CN107436256A - A kind of biochemical calibrating method - Google Patents

A kind of biochemical calibrating method Download PDF

Info

Publication number
CN107436256A
CN107436256A CN201710581212.7A CN201710581212A CN107436256A CN 107436256 A CN107436256 A CN 107436256A CN 201710581212 A CN201710581212 A CN 201710581212A CN 107436256 A CN107436256 A CN 107436256A
Authority
CN
China
Prior art keywords
calibration
product
stablize
biochemical
stored
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201710581212.7A
Other languages
Chinese (zh)
Inventor
赵晓敏
陈晶
陈玲玮
秦康
李慧源
代冰
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
KINGMED CHANGSHA MEDICAL TESTING INSTITUTE Co Ltd
Original Assignee
KINGMED CHANGSHA MEDICAL TESTING INSTITUTE Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by KINGMED CHANGSHA MEDICAL TESTING INSTITUTE Co Ltd filed Critical KINGMED CHANGSHA MEDICAL TESTING INSTITUTE Co Ltd
Priority to CN201710581212.7A priority Critical patent/CN107436256A/en
Publication of CN107436256A publication Critical patent/CN107436256A/en
Pending legal-status Critical Current

Links

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/28Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

The purpose of the application is to disclose a kind of biochemical calibrating method, it is characterised in that including:Step 1:Calibration product corresponding to selection;Step 2:Calibration product in the step 1 are melted according to the store method of the calibration product and again method and operated;Step 3:Specimen holder calibration product in the step 2 being put into calibration instrument;Step 4:The calibration results of the calibration instrument are checked, the record for calibrating baseline results preserves;Step 5:Whether measure definite value quality-control product or routine use quality-control product, see result in allowed band;In the step 2, the calibration product include the calibration product suitable for Roche C501 automatic clinical chemistry analyzers;Simple to operate, flow science, standard is clear and definite, and it is good to put into practice operating effect, and a kind of biochemical calibrating method cost is high, flow not science to solve, and standard is indefinite, puts into practice that operating effect is bad, operation difficulty is high, is difficult to the technical problem that replicates operation.

