people who does not have special qualification such as doctor, under the help of nurse and clinical examination slip-stick artist or professionals and engineers, biological sample with proper volume, as his/her blood of collecting in person, without any processing, for example as whole blood, not quantitative one by one its volume, add in the container of the dilute solution that wherein is filled with prescribed volume, for preventing possible evaporation and leaking wherein contained solution, after adding to it in device, deliver to suitable mechanism (inspection center or hospital) so that described mechanism quantitatively he wants quantitative element.
And among the present invention, the blood collection container has identical external diameter with the sample cup of biochemical analysis device, and in the upper part of blood collection container helical element is arranged, and at cylindrical end portion filter membrane is arranged.Cap shape piston is arranged on cylindrical, cap shape piston has the handle component that can be screwed into helical element and enters cylindrical rod unit from what handle component extended out, sealing cap with the lower end of rod unit, because in case in the blood collection container, collect blood and right cylinder be assembled in the blood collection container, then handle component is screwed in the helical element, and the blood plasma in the blood or serum are by after the filter membrane, cylindrical end portion closed by sealing cap in case hemostasis slurry or serum adverse current receive blood plasma or serum and haemocyte respectively in right cylinder and blood collection container.
And, among the present invention, be equipped with cap shape piston in cylindrical upper part, main element can separate with the upper part, and pin the blood collection container, in case because handle component is screwed into the helical element of blood collection container, main element pins the blood collection container to suppress the mobile of main element and isolate the upper part from main element.
And, among the present invention, provide sealing cap so that sealing cap can be respectively disassembled and be assembled to cylindrical end portion from the lower end of rod unit at the lower end of rod unit and cylindrical end portion, and in case remove at the handle component and the matching status between the helical element of blood collection container, extract cap shape piston, sealing cap comes off to keep the sealing state of cylindrical end portion from the lower end of rod unit.
The step that the present invention includes has: the component containers of separating is fitted into them in the biological specimen collection container of collected biological sample, the predetermined component that receives in the biological sample by filter membrane enters the separation component container, after entering in the separation component container with the predetermined component of reception, by preventing that the adverse current parts from closing the step of the flow channel between separation component container and the biological specimen collection container, with the adverse current that prevents predetermined component with receive respectively and be scheduled to component in the separation component container.
And, the step that the present invention includes has: right cylinder is assembled in the blood collection container that contains collected blood, the handle component that covers the cap shape piston on right cylinder is screwed in the helical element of blood collection container, the blood plasma or the serum that receive in the blood by filter membrane enter right cylinder, with receive blood plasma or serum and enter after the right cylinder, close the step of the flow channel between right cylinder and the blood collection container by sealing cap, in case the adverse current of hemostasis slurry or serum and receive blood plasma respectively or serum enters right cylinder and haemocyte enters in the blood collection container.
According to above-mentioned the present invention, a kind of biological specimen collection operation of simplification is provided, it can reduce inspection cost.And, because biological sample can separate fully, carry out the check of pin-point accuracy so can prevent the time of sample from changing.
Explanation
Fig. 1 is according to the blood system of the specific embodiments of the present invention cross-sectional view strength from instrument;
Fig. 2 is the side view according to the blood collection container of specific embodiments of the present invention;
Fig. 3 is the cross-sectional view strength of Fig. 2 along line A-A;
Fig. 4 is the cylindrical side view according to specific embodiments of the present invention;
Fig. 5 is the cross-sectional view strength of Fig. 4 along line B-B;
Fig. 6 is the side view according to the lid of specific embodiments of the present invention;
Fig. 7 is the cross-sectional view strength of Fig. 6 along line C-C;
Fig. 8 is the side view according to the cap shape piston of specific embodiments of the present invention;
Fig. 9 is the cross-sectional view strength of Fig. 9 along line D-D;
Figure 10 is the side view according to sealing cap of the present invention;
Figure 11 is the cross-sectional view strength of Figure 10 along line E-E;
Figure 12 is that explanation is according to the blood system of the specific embodiments of the present invention cross-sectional view strength from instrumentation; With
Figure 13 is that explanation is according to the blood system of the specific embodiments of the present invention cross-sectional view strength from instrumentation.
