CN109470533A - A kind of preparation method of the source of people whole blood matrix quality-control product for portable glucose meter - Google Patents
A kind of preparation method of the source of people whole blood matrix quality-control product for portable glucose meter Download PDFInfo
- Publication number
- CN109470533A CN109470533A CN201811242366.4A CN201811242366A CN109470533A CN 109470533 A CN109470533 A CN 109470533A CN 201811242366 A CN201811242366 A CN 201811242366A CN 109470533 A CN109470533 A CN 109470533A
- Authority
- CN
- China
- Prior art keywords
- blood
- quality
- control product
- whole blood
- preparation
- 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.)
- Granted
Links
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
Landscapes
- Physics & Mathematics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention discloses a kind of preparation method of source of people whole blood matrix quality-control product for portable glucose meter, the quality-control product including separation whole blood cells, fixed whole blood cells, high, normal, basic three blood sugar concentrations of preparation and etc..By the present invention in that with quality-control product that is high, neutralizing low three glucose concentration levels, can timely and effectively detect portable glucose meter medicine blood glucose signals level height, in and low three blood sugar concentrations detect in mistake that may be present.The quality-control product that the method for the present invention is prepared passes through fixed human whole blood cell, on the one hand guarantees that quality-control product is whole blood matrix, consistent with the specimen types of blood glucose meter identification；The problem of glycolysis can be occurred by also solving blood glucose in blood, stabilizes blood glucose numerical value.The intercommunity for the quality-control product that the method for the present invention is prepared is good, is applicable to the portable glucose meter of a plurality of different brands different models.
Description
Technical field
The present invention relates to the standard items technical fields for clinical examination process, are used for Portable blood more particularly to one kind
The preparation method of the source of people whole blood matrix quality-control product of sugared instrument, especially prepares a variety of blood glucose meters suitable for different brands or model
Source of people whole blood matrix quality-control product method.
Background technique
Now, POCT (point-of-care testing, real-time test) technology is quick by it, easy, specimen amount is few
And potential improvement patient treats and detects advantage by the beds such as prognosis, increasingly obtains the favor of clinician.As medical institutions
The interior highest POCT instrument of frequency of usage, the accuracy and reliability of portable glucose meter detection is to patient's blood glucose in medical institutions
Monitoring is played the role of most important with management.
However, portable glucose meter carries out quality due to lacking effective standard substance (referencematerials, RMs)
Control, the traceability and measurement accuracy of detection method can not be guaranteed completely, therefore can not carry out effective magnitude
Transmitting, frequently results in testing result with central laboratory and differs larger, and some blood glucose meter performances are chronically at and do not conform to trellis
It state and is not easy to be found, to influence clinical implementation rationally effective treatment measure.
Quality is detected for portable glucose meter in specification medical institutions, improves portable glucose meter in treatment of diabetes
Application value, selecting suitable standard substance to carry out quality control is the key that play one of its clinical value.As mark
One kind of quasi- substance, quality-control product (quality control materials, QCMs) are mainly used for the experiment that monitoring had confirmed that
The performance of method can detect the statistics runaway condition that the experimental method changes with time or occurs, comment for quality between room
Valence/proficiency testing (external quality assessment, EQA/proficiency testing, PT) or indoor quality
It controls (internal quality control, QC).Wherein, External quality evaluation/proficiency testing refers to multiple sample periods
Property be sent to laboratory and analyzed and (or) identified, by the result of the result in each laboratory and other laboratories with group
Or designated value is compared, and comparison result is reported to the laboratory of participation.Indoor quality control, which refers to, to be used centainly
Method and steps, the degree of reliability of continuous evaluation experimental room work, it is intended to monitor the precision of the laboratory routine work, improve
The consistency of pattern detection could be issued in criticizing in the laboratory routine work, between criticizing with determining whether laboratory result is reliable
One work of report.
Precision, stability and the blood glucose of the accuracy calibration object or quality-control product for being used to verify blood glucose meter at present are mostly inhuman
Source whole blood matrix, and portable glucose meter uses non-source of people whole blood matrix as Quality Control to detect based on the glucose in people's whole blood
The testing result that product obtain can have differences with actual result；Secondly, the blood glucose meter of different brands, has different quality-control products, very
Blood glucose meter to same brand different model also has different quality-control products, is measured on different brands instrument with same quality-control product, knot
Fruit can be variant, measures on same brand different model instrument, and target value also can be variant, illustrates the testing result of quality-control product not
It can intercommunication.Moreover, the mating calibration object or quality-control product that producer provides are expensive, and some Imported reagent is also by traffic condition
With the limitation of supply chain.This not only adds medical treatment costs, also hide some dangers for for the management of diabetic and treatment.
Intercommunity (Commutability) is the important attribute of standard substance, refers to and measures the substance with different processs of measurement
When, the numerical relation between each obtained measurement result of process of measurement measures actual clinical sample with these processs of measurement
When measurement result numerical relation consistent degree.Portable blood is used for intercommunity as it can be seen that developing based on disadvantages described above
The source of people whole blood matrix quality-control product of sugared instrument is the substantive breakthroughs for improving blood sugar in diabetic patients management, such source of people whole blood base
The preparation method of matter quality-control product is also that this field is urgently to be resolved.
