CN113219182B - Method for analyzing TSH multi-system comparability by using quality evaluation data in rooms - Google Patents
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Abstract
The invention discloses a method for analyzing and detecting comparability between systems and standardization and consistency states of inspection items by utilizing self data of an EQA mechanism. This can provide necessary data support for economical and effective utilization of sanitary resources, and may generate certain economic and social benefits in the future. The method comprises the following steps: the individual serum data and the EQA substance are adopted to respectively obtain the system bias of the TSH detection system and the bias related to the interchangeability of the EQA substance, and then the comparability relationship between the systems is respectively obtained after correction. Experiments prove that the comparability relationship between the systems obtained by the two methods is consistent. The invention provides a new analysis view angle and a new idea for the EQA mechanism to analyze the comparability of specific detection items, and also provides a new method for obtaining the real comparability relationship between certain detection item systems for inspection medicine and clinical medicine.
Description
Technical Field
The invention belongs to the field of indoor quality evaluation data analysis, and particularly relates to a method for analyzing TSH multi-system comparability by using indoor quality evaluation data.
Background
Thyroid Stimulating Hormone (TSH) is a glycoprotein Hormone secreted by adenohypophysis basophils and consists of 211 amino acids, and its molecular structure consists of noncovalent α, β subunit heterodimers, wherein the Hormone is specific for biological and immunological functions and is β subunit, and α subunit is substantially identical to α subunit of Luteinizing Hormone (LH), follicle Stimulating Hormone (FSH) and Human Chorionic Gonadotropin (HCG). TSH can promote secretion of T3 (triiodothyronine) and T4 (thyroxine), and is negatively fed back by T3 and T4, which is the most sensitive index for judging thyroid gland function.
Thyroid diseases are common endocrine diseases in clinic. With the acceleration of modern life rhythm, environmental factors, ray exposure, heredity and other factors, the incidence of diseases is 4-8%, even reaches 50%, wherein the incidence of thyroid diseases of women is 6-10 times higher than that of men, and teachers, medical staff and old people in colleges and universities are high incidence people. Clinical first reduction in gestational period of a pregnant woman can increase the risk of poor pregnancy outcome, and can cause premature delivery, low-weight infants, abortion, pregnancy hypertension, gestational diabetes mellitus, preeclampsia and the like, and can also bring adverse effects on the development of fetal neural intelligence.
The Immunoassay of TSH has been followed by changes in Radioimmunoassay (RIA), immunoradiometric Assay (IRMA), enzyme Linked Immunosorbent Assay (ELISA), chemiluminescence Immunoassay (CLIA), electrochemiluminescence Immunoassay (Electrochemiluminescence Immunoassay, ECLIA), time-resolved Fluoroimmunoassay (TrFIA) and Chemiluminescence Immunoassay (clema Immunoassay, cliaa), and the like, and the development of immunology is closely Linked to the improvement in sensitivity of the method. The methodology has been developed to fourth generation according to functional sensitivity (i.e. the corresponding TSH concentration at a 20% inter-batch coefficient of variation). TSH manufacturers have large differences in detection results, and Beckmann Access2 is about 20 times higher than Siemens Immunite 2000 in some low-concentration TSH detection values. Recent studies have shown that TSH varies less between methods at normal concentrations and more at abnormal concentrations. Comparison research of Ma Donggong and other people in China on 6 TSH detection methods finds that the methods have different differences. However, these studies have been conducted using a single testing system to perform a unified test on a single test sample in a single laboratory. Since there may be system bias in a single system, it cannot reflect the real difference and comparability between a certain detection system and other detection systems.
