CN109061125A - The method and purposes of reliability assessment are carried out to the result of the quantitative detection project of detection system - Google Patents
The method and purposes of reliability assessment are carried out to the result of the quantitative detection project of detection system Download PDFInfo
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- CN109061125A CN109061125A CN201810896947.3A CN201810896947A CN109061125A CN 109061125 A CN109061125 A CN 109061125A CN 201810896947 A CN201810896947 A CN 201810896947A CN 109061125 A CN109061125 A CN 109061125A
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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
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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
- G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
- G01N33/78—Thyroid gland hormones, e.g. T3, T4, TBH, TBG or their receptors
Abstract
The present invention provides methods and purposes that the result of the quantitative detection project of a kind of pair of detection system carries out reliability assessment, are related to medical laboratory's quality control technology.This method is to test indoor true experiment sample as evaluation sample, and compared to quality-control product, there is no have matrix effect.And A representative Sample is selected, i.e., experiment sample includes that the detected value of quantitative detection project is less than experiment sample, the experiment sample greater than the experiment sample of normal reference range and in normal reference range of normal reference range.Furthermore the judgment criteria of this method both examined quality objective requirement in the distinctive analysis of project in view of meeting medical laboratory, it is also considered that the requirement of statistically linear regression.Therefore, this method can the easy, result reliability of quantitative detection project that can operate and efficiently evaluate detection system, the quality of medical laboratory is controlled and is ensured patient's diagnosis and treatment have important more practical value.
Description
Technical field
The present invention relates to medical laboratory's quality control technology, more particularly, to the quantitative inspection of a kind of pair of detection system
The result of survey project carries out the method and purposes of reliability assessment.
Background technique
Medical laboratory must carry out indoor quality control (referred to as: Internal Quality Control), with the analytical of supervision and inspection method
Energy.Therefore, laboratory generally passes through detection quality-control product, and uses statistical method according to Quality Control result, infers whether to need
Correct whether the method for inspection and clinical samples result can be received by clinic.
But there are matrix differences with true clinical samples for quality-control product, and thus bring matrix effect, will cause Quality Control knot
Fruit can not really reflect the reliability of patient's testing result.And since in practical work process, medical laboratory can be indefinite
Phase replace reagent perhaps the lot number of calibration object and different lot number reagent or calibration object for quality-control product matrix effect not
Unanimously and there are randomnesss.Consequently it is difficult to the testing result of the reagent or calibration object of judging different lot numbers is detected with quality-control product
Reliability.The above problem is more prominent as the detection of the immune class of principle using antigen-antibody reaction.
In conclusion traditional Internal Quality Control based on quality-control product, can not evaluate reagent or calibration object lot number changes
Afterwards, whether the analysis performance of detection system is still reliable, and whether clinical samples result can be received by clinic.
In view of this, the present invention is specifically proposed.
Summary of the invention
The first object of the present invention is that the result for providing the quantitative detection project of a kind of pair of detection system carries out reliability
The method of assessment alleviates the Internal Quality Control existing in the prior art based on quality-control product, can not effectively assess detection
The technical issues of result reliability of the quantitative detection project of system.
The second object of the present invention is that the result progress for providing a kind of above-mentioned quantitative detection project to detection system can
Purposes of the method assessed by property in the Internal Quality Control of medical laboratory.
In order to solve the above technical problems, spy of the present invention adopts the following technical scheme that
The method that the result of the quantitative detection project of a kind of pair of detection system carries out reliability assessment, the method includes such as
Lower step:
(a) one group of experiment sample is provided, the result of the quantitative detection project of one group of experiment sample is true value M；Institute
Stating one group of experiment sample includes that true value M is less than the experiment sample of normal reference range, true value M is greater than normal reference range
The experiment sample of experiment sample and true value M in normal reference range；
(b) one group of experiment sample is detected using the detection system, obtains the detected value N of quantitative detection project；
(c) result judgement: if testing result meets following condition, determine the quantitative detection project of the detection system
As a result reliable；
The difference of (I) true value M and detected value N are less than the 1/3 of maximum allowable overall error；
The regression coefficient of the equation of linear regression of (II) true value M and detected value N is 0.9-1.1.
Preferably, the detection system includes one of detection reagent, calibration object and detecting instrument or a variety of.