Summary of the invention
The purpose of the present invention is being directed to technological deficiency existing in the prior art, provide a kind of for portable glucose meter
The preparation method of source of people whole blood matrix quality-control product, the source of people whole blood matrix quality-control product being prepared can be used for different brands different shaped
Number portable glucose meter, and testing result have each blood glucose meter between intercommunity, including from people's whole blood separate whole blood it is thin
Born of the same parents, fixed whole blood cells obtain fixture, the quality-control product for preparing high, normal, basic three blood sugar concentrations.
The source of people whole blood matrix quality-control product is humanized, is prepared by following raw material: people's whole blood, fixative, physiology
Salt water.
The fixative is selected from the solution containing formaldehyde and/or glutaraldehyde.
The fixative is the PBS solution containing 2-8% (v/v) formaldehyde and 2-8% (v/v) glutaraldehyde；Preferably, described
Fixative is the PBS solution containing 2-6% (v/v) formaldehyde and 2-6% (v/v) glutaraldehyde；Preferably comprise 4% (v/v) formaldehyde and
The PBS solution of 4% (v/v) glutaraldehyde.
High blood glucose concentration is 12.0-16.0mmol/L in the quality-control product of high, normal, basic three blood sugar concentrations, and middle blood glucose is dense
Degree is 6.0-8.0mmol/L, low levels 2.0-3.0mmol/L.
People's whole blood is the venous blood containing red blood cell, leucocyte and blood platelet of 18-50 years old normal person.
The separation whole blood cells specifically: people's whole blood is centrifuged 10min in 1500g, abandons upper layer, lower layer is that whole blood is thin
Born of the same parents.
The fixed whole blood cells obtain fixture specifically: the fixed 24- of room temperature in fixative is added in whole blood cells
The volume ratio of 48h, whole blood cells and fixative is 1:(5-10)；
It further include the operation for purifying fixture, specifically: it is centrifuged after the completion of whole blood cells are fixed, discards upper layer fixative,
It is added brine 3-5 times into lower layer's fixture, the volume ratio of fixture and physiological saline is 1:(5-10), then mistake
Filter, filtrate are the fixture purified.
The quality-control product for preparing high, normal, basic three blood sugar concentrations specifically: in fixture or the fixture of purification respectively
The blood plasma that the different blood sugar concentrations prepared in advance are added mixes, and the volume ratio of fixture and blood plasma is 1:(1-2) (preferably 1:1),
Respectively obtain the low levels quality-control product, middle blood sugar concentration quality-control product, high blood glucose concentration quality-control product；Preferably, different blood
The blood plasma of sugared concentration is centrifuged by the venous whole of average blood glucose level, and supernatant is taken to obtain, or addition glucose after supernatant is taken to obtain.
The present invention provides a kind of source of people whole blood matrix matter for being applicable to different brands different model portable glucose meter
The preparation method of control product.The quality-control product being prepared by this method:
Firstly, being related to the height of medicine blood glucose signals level, neutralizing low three concentration.Normal blood glucose level in humans is in 4.4-
Between 6.0mmol/L, hypoglycemia or excessively high can all it do harm to huamn body.Mainly pass through portable blood sugar in medical institutions
Instrument detects blood glucose level in patients, adjusts insulin therapy dosage.If the blood sugar effects of portable glucose meter detection are higher or relatively low,
It will have a direct impact on the dosage of insulin, increase medical-risk, seriously patient's hypoglycemic coma or hyperglycemia can be caused to draw
The ketoacidosis risen.By the present invention in that with quality-control product that is high, neutralizing low three glucose concentration levels, it can be timely and effectively
Detect portable glucose meter medicine blood glucose signals level height, in and low three blood sugar concentrations detection in it is that may be present
Mistake.
Secondly, the quality-control product that the method for the present invention is prepared passes through fixed human whole blood cell, on the one hand guarantee that quality-control product is
Whole blood matrix, it is consistent with the specimen types of blood glucose meter identification；Asking for glycolysis can be occurred in blood by also solving blood glucose
Topic, stabilizes blood glucose numerical value.
Again, the intercommunity for being experimentally confirmed the quality-control product that the method for the present invention is prepared is good, be applicable to it is a plurality of not
With the portable glucose meter of brand different model.
Finally, the quality-control product that the method for the present invention is prepared has raw material sources extensive, preparation process is simple, at low cost
It is honest and clean, the clinical requirement to the control of portable glucose meter quality can be met, there is biggish marketing application value.
Detailed description of the invention
Fig. 1 show the flow diagram of preparation method of the present invention；
Fig. 2-4 show quality-control product that the method for the present invention the is prepared intercommunity evaluation effect in different brands blood glucose meter
Curve graph.
