CN105929173A - Detection kit and detection method of serum amyloid A protein - Google Patents

Detection kit and detection method of serum amyloid A protein Download PDF

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Publication number
CN105929173A
CN105929173A CN201610270124.0A CN201610270124A CN105929173A CN 105929173 A CN105929173 A CN 105929173A CN 201610270124 A CN201610270124 A CN 201610270124A CN 105929173 A CN105929173 A CN 105929173A
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buffer
mass fraction
concentration
saa
preservative
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张宁
陈明峰
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SHENZHEN GOLDSITE DIAGNOSTICS Inc
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SHENZHEN GOLDSITE DIAGNOSTICS Inc
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47—Scattering, i.e. diffuse reflection
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/96—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard

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  • Proteomics, Peptides & Aminoacids (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

The invention relates to the field of immunoassay, and especially relates to a detection kit and a detection method of a serum amyloid A protein. In the kit, a reaction solution well cooperates with a whole blood sample in order to make the kit directly detect the whole blood, so the kit can complete detection only through finger tip blood without drawing venous blood or separating serum. Compared with kits in the prior art, the kit provided by the invention has the advantages of wider linear range (2.4-240mg/L), lower detection limit (2.39mg/L), good linear range and sensitivity, average recovery rate of the detection sample of 101.87%, proportional systematic error being smaller than 5%, and good accuracy. The variation coefficient is smaller than 3% when the kit is used to respectively carry out high-value quality control and low-value quality control 10 times, so the kit has good precision.

Description

The detection kit of a kind of serum amyloid A protein and detection method
Technical field
The present invention relates to immunoassay field, particularly relate to the detection kit of a kind of serum amyloid A protein And detection method.
Background technology
Serum amyloid A protein (serum amyloid A protein, SAA) is a kind of acute-phase response Albumen, during the acute inflammatory reactions such as infection, wound SAA concentration rise be exceedingly fast, the short time through IL-1, IL-6 and TNF stimulates, and macrophage and fibroblast by being activated in liver synthesize in a large number, can raise To more than 1000 times of initial concentration, this characteristic also makes SAA become the most most sensitive acute inflammation One of mark.Meanwhile, including cardiovascular disease, obesity, ankylosing spondylitis various slowly Under property inflammatory pathologies state, outside the liver such as the adipose cell of the mankind, vascular endothelial cell and monocytes/macrophages Tissue also can synthesis secretion SAA albumen to cause Serum SA A level be a certain degree of rising.
Being similar to SAA, the concentration of c reactive protein (CRP) is also reflection infectious disease Earlier period of inflammation Sensitive indicator, both when antibacterial infects, concentration raises parallel, and when virus infects, SAA disappears at convalescence Lose faster.SAA start after inflammatory reaction about 8h raise, and exceed term of reference upper limit time early than CRP.In infectious disease, the absolute rise of SAA is higher than CRP, and therefore SAA measures, the most right Small Acute-phase protein can provide preferably discriminating.Normally about 2/3rds cold patients SAA raise, but Fewer than half patient identical performance CRP raises.Patient for virus infection, kidney transplantation exclusion reaction is (special It is not by the patient of immunosuppressant therapy) and suffer from the cystic fibrosis of adrenocortical hormones in treating Person's aspect, the detection of SAA is more conclusive than CRP, quick.Research finds, is suffering from the case of inflammatory arthritis In, SAA is the closest with the relation of Disease Activity.For SAA amyloidosis patient, with by SAA Level returns back to, normally for the treatment of objective, to improve the state of an illness.SAA physiological concentration is about the 10 of CRP Times, therefore monitoring SAA liter higher position is easier than CRP.
As the primary dcreening operation of infectious disease, SAA detects at a lot of hospitals, market occurs The test kit of distinct methods detection.In terms of the scattered light urbidmetry of SAA, test kit of the prior art is only Can realize the detection of SAA in serum, although the interference of certain hemoglobin can be resisted, but blood red Protein content is higher than 4g/L, then cannot be carried out detection.In normal human blood, the content of hemoglobin is 110g/L～160g/L, so, test kit of the prior art cannot realize the detection to whole blood.And vein Take blood system blood volume needed for serum big.If the direct quantitative of SAA in the whole blood to finger tip can be realized Then can shorten the detection time, reduce testing cost, the least to injury of human.
Summary of the invention
In view of this, the technical problem to be solved in the present invention is to provide a kind of serum amyloid A protein Detection kit and detection method, the test kit that the present invention provides has good sensitivity and precision, Can be used for the detection of whole blood, and detection method is the shortest.