Embodiment
With reference now to accompanying drawing describe in detail according to the biological sample separate apparatus of specific embodiments of the present invention with and separation method.
Fig. 1-13 has illustrated and has used the embodiment of blood as biological sample.Blood system comprises blood collection container 2, can be assembled to right cylinder 3 in the blood collection container 2, cap shape piston 4 on right cylinder 3 tops and the sealing cap 5 that provides in cap shape piston 4 lower ends can be provided from instrument in this embodiment, wherein before use by covering 6 upper end open, as shown in Figure 1 by means of liner 7 sealing blood collection containers 2.
Preferably as shown in Figures 2 and 3, blood collection container 2 is made by transparent material, and is cylindrical, wherein the outside surface of blood collection container 2 upper parts have helical element 8 and within it the surface form outstanding closed block 9.And, form the bottom 10 of inverted-cone shape at the end portion of blood collection container 2, and form cylindrical columns 11 around bottom 10.Pillar 11 has identical external diameter with the sample cup that is used for haemanalysis and check, and preferably relative separately position vertically forms seam 12 in the pillar lower end.And, as shown in Figure 1, will treat quantitative dilute solution 13, for example 500mm in advance
3Be placed in the blood collection container 2.
Preferably as shown in Figure 4 and Figure 5, right cylinder 3 is made by transparent material, and is cylindrical, and wherein part forms diameter expansion parts 14 in the top.Diameter expansion parts 14 are connected by thin wall component 15 with main element 16, and vertically form outstanding plug member 17 at the center section of main element 16.And, form diameter collapsible part 18 at the end portion of right cylinder 3, form outstanding closed block 19 at the inside surface of diameter collapsible part 18.And at the end portion formation outward flange 20 of diameter collapsible part 18, with the lower ending opening of filter membrane 21 covering outward flanges 20, blood plasma or serum that this filter membrane is suitable in the blood pass through, but haemocyte can not pass through.
Preferably as Fig. 8 and shown in Figure 9, cap shape piston 4 is formed by common cylindrical shaped handle component 26 with the handle component 26 concentric rod units 27 that extend downwards.Inner upper end at handle component 26 partly forms cylindrical space 28, and the diameter expansion parts 14 of right cylinder 3 are assembled to this space, and the part below the space forms screw thread so that helical element 8 can be screwed into this part.Rod unit 27 has trochoid lower end 29, and dismountable sealing cap 5 is in contact with it (referring to Fig. 1).Preferably as shown in Figure 10 and Figure 11, cylindrical shape made and is generally by sealing cap 5 by silicon rubber, and its underpart forms outward flange, so form step parts 31 in the bottom of sealing cap outer rim.And, in sealing cap 5, forming groove 32, the lower end 29 of dismountable rod unit 27 adapts to this groove.
With reference now to Fig. 1 and Figure 12-13, the method for separating blood according to specific embodiments of the present invention is described.