Description

A kind of biochemical calibrating method
Technical field
The invention belongs to field of water quality detection, in particular to a kind of biochemical calibrating method.
Background technology
In medical experiment and medical science detection activity, because raw water quality hardness in all parts of the country differs huge, impurity is more, Large effect can be produced to the result tested and detected, therefore the detection for water purification machine water quality has with the science monitored Vital effect.
But existing detection and monitoring method flow not science, standard is indefinite, and it is bad to put into practice operating effect.
Therefore, a kind of biochemical calibrating method how is researched and developed, can solve the problem that above mentioned problem, becomes and is asked for technology urgently to be resolved hurrily Topic.
The content of the invention
The subject matter that the application solves is to provide a kind of biochemical calibrating method, simple to operate, flow science, and standard is bright Really, it is good to put into practice operating effect, to solve a kind of biochemical calibrating method cost height, flow not science, standard is indefinite, practice operation It is ineffective, operation difficulty is high, be difficult to replicate operation technical problem.
In order to solve the above-mentioned technical problem, the invention discloses a kind of biochemical calibrating method, its technical scheme are as follows:
A kind of biochemical calibrating method, it is characterised in that including:
Step 1:Calibration product corresponding to selection;
Step 2:Calibration product in the step 1 are melted according to the store method of the calibration product and again method and grasped Make;
Step 3:Specimen holder calibration product in the step 2 being put into calibration instrument;
Step 4:The calibration results of the calibration instrument are checked, the record for calibrating baseline results preserves;
Step 5:Whether measure definite value quality-control product or routine use quality-control product, see result in allowed band;
In the step 2, the calibration product include the calibration product suitable for Roche C501 automatic clinical chemistry analyzers;.
Further, calibration is re-started when there is any situation:A. reagent lot changes;B. Quality Control will Ask change;C. six months were calibrated apart from last time;D. instrument carries out larger maintenance, maintenance or has changed important portion Part, detection performance may be influenceed.
Further, the calibration product for Roche C501 automatic clinical chemistry analyzers include:Multinomial biochemical calibration object, lipid Multinomial detection calibration object, creatine kinase isozyme detection calibration object, the multinomial calibration object of protein, prealbumin-anti-hammer Bacterium hemolysin O-CER detection calibration object, rheumatoid factor calibration solution, open channel calibration solution are the supporting school of kit Quasi- product.
Further, the store method of the multinomial biochemical calibration object includes:2~8 DEG C are deposited in the case of not opening can The stable extremely regulation term of validity;15~25 DEG C are stored in after redissolution, can be stablized 8 hours;2~8 DEG C are stored in, can be stablized 2 days;Preserve In -15~-25 DEG C, can stablize 30 days, it is impossible to multigelation;
The redissolution method of the multinomial biochemical calibration object includes:Accurately drawn using corrected pipette or measuring pipette 3mL reagents are entered in bottle with water to be stood, and bottle is inverted after 15 minutes, is mixed after placing 30 minutes altogether.
Further, redissolution is additionally included in the step 2 and carries out packaging operation afterwards, the packaging operation includes:Press It is put into cystosepiment and freezes after daily expense packing, is fitted into after staying overnight in polybag;
Dispense the calibration object frozen and machine testing is mixed after room temperature is melted 15 minutes again.
Further, the store method of the multinomial detection calibration object of the lipid includes:Deposit in 2 in the case of not opening~ 8 DEG C can stablize to the regulation term of validity;15~25 DEG C are stored in after melting again, can be maintained 8 hours;2~8 DEG C are stored in, 5 can be maintained My god;- 15~-25 DEG C are stored in, can be maintained 4 weeks, it is impossible to multigelation;
The redissolution method of the multinomial detection calibration object of lipid includes:It is accurate using corrected pipette or measuring pipette Really draw 1mL reagents to be entered in bottle to stand with water, bottle is inverted after 15 minutes, is mixed after placing 30 minutes altogether.
Further, the store method of the kinase isozyme detection calibration object includes:2 are deposited in the case of not opening ~8 DEG C can stablize to the regulation term of validity, and 15~25 DEG C are stored in after redissolution, can be maintained 24 hours;2~8 DEG C are stored in, can be maintained 2 days;- 15~-25 DEG C are stored in, can be maintained 4 weeks, it is impossible to multigelation;