Indoor Quality Assessment (EQA) is a process in which multiple laboratories analyze the same batch of samples (substances) and collect and feed back laboratory reported results by an External independent mechanism to assess accuracy and comparability between laboratory test results. In this process, the EQA substance is indispensable, and foreign scholars classify the substances used in EQA into 5 categories, the highest category being the ones that use the constant value substances with interchangeability to evaluate the real difference of results between laboratories. However, the EQA of TSH in China is based on grouping evaluation based on the problems in many aspects such as sample preparation, storage, transportation and value determination, and the internal reason is that the interchangeability of the used EQA substance is unknown. Researchers at home and abroad also evaluate and quantify the bias related to the EQA substance interchangeability of some detection items, but do not utilize the data to further analyze the real comparability relationship among detection systems.
Disclosure of Invention
In order to solve the above problems, the present invention provides a method for analyzing TSH (thyroid stimulating hormone) multisystem comparability using intercellular quality evaluation data.
The method for analyzing TSH multi-system comparability by using quality evaluation data of the indoor space comprises the following steps: the method comprises the steps of adopting individual blood serum and EQA substances with different TSH concentrations to respectively obtain system bias of a detection system and bias related to interchangeability of an outdoor Quality Assessment (EQA) substance, and obtaining comparative relations among systems after correction.
The serum of the individuals with different TSH concentrations at least comprises 20 samples.
The EQA substance includes at least 20 different concentrations of the EQA substance.
The detection system is a mainstream detection system on the market and at least comprises 5 different detection systems.
The method comprises the following specific steps:
1) For a certain detection system, the TSH concentration mean values of different EQA samples obtained are respectively compared with the median value (C) of a certain detection system Median value ) Comparing to obtain the system bias of the system, wherein the calculation formula is shown in formula (1), and calculating the average value;
wherein, C Mean value The method refers to the TSH concentration mean value of EQA substances obtained by a certain laboratory of a certain detection system; c Median value The method is 'median of multiple NCCL participating EQA laboratories after 3 times of standard deviation is removed', namely, firstly, the mean value and the standard deviation of the return results of all the participating laboratories of a certain type of detection system are calculated, the return results exceeding 3 times of standard deviation are removed, and then the median is taken for the residual data;
the detection system of a certain type refers to an instrument system which is the same series and the same model or different models as the detection system of the same manufacturer, and is divided into the same group in the field of EQA;
the detection system and the detection system of the certain type adopt the same reagent during detection;
all of the laboratories described are those participating in EQA and developed by the national institutes of health and health (NCCL) organization.
2) Correcting individual serum values with different TSH concentrations by using the obtained system bias average value, wherein the correction method is to multiply the individual serum value data by (1 + system bias average value%) to obtain an individual sample correction value (namely a real detection result) detected by the system, process other detection systems by using the same method, perform Passing-Bablok regression among the systems to obtain a real proportional relation of the TSH concentration measurement value of the individual serum among the systems, and adopt software MedCalc (version number 19.0.7, belgium Ostand);
3) For a certain detection system, the American clinical laboratory standardization research institute (CLSI) EP-30A guidelines are utilized, corrected individual serum values with different TSH concentrations and correction values of EQA samples are adopted to respectively obtain interchangeability related biases (the interchangeability bias is the inherent attribute of the EQA substance of non-individual human serum, if the real comparability relation between systems is obtained by utilizing the substance, correction is needed), other detection systems are processed by the same method, the formula is shown in a formula (2), and the average value is obtained;
wherein, C Mean value, other Refers to the TSH concentration mean value, C, of EQA substance obtained by other detection systems (evaluation methods) Mean value, comparison The method is characterized in that the method is the TSH concentration mean value of the EQA substance obtained by a certain detection system (comparison method), and beta and alpha respectively refer to the slope and intercept of Deming regression;
4) From the EQA plan of NCCL for many years (the source and preparation process of the adopted EQA material should be the same), at least 20 median values are obtained for each type of detection system (the formula of the used reagent should be the same); the median data refers to a median of a certain detection system of multiple laboratories, from which TSH with 3 times of standard deviation is removed, obtained from a NCCL EQA data return client, and the principle is that TSH concentration measured by the certain detection system of the multiple laboratories is adopted, mean value and standard deviation are calculated, return results exceeding 3 times of standard deviation are removed, and then the median is taken for residual data (more than at least 10 families);
5) Correcting the median value data obtained in the step 4) by using the interchangeability related bias mean value obtained in the step 3); performing Passsing-Bablok regression on the corrected data to obtain a true proportional relation between systems adopting EQA data, wherein the adopted software is MedCalc (version number 19.0.7, belgium Ostand);
6) Comparing the proportional relation between the systems obtained in the step 2) and the step 5), and judging whether the EQA data can reflect and analyze the comparability between the systems.