When from blood collection container 2, remove cover 6 and liner 7 after, the person under inspection is thrust blood taking needle and is entered blood collection container 2 to collect a small amount of blood (for example 1-2 bleeds) at his positions such as finger.Collected blood is separated into haemocyte and blood plasma or serum gradually in dilute solution 13, haemocyte begins grumeleuse and is deposited in the dilute solution, when blood plasma or serum begin to swim in the dilute solution 13 simultaneously.Under this condition, as shown in figure 12, the right cylinder 3 that is stamped cap shape piston 4 in the above is assembled in the blood collection container 2, simultaneously helical element 8 is screwed in the handle component 26.At first, with handle 26 rotating cylindrical bodys 3, in case but closed block 9 pins plug member 17, and will limit the rotation of rotating cylindrical body 3 and distortion thin wall component 15 is consequently broken, cause right cylinder 3 to be separated into main element 16 and diameter expansion parts 14.Then, when rotary handle parts 26 further, the upper part 33 of main element 16 is invaded the inside that spaces 28 become diameter expansion parts 14, and by the inside surface at the top 34 of handle component 26 to pressing down, so further reduced right cylinder 3.When right cylinder reduces, be suspended in blood plasma in the dilute solution 13 or serum by filter membrane 21 to move into right cylinder 3, haemocyte can not pass through filter membrane 21 simultaneously, is retained in the blood collection container 2.At this moment, because the end portion of the external diameter of projecting part 23 and lid 22 is greater than the external diameter of the main element 16 of right cylinder 3, right cylinder 3 reduces and is closely approaching with the inside surface of blood collection container 2.So when right cylinder 3 being assembled in the process of blood collection container 2, blood or dilute solution 13 can not leak into its outside by the space between blood collection container 2 and the right cylinder 3 from blood collection container 2.Then, when handle 26 was screwed into the foot of helical element 8, sealing cap 5 and diameter collapsible part 18 closely cooperated with the flow channel between sealing blood collection container 2 and the right cylinder 3, thereby guaranteed the released state between haemocyte and blood plasma or the serum.
Then, keeping under this state blood system being transported to check ground from instrument 1, by rotary handle parts 26 it is disassembled down there.At this moment, the ladder parts 31 of sealing cap 5 pin outstanding closed block 19 and separate sealing cap 5 to remain on diameter collapsible part 18 inside, so that only be removed and then make haemocyte and blood plasma or serum not to mix handle component 26 and rod unit 27 from the lower end 29 of rod unit 27.Then, remove right cylinder 3 from blood collection container 2, haemocyte in the operational analysis instrumental analysis blood collection container 2 and the blood plasma in the right cylinder 3 or serum are to be scheduled to check.At this moment, because blood collection container 2 has identical external diameter with sample cup, blood collection container 2 can directly be placed in the analytical instrument and the haemocyte in the blood collection container need not be transferred in the sample cup, like this in work efficiency with minimize and just improve to some extent aspect the collected blood volume.
Similarly, collect after the blood the present invention can be on the spot immediately with blood system from haematoblast and blood plasma or serum, and keeping under the constant situation of released state blood being transported to the place of survey, thus prevent at haulage stage blood haemolysis, solidify or the like.So, can preserve blood well and improve the accuracy of checking.In addition, because blood system so only need to collect a small amount of blood, just can be checked all required Interventions Requested from not using cyclone usually.
It should be noted that, although cap shape piston 4 is applicable to that rotation is screwed in the blood collection container 2 in the above-mentioned specific embodiments, but method of attachment is not limited to the use helical element, can comprise that other method for example forms taper shape, keeps its bubble-tight removably connecting as long as it can provide.
And, although in the implementation process of above-mentioned specific embodiments of the present invention, the example of collecting for self blood is described, wherein the person under inspection collects his blood in person, clearly for the blood collection method by licensed personnel (as the doctor) use syringe collection blood of routine, the present invention also can implement.
And, use the above-mentioned specific embodiment of blood although described as biological sample, except blood, the biological sample that the present invention can implement has, as urine, ight soil, leural effusion, ascites, saliva or the like.
According to the present invention, provide a kind of biological specimen collection method of simplification as mentioned above, it can reduce inspection cost.And, because biological sample can separate fully, various excellent results are arranged so can prove it, comprise that the time that for example prevents sample changes so that the check pin-point accuracy.