The serum amyloid A protein detection kit that the present invention provides includes antibody suspension and reactant liquor；
Antibody suspension includes: SAA antibody microsphere conjugate, buffer, stabilizer, preservative；pH Value is 6～9；
Reactant liquor includes: buffer, electrolyte, surfactant, preservative and coagulant；PH value is 6～9.
In the test kit that the present invention provides, what reactant liquor can be good with whole blood sample coordinates, so making this The test kit of invention can have good susceptiveness and elaboration when detecting SAA.The more important thing is, Reactant liquor formula in test kit of the present invention is through optimizing, so that the test kit of the present invention can be direct Whole blood is detected, so that during Clinical practice, it is not necessary to venous blood samples separation serum, And only can complete detection with finger tip blood.
In certain embodiments, the mass fraction of SAA antibody microsphere conjugate is 0.05%～1%；
SAA antibody microsphere conjugate is prepared with latex beads coupling by SAA antibody, and described latex beads is Polystyrene microsphere, its surface functional group is carboxyl, amino, aldehyde radical, hydrazides, epoxy radicals or chloromethyl.
As preferably, surface functional group is carboxyl.
As preferably, the mass fraction of SAA antibody microsphere conjugate is 0.1%～0.5%.
After SAA antibody is carried out coupling with latex beads or latex particle by SAA antibody microsphere conjugate Product, in the present invention, the antibody in SAA antibody microsphere conjugate can be monoclonal antibody, it is possible to for many Clonal antibody.Its acquisition pattern can be that self-control also can be buied in market.SAA antibody and the step of latex coupling Suddenly can be to prepare voluntarily, it is possible to by being either commercially available, this is not construed as limiting by the present invention.The present invention makes Monoclonal antibody purchased from Meridian company (article No.: H86177M, H86178M).Even with antibody The latex beads of connection is carboxyl polystyrene microsphere.
The preparation method of SAA antibody microsphere conjugate includes: carboxyl polystyrene microsphere is with MES buffer Suspend, after activating with carbodiimide and N-hydroxy thiosuccinimide, with MES buffer or HEPES Buffer is resuspended, then mixes with SAA antibody and carries out coupling reaction, then in the buffer containing BSA Close, clean, finally suspend with suitably storage liquid and make.
Concrete, the preparation method of SAA antibody microsphere conjugate is: by carboxyl polystyrene microsphere, add MES (pH6.0) buffer solution for cleaning of 10mM～100mM 2-3 time, then with 10mM～100mM MES (pH6.0) buffer is settled to 0.5%～2% (mass volume ratio) concentration；It is added thereto to carbodiimide With N-hydroxy thiosuccinimide, be stirred at room temperature 15～40min activate after, with 10mM～100mM HEPES or MES buffer solution for cleaning 2 times, fixed with 10mM～100mM HEPES or MES buffer Hold to 0.2%～1% (mass volume ratio) concentration；Microsphere suspensions after activation being cleaned adds isopyknic In the SAA antibody-solutions of 0.01%～0.2%, it is stirred at room temperature 2～6h, adds 0.1%～1% (mass volume ratio) BSA is stirred at room temperature 1～6h, then with 10mM～100mM containing 0.1%～1% (mass volume ratio) BSA HEPES or Tris hydrochloride buffer clean 2 times, and be finally dispersed in and suitably store in liquid, prepare SAA antibody microsphere conjugate.
In an embodiment of the present invention, in antibody suspension,
Buffer is selected from phosphate buffer, borate buffer solution, carbonate buffer solution, barbital buffering Liquid, Tris hydrochloride buffer, glycine buffer or Good ' s buffer.
Preferably, buffer is selected from HEPES buffer or Tris hydrochloride buffer；
Stabilizer is selected from bovine serum albumin, casein, gelatin, sucrose, trehalose or polyvinyl pyrrole Alkanone.
Preferably, stabilizer is bovine serum albumin or sucrose.
Preservative is selected from sodium azide, thimerosal, macrolide antibiotics, P-hydroxybenzoic acid or ProClin Series.
Preferably, preservative is sodium azide or ProClin300.
In an embodiment of the present invention, in antibody suspension,
The concentration of buffer is 10mmol/L～500mmol/L.
Preferably, the concentration of buffer is 20～50mmol/L.
The mass fraction of stabilizer is 0.01%～5%.
Preferably, the mass fraction of stabilizer is 0.1%～3%.
The mass fraction of preservative is 0.05%～1%.
Preferably, the mass fraction of preservative is 0.05%～0.1%.