Preferably, using having been evaluated as having the detection system of reliability to detect one group of experiment sample, institute is obtained
State true value M；
It include testing product A in the detection system for having been evaluated as that there is reliability, in detection system to be assessed
Include testing product B；The testing product B is the product after the change of testing product A batch；
Preferably, the batch change includes the brand switching or lot number change of testing product.
Preferably, the testing product B includes detection reagent, calibration object or detecting instrument.
Preferably, the experiment sample includes clinical sample；
Preferably, the clinical sample includes clinical patients serum, blood plasma, urine or Pleural effusions.
Preferably, one group of experiment sample includes 10-20 parts of samples；
Wherein, true value M accounts for the 25%-35% of whole sample sizes lower than the sample of normal reference range；True value M exists
Sample in normal reference range accounts for the 35%-45% of whole sample sizes；True value M is higher than the sample of normal reference range
Account for the 25%-35% of whole sample sizes.
Preferably, one group of experiment sample is provided, sample size is 10 parts；Wherein, true value M is lower than normal reference range
3 parts of sample；True value M is 4 parts of sample of normal reference range；True value M is higher than 3 parts of sample of normal reference range.
Preferably, using true value M as independent variable, using detected value N as dependent variable, equation of linear regression is established.
Preferably, the method also includes readjusting Quality Control range.
The present invention also provides a kind of results of above-mentioned quantitative detection project to detection system to carry out reliability assessment
Purposes of the method in the Internal Quality Control of medical laboratory.
Compared with prior art, the invention has the following beneficial effects:
The evaluation sample that the present invention uses is for true experiment sample, and compared to quality-control product, there is no have matrix effect.
And A representative Sample is selected, i.e., experiment sample includes that the detected value of quantitative detection project is less than the reality of normal reference range
Test sample, the experiment sample greater than the experiment sample of normal reference range and in normal reference range；
Furthermore judgment criteria proposed by the invention was both examined in the distinctive analysis of project in view of meeting medical laboratory
Quality objective (i.e. maximum allowable overall error) requirement, it is also considered that the requirement of statistically linear regression.
Therefore, the present invention can the result of quantitative detection project that is easy, can operating and efficiently evaluate detection system can
By property, the quality of medical laboratory is controlled and is ensured patient's diagnosis and treatment have important more practical value.
Detailed description of the invention
It, below will be to specific in order to illustrate more clearly of the specific embodiment of the invention or technical solution in the prior art
Embodiment or attached drawing needed to be used in the description of the prior art be briefly described, it should be apparent that, it is described below
Attached drawing is some embodiments of the present invention, for those of ordinary skill in the art, before not making the creative labor
It puts, is also possible to obtain other drawings based on these drawings.
Fig. 1 is lot number in the quantitative detection project after evaluation detection reagent provided by the invention or the change of standard items lot number
Change front and back, the results change schematic diagram of different level quality-control product；
Fig. 2 is that the embodiment of the present invention mentions the quantitative detection item after the evaluation detection reagent that 1 provides or the change of standard items lot number
The flow chart of the method for purpose result reliability；
Fig. 3 is that the embodiment of the present invention mentions the quantitative detection item after the evaluation detection reagent that 1 provides or the change of standard items lot number
The Method of Sample Selection of the method for purpose result reliability；
Fig. 4 is that the embodiment of the present invention mentions the quantitative detection item after the evaluation detection reagent that 1 provides or the change of standard items lot number
Regression equation curve in the method for purpose result reliability；
Fig. 5 is the Quality Control figures on the 30th that the embodiment of the present invention proposes the detection thyrotropic hormone level 1 that 2 provide；
Fig. 6 is the Quality Control figures on the 30th that the embodiment of the present invention proposes the detection thyrotropic hormone level 2 that 2 provide；
Fig. 7 is difference (%) judgement that the embodiment of the present invention mentions that the new and old lot number reagent that 2 provide detects thyrotropic hormone
Figure；
Fig. 8, which proposes the new and old lot number reagent detection thyrotropic hormone result linear regression that 2 provide for the embodiment of the present invention, to be intended
Close figure；
Fig. 9 is the Quality Control figure that the embodiment of the present invention mentions that the new lot number reagent that 2 provide detects thyrotropic hormone level 2.