Specific embodiment
Being directed to the quality-control product of blood sugar test both at home and abroad at present is mostly serum matrix or water-based, is lacked suitable for Portable blood
The whole blood matrix quality-control product of sugared instrument, technical difficult points also reside in whole blood matrix that cell stability is poor, and retention cycle is short, blood
Sugar is easy to happen glycolytic (with 5-7%/hour speed glycolysis can occur for blood glucose numerical value in normal person's whole blood), in turn
Cause the reduction of blood glucose numerical value.It is used for although having both at home and abroad using artificial synthesized latex particle quality-control product or serum matrix quality-control product
The quality of portable glucose meter controls, but obtained quality-control product can not still be accomplished to be suitble to different brands Multiple Type blood glucose meter.Base
In the above reason, research and develop a kind of whole blood matrix quality-control product, make its testing result have different brands different model blood glucose meter it
Between intercommunity, the quality applied to medical institutions' portable glucose meter controls, can effectively reduce medical treatment cost, improve portable
Application value of the blood glucose meter in blood sugar monitoring.
The present invention provides a kind of preparation method of source of people whole blood matrix quality-control product, the quality-control product that this method is prepared is
Humanized is prepared by following raw material: raw material includes normal whole blood, fixative, physiological saline etc..Wherein,
Normal whole blood is the venous blood of 18-50 years old Healthy People, using EDTK-K2It is anticoagulant, identical blood group, including red blood cell,
Leucocyte and blood platelet；
Fixative can be selected from formaldehyde and/or glutaraldehyde, and the molecular weight of formaldehyde is small, and penetration capacity is strong, and reaction is mild, can be used for
The preceding fixation of Histochemistry stain research, but it saves poor, most of matrix loss after dehydration to cellular matrix；And glutaraldehyde is made
For fixative, reaction speed is fast, but seepage velocity is slow compared with formaldehyde, it is best with the use of effect with formaldehyde.Fixative is excellent
(PBS buffer solution is dissolved in 1L by 10.2g phosphate to PBS solution of the choosing containing 2-8% (v/v) formaldehyde and 2-8% (v/v) glutaraldehyde
Distilled water, then adjust pH to 7.2 with dilute hydrochloric acid and obtain), more preferably contain 2-6 (v/v) % formaldehyde and 2-6 (v/v) % penta 2
The PBS solution of aldehyde most preferably contains the PBS solution of 4% (v/v) formaldehyde and 4% (v/v) glutaraldehyde.
The method provided by the invention for preparing the source of people whole blood matrix quality-control product, specifically includes the following steps:
(1) normal whole blood is taken, 10min is centrifuged using low speed centrifuge 1500g, upper layer is blood plasma, and lower layer is whole blood cells,
Separated plasma and whole blood cells are stand-by；
(2) fixative, the fixed 24-48h of room temperature is added in the whole blood cells for obtaining step (1)；Whole blood cells and fixative
Volume ratio be 1:(5-10)；
(3) 1500g is centrifuged 10min after the completion of fixed, discards upper layer fixer, and 0.9% physiological saline is added to lower layer
Fixture washs 3-5 times, and the volume ratio of fixture and physiological saline is 1:(5-10), washing specifically: by fixture and physiology
Salt water is sufficiently mixed, and 1500g is centrifuged 10min, abandons upper layer cleaning solution, leaving layer fixture；Then using strainer, (aperture is 40 μ
M) lower layer's fixture after washing is filtered to remove precipitating and impurity, filtrate is the fixture purified；
(4) blood plasma of different blood sugar concentrations is added in the fixture for the purification that step (3) obtains, places shaking table and mixes
30min respectively obtains low levels quality-control product, middle blood sugar concentration quality-control product, high blood glucose concentration quality-control product, fixture and blood plasma
Volume ratio be 1:(1-2) (preferably 1:1)；The blood plasma of different blood sugar concentrations is human plasma, due to most of portable glucose meter
Blood glucose measurement range between 1.1-33.3mmol/L, therefore quality-control product is set low, medium and high three blood glucose by the present invention
Level, blood plasma realization of the blood glucose level of quality-control product by different blood sugar concentrations, the preparation process of the blood plasma of different blood sugar concentrations
Specifically: (1) low levels blood plasma: selecting blood sugar concentration is the venous whole of 4.0-6.0mmol/L or so, 1500g centrifugation
10min takes supernatant, is low levels blood plasma, as blood plasma needed for preparation low levels quality-control product；(2) blood sugar concentration in
Blood plasma: selecting the venous whole of blood sugar concentration 4.0-6.0mmol/L or so, and 1500g is centrifuged 10min, takes supernatant, then presses every milli
It goes up and resets and add into 40 μ l of 200mmol/L glucose solution, be middle blood sugar concentration blood plasma, as blood sugar concentration quality-control product institute in preparation
Need blood plasma；(3) venous whole of blood sugar concentration 4.0-6.0mmol/L or so, 1500g centrifugation high blood glucose concentration blood plasma: are selected
10min takes supernatant, and 100 μ l of 200mmol/L glucose solution then is added by every milliliter of supernatant, is high blood glucose concentration blood plasma, i.e.,
For blood plasma needed for preparation high blood glucose concentration quality-control product；
(5) quality-control product for the basic, normal, high blood sugar concentration that step (4) obtains is divided in sterile cuvette, 2-8 DEG C of storage
Hiding, mixes well before each use.