As preferably, in antibody suspension,
Buffer is HEPES buffer or Tris hydrochloride buffer；Its concentration is 20mmol/L ～50mmol/L；
Stabilizer is bovine serum albumin or sucrose；Its mass fraction is 0.1%～3%；
Preservative is sodium azide or ProClin300；Its mass fraction is 0.05%～0.1%.
In certain embodiments, antibody suspension includes: SAA antibody microsphere conjugate, HEPES are slow Rush liquid, BSA, sodium azide；PH value is 7.5.
In this embodiment, in antibody suspension, the concentration of each component is:
In certain embodiments, antibody suspension includes: SAA antibody microsphere conjugate, Tris hydrochloric acid Buffer, BSA, sucrose, ProClin300；PH value is 8.0.
In this embodiment, in antibody suspension, the concentration of each component is:
In an embodiment of the present invention, in reactant liquor,
Buffer is selected from phosphate buffer, borate buffer solution, carbonate buffer solution, barbital buffering Liquid, Tris hydrochloride buffer, glycine buffer or Good ' s buffer.
Preferably, buffer is phosphate buffer or Tris hydrochloride buffer；
Electrolyte is selected from sodium chloride, potassium chloride, magnesium chloride or magnesium sulfate.
Preferably, electrolyte is sodium chloride.
Surfactant is selected from sodium lauryl sulphate, tween 20 or triton x-100.
Preferably, surfactant is sodium lauryl sulphate or tween 20.
Preservative is selected from sodium azide, thimerosal, macrolide antibiotics, P-hydroxybenzoic acid or ProClin Series.
Preferably, preservative is sodium azide or ProClin300.
Coagulant gathers selected from Macrogol 4000, polyethylene glycol 6000, PEG 8000 or sulphuric acid Portugal Sugar.
Preferably, coagulant is polyethylene glycol 6000 or PEG 8000.
In an embodiment of the present invention, in reactant liquor,
The concentration of buffer is 10mmol/L～500mmol/L.
Preferably, the concentration of buffer is 20～100mmol/L.
The concentration of electrolyte is 50mmol/L～1000mmol/L.
Preferably, the concentration of electrolyte is 100～300mmol/L.
The mass fraction of surfactant is 0.01%～1%.
Preferably, the mass fraction of surfactant is 0.01%～0.1%.
The mass fraction of preservative is 0.05%～1%.
Preferably, the mass fraction of preservative is 0.05%～0.1%.
The mass fraction of coagulant is 0.1%～10%.
Preferably, the mass fraction of coagulant is 1%～5%.
In an embodiment of the present invention, in reactant liquor,
Buffer is phosphate buffer or Tris hydrochloride buffer；Its concentration is 20mmol/L ～100mmol/L；
Electrolyte is sodium chloride；Its concentration is 100mmol/L～300mmol/L；
Surfactant is sodium lauryl sulphate and tween 20；Its mass fraction is 0.01%～0.1%；
Preservative is sodium azide or ProClin300；Its mass fraction is 0.05%～0.1%；
Coagulant is polyethylene glycol 6000 or PEG 8000；Its mass fraction is 1～5%.
In certain embodiments, reactant liquor includes: phosphate buffer, sodium chloride, dodecyl sulfur Acid sodium, tween 20, sodium azide, polyethylene glycol 6000, pH value is 7.4.
In this embodiment, in reactant liquor, the concentration of each component is:
In certain embodiments, reactant liquor includes: Tris hydrochloride buffer, sodium chloride, dodecyl sulfur Acid sodium, tween 20, ProClin300, PEG 8000, pH value is 7.6.
In this embodiment, in reactant liquor, the concentration of each component is:
The present invention provide test kit in also include calibration object solution, including SAA antigen, buffer, Electrolyte, stabilizer and preservative.
In embodiments of the present invention, in calibration object solution,
Calibration object be mainly composed of SAA antigen；Described SAA antigen can be recombinant antigen or sky So antigen；
Buffer is selected from phosphate buffer, borate buffer solution, carbonate buffer solution, barbital buffering Liquid, Tris hydrochloride buffer, glycine buffer or Good ' s buffer.
Preferably, buffer is phosphate buffer.
Electrolyte is selected from sodium chloride, potassium chloride, magnesium chloride or magnesium sulfate.
Preferably, electrolyte is sodium chloride.
Stabilizer is selected from bovine serum albumin, casein, gelatin, sucrose or trehalose.
Preferably, stabilizer is bovine serum albumin；
Preservative is selected from sodium azide, thimerosal, macrolide antibiotics, P-hydroxybenzoic acid or ProClin Series.
Preferably, preservative is sodium azide.
In an embodiment of the present invention, in calibration object solution,
The concentration of buffer is 10mmol/L～500mmol/L.