Specific embodiment
Technical solution of the present invention is clearly and completely described below in conjunction with drawings and examples, it is clear that retouched
The embodiment stated is a part of the embodiment of the present invention, instead of all the embodiments.Based on the embodiments of the present invention, this field
Those of ordinary skill's every other embodiment obtained without making creative work, belongs to protection of the present invention
Range.The person that is not specified actual conditions in embodiment, carries out according to conventional conditions or manufacturer's recommended conditions.Agents useful for same or
Production firm person is not specified in instrument, is the conventional products that can be obtained by commercially available purchase.
The present invention provides the method that the result of the quantitative detection project of a kind of pair of detection system carries out reliability assessment, institutes
The method of stating includes the following steps:
(a) one group of experiment sample is provided, the result of the quantitative detection project of one group of experiment sample is true value M；Institute
Stating one group of experiment sample includes that true value M is less than the experiment sample of normal reference range, true value M is greater than normal reference range
The experiment sample of experiment sample and true value M in normal reference range；
(b) one group of experiment sample is detected using the detection system, obtains the detected value N of quantitative detection project；
(c) result judgement: if testing result meets following condition, determine the quantitative detection project of the detection system
As a result reliable；
The difference of (I) true value M and detected value N are less than the 1/3 of maximum allowable overall error；
The regression coefficient of the equation of linear regression of (II) true value M and detected value N is 0.9-1.1.
Detection system may include detection reagent, calibration object or detecting instrument etc. be completely used for detection various entities and because
Element.The change of any one factor in detection system, such as reagent, the replacement of calibration object or detecting instrument brand or reagent
Or the calibration object batch alternation of signs, it can all cause detection system result when detecting quantitative detection project to change.Medical experiment
Room must carry out indoor control to monitor the analysis performance of the method for inspection after detection system changes, in the prior art usually using matter
The analysis performance of the method for inspection after estimating detection system change is judged in control.Quality-control product is the quality control substance for in-vitro diagnosis
Matter, be it is a kind of be intended for substance, material used in the testing product of medical usage or equipment, the purpose is to evaluate or verify
Precision of measurement measures correctness, due to property such as the issuable analysis deviations of the variation testing product of reagent or analysis instrument
It can feature.When factor a certain in detection system changes, the matrix effect of quality-control product is not consistent and there are randomness,
Consequently it is difficult to the result reliability of the quantitative detection project after quality-control product assessment detection system change.
Therefore the result of the quantitative detection project provided by the invention to detection system carries out the method for reliability assessment not
Use quality-control product as evaluation sample, but using experiment sample as evaluation sample, experiment sample is really to examine in laboratory
The sample of survey obtains one group of detected value, using the quantitative detection project of detection system evaluation sample to be assessed with group detection
Whether value, which meets medical laboratory, is examined quality objective (i.e. maximum allowable overall error) in the distinctive analysis of project to require and count
The requirement of linear regression judges whether the quantitative detection result of reagent to be assessed has reliability as evaluation criteria on.
Firstly, the evaluation sample that the present invention uses is experiment sample, rather than quality-control product.Experiment sample is that laboratory is quantitatively examined
The target sample of survey project, i.e. authentic specimen, or the clinical sample of clinical quantitative detection project, experiment sample and quality-control product
Difference is that the sample composition in experiment sample and routine experimentation or detection is same or similar, compared to quality-control product, experiment
Sample is of identical composition there is no there is matrix effect with daily target detection sample.Matrix is analyte in sample
Component in addition, since matrix usually has significant interference, and the accuracy of impact analysis result to the analytic process of analyte,
These are influenced and interference is referred to as matrix effect (matrix effect).In some alternative embodiments, the experiment sample
Originally including clinical sample, the clinical sample for example can be but be not limited to the serum of patient, blood plasma, urine or Pleural effusions etc.
Various body fluid sample forms, the preferably serum sample of patient.
Meanwhile the true detected value of the quantitative detection project of experiment sample is answered representative, is in particular in true inspection
Measured value should cover less than normal reference range, be greater than normal reference range and this three parts in normal reference range, very
Real value can have the detection system of reliability to detect to obtain by the result for being assessed as quantitative detection project.Nominal reference
Range is subject to the regulation of quantitative detection project.
In some optionally embodiments, the experiment sample as present invention evaluation sample also needs to meet following item
Part:
(I) considers that the detectable range of quantitative testing project, the quantity of experiment sample are advisable with 10-20 parts, sample size
Very few easy increase random error, leads to subsequent calculated result inaccuracy, and the excessive cost that will increase experiment of sample size extends real
Test the time.