The redissolution method of the kinase isozyme detection calibration object includes:Using corrected pipette or measuring pipette Accurate 1mL reagents of drawing are entered in bottle to stand with water, and bottle is inverted after 15 minutes, is mixed after placing 30 minutes altogether
Further, the calibration product also include the calibration product suitable for Roche E601 electrochemiluminescence analysis instrument, Roche The calibration product of E601 electrochemiluminescence analysis instrument include that needs packing freezes and need not dispense two kinds of frost;
The project that the calibration product for needing packing to freeze use includes INS, CP, AFP, CA199, TPSA, hGH, HE4 and PCT;
Need not dispense frost calibration product use project include FT3, T3, T4, TSH, FT4, HCG, CEA, CA125, CA153, FPSA, CYF211 and NSE.
Further, it is necessary to which dispensing the store method of the calibration product of frost includes:2~8 DEG C are deposited in the case of not opening It can stablize to the regulation term of validity;- 20 DEG C are stored in after redissolution, INS can stablize March;AFP and TPSA can stablize 12 weeks;CP can only Stable January;CA199 can stablize 2 months;HGH can stablize 1 month;HE4, PCT can stablize 2 months;It is unable to multigelation;
Needing the redissolution method of the calibration product of packing frost includes:Accurately inhaled using corrected pipette or measuring pipette Take 1.0mL reagents to be entered in bottle to stand with water, bottle is inverted after 15 minutes, mixed after placing 30 minutes altogether.
Further, it is not necessary to which dispensing the store method of the calibration product of frost includes:2~8 are deposited in the case of not opening DEG C can stablize to regulation the term of validity.The stability of calibration object composition after redissolution:2~8 DEG C are stored in, NSE can stablize 1 month, FT3, T3, CYF211 can stablize 8 weeks, FT4, T4, TSH, HCG, and CEA, CA125, CA153, FPSA can stablize 12 weeks;
The redissolution method of the calibration product of frost, which need not be dispensed, to be included:FT3, T3, HCG, NSE, CYF211 are freeze-dried powder, 1.0mL reagents are accurately drawn using corrected pipette or measuring pipette to enter in bottle to stand with water, and bottle is inverted after 15 minutes, Mix and be stored in 2~8 DEG C of refrigerator cold-storage layers after placing 30 minutes altogether;
Other project calibration solutions are liquid, during calibration, daily need amount are drawn after mixing in sample cup, is stoppered rubber Plug, room temperature mix upper machine testing after placing 5 minutes, remaining calibration product put back to 2~8 DEG C of refrigerators immediately after daily need amount is drawn Refrigerate in layer.
The application provide biochemical calibrating method facility simple to operate and flexibly, not only have common staining method operation The advantages that simple flow science, standard is clear and definite, and it is good to put into practice operating effect.
Embodiment
Some vocabulary has such as been used to censure specific components among specification and claim.Those skilled in the art should It is understood that hardware manufacturer may call same component with different nouns.This specification and claims are not with name The difference of title is used as the mode for distinguishing component, but is used as the criterion of differentiation with the difference of component functionally.Specification Subsequent descriptions for implement the application better embodiment, so it is described description be for the purpose of the rule for illustrating the application, It is not limited to scope of the present application.The protection domain of the application is worked as to be defined depending on appended claims institute defender.
Embodiment one:
A kind of biochemical calibrating method, it is characterised in that including:
Step 1:Calibration product corresponding to selection;
Step 2:Calibration product in the step 1 are melted according to the store method of the calibration product and again method and grasped Make;
Step 3:Specimen holder calibration product in the step 2 being put into calibration instrument;
Step 4:The calibration results of the calibration instrument are checked, the record for calibrating baseline results preserves;
Step 5:Whether measure definite value quality-control product or routine use quality-control product, see result in allowed band.
Calibration is re-started when there is any situation:A. reagent lot changes;B. Quality Control requires to change;c. Six months were calibrated apart from last time;D. instrument carries out larger maintenance, maintenance or has changed important component, Ke Nengying Ring detection performance.
In the step 2, the calibration product are included suitable for Roche C501 automatic clinical chemistry analyzers and Roche E601 electricity The calibration product of chemiluminescent analyzer;