Preferably, the concentration of buffer is 10mmol/L～50mmol/L；
The mass fraction of electrolyte is 0.01%～5%.
Preferably, the mass fraction of electrolyte is 0.9%.
The mass fraction of stabilizer is 0.01%～5%.
Preferably, the mass fraction of stabilizer is 1%～5%.
The mass fraction of preservative is 0.05%～1%.
Preferably, the mass fraction of preservative is 0.05%～0.1%.
As preferably, in calibration object solution,
Buffer is phosphate buffer；Its concentration is 20mmol/L；
Electrolyte is sodium chloride；Its mass fraction is 0.9%；
Stabilizer is bovine serum albumin；Its mass fraction is 5%；
Preservative is sodium azide；Its mass fraction is 0.09%.
SAA is detected by the test kit that the present invention provides by timing scattering turbidimetry method of testing.It uses Method is:
After testing sample is mixed with reactant liquor, measure photoelectricity value and be designated as S1；Mix with suspension again, so Rear mensuration photoelectricity value is designated as S2；According to S2-S1 value, calculate SAA in testing sample with standard curve method Content；Described testing sample is finger Peripheral whole blood, anticoagulant venous whole, blood plasma or serum, preferably Finger Peripheral whole blood.
Concrete, first with normal saline by 5 concentration of calibration object gradient dilution, it is thus achieved that 6 concentration schools Quasi-product solution, takes respectively and mixes with reactant liquor on a small quantity, adds SAA antibody suspension, and now instrument is read The scattering photoelectricity value taken is designated as S1, and after question response a period of time, scattering photoelectricity value is designated as S2, with calibration object Concentration is abscissa, and S2-S1 scattering photoelectricity value difference value is vertical coordinate fit equation Criterion curve.Secondly, Testing sample can be mixed with reactant liquor, then mix with SAA antibody suspension, S2-S1 is scattered photoelectricity Value difference value is brought in standard curve, can calculate the content of SAA in testing sample.
Described detection method is timing scattered light urbidmetry；Described detecting instrument is specific protein analyser； The described response time is 90～150 seconds, preferably 120 seconds.
In the test kit that the present invention provides, what reactant liquor can be good with whole blood sample coordinates, so that Whole blood can directly be detected by the test kit of the present invention, so that during Clinical practice, no Must venous blood samples separation serum, and only with finger tip blood can complete detection.Compared with prior art, originally The range of linearity of the test kit of invention is wider (2.4～240mg/L)；Detection limits lower (2.39mg/L), says The test kit that the bright present invention provides has the good range of linearity and sensitivity；The detection sample mean response rate It is 101.87%, ratio system error ＜ 5%, illustrate that the test kit that the present invention provides has good accurate Degree.Respectively high level Quality Control and low value Quality Control are detected 10 times, coefficient of variation ＜ 3%, illustrate that the present invention provides Test kit there is good precision.
Accompanying drawing explanation
Fig. 1 shows the standard curve of embodiment 1 test kit of the present invention；
Fig. 2 shows that embodiment 1 test kit of the present invention compares with the dependency of similar test kit；
Fig. 3 shows the range of linearity of embodiment 1 test kit of the present invention.
Detailed description of the invention
The invention provides detection kit and the detection method of a kind of serum amyloid A protein, this area Technical staff can use for reference present disclosure, is suitably modified technological parameter and realizes.Special needs to be pointed out is, All similar replacements and change apparent to those skilled in the art, they are considered as It is included in the present invention.Method and the application of the present invention are described by preferred embodiment, relevant Methods herein and application substantially can be changed in without departing from present invention, spirit and scope by personnel Dynamic or suitable change and combination, realize and apply the technology of the present invention.
The reagent of present invention employing, sample, instrument are all common commercially available product, all can buy in market.
SAA monoclonal antibody of the present invention is purchased from Meridian company (article No.: H86177M, H86178M)； Carboxyl polystyrene microsphere is purchased from Thermo Fisher company (article No.: C37479)；BSA, carbon two are sub- Amine and N-hydroxy thiosuccinimide be purchased from Aladdin company (BSA article No.: A104912-25g, Carbodiimide article No.: E106172-5g, N-hydroxy thiosuccinimide article No.: H109337-5g)；Its His chemical reagent is analytical pure.
Below in conjunction with embodiment, the present invention it is expanded on further:
The test kit that embodiment 1 present invention provides
Reactant liquor component:
SAA antibody suspension component:
Calibration object solution component:
Wherein, after reactant liquor is formulated as mixing each component, 0.22 micron membrane filter filters, subpackage ,-20 DEG C Preserve.