(II) experiment sample first using have been evaluated as quantitative detection result with reliability detection system to quantitative survey
Determine project to be detected, obtain one group of true value M, then filters out standard compliant experiment sample as evaluation sample.Wherein,
True value M accounts for the 25-35% of whole sample sizes lower than the sample of normal reference range；True value M is in normal reference range
Sample account for the 35-45% of whole sample sizes；The sample that true value M is higher than normal reference range accounts for whole sample sizes
25-35%；In some preferred embodiments, one group of experiment sample is provided, sample size is 10 parts, and wherein true value M is low
In 3 parts of sample of normal reference range；True value M is 4 parts of sample of normal reference range；True value M is higher than nominal reference model
3 parts of the sample enclosed；According to above-mentioned distribution choice experiment sample, keep experiment sample more representative, experiment sample can be covered
Originally for the various testing results of a quantitative detection project.Preferably, evaluation samples selection various concentration is horizontal and tool represents
The sample of property (term of reference division).
Further, after obtaining above-mentioned one group of experiment sample as evaluation sample, using detection system to be assessed to commenting
The same quantitative determination project of valence sample is detected, and detected value N is obtained.
In practical work process, medical laboratory can irregularly replace testing product, such as can be but be not limited to
Replace detection reagent, the brand of calibration object or detecting instrument；Or the lot number of replacement detection reagent or calibration object.Such as can be
In carrying out the related experiment based on immunoassay, such as in the experiment such as ELISA, immunochromatography or immunohistochemistry, antibody brand
Variation, the variation of antibody lot number, marker batch alternation of signs or the replacement of microplate reader etc. will cause quantifying for detection system
The change of the result of detection project, and the testing product of different brands or lot number it is not consistent for the matrix effect of quality-control product and
There are randomnesss.
The quality-control product Quality Control of multiple concentration levels, Fig. 1 are generallyd use when medical laboratory's Quality Control indoors as shown in Figure 1:
By taking the quality-control product of two concentration as an example, wherein ellipse represents the testing result of the quality-control product of concentration a, diamond shape represents concentration b's
The testing result of Quality Control, abscissa are the date, and ordinate is the detected value of quality-control product.It is a certain due to having replaced when on 11st
Detection reagent lot number causes the detected value of the quality-control product of concentration b to have raising by a relatively large margin, and here it is matrix effect matter indoors
Embodiment in control.
Consequently it is difficult to detect the reliability for judging the testing product testing result of different brands or lot number with quality-control product.Cause
This uses the detection system detection one group of experiment sample for having been evaluated as having reliability in some preferred embodiments
This, obtains the true value M；It wherein, include testing product A in the detection system for having been evaluated as that there is reliability, to
It include testing product B in the detection system of assessment；The testing product B is the product after the change of testing product A batch；Some
In preferred embodiment, the batch change includes the brand switching or lot number change of testing product.
After obtaining the true value M of quantitative detection project of one group of experiment sample and detected value N, to detected value N according to such as
Lower method is assessed.
(I) first has to meet quality objective (i.e. TEa) requirement in medical laboratory's inspection distinctive analysis of project, that is, examines
The difference of measured value N and true value M are less than the 1/3 of maximum allowable overall error (total error allowable, TEa), quantitative to examine
The maximum allowable overall error of survey project is a normal value or specified value, therefore when detecting, really according to the difference of Testing index
Determine the limits of error of the project to be quantitative determined in standing order.
(II) meets the requirement of statistically linear regression: the recurrence system of the equation of linear regression of detected value N and true value M
Number is 0.9-1.1.
In statistics, linear regression (Linear Regression) is flat using the minimum of referred to as equation of linear regression
A kind of regression analysis that square function models relationship between one or more independents variable and dependent variable.This function is one
Or the linear combination of multiple model parameters for being known as regression coefficient.In regression analysis, an independent variable and one are only included because becoming
Amount, and the relationship of the two can use straight line approximate representation, this regression analysis is known as simple linear regression analysis.The present invention makes
The correlation between detected value N and true value M is verified with one-variable linear regression, when the linear regression side of detected value N and true value M
When the regression coefficient of journey is 0.9-1.1, show detected value N that the quantitative detection project of reagent set B detection to be assessed obtains with
True value M is close, and regression coefficient then shows more close between detected value N and true value M closer to 1, and reagent set B's quantifies
Testing result is more reliable.Since really value M is as known value, in some preferred embodiments, it is with true value M
Independent variable establishes equation of linear regression using detected value N as dependent variable.