In order to extend the pot-life of quality-control product of the present invention, the fixture for the purification that step (3) obtain can also be added
0.9% physiological saline suspends, and the volume ratio of fixture and physiological saline is 1:(1-2), it is divided in sterile cuvette, then
10min is centrifuged using low speed centrifuge 1500g, upper layer is physiological saline, and lower layer is the fixture of purification, sets 2-8 DEG C of storage.It will
The blood plasma for the different blood sugar concentrations that step (4) obtains, is divided in sterile cuvette, sets -20 DEG C of long-term storages.What is purified consolidates
Earnest is separately packed from the blood plasma of different blood sugar concentrations, and the upper layer physiological saline of fluid-tight fixture is discarded when to be used, will be different
The blood plasma of blood sugar concentration sets 2-8 DEG C of redissolution, then mixes fixture with blood plasma, and matching while using obtains the basic, normal, high blood of the present invention
The quality-control product of sugared concentration.
Quality-control product of the invention do not have to distinguish blood group, be only at step (1) by the normal whole blood of same blood group mix from
The heart does not have to distinguish blood group, can be used directly when using quality-control product of the invention.
Emphasis of the present invention reduces the activity of cell by the fixed cell of aldehydes, and then reaches the Portugal inhibited in whole blood cells
Grape glycolysis maintains the stabilization of blood glucose numerical value.On the one hand, the presence of haemocyte in the quality-control product that the method for the present invention is prepared,
Meet the requirement that portable glucose meter detection needs to reach 20-60% hematocrit (HCT).On the other hand, the quality-control product
In addition to the ingredient that cell is fixed, do not add any other substance (such as sucrose, glucose, fructose, galactolipin, lactose,
The preservatives such as the polysaccharide such as maltose, starch and dextrin, antibiotic and sodium citrate), it ensure that one with clinical samples matrix
Cause property, avoids portable glucose meter from being made it by the interference of many kinds of substance, such as maltose, xylose, galactolipin in the detection process
As a result higher, preservative will also result in the unstable of testing result.In addition, the quality-control product user that the method for the present invention is prepared
Blood replaces animal blood, and the cellular morphology for being primarily due to animal blood and people's blood differs greatly, the hematocrit (HCT) of two kinds of blood
It differs greatly, also will affect the accuracy of testing result and causes the intercommunity of quality-control product between different brands portable glucose meter
Difference.It is consistent with clinical samples that the quality-control product that the method for the present invention is prepared meets matrix to the full extent, and no addition is not appointed
What influences the interfering substance of instrument detection, while can maintain the stabilization of blood glucose numerical value, it can be achieved that only just by detection quality-control product again
It can judge the accuracy of portable glucose meter inspection result, if need to do system correction, whether patient test's result is subjected to
Etc. performances.
Below in conjunction with specific embodiment, the content of the present invention will be explained in more detail, and the present invention is further elaborated, but
These embodiments limit the invention absolutely not.
The source of people whole blood matrix quality-control product for portable glucose meter that experimental example one, the method for the present invention are prepared it is equal
The verifying of one property
Referring to CNAS-GL29 the standard --- " standard substance/standard sample of China National Accreditation Service for Conformity Assessment publication
The rule and statistical method of product definite value " in about uniform Journal of Sex Research assessment content, use HORIBA glucose electrode formula
Analyzer (LP-150C) is tested, and randomly selects 10 (number 1- in the quality-control product of each blood sugar concentration (basic, normal, high)
10) Evaluation for Uniformity, each sample replication 3 times are carried out as sample.The sequence measured for the first time in measurement process are as follows: 1-
3-5-7-9-2-4-6-8-10；The sequence of second of measurement are as follows: 10-9-8-7-6-5-4-3-2-1；The sequence of third time measurement
Are as follows: 2-4-6-8-10-1-3-5-7-9 the results are shown in Table 1.Using statistics one-way analysis of variance method (one way ANOVA) into
Row analysis, the results are shown in Table 2.
For the uniformity of sample survey, extract i sample (i=1,2 ... m), each sample tests j under repeat condition
It is secondary (j=1,2 ..., n).
The testing mean of each sample
The overall average of whole samples test
Test total degree
Sample room quadratic sumSide MS1=SS1/f1
Quadratic sum in sampleSide MS2=SS2/f2
Freedom degree f1=m-1
f2=N-m
Statistic F=MS1/MS2
If F < freedom degree is (f1, f2) and given level of significance α (usual α=0.05) critical value F α (f1, f2), then
Show that there was no significant difference with sample room in sample, sample is uniform.
The measurement data (unit: mmol/L) of the uniform Journal of Sex Research of 1 quality-control product of table
The analysis of variance table of the uniform Journal of Sex Research of 2 quality-control product of table
It is complete to can be seen that the source of people for portable glucose meter that the method for the present invention is prepared from the result of Tables 1 and 2
Heme quality-control product whether in sample or sample room there are no significant difference, illustrates the Quality Control that the method for the present invention is prepared
Product are uniformly, to can be used as quality-control product for portable glucose meter.