Being formulated as of antibody suspension:
Take 10mg carboxyl polystyrene microsphere, add appropriate 50mM MES pH6.0 buffer solution for cleaning 2-3 Secondary, finally it is settled to 0.5% (mass volume ratio) concentration with 50mM MES pH6.0 buffer.To work The polystyrene microsphere changed adds carbodiimide and N-hydroxy thiosuccinimide is appropriate, be stirred at room temperature 20min, 20mM HEPES pH7.5 buffer solution for cleaning 2 times, with 20mM HEPES pH7.5 buffer It is settled to 1% (mass volume ratio) concentration.Microsphere equal-volume after activation being cleaned adds 0.1% concentration SAA antibody-solutions in, 2h is stirred at room temperature, (mass volume ratio) BSA is stirred at room temperature 1h to add 1%, Again by the 20mM HEPES pH7.5 buffer solution for cleaning containing 1% (mass volume ratio) BSA 2 times, After SAA antibody microsphere conjugate is dispersed to containing 1% (mass volume ratio) BSA's by 0.12% concentration In 20mM HEPES pH7.5 buffer, wherein adding sodium azide mass fraction is 0.09%, makes SAA Antibody suspension.
Being formulated as of calibration object solution:
Make an addition to, in the phosphate buffer containing bovine serum albumin, make by certain density SAA antigen Its final concentration of 200mg/L, wherein adds 0.9% sodium chloride and 0.09% sodium azide, 0.22 micron membrane filter Filter, subpackage ,-20 DEG C of preservations.Can use as calibration object after assignment of tracing to the source.
The test kit that embodiment 2 present invention provides
Reactant liquor component:
SAA antibody suspension component:
Calibration object solution component:
Wherein, after reactant liquor is formulated as mixing each component, 0.22 micron membrane filter filters, subpackage ,-20 DEG C Preserve.
Being formulated as of antibody suspension:
Take 10mg carboxyl polystyrene microsphere, add appropriate 25mM MES pH6.0 buffer solution for cleaning 2-3 Secondary, finally it is settled to 1% (mass volume ratio) concentration with 25mM MES pH6.0 buffer.To activation Polystyrene microsphere in add carbodiimide and N-hydroxy thiosuccinimide appropriate, be stirred at room temperature 20min, 50mM HEPES pH7.5 buffer solution for cleaning 2 times, with 20mM HEPES pH7.5 buffer It is settled to 0.5% (mass volume ratio) concentration.It is dense that microsphere equal-volume after activation being cleaned adds 0.08% In the SAA antibody-solutions of degree, 3h being stirred at room temperature, (mass volume ratio) BSA is stirred at room temperature to add 0.5% 1h, then by the 50mM HEPES pH7.5 buffer solution for cleaning 2 containing 0.5% (mass volume ratio) BSA Secondary, finally SAA antibody microsphere conjugate is dispersed to containing 0.5% (mass volume ratio) by 0.2% concentration In the 50mM HEPES pH7.5 buffer of BSA and 2% (mass volume ratio) sucrose, add nitrine Sodium value mass fraction is 0.09%, makes SAA antibody suspension.
Being formulated as of calibration object solution:
Make an addition to, in the phosphate buffer containing bovine serum albumin, make by certain density SAA antigen Its final concentration of 220mg/L, wherein adds 0.9% sodium chloride and 0.09% sodium azide, 0.22 micron membrane filter Filter, subpackage ,-20 DEG C of preservations.Can use as calibration object after assignment of tracing to the source.
The test kit that embodiment 3 present invention provides
Reactant liquor component:
SAA antibody suspension component:
Calibration object solution component:
Wherein, after reactant liquor is formulated as mixing each component, 0.22 micron membrane filter filters, subpackage ,-20 DEG C Preserve.
Being formulated as of antibody suspension:
Take 10mg carboxyl polystyrene microsphere, add appropriate 25mM MES pH6.0 buffer solution for cleaning 2-3 Secondary, finally it is settled to 0.5% (mass volume ratio) concentration with 25mM MES pH6.0 buffer.To work The polystyrene microsphere changed adds carbodiimide and N-hydroxy thiosuccinimide is appropriate, be stirred at room temperature 20min, 25mM MES pH6.0 buffer solution for cleaning 2 times, with 25mM MES pH6.0 buffer constant volume To 0.5% (mass volume ratio) concentration.Microsphere equal-volume after activation being cleaned adds 0.05% concentration In SAA antibody-solutions, 3h being stirred at room temperature, (mass volume ratio) BSA is stirred at room temperature 1h to add 1%, then By the 20mM Tris-HCl pH8.0 buffer solution for cleaning containing 2% (mass volume ratio) BSA 2 times, finally SAA antibody microsphere conjugate is dispersed to the 20mM containing 1% (mass volume ratio) BSA by 0.3% concentration In Tris-HCl pH8.0 buffer, adding ProClin300 mass fraction is 0.1%, makes SAA antibody Suspension.