The detection system described in the present invention relates to different manufacturers of in vitro diagnostic reagents, namely: siemens ADVIA
Centaur XP, siemens Immunite 2000, beckman DXI, autoLumo A2000Plus, new Production Magumi 2000Plus, cobas 601, architect i2000sr and SolalinLiaison XL.
In the step 1), the standard deviation is a standard deviation calculated by using TSH detection values obtained by detecting the same batch of samples in all participating laboratories of the same type of detection systems (i.e. the same series of instrument systems of the same manufacturer and the same or different models), so-called the same type, and is divided into the same group in the EQA field.
In the above step 1), the above-mentioned compound C Median value The method is 'median value of multiple NCCL participating EQA laboratories after 3 times of standard deviation is removed', namely, firstly, the mean value and the standard deviation of the return results of all the participating laboratories of a certain type of detection system are calculated, the return results exceeding 3 times of standard deviation are removed, and then the median value is taken for the residual data.
The detection systems in the step 1) and the step 3) are the same detection system (namely, the detection systems with the same manufacturer and model).
In the step 2), the method for correcting the serum values of the individuals with different TSH concentrations by using the obtained system bias mean value is to multiply the measured serum values of the individuals with different TSH concentrations by (1 + system bias mean value%); for example: the calculated system bias was positive 5% and all measurements were multiplied by 1.05.
In the step 3), the correction value of the EQA sample is obtained by multiplying the serum value data of the EQA sample by (1 + system bias mean%).
In the step 5), the median value data obtained in the step 4) is corrected by the interchangeability-related bias average value obtained in the step 3) by multiplying the median value data by (1 + interchangeability-related bias average value%).
In step 6) above, the slope and intercept are mainly compared, i.e. the proportional relationship between different detection systems. The comparison between different systems, which is mainly obtained by comparing the two methods, shows that the slope and the intercept are similar, and 95% confidence intervals are mutually overlapped (fig. 3 and 4). The comparability relationship among the systems is true and reliable, and simultaneously, the big data of the EQA material without interchangeability is verified, and the comparability among different detection systems can be reflected through complex and scientific operation.
Compared with the prior art, the method has the following beneficial effects:
1. the method comprises the steps of adopting big data of national indoor quality Evaluation (EQA), obtaining system deviation of a certain detection system by utilizing more than 2 EQA sample median values of the certain detection system, re-correcting detected individual serum sample data, and processing other detection systems by adopting the same method, thereby obtaining real comparability relation among different systems.
2. For a certain type of detection system, the interchangeability bias of more than 2 EQA samples used for the national quality evaluation of the indoor space is calculated, then the median values of the EQA samples are re-corrected, and the same method is adopted for processing other detection systems, so that the real comparability relationship among the systems is obtained by using the quality evaluation data of the indoor space.
3. And comparing the obtained intersystem comparative relationship with each other, and finding that the results are consistent, thereby proving that the mode for obtaining the intersystem comparative relationship is reliable.
Drawings
FIG. 1 is a comparative box plot of TSH 8 detection systems before and after correction of system bias and interchangeability related bias; wherein A and B represent the individual serum detection results before and after the system bias correction respectively; c and D, respectively representing the detection results of the EQA data before and after the interchangeability related bias correction; a represents that siemens Immulite 2000 samples gave results outside the analytical measurement range.