Calibration product for Roche C501 automatic clinical chemistry analyzers include:Multinomial biochemical calibration object, the multinomial detection of lipid With calibration object, creatine kinase isozyme detection calibration object, the multinomial calibration object of protein, prealbumin-antistreptolysin O- CER detection calibration objects, rheumatoid factor calibration solution, open channel calibration solution are the supporting calibration object of kit.
The each project of Roche E601 electrochemiluminescence analysis instrument has corresponding calibration product.
ARCHITECT i2000SR calibration object:Abbott Laboratories use the corresponding internal reference of project.
Calibration object used in TOSOH G8 glycosylated hemoglobin instruments:The supporting calibration product of TOSOH HbA1C.
For any of the above calibration product, biochemical/luminous personnel are when carrying out an acceptance inspection, it should be noted that whether its transport conforms to Ask, whether enough, outer packing is good, whether article damages, whether preservation condition and the term of validity meet related request for quantity. If query be present, it is necessary to be handled in time, and make respective record.The calibration object of reception need to indicate date received and according to rule Surely stored, guarantee uses before the deadline.
The store method of the multinomial biochemical calibration object includes:2~8 DEG C are deposited in the case of not opening can stablize to regulation The term of validity;15~25 DEG C are stored in after redissolution, can be stablized 8 hours;2~8 DEG C are stored in, can be stablized 2 days;It is stored in -15~-25 DEG C, it can stablize 30 days, it is impossible to multigelation;
The redissolution method of the multinomial biochemical calibration object includes:Accurately drawn using corrected pipette or measuring pipette 3mL reagents are entered in bottle with water to be stood, and bottle is inverted after 15 minutes, is mixed after placing 30 minutes altogether.
Redissolution is additionally included in the step 2 and carries out packaging operation afterwards, the packaging operation includes:Need to use by daily It is put into cystosepiment and freezes after amount packing, is fitted into after staying overnight in polybag;
Dispense the calibration object frozen and machine testing is mixed after room temperature is melted 15 minutes again.
The store method of the multinomial detection calibration object of lipid includes:2~8 DEG C are deposited in the case of not opening to stablize To the regulation term of validity;15~25 DEG C are stored in after melting again, can be maintained 8 hours;2~8 DEG C are stored in, can be maintained 5 days;Be stored in- 15~-25 DEG C, it can maintain 4 weeks, it is impossible to multigelation;
The redissolution method of the multinomial detection calibration object of lipid includes:It is accurate using corrected pipette or measuring pipette Really draw 1mL reagents to be entered in bottle to stand with water, bottle is inverted after 15 minutes, is mixed after placing 30 minutes altogether.
The store method of the kinase isozyme detection calibration object includes:2~8 DEG C are deposited in the case of not opening can be steady The fixed extremely regulation term of validity, is stored in 15~25 DEG C, can maintain 24 hours after redissolution;2~8 DEG C are stored in, can be maintained 2 days;Preserve In -15~-25 DEG C, can maintain 4 weeks, it is impossible to multigelation;
The redissolution method of the kinase isozyme detection calibration object includes:Using corrected pipette or measuring pipette Accurate 1mL reagents of drawing are entered in bottle to stand with water, and bottle is inverted after 15 minutes, is mixed after placing 30 minutes altogether.
The store method of the multinomial calibration object of protein includes:Liquid deposits in 2~8 DEG C in the case of not opening can stablize To the regulation term of validity, 2~8 DEG C are stored in after opening, can stablize 4 weeks, lid please be cover tightly when not in use;
The redissolution method of the multinomial calibration object of protein includes:This product is liquid, and daily need amount is drawn after mixing (300 μ l) is stoppered rubber stopper in Hitachi's sample cup, and room temperature mixes upper machine testing after placing 5 minutes, remaining calibration product are being drawn Put back to immediately after daily need amount in 2~8 DEG C of environment.
The store method of the prealbumin-antistreptolysin O (ASO)-CER detection calibration object includes:Do not open Depositing in 2~8 DEG C in the case of bottle can stablize to the regulation term of validity, and 15~25 DEG C are stored in after redissolution, can be maintained 8 hours;Preserve In 2~8 DEG C, can maintain 2 days;- 15~-25 DEG C are stored in, can be maintained 2 weeks, it is impossible to multigelation;
The redissolution method of the prealbumin-antistreptolysin O (ASO)-CER detection calibration object includes:Using Corrected pipette or measuring pipette accurately draw 1mL reagents and are entered in bottle to stand with water, and bottle is inverted after 15 minutes, place altogether Mixed after 30 minutes.
Calibration uses the project of the supporting calibration solution of kit:TBA, TSGF.