Being formulated as of calibration object solution:
Make an addition to, in the phosphate buffer containing bovine serum albumin, make by certain density SAA antigen Its final concentration of 250mg/L, wherein adds 0.9% sodium chloride and 0.09% sodium azide, 0.22 micron membrane filter Filter, subpackage ,-20 DEG C of preservations.Can use as calibration object after assignment of tracing to the source.
The test kit that embodiment 4 present invention provides
Reactant liquor component:
SAA antibody suspension component:
Standard solution component:
Wherein, after reactant liquor is formulated as mixing each component, 0.22 micron membrane filter filters, subpackage ,-20 DEG C Preserve.
Being formulated as of antibody suspension:
Take 10mg carboxyl polystyrene microsphere, add appropriate 20mM MES pH6.0 buffer solution for cleaning 2-3 Secondary, finally it is settled to 0.5% (mass volume ratio) concentration with 20mM MES pH6.0 buffer.To work The polystyrene microsphere changed adds carbodiimide and N-hydroxy thiosuccinimide is appropriate, be stirred at room temperature 20min, 20mM MES pH6.0 buffer solution for cleaning 2 times, with 20mM MES pH6.0 buffer constant volume To 0.5% (mass volume ratio) concentration.Microsphere equal-volume after activation being cleaned adds 0.02% concentration In SAA antibody-solutions, 4h being stirred at room temperature, (mass volume ratio) BSA is stirred at room temperature 1h to add 1%, then By the 20mM Tris-HCl pH8.0 buffer solution for cleaning containing 1% (mass volume ratio) BSA 2 times, finally SAA antibody microsphere conjugate is dispersed to containing 0.2% (mass volume ratio) BSA and 3% by 0.4% concentration In the 20mM Tris-HCl pH8.0 buffer of sucrose (mass volume ratio), add ProClin300 mass Mark is 0.1%, makes SAA antibody suspension.
Being formulated as of calibration object solution:
Make an addition to, in the phosphate buffer containing bovine serum albumin, make by certain density SAA antigen Its final concentration of 180mg/L, wherein adds 0.9% sodium chloride and 0.09% sodium azide, 0.22 micron membrane filter Filter, subpackage ,-20 DEG C of preservations.Can use as calibration object after assignment of tracing to the source.
Embodiment 5 present invention provides the using method of test kit
With embodiment 1 preparation test kit as experimental subject, as a example by state's Saite determines protein analyzer, adopt Test with timing scattered light urbidmetry:
A. Criterion curve (as shown in Figure 1): by SAA calibration object gradient dilution to 6 concentration, point Do not take 2 μ L calibration objects to add to 500 μ L reactant liquors mix, then add 40 μ LSAA antibody suspension mixings, Now instrument reads scattering photoelectricity value S1, and after 120 seconds, instrument reads scattering photoelectricity value S2 again, With concentration as abscissa, S2-S1 scattering photoelectricity value difference value is vertical coordinate matched curve, is standard curve. The fitting formula of gained standard curve is y=-0.000x3+0.071x2+28.58x-58.54；R2=0.999.
B. the detection of whole blood sample: take people's whole blood sample 2 μ L to be measured and add to mix in the reactant liquor of 500 μ L, Adding 40 μ LSAA antibody suspension mixings again, the S2-S1 of gained is scattered photoelectricity value difference value is 2127, band Entering standard curve, calculating the content of SAA in testing sample is 65.74mg/L.
Embodiment 6 present invention provides the detection of test kit to limit
Experimental technique:
Detect as blank sample with zero-dose calibration object or sample diluting liquid, replication 20 times, Draw the scattering photoelectricity value of 20 results, calculate its meansigma methods (Xm) and standard deviation (SD), draw Xm+ 2SD, by Xm+ 2SD value brings standard curve equation into, obtains the concentration value of correspondence, is minimum inspection Survey limit.
Experimental result:
The scattering photoelectricity value of 20 tests is computed shown in table 1, by Xm+ 2SD value brings standard curve into Equation, obtains lowest detection and is limited to 2.39mg/L.