The stability for the source of people whole blood matrix quality-control product that experimental example two, the method for the present invention are prepared is verified
Referring to CNAS-GL29 the standard --- " standard substance/standard sample of China National Accreditation Service for Conformity Assessment publication
The rule and statistical method of product definite value " in about estimation of stability require source of people whole blood that the method for the present invention is prepared
Matrix quality-control product carries out short-term 2-8 DEG C of estimation of stability.The quality-control product of each blood sugar concentration (basic, normal, high) randomly selects 3 works
For sample, each sample replication 2 times, measurement is completed in 10min every time, immediately after by remaining Sample preservation in 2-8
DEG C, using HORIBA glucose electrode formula analyzer (LP-150C) METHOD FOR CONTINUOUS DETERMINATION 20 days, observation saved the 2nd, 3,5,10,15,20
The difference of its result and the 1st day result.It is analyzed after measurement using statistics t method of inspection, the results are shown in Table 3.
T value is calculated as follows:
In formula:- first time examines the average value of measurement data；
- second examines the average value of measurement data；
s1- first time examines the standard deviation of measurement data；
s2- second examines the standard deviation of measurement data；
n1- pendulous frequency measured is examined for the first time；
n2- second examines the pendulous frequency of measurement.
Note: the accuracy in order to guarantee average value and standard deviation, n1 and n2 are >=6.
If t < level of significance α (usual α=0.05) freedom degree is the critical value t of n1+n2-2α(n1+n2-2), then put down for two
There was no significant difference between mean value.
The measurement data (unit: mmol/L) of 3 quality-control product stability study of table
Table 3 as the result is shown high, medium and low three blood sugar concentrations quality-control product save the 15th day when result and the 1st day ratio
Compared with still there was no significant difference (P equal > 0.05), and the quality-control product stability for illustrating that the method for the present invention is prepared is good.
The source of people whole blood matrix quality-control product for portable glucose meter that experimental example three, the method for the present invention are prepared it is mutual
General character verifying
The clinical samples that 33 parts of blood sugar concentrations are respectively at high, medium and low three concentration ranges are collected, respectively by sample and need
The quality-control product of three blood sugar concentrations being verified is divided in different brands different model blood glucose meter with the large-scale biochemistry of central laboratory
Analyzer (HITACHI 7600) is detected, and two groups of data are carried out linear regression, draws blood glucose meter detection and center is tested
95% confidence interval of room detection method, judges whether the measured value of quality-control product falls in 95% confidence interval, quality-control product measured value
It falls in 95% confidence interval, illustrates that intercommunity is good, do not fall in 95% confidence interval, illustrate that intercommunity is poor, as a result
See Fig. 2-4 (in figure: ● represent clinical sample, ■ represents three concentration blood glucose quality-control products ... ... and represents 95% confidence interval).
This experimental example is related to 15 sections of portable glucose meters, respectively Roche ACCU-CHEK Performa, Roche ACCU-
CHEK Active, Bayer CONTOUR TS, Bayer CONTOUR PLUS, Bayer Bayer1455, Abbott Laboratories
FreeStyleOptium, Ai Kelai ARKRAY GT-1820, Ai Kelai ARKRAY GT-1970, Terumo MEDISAFEFIT,
HORIBA LP-150C, Johnson & Johnson StatStrip, Johnson & Johnson ONETOUCH UltraVue, Rett Rightest GM300, ten thousand inspire confidence in EC-
The flat II type of 102 and Bo Tang.
The result of Fig. 2-4 illustrates quality-control product that the method for the present invention is prepared in Roche ACCU-CHEK Performa, sieve
Family name ACCU-CHEK Active, Bayer CONTOUR TS, Bayer CONTOUR PLUS, Abbott Laboratories FreeStyleOptium, Ai Kelai
This 9 sections of portable blood sugars of ARKRAY GT-1820, Terumo MEDISAFE FIT, HORIBA LP-150C, Johnson & Johnson StatStrip
Intercommunity is good in instrument, and the quality-control product measured value of three blood sugar concentrations all falls within 95% confidence interval.Relative to existing matter
Control product may be only available for the portable glucose meter of a certain model of a certain brand, and the quality-control product that the method for the present invention is prepared has been
A breakthrough.
Experimental example four, indoor quality control application
It takes the quality-control product of high, medium and low three blood sugar concentrations to be applied to indoor quality control, while choosing 2 Portable bloods
The quality-control product of matched two blood sugar concentrations of sugared instrument compares, and continuous detection 5 days is repeated 4 times daily.Portable glucose meter 1:
HORIBA glucose electrode formula analyzer (LP-150C), quality-control product are respectively QC1, QC2；Portable glucose meter 2:ROCHE,
ACCU-CHEK Performa, quality-control product are respectively QC3, QC4.Calculate testing result mean value and standard deviation (SD), the coefficient of variation
(CV), and with State Food and Drug Administration, the People's Republic of China (PRC), issue national standard " in-vitro diagnosis checking system from
Survey and use blood glucose monitoring system general technical specifications [S/OL] " as blood sugar concentration < 5.5mmol/L, SD < 0.42mmol/L；Work as blood
When sugared concentration>=5.5mmol/L, CV<7.5% compares.