In TBA projects, calibration object is liquid, be can be used directly;Bottle cap is tightened after use, avoids polluting, at (2-8) DEG C preserve, can not freeze, used calibration object can not be refunded in original packing bottle;With 2 points of deionized water and TBA calibration objects Calibration;Calibration and the requirement of the calibration frequency:Under normal circumstances, primary calibration at least should be carried out to measure weekly, it is following when occurring During situation, when the reagent lot such as used changes, the instrument that uses safeguarded, maintained or critical component is changed Afterwards, the measurement result of quality-control product occurs drift or beyond defined scope, to the sample of patient after should being calibrated again to measure This is detected;Usage amount is about 3 drops.
In TSGF projects, 2-8 DEG C can stablize to the term of validity;Standard curve is calibrated using two point Linears;Reagent lot changes Suggest re-scaling after change;It is recommended that using T5DLCAL1, T5DLCAL2 standard items that Reagent Company provides in full-automatic biochemical point Carried out in analyzer.
Wherein, calibration is included using the project of prealbumin-antistreptolysin O (ASO)-CER detection calibration object ASO;Calibration includes C3, C4, CRP, IGA, IGG, IGM using the project of the multinomial calibration object of protein;Calibration uses creatine kinase The project of isodynamic enzyme detection calibration object includes CK-MB;Calibration using the multinomial detection calibration object of lipid project include HDL, LDL、APOA、APOB;Calibration using multinomial biochemical calibration object project include routine biochemistry series, as ALB, ALP, ALT, AST, DBIL, TBIL, CHOL, CK, CR, GGT, GLU, HBDH, LDH, TP, TG, UA and UREA.
The calibration product of Roche E601 electrochemiluminescence analysis instrument include needing to dispense freezing and need not dispense frost two Kind;
The project that the calibration product for needing packing to freeze use includes INS, CP, AFP, CA199, TPSA, hGH, HE4 and PCT;
Need not dispense frost calibration product use project include FT3, T3, T4, TSH, FT4, HCG, CEA, CA125, CA153, FPSA, CYF211 and NSE.
Needing the store method of the calibration product of packing frost includes:2~8 DEG C are deposited in the case of not opening can stablize to rule Determine the term of validity;- 20 DEG C are stored in after redissolution, INS can stablize March;AFP and TPSA can stablize 12 weeks;CP can only stablize January; CA199 can stablize 2 months;HGH can stablize 1 month;HE4, PCT can stablize 2 months;It is unable to multigelation;
Needing the redissolution method of the calibration product of packing frost includes:Accurately inhaled using corrected pipette or measuring pipette Take 1.0mL reagents to be entered in bottle to stand with water, bottle is inverted after 15 minutes, mixed after placing 30 minutes altogether.
The store method of the calibration product of frost, which need not be dispensed, to be included:2~8 DEG C are deposited in the case of not opening can stablize extremely Provide the term of validity.The stability of calibration object composition after redissolution:2~8 DEG C are stored in, NSE can stablize 1 month, FT3, T3, CYF211 can stablize 8 weeks, FT4, T4, TSH, HCG, and CEA, CA125, CA153, FPSA can stablize 12 weeks;
The redissolution method of the calibration product of frost, which need not be dispensed, to be included:FT3, T3, HCG, NSE, CYF211 are freeze-dried powder, 1.0mL reagents are accurately drawn using corrected pipette or measuring pipette to enter in bottle to stand with water, and bottle is inverted after 15 minutes, Mix and be stored in 2~8 DEG C of refrigerator cold-storage layers after placing 30 minutes altogether;
Other project calibration solutions are liquid, during calibration, daily need amount are drawn after mixing in sample cup, is stoppered rubber Plug, room temperature mix upper machine testing after placing 5 minutes, remaining calibration product put back to 2~8 DEG C of refrigerators immediately after daily need amount is drawn Refrigerate in layer.
The biochemical calibrating method facility simple to operate and flexible, flow science that the application provides, standard is clear and definite, practice behaviour It is good to make effect;Provide that careful, reality has strong operability, it is simple to operate.
Some preferred embodiments of the application have shown and described in described above, but as previously described, it should be understood that the application Be not limited to form disclosed herein, be not to be taken as the exclusion to other embodiment, and available for various other combinations, Modification and environment, and above-mentioned teaching or the technology or knowledge of association area can be passed through in application contemplated scope described herein It is modified., then all should be in this Shen and the change and change that those skilled in the art are carried out do not depart from spirit and scope Please be in the protection domain of appended claims.