It is preferably carried out in mode some, when the result that detection system is assessed as quantitative detection project can make rearward
Detect quality-control product with the detection system, if quality-control product in detection system and original detection system, i.e. such as testing product lot number
Detection system before changing, between there are the differences of matrix effect, then further adjust and redefine Quality Control range.
The present invention also provides a kind of results of above-mentioned quantitative detection project to detection system to carry out reliability assessment
Purposes of the method in the Internal Quality Control of medical laboratory, the present invention can it is easy, can operate and efficiently evaluate detection system
Quantitative detection project result reliability, control the quality of medical laboratory and ensure that patient's diagnosis and treatment have important practice
Value.
Beneficial effects of the present invention are further illustrated below with reference to preferred embodiment:
Embodiment 1
The method that the result of the quantitative detection project of a kind of pair of detection system carries out reliability assessment is present embodiments provided,
Reagent or standard items lot number before changing after different level quality-control product results change schematic diagram as shown in Figure 1, the present embodiment
The process of method is with reference to shown in Fig. 2.
A, the selection of sample is evaluated: the actual patient blood detected of selection 10 parts of reagents/calibration object lot number before changing
Sample is evaluated in this conduct of final proof, and in this 10 parts of samples, has the detected value of 4 parts of samples within normal reference range, 3 parts of samples
This detected value is lower than normal reference range, and the detected value of 3 parts of samples is higher than normal reference range, with reference to shown in Fig. 3.
B, it evaluates the detection of sample: with reagent/calibration object of new lot number, detecting above-mentioned 10 parts of evaluations sample.
C, the establishment of judgment criteria:, as a result whether can be with received judgment criteria master after reagent/calibration object lot number change
There are 2:
1. evaluating difference of the sample between the detection of new and old lot number in 1/3TEa (maximum allowable overall error, total error
Allowable within)；
2. slope (slope) is in 0.9- with testing result of the linear regression analysis evaluation sample between new and old lot number
In the range of 1.1, refering to what is shown in Fig. 4, wherein region a indicates 3 parts of samples for being lower than normal reference range；Region b is indicated at 4 parts
In the sample in normal reference range；Region c indicates 3 parts of samples for being higher than normal reference range；Wherein regression equation is with y=a+
Bx indicates that b is the slope of regression equation, and a is the intercept of regression equation.
D, the reconstruction of Quality Control range: if by above-mentioned steps, after judging the change of reagent/calibration object, inspection result can be with
Received, but Quality Control result has been found that and substantially change, it is believed that this is because matrix effect of the quality-control product on new and old lot number
Caused by difference, not the method for inspection is unreliable, and laboratory can be re-established when enabling reagent/calibration object of new lot number
New Quality Control range, and give up the Quality Control range of original old lot number reagent/calibration object.
Embodiment 2
Certain laboratory is using A brand Chemiluminescence Apparatus (matched reagent) detection thyrotropic hormone (TSH), and TSH is just
Normal term of reference is 0.3~3.0mIU/L.The laboratory uses elder brother Lai simultaneouslyComplex immunity analyzes non-definite value Quality Control
Product (double levels), in replacement reagent lot on the 15th, Quality Control parameter and Quality Control figure were as shown in Figure 5 and Figure 6, and wherein abscissa is
Date, ordinate are detection thyrotropic hormone (TSH), and unit is μ IU/mL.Quality Control result original value is as shown in table 1- table 3.
1 Quality Control result original value of table
2 Quality Control result original value of table
3 Quality Control result original value of table
It is apparent that by Fig. 5 and Fig. 6 and 3 data of table 1- table, after replacing reagent lot, the Quality Control result of level 1 is not
It substantially change, and the Quality Control result of level 2 has the tendency that obviously rising.And the reason of causing this phenomenon, it may be possible to different
The quality-control product of concentration it is different for the matrix effect of new lot number and caused by, it is therefore desirable to the TSH reagent of new and old lot number is carried out
Assessment.Experiment flow is as follows:
(I) selects 10 parts of clinical samples, and numbering is 1-10；
(II) respectively detects above-mentioned 10 parts of samples using new and old lot number TSH reagent.