FIG. 2 is a diagram of inter-system comparability (left) obtained using individual sample data after system bias correction and inter-system comparability (right) obtained using EQA data after interchangeability related bias correction; wherein, a comprises Siemens ADVIA Centaur CP/XP; b, comprises Siemens Immunite 2000/2000XPi; c, comprising beckman DXI, dxi800; d, comprising atlas AutoLumo a2000/a2000Plus; e, including the New industry Maglumi600/800/1000/1000Plus/2000/2000Plus; f, including Cobas e601/e602 Roche; g, comprising Yapei Architect i2000sr/i2000/i1000sr; h, comprising SolalinLiaison/XL.
FIG. 3 is a graph of the inter-system slope comparability obtained by two methods; A-G represent two-by-two comparisons of Siemens ADVIA Centaur XP with Siemens Immunite 2000, beckmann DXI, anTu AutoLumo A2000Plus, new Productivity Maglumi2000Plus, roche Cobas 601, yapei Architect i2000sr and Solidason XL, respectively. a-g represent the comparison of two-by-two of Siemens ADVIA Centaur CP/XP with Siemens Immunite 2000/2000XPi, beckmann DXI, DXI800, atlas AutoLumo A2000/A2000Plus, new Productivity Magumi 600/800/1000/1000Plus/2000/2000Plus, roche Cobas e601/e602, yapei Architect i2000sr/i2000/i1000sr and SolalinLiaison/XL, respectively.
FIG. 4 shows two methods for obtaining intersystem intercept comparability; A-G represent two-by-two comparisons of Siemens ADVIA Centaur XP with Siemens Immunite 2000, beckman DXI, anchart AutoLumo A2000Plus, new Productivity Magumi 2000Plus, cobas 601, yapei Architect i2000sr and Solinelison XL, respectively. a-g respectively represent two-to-two comparison between Siemens ADVIA Centaur CP/XP and Siemens Immunite 2000/2000XPi, beckmann DXI, DXI800, atlas AutoLumo A2000/A2000Plus, new Productivity Maglumi600/800/1000/1000Plus/2000/2000Plus, roche cobalt e601/e602, yapei Architect i2000sr/i 1000sr and Soling Liaison/XL.
Detailed Description
The present invention is described below with reference to specific embodiments, but the present invention is not limited thereto, and any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the scope of the present invention.
The experimental procedures used in the following examples are all conventional procedures unless otherwise specified.
Materials, reagents and the like used in the following examples are commercially available unless otherwise specified.
Example method for analyzing TSH Multi-System comparability Using Chamber Mass evaluation data
The method comprises the following steps:
1) Serum from 29 individuals at different TSH concentrations was collected from the kyoto yang hospital affiliated with the university of capital medical (ethical approval 2018-2-26-1). Serum of each sample was divided into 8 portions (frozen in a refrigerator at-80 ℃ for later use) according to the manufacturer's requirements, and then tested 3 times in 8 different systems. Samples were required to be free of hemolysis, lipemia and jaundice in appearance, and initial concentrations of TSH were measured using a Siemens ADVIA CentauerXP immunoassay to range from 0.09. Mu.IU/mL to 84.03. Mu.IU/mL.
2) 2 EQA substances (the batch numbers are 201811 and 201812 respectively) with different concentrations are obtained from the national center for health and wellness committee clinical laboratory (NCCL), the substances are dry powder, each concentration is 2 bottles, 3ml of ultrapure water is added into each bottle when the substance is used, 2 bottles of samples with each concentration are fully mixed, and then the samples are divided into 8 parts (frozen and stored in a refrigerator at minus 80 ℃ for standby) according to the required amount of each manufacturer, and then the 8 parts are randomly inserted into the serum of the above 29 individual samples and are uniformly detected by the following 8 detection systems.