Result is applied in quality control in 4 quality-control product room of table
| Quality-control product | Mean value (mmol/L) | SD | CV (%) |
| High blood glucose concentration | 14.48 | 0.09 | 0.63 |
| Middle blood sugar concentration | 7.56 | 0.05 | 0.66 |
| Low levels | 2.48 | 0.04 | 1.65 |
| QC1 | 2.55 | 0.09 | 3.71 |
| QC2 | 26.69 | 0.30 | 1.12 |
| QC3 | 2.56 | 0.07 | 2.69 |
| QC4 | 17.1 | 0.22 | 1.29 |
Table 4 shows that the low levels quality-control product SD value that the method for the present invention is prepared is 0.04, is less than 0.42mmol/L,
Middle blood sugar concentration quality-control product and high blood glucose concentration quality-control product CV value are respectively 0.66% and 0.63%, respectively less than 7.5%, illustrate three
The quality-control product of a blood sugar concentration meets national standard, and result is close with commercialization quality-control product, shows that it can be applied to just
Take the daily indoor quality control of formula blood glucose meter.
Quality-control product can be divided into definite value quality-control product and non-definite value quality-control product.Non- definite value quality-control product mean value and standard deviation are using real
Room conventional method is tested in the not interior detection at least making 20 bottles on the same day, or at least in 5 days, per heaven-made no less than 4 repetition detections
To obtain.Due to be suitable for whole blood matrix blood sugar test, have traceability, can carry out quality-control product assignment instrument at present clinic cure
Treating mechanism application is not very universal, therefore the quality-control product that the method for the present invention is prepared is used as non-definite value quality-control product.
The above is only a preferred embodiment of the present invention, it is noted that for the common skill of the art
For art personnel, various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications
Also the contents of the present invention be should be regarded as.
Claims (10)
1. a kind of preparation method of the source of people whole blood matrix quality-control product for portable glucose meter, which is characterized in that including from people
Whole blood cells are separated in whole blood, fixed whole blood cells obtain the steps such as fixture, the quality-control product for preparing high, normal, basic three blood sugar concentrations
Suddenly.
2. preparation method according to claim 1, which is characterized in that the source of people whole blood matrix quality-control product is humanized, by
Following raw material is prepared: people's whole blood, fixative, physiological saline.
3. preparation method according to claim 2, which is characterized in that the fixative is selected from containing formaldehyde and/or glutaraldehyde
Solution.
4. preparation method according to claim 3, which is characterized in that the fixative is to contain 2-8% (v/v) formaldehyde and 2-
The PBS solution of 8% (v/v) glutaraldehyde；Preferably, the fixative is to contain 2-6% (v/v) formaldehyde and 2-6% (v/v) penta 2
The PBS solution of aldehyde；Preferably comprise the PBS solution of 4% (v/v) formaldehyde and 4% (v/v) glutaraldehyde.
5. -4 any preparation method according to claim 1, which is characterized in that the Quality Control of high, normal, basic three blood sugar concentrations
High blood glucose concentration is 12.0-16.0mmol/L in product, and middle blood sugar concentration is 6.0-8.0mmol/L, low levels 2.0-
3.0mmol/L。
6. -5 any preparation method according to claim 1, which is characterized in that people's whole blood is 18-50 years old normal person
Venous blood containing red blood cell, leucocyte and blood platelet.
7. -6 any preparation method according to claim 1, which is characterized in that the separation whole blood cells specifically: people is complete
Blood is centrifuged 10min in 1500g, abandons upper layer, lower layer is whole blood cells.
8. -7 any preparation method according to claim 1, which is characterized in that the fixed whole blood cells obtain fixture tool
Body are as follows: by the fixed 24-48h of room temperature in whole blood cells addition fixative, the volume ratio of whole blood cells and fixative is 1:(5-10).
9. preparation method according to claim 8, which is characterized in that it further include the operation for purifying fixture, specifically: whole blood
It is centrifuged after the completion of cell is fixed, discards upper layer fixative, be added brine 3-5 times into lower layer's fixture, fixture
Volume ratio with physiological saline is 1:(5-10), it then filters, filtrate is the fixture purified.