Claims (10)

  1. A kind of 1. biochemical calibrating method, it is characterised in that including:
    Step 1:Calibration product corresponding to selection;
    Step 2:Calibration product in the step 1 are melted according to the store method of the calibration product and again method and operated;
    Step 3:Specimen holder calibration product in the step 2 being put into calibration instrument;
    Step 4:The calibration results of the calibration instrument are checked, the record for calibrating baseline results preserves;
    Step 5:Whether measure definite value quality-control product or routine use quality-control product, see result in allowed band;
    In the step 2, the calibration product include the calibration product suitable for Roche C501 automatic clinical chemistry analyzers.
  2. 2. biochemical calibrating method according to claim 1, it is characterised in that when there is any situation again Calibrated:A. reagent lot changes;B. Quality Control requires to change;C. six months were calibrated apart from last time;D. instrument is carried out larger Maintenance, maintenance or changed important component, detection performance may be influenceed.
  3. 3. biochemical calibrating method according to claim 2, it is characterised in that for Roche C501 automatic clinical chemistry analyzers Calibration product include:Multinomial biochemical calibration object, the multinomial detection calibration object of lipid, creatine kinase isozyme detection calibration object, The multinomial calibration object of protein, prealbumin-antistreptolysin O (ASO)-CER detection calibration object, rheumatoid factor calibration Liquid, open channel calibration solution are the supporting calibration object of kit.
  4. 4. biochemical calibrating method according to claim 3, it is characterised in that the store method of the multinomial biochemical calibration object Including:2~8 DEG C are deposited in the case of not opening can stablize to the regulation term of validity;15~25 DEG C are stored in after redissolution, 8 can be stablized Hour;2~8 DEG C are stored in, can be stablized 2 days;- 15~-25 DEG C are stored in, can be stablized 30 days, it is impossible to multigelation;
    The redissolution method of the multinomial biochemical calibration object includes:3mL is accurately drawn using corrected pipette or measuring pipette Reagent is entered in bottle with water to be stood, and bottle is inverted after 15 minutes, is mixed after placing 30 minutes altogether.
  5. 5. biochemical calibrating method according to claim 4, it is characterised in that be additionally included in the step 2 after redissolution Packaging operation is carried out, the packaging operation includes:It is put into cystosepiment and freezes after being dispensed by daily expense, loads modeling after staying overnight In pocket;
    Dispense the calibration object frozen and machine testing is mixed after room temperature is melted 15 minutes again.
  6. 6. biochemical calibrating method according to claim 5, it is characterised in that the guarantor of the multinomial detection calibration object of lipid The method of depositing includes:2~8 DEG C are deposited in the case of not opening can stablize to the regulation term of validity;15~25 DEG C are stored in after melting again, can Maintain 8 hours;2~8 DEG C are stored in, can be maintained 5 days;- 15~-25 DEG C are stored in, can be maintained 4 weeks, it is impossible to multigelation;
    The redissolution method of the multinomial detection calibration object of lipid includes:Accurately inhaled using corrected pipette or measuring pipette Take 1mL reagents to be entered in bottle to stand with water, bottle is inverted after 15 minutes, mixed after placing 30 minutes altogether.
  7. 7. biochemical calibrating method according to claim 6, it is characterised in that the kinase isozyme detection calibration object Store method includes:2~8 DEG C are deposited in the case of not opening can stablize to the regulation term of validity, and 15~25 DEG C are stored in after redissolution, It can maintain 24 hours;2~8 DEG C are stored in, can be maintained 2 days;- 15~-25 DEG C are stored in, can be maintained 4 weeks, it is impossible to multigelation;
    The redissolution method of the kinase isozyme detection calibration object includes:It is accurate using corrected pipette or measuring pipette Draw 1mL reagents to be entered in bottle to stand with water, bottle is inverted after 15 minutes, mixed after placing 30 minutes altogether.
  8. 8. biochemical calibrating method according to claim 7, it is characterised in that the calibration product also include being applied to Roche The calibration product of E601 electrochemiluminescence analysis instrument, the calibration product of Roche E601 electrochemiluminescence analysis instrument include needing to dispense frost And need not dispense frost two kinds;
    The project that the calibration product for needing packing to freeze use includes INS, CP, AFP, CA199, TPSA, hGH, HE4 and PCT;
    Need not dispense frost calibration product use project include FT3, T3, T4, TSH, FT4, HCG, CEA, CA125, CA153, FPSA, CYF211 and NSE.
  9. 9. biochemical calibrating method according to claim 8, it is characterised in that need to dispense the preservation side of the calibration product of frost Method includes:2~8 DEG C are deposited in the case of not opening can stablize to the regulation term of validity;- 20 DEG C are stored in after redissolution, INS can stablize March;AFP and TPSA can stablize 12 weeks;CP can only stablize January;CA199 can stablize 2 months;HGH can stablize 1 month;HE4, PCT can Stablize 2 months;It is unable to multigelation;
    Needing the redissolution method of the calibration product of packing frost includes:Accurately drawn using corrected pipette or measuring pipette 1.0mL reagents are entered in bottle with water to be stood, and bottle is inverted after 15 minutes, is mixed after placing 30 minutes altogether.
  10. 10. biochemical calibrating method according to claim 9, it is characterised in that the guarantor of the calibration product of frost need not be dispensed The method of depositing includes:2~8 DEG C are deposited in the case of not opening can stablize to the regulation term of validity.Calibration object composition after redissolution it is steady It is qualitative:2~8 DEG C are stored in, NSE can stablize 1 month, and FT3, T3, CYF211 can stablize 8 weeks, FT4, T4, TSH, HCG, CEA, CA125, CA153, FPSA can stablize 12 weeks;
    The redissolution method of the calibration product of frost, which need not be dispensed, to be included:FT3, T3, HCG, NSE, CYF211 are freeze-dried powder, are used Corrected pipette or measuring pipette accurately draw 1.0mL reagents and are entered in bottle to stand with water, and bottle is inverted after 15 minutes, is put altogether Mix and be stored in 2~8 DEG C of refrigerator cold-storage layers after putting 30 minutes;
    Other project calibration solutions are liquid, during calibration, daily need amount are drawn after mixing in sample cup, is stoppered rubber stopper, Room temperature mixes upper machine testing after placing 5 minutes, it is cold that remaining calibration product put back to 2~8 DEG C of refrigerators immediately after daily need amount is drawn Hide in layer.
CN201710581212.7A 2017-07-17 2017-07-17 A kind of biochemical calibrating method Pending CN107436256A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201710581212.7A CN107436256A (en) 2017-07-17 2017-07-17 A kind of biochemical calibrating method