It should be noted that: the concentration of the EQA substance is unknown, and the concentrations of substances employed in the field of quantitative assessment of the interstitial space (EQA) are mostly unknown, but require different concentration levels. These EQA substances are sent to clinical laboratories and the results are reported after their detection. Since the concentration is unknown, only the mean value of all laboratories can be used, and this mean value is obtained by continuous screening/iteration using a robust algorithm, and is called a robust mean value.
3) The information for the 8 detection systems is shown in table 1,
table 1 tsh detection system basic information
AMR, analyzing the measuring range; RR, reference range; ECL, electrochemiluminescence; CL, chemiluminescence; CMIA, chemiluminescent microparticle immunoassay.
4) The above 31 samples were tested 3 times each using the above 8 test systems.
5) For a certain detection system, the obtained detection mean values of 2 EQA samples are respectively compared with median values (shown in table 2) of a plurality of NCCL adopting a certain detection system and participating in an EQA laboratory after 3 times of standard deviation is removed, so that the system bias of the system is obtained, and the mean value is calculated (shown in table 3).
TABLE 2 TSH concentration median of all participating laboratories of certain type of test system
6) The obtained system bias average value (see formula 1) is used for correcting the serum values of 29 individuals with different TSH concentrations (the correction method is to multiply the measured serum values of the individuals with different TSH concentrations by (1 + system bias average value%)), so as to obtain the accurate detection result of 29 individual samples detected by the system, the same method is adopted for other detection systems for processing, then Passing-Bablok regression is carried out among the systems, so as to obtain the true proportional relation of the individual serum TSH concentrations among the systems (specifically embodied by the slope and the intercept in Table 4), and the adopted software is MedCalc (version number 19.0.7, belgium Ostand) (see Table 4).
Wherein, C Mean value The method refers to the TSH concentration mean value of EQA substances obtained by a certain laboratory of a certain detection system; c Median value The method refers to the TSH concentration median of EQA substances obtained by all laboratories of a certain type of detection system, wherein a certain type of detection system refers to the same series of instrument systems with the same or different models of manufacturers and adopting the same reagent;
7) For one test system, the compatibility-related biases of 2 EQA samples were obtained using 29 corrected individual sera and 2 EQA sample corrections using the american Clinical Laboratory Standards Institute (CLSI) EP-30A guidelines, averaged (see table 5), and processed in the same manner for the other test systems. The interchangeability related bias calculation formula is as follows:
wherein, C Mean value, other Refers to the TSH concentration mean value, C, of EQA substance obtained by other detection systems Mean value, cen The mean value of the TSH concentration of the EQA substance obtained from the Siemens ADVIA CentaurXP is shown, and beta and alpha respectively refer to the slope and intercept of the Deming regression.
8) Obtaining a median value of a certain detection system from a NCCL EQA data reporting client of a Beijing Chaoyang hospital affiliated to the university of capital medical science; the time of data collection was from 2016 to the first half of 2019 for a total of 7 EQA plans, 5 samples at a time, for a total of 35 median data (see table 6). The median data refers to a median of a certain detection system of multiple laboratories, from which TSH with 3 times of standard deviation is removed, obtained from a NCCL EQA data return client, and the principle is that TSH concentration measured by the certain detection system of the multiple laboratories is adopted, mean value and standard deviation are calculated, return results exceeding 3 times of standard deviation are removed, and then the median is taken for residual data (more than at least 10 families); the same approach is used for other detection systems.
9) Correcting the 35 median data in step 8) by using the interchangeability related bias means in step 7) (the median data is multiplied by (1 + interchangeability related bias means%)).
And performing Passsing-Bablok regression on the corrected data to obtain a true proportional relation of EQA data adopted among systems, wherein the adopted software is MedCalc (version number 19.0.7, belgium Ostand) (see table 7).