Table 1 test kit of the present invention detection limit
Scattering photoelectricity value
Average Xm(mg/L) 1.5
Standard deviation SD 4.2981
Xm+2SD 10.0962
Embodiment 7 present invention provides the precision of test kit
Experimental technique:
(target value is for the SAA high level Quality Control (target value is 99mg/L) of preparation certain concentration and low value Quality Control 22mg/L) each portion, carries out 10 times with the test kit that the embodiment of the present invention 1 provides to every part of Quality Control thing Detection, calculates the meansigma methods (X of testing result respectivelym), standard deviation (SD) and the coefficient of variation (CV%), CV%=SD/Xm× 100%.
Experimental result:
The coefficient of variation of high level Quality Control is 1.38%, and the coefficient of variation of low value Quality Control is 2.34%, is respectively less than 10%, illustrate that the precision of test kit of the present invention is good.The inspection of the test kit that other embodiments of the invention provide Survey result similarly.The results are shown in Table 2.
Table 2 test kit of the present invention precision
High level Quality Control Low value Quality Control
Average Xm(mg/L) 98.93 21.9
Standard deviation SD 1.36 0.51
Coefficient of variation CV 1.38% 2.34%
Embodiment 8 present invention provides the accuracy of test kit
Experimental technique:
Take certain density conventional sense sample (venous whole), points three parts, every part of 1mL, wherein one Part adds the SAA solution 0.1mL that concentration is 100mg/L, makes analysis sample 1；Portion adds wherein Enter the SAA solution 0.1mL that concentration is 500mg/L, make analysis sample 2；Another part adds physiology salt Water 0.1mL, makes basis sample.Respectively basis sample and analysis sample 1,2 are tested, each sample This test calculates average three times, and calculates the response rate and ratio system error.
The response rate=(analyzing test sample average-basis test sample average)/add concentration × 100%
Average recovery rate=(response rate 1+ response rate 2)/2 × 100%
Ratio system error=| 100%-average recovery rate |
Experimental result:
As shown in table 3, average recovery rate is 101.87%, and ratio system error is 1.87% less than 5%, Illustrate that the test kit testing result accuracy of the present invention is higher.The test kit that other embodiments of the invention provide Testing result similarly.
Table 3 test kit of the present invention accuracy
Embodiment 9 present invention provides the range of linearity of test kit
Experimental technique:
Preparation 240mg/LSAA high concentration sample, used normal saline dilution 100 again to 2.4mg/L, Again the two is carried out doubling dilution, obtain the sample of 5 concentration, be designated as theoretical value (T).Use the present invention The test kit that embodiment 1 provides sample parallel assay 3 times to each concentration respectively, calculates meansigma methods (Xm), with diluted concentration theoretical value X-axis, with detectable concentration meansigma methods for Y-axis EXCEL software Drawing scatterplot, carry out fitting a straight line with method of least square, software calculates coefficient R automatically2, and Calculate deviation from linearity B, B=(T-Xm)/T × 100%.
Experimental result:
Equation of linear regression is Y=0.982X+2.365, coefficient R2=0.997, and deviation from linearity Within ± 10%, illustrate that test kit of the present invention returns in 2.4～240mg/L internal linear good.The present invention its The testing result of the test kit that his embodiment provides is similarly.As shown in Figure 3.Concrete data are shown in Table 4.
The table 4 test kit of the present invention range of linearity
Theoretical value T (mg/L) Measured value Xm(mg/L) Deviation from linearity B
240 232.12 -3.28%
180.6 186.4 3.21%
121.2 124.03 2.33%
61.8 62.6 1.29%
2.4 2.17 -9.58%
Below it is only the preferred embodiment of the present invention, it is noted that for the common skill of the art For art personnel, under the premise without departing from the principles of the invention, it is also possible to make some improvements and modifications, These improvements and modifications also should be regarded as protection scope of the present invention.

Claims (10)

1. a serum amyloid A protein detection kit, it is characterised in that include antibody suspension, Reactant liquor；
Described antibody suspension includes: SAA antibody microsphere conjugate, buffer, stabilizer, preservative； PH value is 6～9；
Described reactant liquor includes: buffer, electrolyte, surfactant, preservative and coagulant；pH Value is 6～9.
Serum amyloid A protein detection kit the most according to claim 1, it is characterised in that Wherein, the mass fraction of described SAA antibody microsphere conjugate is 0.05%～1%；
Described SAA antibody microsphere conjugate is prepared with latex beads coupling by SAA antibody, described latex Microsphere is polystyrene microsphere, its surface functional group be carboxyl, amino, aldehyde radical, hydrazides, epoxy radicals or Chloromethyl.