Claims (36)
1. instrument that is used for separation of biological samples comprises:
Be used to receive the biological specimen collection device of the biological sample of collection;
The filtration unit that is used for making the predetermined component of the biological sample of described collection to pass through;
Be used to receive described predetermined component, can be assembled to the device that holds separation component in the described biological specimen collection device by described filtration unit; With
Prevent that the described predetermined component that is received from entering the backflow device that prevents of described biological specimen collection device by described filtration unit backflow in containing the device of described separation component;
Wherein in case in described biological specimen collection device collection of biological sample and the device that will contain described separation component be assembled in the described biological specimen collection device, with after the predetermined component in the described biological sample is passed through described filtration unit, the described backflow device that prevents is closed in the device that contains described separation component and the flow channel between the described biological specimen collection device preventing the adverse current of described predetermined component, and receives the predetermined component of described biological sample in containing the device of described separation component respectively.
2. instrument that is used for separation of biological samples comprises:
Be used to receive the blood collection container of collecting blood;
Can make blood plasma or the serum collected in the blood pass through and the intransitable filter membrane of haemocyte;
Can be assembled in the described blood collection container and can receive by the blood plasma of described filter membrane or the right cylinder of serum; With
Preventing that the blood plasma that receives in right cylinder or serum from refluxing by described filter membrane enters the sealing cap of described blood collection container;
Wherein in case in described blood collection container, collect blood and described right cylinder be assembled in the described blood collection container, with when the blood plasma in the described blood or serum by after the described filter membrane, described sealing cap is closed in the flow channel between described right cylinder and the described blood collection container in case the adverse current of hemostasis slurry or serum receives haemocyte and blood plasma or serum separately respectively in described blood collection container and described right cylinder.
3. according to the instrument that is used for separation of biological samples of claim 2, wherein dilute solution is placed in the described blood collection container.
4. according to the instrument that is used for separation of biological samples of claim 2, wherein said blood collection container has identical external diameter with sample cup, and the upper part at described container provides helical element, provide described filter membrane at described cylindrical end portion, be stamped cap shape piston described above cylindrical, described cap shape piston has the handle component that can be screwed into described helical element and extends out from described handle component and enters described cylindrical rod unit and provide described sealing cap in the lower end of described rod unit; With
Wherein in case in described blood collection container, collect blood and described right cylinder be assembled in the described blood collection container, then described handle component is screwed in the described helical element, and the blood plasma in the blood or serum are by after the described filter membrane, described sealing cap is closed in described cylindrical end portion in case the adverse current of hemostasis slurry or serum receives blood plasma or serum and haemocyte respectively in described right cylinder and described blood collection container.
5. according to the instrument that is used for separation of biological samples of claim 4, wherein be equipped with described cap shape piston in described cylindrical upper part, main element can separate with described upper part, and pins described blood collection container; With
Wherein in a single day described handle component is screwed into the helical element of described blood collection container, and described main element will pin described blood collection container to suppress the mobile of described main element and isolate described upper part from described main element.
6. according to the instrument that is used for separation of biological samples of claim 5, can be respectively disassemble and be assembled to described cylindrical end portion to such an extent as to wherein provide the described sealing cap of described sealing cap from the lower end of described rod unit at the lower end of described rod unit and described columned end portion, and in case separate at the described handle component and the matching status between the helical element of described blood collection container, extract described cap shape piston, described sealing cap comes off to keep the sealing state of described cylindrical end portion from the lower end of described rod unit.
7. the method for a separation of biological samples, comprise step: the device that will hold separation component is assembled in the biological specimen collection device that contains collected biological sample, and the predetermined component that receives in the described biological sample by filtration unit enters the described device that holds separation component; With
Receive after described predetermined component enters in the described device that holds separation component, by preventing that backflow device is closed in the described device of separation component and the flow channel between the described biological specimen collection device of holding, with the adverse current that prevents described predetermined component with receive predetermined component respectively in the described device that holds separation component.
8. the method for a separation of biological samples, comprise step: right cylinder is assembled in the blood collection container that contains collected blood, the handle component that covers the cap shape piston on described right cylinder is screwed in the helical element of described blood collection container, and the blood plasma or the serum that receive in the described blood by filter membrane enter described right cylinder; With
Receiving described blood plasma or serum enters after the described right cylinder, be closed in flow channel between described right cylinder and the described blood collection container by sealing cap, with the adverse current that prevents described blood plasma or serum with receive blood plasma respectively or serum enters described right cylinder and haemocyte enters in the described blood collection container.