10 Compare the inter-system proportional relationship obtained in step 6) and step 9) and determine whether the EQA data reflects the inter-system comparability analysis (tables 4 and 7). The comparison relationship between different systems obtained by comparing the two methods shows that the slope and the intercept are similar, and 95% confidence intervals are mutually overlapped (fig. 3 and 4). The comparability relationship between the systems is true and reliable, and simultaneously, the big data of the EQA substance without interchangeability is verified, and the comparability between different detection systems can be reflected through complex and scientific operation.
11 All systems were compared (X-axis) with Siemens ADVIA CentaurXP and the other 7 systems were evaluated (Y-axis). The reason why siemens ADVIA CentaurXP was used as a comparative method is that the detection system is routinely used by the laboratory of the inventor of the present application, and the laboratory has passed ISO 15189 and CAP approval, and has a good quality management system. Although the present invention can obtain the true proportional relationship of the individual samples detected among the systems, the proportional relationship of any detection system and other detection systems can be obtained by using the raw data and the method without creative efforts.
TABLE 3 System bias of Pre-calibration 8 detection System and Interchangeable compatibility of NCCL EQA materials between systems (Siemens ADVIA CentauerXP as comparison method)
TABLE 4 Transmission-Bablok regression with individual samples after correction of system bias
r refers to pearson correlation coefficient, and CI refers to confidence interval.
TABLE 5 System bias of post-calibration 8 detection System and related bias for interchangeability of NCCL EQA materials between systems (Siemens ADVIA CentauerXP as comparison method)
TABLE 6 number of laboratories participating in NCCL EQA (2016-2019)
a, comprises Siemens ADVIA Centaur CP/XP; b, comprises Siemens Immunite 2000/2000XPi; c, comprising beckman DXI, dxi800; d, comprises atlas AutoLumo A2000/A2000plus; e, including the New industry Maglumi600/800/1000/1000Plus/2000/2000Plus; f, containing Roche cobalt e601/e602; g, comprising Abbott Architect i2000sr/i2000/i1000sr; h, comprising SolalinLiaison/XL.
TABLE 7 interchangeability-related bias corrected NCCL EQA substance packing-Bablok regression (2016-2019)
a, comprises Siemens ADVIA Centaur CP/XP; b, comprises Siemens Immunite 2000/2000XPi; c, comprising beckman DXI, dxi800; d, comprises atlas AutoLumo A2000/A2000plus; e, including the New industry Maglumi600/800/1000/1000Plus/2000/2000Plus; f, including Cobas e601/e602 Roche; g, comprising Yapei Architect i2000sr/i2000/i1000sr; h, comprising Soling Liaisson/XL. R, refers to pearson correlation coefficient, and CI refers to confidence interval.
Experiments prove that the data of TSH EQA and 8 clinical common detection systems are adopted, and after relevant bias of interchangeability is corrected, the data are consistent with the intersystem TSH detection result comparability relation obtained by real individual sample detection data. Because the prior EQA material generally lacks interchangeability and the systematic deviation of the conventional clinical detection system also generally exists, the analysis method of the invention is suitable for the EQA mechanism to analyze the comparability between detection systems and the standardization and the consistency state of the detection items by utilizing the data of the EQA mechanism. On the other hand, the method can provide a new method for obtaining the real comparability relationship between certain detection project systems in inspection medicine and clinical medicine, provides necessary data support for saving and effectively utilizing sanitary resources, and possibly generates certain economic benefits and social benefits in the future.