Serum amyloid A protein detection kit the most according to claim 1, it is characterised in that In described antibody suspension,
The concentration of described buffer is 10mmol/L～500mmol/L；
The mass fraction of described stabilizer is 0.01%～5%；
The mass fraction of described preservative is 0.05%～1%；
Described buffer is selected from phosphate buffer, borate buffer solution, carbonate buffer solution, barbital Buffer, Tris hydrochloride buffer, glycine buffer or Good ' s buffer；
Described stabilizer is selected from bovine serum albumin, casein, gelatin, sucrose, trehalose or polyethylene Ketopyrrolidine；
Described preservative selected from sodium azide, thimerosal, macrolide antibiotics, P-hydroxybenzoic acid or ProClin series.
Serum amyloid A protein detection kit the most according to claim 1, it is characterised in that In described antibody suspension,
Described buffer is HEPES buffer or Tris hydrochloride buffer；Its concentration is 20mmol/L ～50mmol/L；
Described stabilizer is bovine serum albumin or sucrose；Its mass fraction is 0.1%～3%；
Described preservative is sodium azide or ProClin300；Its mass fraction is 0.05%～0.1%.
Serum amyloid A protein detection kit the most according to claim 1, it is characterised in that In described reactant liquor,
The concentration of described buffer is 10mmol/L～500mmol/L；
The concentration of described electrolyte is 50mmol/L～1000mmol/L；
The mass fraction of described surfactant is 0.01%～1%；
The mass fraction of described preservative is 0.05%～1%；
The mass fraction of described coagulant is 0.1%～10%；
Described buffer is selected from phosphate buffer, borate buffer solution, carbonate buffer solution, barbital Buffer, Tris hydrochloride buffer, glycine buffer or Good ' s buffer；
Described electrolyte is selected from sodium chloride, potassium chloride, magnesium chloride or magnesium sulfate；
Described surfactant is selected from sodium lauryl sulphate, tween 20 or triton x-100；
Described preservative selected from sodium azide, thimerosal, macrolide antibiotics, P-hydroxybenzoic acid or ProClin series；
Described coagulant is selected from Macrogol 4000, polyethylene glycol 6000, PEG 8000 or sulphuric acid Glucosan.
Serum amyloid A protein detection kit the most according to claim 1, it is characterised in that In described reactant liquor,
Described buffer is phosphate buffer or Tris hydrochloride buffer；Its concentration is 20mmol/L ～100mmol/L；
Described electrolyte is sodium chloride；Its concentration is 100mmol/L～300mmol/L；
Described surfactant is sodium lauryl sulphate and tween 20；Its mass fraction is 0.01%～0.1%；
Described preservative is sodium azide or ProClin300；Its mass fraction is 0.05%～0.1%；
Described coagulant is polyethylene glycol 6000 or PEG 8000；Its mass fraction is 1%～5%.
Serum amyloid A protein detection kit the most according to claim 1, it is characterised in that Also include calibration object solution, including SAA antigen, buffer, electrolyte, stabilizer and preservative.
Serum amyloid A protein detection kit the most according to claim 7, it is characterised in that In described calibration object,
Described calibration object be mainly composed of SAA antigen；
The concentration of described buffer is 10mmol/L～500mmol/L；
The mass fraction of described electrolyte is 0.01%～5%；
The mass fraction of described stabilizer is 0.01%～5%；
The mass fraction of described preservative is 0.05%～1%；
Described buffer is selected from phosphate buffer, borate buffer solution, carbonate buffer solution, barbital Buffer, Tris hydrochloride buffer, glycine buffer or Good ' s buffer；
Described electrolyte is selected from sodium chloride, potassium chloride, magnesium chloride or magnesium sulfate；
Described stabilizer is selected from bovine serum albumin, casein, gelatin, sucrose or trehalose；
Described preservative selected from sodium azide, thimerosal, macrolide antibiotics, P-hydroxybenzoic acid or ProClin series.
Serum amyloid A protein detection kit the most according to claim 7, it is characterised in that In described calibration object solution,
The concentration of described SAA antigen is 150～250mg/L；
Described buffer is phosphate buffer；Its concentration is 20mmol/L；
Described electrolyte is sodium chloride；Its mass fraction is 0.9%；
Described stabilizer is bovine serum albumin；Its mass fraction is 5%；
Described preservative is sodium azide；Its mass fraction is 0.09%.
10. the using method of serum amyloid A protein detection kit described in any one of claim 1～9, It is characterized in that, after testing sample is mixed with reactant liquor, measure photoelectricity value and be designated as S1；Again with suspension Mixing, then measures photoelectricity value and is designated as S2；According to S2-S1 value, calculate testing sample with standard curve method The content of middle SAA；Described testing sample is finger Peripheral whole blood, anticoagulant venous whole, blood plasma or blood Clearly.
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