9. the method for the preparation sample that is used to quantize from biological sample, this method is used for quantitatively the secondary element undetermined at described biological sample, described method be characterised in that comprise the steps: with not quantitatively under the situation of its volume the biological sample of collected unknown volume mix with the dilute solution of prescribed volume.
10. according to the method for claim 9, the dilute solution of wherein said prescribed volume contains the indication material of ormal weight.
11., it is characterized in that also comprising the step of the dilute solution that adds the prescribed volume that contains ormal weight indication material according to the method for claim 9.
12. according to the method for claim 9, wherein said indication material is pigment or chromogen.
13. according to the method for claim 12, wherein said chromogen is an oxidation colour pattern chromogen.
14. according to the method for claim 9, wherein said biological sample is any in whole blood, blood plasma or the serum.
15. according to the method for claim 9, wherein said dilute solution is a buffer solution.
16. according to the method for claim 9, wherein said secondary element undetermined is the element in the serum.
17. the method for secondary element undetermined in the quantitative biological sample, described method is characterised in that and is used to the sample that quantizes, and this sample that is used to quantize is preparation method's preparation as follows: will not quantitatively under the situation of its volume the biological sample of collected unknown volume with contain ormal weight and indicate the dilute solution of the prescribed volume of material to mix.
18. according to the method for claim 17, wherein will not quantitatively under the situation of its volume the described biological sample of collected unknown volume mix with the dilute solution of described prescribed volume.
19. according to the method for claim 17, described method is characterised in that and comprises step:
Determine dilution ratio at biological sample described in the described sample that is used to quantize; With
Quantitative concentration at the described sample secondary element undetermined that is used for quantizing.
20. according to the method for claim 17, wherein said indication material is pigment or chromogen.
21. according to the method for claim 20, wherein said chromogen is an oxidation colour pattern chromogen.
22. according to the method for claim 17, wherein said biological sample is any in whole blood, blood plasma or the serum.
23. according to the method for claim 17, wherein said dilute solution is a buffer solution.
24. according to the method for claim 17, wherein said secondary element undetermined is the element in the serum.
25. container that is used to preserve biological sample, it is used to be kept at not the biological sample of the unknown volume that contains secondary element undetermined of collecting under the situation of quantitative its volume, up to its quilt quantitatively, described vessel filling has the dilute solution of prescribed volume and described vessel to be useful on the closable opening/closing device that adds described biological sample.
26. container that is used to prepare the sample that is used to quantize, it is used for the sample that is used to quantize from the biological sample preparation in the unknown volume that contains secondary element undetermined of quantitatively not collecting under the situation of its volume, fill described container and described vessel with the dilute solution of prescribed volume and be useful on the closable opening/closing device that adds described biological sample.
27. according to the container of claim 25, the dilute solution of wherein said prescribed volume is the solution that contains ormal weight indication material.
28. according to the container of claim 27, wherein said indication material is pigment or chromogen.
29. according to the container of claim 28, wherein said chromogen is an oxidation colour pattern chromogen.
30. according to the container that is used for the collection of biological sample of claim 25, wherein said biological sample is any in whole blood, blood plasma or the serum.
31. according to the container that is used for the collection of biological sample of claim 25, wherein said secondary element undetermined is the element in the serum.
32. the method for secondary element undetermined in the quantitative biological sample, described method comprises step:
1) preparation is by at the biological sample of the unknown volume that contains secondary element undetermined of quantitatively not collecting under the situation of its volume with contain the sample that is used to quantize that the dilute solution of the prescribed volume of ormal weight indication material is formed;
2) indicate concentration of material (C1) in the dilute solution by the described prescribed volume that contains described ormal weight indication material and the sample that is used for quantizing indicates concentration of material (C2) to determine the dilution ratio (a) of described biological sample;
3) determine concentration (Y) at the described sample secondary element undetermined that is used for quantizing; With
4) based on step 2) in the dilution ratio (a) of the biological sample determined and the step 3) the described concentration (Y) of definite sample secondary element undetermined that is used for quantizing determine secondary element undetermined in the biological sample.