As a result:
1. it is as shown in table 1 to detect baseline results:
Table 4 detects baseline results
Wherein,
Difference=new lot number result-old lot number result；
2. the evaluation of new and old lot number difference (%) as shown in fig. 7, the limits of error (TEa) that wherein TSH allows ± be
43%, (limits of error value refers to Laboratory medicine practice guidelines.Laboratory
support for the diagnosis and monitoring of thyroid disease.Thyroid.2003Jan；
13 (1): 3-126) i.e. acceptable standard be ± 14.3% (i.e. in 1/3TEa, Fig. 7 described in horizontal line).As seen from Figure 7, institute
There is the result differences (%) of 10 parts of samples within the scope of permission.
3. linear regression evaluation is as shown in figure 8, new and old lot number equation of linear regression is y=1.02x-0.02, linear regression
The slope of equation is 1.02, is between 0.9-1.1, meets judgment criteria.
Based on above-mentioned deterministic process, we may safely draw the conclusion: the testing result of 2 quality-control product of level rises, and is due to base
Caused by mass effect.The Quality Control figure of level 2 needed to remake Quality Control figure, shown in new Quality Control Fig. 9 after 15 days.
Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention., rather than its limitations；To the greatest extent
Pipe present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that: its according to
So be possible to modify the technical solutions described in the foregoing embodiments, or to some or all of the technical features into
Row equivalent replacement；And these are modified or replaceed, various embodiments of the present invention technology that it does not separate the essence of the corresponding technical solution
The range of scheme.
Claims (10)
1. the method that the result of the quantitative detection project of a kind of pair of detection system carries out reliability assessment, which is characterized in that described
Method includes the following steps:
(a) one group of experiment sample is provided, the result of the quantitative detection project of one group of experiment sample is true value M；Described one
Group experiment sample includes the experiment that true value M is less than the experiment sample of normal reference range, true value M is greater than normal reference range
The experiment sample of sample and true value M in normal reference range；
(b) one group of experiment sample is detected using the detection system, obtains the detected value N of quantitative detection project；
(c) result judgement: if testing result meets following condition, determine the result of the quantitative detection project of the detection system
Reliably；
The difference of (I) true value M and detected value N are less than the 1/3 of maximum allowable overall error；
The regression coefficient of the equation of linear regression of (II) true value M and detected value N is 0.9-1.1.
2. the method according to claim 1, wherein the detection system includes detection reagent, calibration object and inspection
Survey one of instrument or a variety of.
3. the method according to claim 1, wherein using having been evaluated as having the detection system of reliability to examine
One group of experiment sample is surveyed, the true value M is obtained；
Include testing product A in the detection system for having been evaluated as that there is reliability, includes in detection system to be assessed
Testing product B；The testing product B is the product after the change of testing product A batch；
Preferably, the batch change includes the brand switching or lot number change of testing product.
4. according to the method described in claim 3, it is characterized in that, the testing product B includes detection reagent, calibration object or inspection
Survey instrument.
5. method according to any of claims 1-4, which is characterized in that the experiment sample includes clinical sample；
Preferably, the clinical sample includes clinical patients serum, blood plasma, urine or Pleural effusions.
6. method according to any of claims 1-4, which is characterized in that one group of experiment sample includes 10-20 parts of samples
This；
Wherein, true value M accounts for the 25%-35% of whole sample sizes lower than the sample of normal reference range；True value M is normal
Sample in term of reference accounts for the 35%-45% of whole sample sizes；The sample that true value M is higher than normal reference range accounts for whole
The 25%-35% of sample size.
7. according to the method described in claim 6, sample size is 10 parts it is characterized in that it provides one group of experiment sample；Its
In, true value M is lower than 3 parts of sample of normal reference range；True value M is 4 parts of sample of normal reference range；True value M high
In 3 parts of sample of normal reference range.
8. method according to any of claims 1-4, which is characterized in that using true value M as independent variable, with detected value
N is dependent variable, establishes equation of linear regression.
9. method according to any of claims 1-4, which is characterized in that the method also includes readjusting Quality Control
The step of range.
10. a kind of result of the quantitative detection project of any of claims 1-9 to detection system carries out reliability
Purposes of the method for assessment in the Internal Quality Control of medical laboratory.
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| CN111696655A (en) * | 2020-06-12 | 2020-09-22 | 上海市血液中心 | Internet-based real-time sharing blood screening indoor quality control system and method |
| CN111721945A (en) * | 2020-06-22 | 2020-09-29 | 中山市滔略生物科技有限公司 | Quality control product for endocrine mesenchyme assessment |
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