Claims (8)
1. A method for analyzing TSH multi-system comparability using quality of laboratory data, comprising the steps of: adopting individual blood serum and EQA substances with different TSH concentrations to respectively obtain system bias of a detection system and bias related to interchangeability of the EQA substances, and respectively obtaining comparative relations among systems after correction;
the serum of the individuals with different TSH concentrations at least comprises 20 samples;
the EQA species includes at least 20 different concentrations of an EQA species;
the detection system is a mainstream detection system in the market and at least comprises 5 different detection systems;
the method comprises the following specific steps:
1) For a certain detection system, comparing the TSH concentration mean values of different EQA samples with the median value of a certain detection system respectively to obtain the system bias of the system, wherein the calculation formula is shown in formula (1), and calculating the mean value;
wherein, C Mean value The method refers to the TSH concentration mean value of the EQA substance obtained by a certain laboratory of a certain detection system; c Median value The method is 'median of multiple NCCL participating EQA laboratories after 3 times of standard deviation is removed', namely, firstly, the mean value and the standard deviation of the return results of all the participating laboratories of a certain type of detection system are calculated, the return results exceeding 3 times of standard deviation are removed, and then the median is taken for the residual data;
the detection system of a certain type refers to an instrument system which is the same series and the same model or different models as the detection system of the same manufacturer, and is divided into the same group in the field of EQA;
the certain detection system and the certain detection system adopt the same reagent during detection;
2) Correcting the serum values of individuals with different TSH concentrations by using the obtained system bias mean value to obtain an individual sample correction value detected by the system, processing other detection systems by using the same method, and then performing Passing-Bablok regression among the systems to obtain a true proportional relation of the individual serum TSH concentration measurement values among the systems, wherein the adopted software is MedCalc, and the version number is 19.0.7;
3) For a certain detection system, the guidelines of the American Clinical Laboratory Standardization Institute (CLSI) EP-30A are utilized, the interchangeability related biases of 2 EQA samples are respectively obtained by adopting the corrected individual serum with different TSH concentrations and the corrected values of the EQA samples, the calculation formula is shown in formula (2), the average value is calculated, and the same method is adopted for processing other detection systems;
wherein, C The average value of the average value is calculated,others Refers to the TSH concentration mean value, C, of EQA substance obtained by other detection systems Mean value, comparison The method is characterized in that the method refers to the TSH concentration mean value of the EQA substance obtained by a certain detection system, and beta and alpha respectively refer to the slope and intercept of Deming regression;
4) In the EQA plan of NCCL for multiple times over years, each type of detection system obtains at least 20 median value data;
5) Correcting the median data of the plurality of detection systems in the step 4) by using the interchangeability related bias mean in the step 3); performing intersystem paging-Bablok regression on the corrected data to obtain a true proportional relation of EQA data adopted among the systems, wherein the adopted software is MedCalc, and the version number is 19.0.7;
6) Comparing the proportional relation between the systems obtained in the step 2) and the step 5), and judging whether the EQA data can reflect and analyze the comparability between the systems.
2. The method of claim 1, wherein: the detection system comprises: siemens ADVIA Centaur XP, siemens Immunite 2000, beckmann DXI, andon AutoLumo A2000Plus, new Productions Maglumi2000Plus, roche Cobas 601, yapei Architect i2000sr and Solineson XL.
3. The method according to claim 1 or 2, characterized in that: in the step 1), the standard deviation is calculated by adopting TSH detection values obtained by detecting the same batch of samples in all participating laboratories of the same type of detection system.
4. The method according to claim 1 or 2, characterized in that: the detection system in the step 1) and the detection system in the step 3) are the same detection system.
5. The method of claim 1, wherein: in the step 2), the serum values of the individuals with different TSH concentrations are corrected by multiplying the measured serum values of the individuals with different TSH concentrations by (1 + system bias mean%).
6. The method of claim 1, wherein: in the step 3), the correction value of the EQA sample is obtained by multiplying the serum value data of the EQA sample by (1 + system bias mean%).
7. The method of claim 1, wherein: in the step 4), the EQA material source and the preparation process adopted in the EQA plan should be the same, and the reagent formula used by each type of detection system should be the same;
the median data refers to the median of TSH detection results of a certain type of detection systems of multiple laboratories, which are obtained from the NCCL EQA data return client side and from which TSH with 3 times of standard deviation is removed.
8. The method of claim 1, wherein: in the step 5), the median value data obtained in the step 4) is corrected by using the interchangeability related bias average value obtained in the step 3), by multiplying the median value data by (1 + interchangeability related bias average value%).
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