33. according to the method for claim 32, wherein said dilute solution is a buffer solution.
34. according to the method for claim 32, wherein said indication material is pigment or chromogen.
35. according to the method for claim 34, wherein said chromogen is an oxidation colour pattern chromogen.
36., wherein contain the alternative respectively concentration (C1) of absorptivity (E2) of the absorptivity (E1) of dilute solution of described prescribed volume of described ormal weight indication material and secondary element undetermined and (C2) according to the method for claim 34.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03125586 CN1603820A (en) | 2003-09-29 | 2003-09-29 | Instrument for separating biological sample and separation method therefor |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03125586 CN1603820A (en) | 2003-09-29 | 2003-09-29 | Instrument for separating biological sample and separation method therefor |
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| CN1603820A true CN1603820A (en) | 2005-04-06 |
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| CN 03125586 Pending CN1603820A (en) | 2003-09-29 | 2003-09-29 | Instrument for separating biological sample and separation method therefor |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103063500A (en) * | 2011-10-19 | 2013-04-24 | 封江南 | Suspension cell dyeing device |
| CN103728172A (en) * | 2014-01-02 | 2014-04-16 | 爱威科技股份有限公司 | Method and equipment for making defecate detection solution, and diafiltration device thereof |
| CN104039372A (en) * | 2012-03-05 | 2014-09-10 | 东丘生物制药股份公司 | Blood ingredient separator |
| CN106456851A (en) * | 2014-05-14 | 2017-02-22 | 东丘生物制药股份公司 | Component separator |
| CN107884561A (en) * | 2012-04-04 | 2018-04-06 | 辛辛那提大学 | sweat simulation, collection and sensing system |
| WO2019127958A1 (en) * | 2017-12-26 | 2019-07-04 | 江苏英诺华医疗技术有限公司 | Medical rapid biochemical detection system and detection method |
| CN112689536A (en) * | 2018-08-23 | 2021-04-20 | 特鲁维安科学公司 | Plasma separation device |
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2003
- 2003-09-29 CN CN 03125586 patent/CN1603820A/en active Pending
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103063500A (en) * | 2011-10-19 | 2013-04-24 | 封江南 | Suspension cell dyeing device |
| CN103063500B (en) * | 2011-10-19 | 2015-06-17 | 封江南 | Suspension cell dyeing device |
| CN104039372A (en) * | 2012-03-05 | 2014-09-10 | 东丘生物制药股份公司 | Blood ingredient separator |
| CN107884561A (en) * | 2012-04-04 | 2018-04-06 | 辛辛那提大学 | sweat simulation, collection and sensing system |
| CN103728172A (en) * | 2014-01-02 | 2014-04-16 | 爱威科技股份有限公司 | Method and equipment for making defecate detection solution, and diafiltration device thereof |
| CN103728172B (en) * | 2014-01-02 | 2017-02-15 | 爱威科技股份有限公司 | Method and equipment for making defecate detection solution, and diafiltration device thereof |
| CN106456851A (en) * | 2014-05-14 | 2017-02-22 | 东丘生物制药股份公司 | Component separator |
| CN106456851B (en) * | 2014-05-14 | 2018-06-08 | 东丘生物制药股份公司 | Ingredient separator |
| WO2019127958A1 (en) * | 2017-12-26 | 2019-07-04 | 江苏英诺华医疗技术有限公司 | Medical rapid biochemical detection system and detection method |
| CN112689536A (en) * | 2018-08-23 | 2021-04-20 | 特鲁维安科学公司 | Plasma separation device |
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