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201710581212.7A CN107436256A (en) 2017-07-17 2017-07-17 A kind of biochemical calibrating method

Publications (1)

Publication Number Publication Date
CN107436256A true CN107436256A (en) 2017-12-05

Family

ID=60461286

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201710581212.7A Pending CN107436256A (en) 2017-07-17 2017-07-17 A kind of biochemical calibrating method

Country Status (1)

Country Link
CN (1) CN107436256A (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112162102A (en) * 2020-07-22 2021-01-01 三诺生物传感股份有限公司 Correction method for four-item blood coagulation test
CN113504369A (en) * 2021-06-23 2021-10-15 中山大学肿瘤防治中心(中山大学附属肿瘤医院、中山大学肿瘤研究所) Individual correction formula for eliminating positive interference of serum nerve specific enolase detection caused by specimen hemolysis and application thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102128917A (en) * 2010-12-07 2011-07-20 江西特康科技有限公司 Clinical biochemical quality control products and preparation process thereof
CN103186705A (en) * 2011-12-30 2013-07-03 孚诺科技(大连)有限公司 Project setting system for biochemical analyzer
CN103900884A (en) * 2014-04-11 2014-07-02 深圳市博锐德生物科技有限公司 Seminal plasma compound quality control product and preparation method thereof and kit
CN105116156A (en) * 2015-07-22 2015-12-02 江苏英诺华医疗技术有限公司 Optimized biochemical detection method suitable for medical examination

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102128917A (en) * 2010-12-07 2011-07-20 江西特康科技有限公司 Clinical biochemical quality control products and preparation process thereof
CN103186705A (en) * 2011-12-30 2013-07-03 孚诺科技(大连)有限公司 Project setting system for biochemical analyzer
CN103900884A (en) * 2014-04-11 2014-07-02 深圳市博锐德生物科技有限公司 Seminal plasma compound quality control product and preparation method thereof and kit
CN105116156A (en) * 2015-07-22 2015-12-02 江苏英诺华医疗技术有限公司 Optimized biochemical detection method suitable for medical examination

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
LUFENG10020: ""罗氏试剂报价(标价报价)"", 《豆丁网》 *
余平安: ""Roche cobas 8000校准程序"", 《百度文库》 *
周庭银 等: "《临床微生物检验标准化操作 第三版》", 31 May 2015, 上海:上海科学技术出版社 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112162102A (en) * 2020-07-22 2021-01-01 三诺生物传感股份有限公司 Correction method for four-item blood coagulation test
CN112162102B (en) * 2020-07-22 2023-09-08 三诺生物传感股份有限公司 Correction method for four blood coagulation tests
CN113504369A (en) * 2021-06-23 2021-10-15 中山大学肿瘤防治中心(中山大学附属肿瘤医院、中山大学肿瘤研究所) Individual correction formula for eliminating positive interference of serum nerve specific enolase detection caused by specimen hemolysis and application thereof

Similar Documents

Publication Publication Date Title
Plebani Quality indicators to detect pre-analytical errors in laboratory testing
CN102109528B (en) Analysis system and method for analyzing biological samples
Bourner et al. ICSH guidelines for the verification and performance of automated cell counters for body fluids
Bowen et al. Blood collection tubes as medical devices: the potential to affect assays and proposed verification and validation processes for the clinical laboratory
CN108303548B (en) Calibration method for improving consistency of detection result of C-reactive protein
Lippi Systematic assessment of the hemolysis index: pros and cons
CN107340399A (en) A kind of biochemical luminous quality control method
Vashist et al. Bioanalytical requirements and regulatory guidelines for immunoassays
CN107436256A (en) A kind of biochemical calibrating method
CN108333021A (en) A kind of c reactive protein multisystem valued methods based on magnitude tracing
CN107389666A (en) A kind of biochemical luminesceence analysis calibrating method
Oosterhuis et al. Sigma metrics in laboratory medicine revisited: We are on the right road with the wrong map
JP2020204610A (en) Method and laboratory system for supplying comparison sample for determining efficiency of diagnostic test
Peng et al. Practical application of Westgard Sigma rules with run size in analytical biochemistry processes in clinical settings
Chen et al. Two evaluation budgets for the measurement uncertainty of glucose in clinical chemistry
Kearney Internal quality control
Gomez-Rioja et al. Recommendation for the design of stability studies on clinical specimens
Middle et al. Characterisation and evaluation of external quality assessment scheme serum
Wood et al. Progesterone assays: guidelines for the provision of a clinical biochemistry service
Tevis et al. Assessing the stability of Cd, Mn, Pb, Se, and total Hg in whole human blood by ICP-DRC-MS as a function of temperature and time
Philipp et al. Ethanol/water solutions as certified reference materials for breath alcohol analyzer calibration
Pasqualetti et al. A step towards optimal efficiency of HbA1c measurement as a first-line laboratory test: the TOP-HOLE (Towards OPtimal glycoHemOgLobin tEsting) project
White et al. The evaluation kit for clinical chemistry: a practical guide for the evaluation of methods, instruments and reagent kits
Human et al. Elisa Kit
Marlar Hemostasis test validation, performance, and reference intervals: international recommendations and guidelines

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
WD01 Invention patent application deemed withdrawn after publication
WD01 Invention patent application deemed withdrawn after publication

Application publication date: 20171205