10. preparation method according to claim 9, which is characterized in that the Quality Control for preparing high, normal, basic three blood sugar concentrations
Product specifically: the blood plasma mixing for the different blood sugar concentrations prepared in advance is separately added into fixture or the fixture of purification, Gu
The volume ratio of earnest and blood plasma is 1:(1-2) (preferably 1:1), respectively obtain the low levels quality-control product, middle blood sugar concentration
Quality-control product, high blood glucose concentration quality-control product；Preferably, the blood plasma of different blood sugar concentrations by average blood glucose level venous whole from
The heart takes supernatant to obtain, or addition glucose after supernatant is taken to obtain.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811242366.4A CN109470533B (en) | 2018-10-24 | 2018-10-24 | Preparation method of human whole blood matrix quality control product for portable glucometer |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811242366.4A CN109470533B (en) | 2018-10-24 | 2018-10-24 | Preparation method of human whole blood matrix quality control product for portable glucometer |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN109470533A true CN109470533A (en) | 2019-03-15 |
| CN109470533B CN109470533B (en) | 2021-09-21 |
Family
ID=65665880
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811242366.4A Active CN109470533B (en) | 2018-10-24 | 2018-10-24 | Preparation method of human whole blood matrix quality control product for portable glucometer |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109470533B (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115327139A (en) * | 2022-09-16 | 2022-11-11 | 杭州同创医学检验实验室有限公司 | Blood quality control product for portable glucometer and preparation method thereof |
| CN117373586A (en) * | 2023-08-28 | 2024-01-09 | 北京华益精点生物技术有限公司 | Blood glucose data comparison method and related equipment |
Citations (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2175907A1 (en) * | 1993-11-12 | 1995-05-18 | Myron Rapkin | Glucose control material for test strips |
| CN1584591A (en) * | 2004-05-31 | 2005-02-23 | 苏州市第二人民医院 | All blood quality controlling arlicles for blood rheology and their preparation |
| US20060188995A1 (en) * | 2005-02-24 | 2006-08-24 | Ryan Wayne L | Process, composition and kit for providing a stable whole blood calibrator/control |
| CN1873413A (en) * | 2006-06-27 | 2006-12-06 | 四川省迈克科技有限责任公司 | Quality control objects of whole blood, and production method |
| US20070134798A1 (en) * | 2005-12-08 | 2007-06-14 | Mccormick Patric | Light curing fixative |
| RU2006146748A (en) * | 2006-12-28 | 2008-07-10 | ГНУ Всероссийский научно-исследовательский институт крахмалопродуктов (RU) | METHOD FOR OBTAINING A GLUCOSE SMOOTH |
| CA2650095A1 (en) * | 2008-01-18 | 2009-07-18 | Lifescan Scotland Limited | Analyte testing method and system |
| US20130034871A1 (en) * | 2011-08-04 | 2013-02-07 | Cilag Gmbh International | Hand-held test meter and analytical test strip cartridge combination |
| CN103076214A (en) * | 2012-12-26 | 2013-05-01 | 宁波美康生物科技股份有限公司 | Preparation method of glycosylated hemoglobin quality control |
| CN103267838A (en) * | 2013-05-15 | 2013-08-28 | 中山市滔略生物科技有限公司 | Quality control material and calibration material for verifying hematology analyzer and preparation method thereof |
| CN103336110A (en) * | 2013-06-18 | 2013-10-02 | 南京普朗医疗设备有限公司 | Whole blood quality control material and preparation method thereof |
| WO2015098784A1 (en) * | 2013-12-24 | 2015-07-02 | Ricoh Company, Ltd. | Analytical device |
| CN105092336A (en) * | 2015-08-28 | 2015-11-25 | 宁波瑞源生物科技有限公司 | Preparation method of stable glycated albumin calibrating material and quality control material |
| CN105758700A (en) * | 2016-03-28 | 2016-07-13 | 广西壮族自治区人民医院 | Lyophilized whole blood controls for G6PD (glucose-6-phosphate dehydrogenase) and preparation method of lyophilized whole blood controls |
| CN106370872A (en) * | 2016-08-30 | 2017-02-01 | 广州金域医学检验中心有限公司 | Method for adding high-concentration metallic elements in bovine whole blood and bovine whole blood quality control serum |
| CN107266563A (en) * | 2017-08-01 | 2017-10-20 | 四川沃文特生物技术有限公司 | A kind of preparation method of hemoglobin quality-control product |
-
2018
- 2018-10-24 CN CN201811242366.4A patent/CN109470533B/en active Active
Patent Citations (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2175907A1 (en) * | 1993-11-12 | 1995-05-18 | Myron Rapkin | Glucose control material for test strips |
| CN1584591A (en) * | 2004-05-31 | 2005-02-23 | 苏州市第二人民医院 | All blood quality controlling arlicles for blood rheology and their preparation |
| US20060188995A1 (en) * | 2005-02-24 | 2006-08-24 | Ryan Wayne L | Process, composition and kit for providing a stable whole blood calibrator/control |
| US20070134798A1 (en) * | 2005-12-08 | 2007-06-14 | Mccormick Patric | Light curing fixative |
| CN1873413A (en) * | 2006-06-27 | 2006-12-06 | 四川省迈克科技有限责任公司 | Quality control objects of whole blood, and production method |
| RU2006146748A (en) * | 2006-12-28 | 2008-07-10 | ГНУ Всероссийский научно-исследовательский институт крахмалопродуктов (RU) | METHOD FOR OBTAINING A GLUCOSE SMOOTH |
| CA2650095A1 (en) * | 2008-01-18 | 2009-07-18 | Lifescan Scotland Limited | Analyte testing method and system |
| US20130034871A1 (en) * | 2011-08-04 | 2013-02-07 | Cilag Gmbh International | Hand-held test meter and analytical test strip cartridge combination |
| CN103076214A (en) * | 2012-12-26 | 2013-05-01 | 宁波美康生物科技股份有限公司 | Preparation method of glycosylated hemoglobin quality control |
| CN103267838A (en) * | 2013-05-15 | 2013-08-28 | 中山市滔略生物科技有限公司 | Quality control material and calibration material for verifying hematology analyzer and preparation method thereof |
| CN103336110A (en) * | 2013-06-18 | 2013-10-02 | 南京普朗医疗设备有限公司 | Whole blood quality control material and preparation method thereof |
| WO2015098784A1 (en) * | 2013-12-24 | 2015-07-02 | Ricoh Company, Ltd. | Analytical device |
| CN105092336A (en) * | 2015-08-28 | 2015-11-25 | 宁波瑞源生物科技有限公司 | Preparation method of stable glycated albumin calibrating material and quality control material |
| CN105758700A (en) * | 2016-03-28 | 2016-07-13 | 广西壮族自治区人民医院 | Lyophilized whole blood controls for G6PD (glucose-6-phosphate dehydrogenase) and preparation method of lyophilized whole blood controls |
| CN106370872A (en) * | 2016-08-30 | 2017-02-01 | 广州金域医学检验中心有限公司 | Method for adding high-concentration metallic elements in bovine whole blood and bovine whole blood quality control serum |
| CN107266563A (en) * | 2017-08-01 | 2017-10-20 | 四川沃文特生物技术有限公司 | A kind of preparation method of hemoglobin quality-control product |
Non-Patent Citations (1)
| Title |
|---|
| 林贵兰: "血糖即时检验室间质控品的制备和评价", 《检验医学教育》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115327139A (en) * | 2022-09-16 | 2022-11-11 | 杭州同创医学检验实验室有限公司 | Blood quality control product for portable glucometer and preparation method thereof |
| CN115327139B (en) * | 2022-09-16 | 2023-07-04 | 杭州同创医学检验实验室有限公司 | Blood quality control product for portable glucometer and preparation method thereof |
| CN117373586A (en) * | 2023-08-28 | 2024-01-09 | 北京华益精点生物技术有限公司 | Blood glucose data comparison method and related equipment |
Also Published As
| Publication number | Publication date |
|---|---|
| CN109470533B (en) | 2021-09-21 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| Gounden et al. | Renal function tests | |
| Lippi et al. | Preanalytical variability: the dark side of the moon in laboratory testing | |
| Rackoff et al. | Pulse oximetry and factors associated with hemoglobin oxygen desaturation in children with sickle cell disease | |
| MOLITCH et al. | Spurious serum creatinine elevations in ketoacidosis | |
| Johnson et al. | Analytical error of home glucose monitors: a comparison of 18 systems | |
| Whitfield et al. | Relationship between concentration and anticoagulant effect of heparin in plasma of normal subjects: magnitude and predictability of interindividual differences | |
| CN108133754B (en) | The forecasting system of bleeding risk after a kind of thrombolysis | |
| CN106645665A (en) | Thrombin time detection reagent | |
| CN109470533A (en) | A kind of preparation method of the source of people whole blood matrix quality-control product for portable glucose meter | |
| CN109521201A (en) | A kind of source of people whole blood matrix quality-control product for portable glucose meter | |
| CN109239374A (en) | A kind of liquid thrombin time detection reagent | |
| Cartier et al. | Pseudohypobicarbonatemia in a patient presenting with suspected diabetic ketoacidosis | |
| CN108593811A (en) | A method of measuring Detection of Paraquat in Biological Fluid and diquat dibromide content | |
| Lascola et al. | Comparison of jugular and transverse facial venous sinus blood analytes in healthy and critically ill adult horses | |
| El-Gamasy | Study of some pulmonary function tests in Egyptian children with end-stage renal disease under regular hemodialysis in correlation with dialysis duration | |
| CN107941722B (en) | Blood sample analysis and test system | |
| Tsai et al. | Hematologic, plasma biochemical, protein electrophoretic, and total solid values of captive oriental turtle doves (Streptopelia orientalis) | |
| Rajbhandari et al. | Comparison of Capillary and Venous Glucose in Diabetic Patient in a Peripheral Hospital | |
| Salmond et al. | Comparison of point-of-care device DiaSpect against the HemoCue and laboratory analyser in an ICU population | |
| McIlroy et al. | Comparison of venous glucose to finger-prick glucose in patients with diabetes under hyperbaric hyperoxic conditions: A pilot study | |
| RU2275640C1 (en) | Method for selecting thrombocytopathy treatment approach in metabolic syndrome cases | |
| Gholami et al. | Effect of Different Heparin Volumes on Blood Gas Analysis | |
| CN108107195B (en) | Blood sample analysis test method | |
| Kapil et al. | Pre collection variables anthral laboratory testing | |
| Asfour et al. | Study of Serum Leptin in Polytransfused Children with Beta Thalassemia Major |
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 | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |