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Reference intervals for common clinical biochemistry tests - Part 9: Serum C-reactive protein, prealbumin, transferrin, β2-microglobulin
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Basic data
| Standard ID | WS/T 404.9-2018 (WS/T404.9-2018) |
| Description (Translated English) | Reference intervals for common clinical biochemistry tests - Part 9: Serum C-reactive protein, prealbumin, transferrin, ��2-microglobulin |
| Sector / Industry | Health Industry Standard (Recommended) |
| Classification of Chinese Standard | C59 |
| Word Count Estimation | 10,166 |
| Date of Issue | 2018-12-12 |
| Date of Implementation | 2019-06-01 |
| Regulation (derived from) | State-Health-Communication (2018) No.24 |
| Issuing agency(ies) | National Health Commission |
WS/T 404.9-2018: Reference intervals for common clinical biochemistry tests - Part 9: Serum C-reactive protein, prealbumin, transferrin, β2-microglobulin
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Reference intervals for common clinical biochemistry tests - Part 9. Serum C-reactive protein, prealbumin, transferrin, β2-microglobulin
ICS 11.100
C 50
WS
People's Republic of China Health Industry Standard
Clinical common biochemical test project reference interval
Part 9. serum C-reactive protein, prealbumin,
Transferrin, β2-microglobulin
Reference intervals for common clinical biochemistry tests-
Part 9. Serum C-reactive protein, prealbumin, transferrin, β2-microglobulin
Published on.2018 - 12 - 12
2019 - 06 - 01 implementation
National Health and Wellness Committee of the People's Republic of China
Foreword
WS/T 404 "Clinical Common Biochemical Test Project Reference Interval" is divided into 9 parts.
-- Part 1. Serum alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and gamma-glutamyl transfer
Enzyme
-- Part 2. Serum total protein, albumin;
-- Part 3. Serum potassium, sodium, chlorine;
-- Part 4. Serum total bilirubin, direct bilirubin;
-- Part 5. Serum urea, creatinine;
-- Part 6. Serum total calcium, inorganic phosphorus, magnesium, iron;
-- Part 7. serum lactate dehydrogenase, creatine kinase;
-- Part 8. Serum amylase;
-- Part 9. Serum C-reactive protein, prealbumin, transferrin, β2-microglobulin.
This part is the ninth part of WS/T 404.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section was drafted by. First Affiliated Hospital of China Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Beijing Hospital, Zhongshan Hospital of Fudan University,
Peking University Third Hospital, First Affiliated Hospital of the People's Liberation Army Air Force Military Medical University, West China Hospital of Sichuan University.
The main drafters of this section. Shang Hong, Huang Xianzhang, Chen Wenxiang, Pan Baishen, Zhang Jie, Hao Xiaoke, Wang Lanlan, Zhao Min, Mu Runqing, Zhang
Treasure.
Clinical common biochemical test project reference interval
Part 9. Serum C-reactive protein, prealbumin, transferrin, β2-microglobulin
1 Scope
This section specifies the reference for serum C-reactive protein, prealbumin, transferrin, and β2-microglobulin in Chinese adults (≥18 years old).
Interval and its application.
This section applies to the clinical laboratory of medical institutions for serum C-reactive protein, prealbumin, transferrin, β2-microglobulin test
The report of the test results, the manufacturer of the relevant in vitro diagnostic products can refer to the use.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the version of that date applies to this document.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
WS/T 225 Clinical Chemistry Test Blood Collection and Processing
Development of reference intervals for WS/T 402 clinical laboratory test items
3 Terms and definitions
The terms and definitions defined by WS/T 402 apply to this document.
4 reference interval
4.1 The reference intervals of serum C-reactive protein, prealbumin, transferrin and β2-microglobulin in Chinese adults (≥18 years old) are shown in Table 1.
Table 1 Chinese adult serum C-reactive protein, prealbumin, transferrin, β2-microglobulin reference interval
Project unit grouping reference interval
C-reactive protein (CRP) mg/L male/female ≤6.0
Prealbumin (PA) mg/L
Male.200 ~ 430
Female 180～350
Transferrin (TRF) g/L male/female 2.0 to 3.6
2-2-microglobulin (β2-MG) mg/L
18 to 59 years old 1.0 to 2.3
≥60 years old 1.3～3.0
Note 1. The CRP test results are derived from non-supersensitive kits. The reference interval in this document does not apply to the assessment of heart disease risk.
Note 2. The reference interval of this document does not apply to children, adolescents (age < 18 years old) and pregnant women.
4.2 Relevant information on the establishment process of Chinese adult serum C-reactive protein, prealbumin, transferrin and β2-microglobulin reference interval
See Appendix A.
5 Reference interval application
5.1 General principles
5.1.1 Clinical laboratories should first consider the reference interval in this document.
Note 1. The research workload of establishing the reference interval is large and costly. It is more realistic and feasible for the clinical laboratory to reference the reference interval than to establish the reference interval.
Note 2. This reference interval is based on the results of a large-scale multicenter study of the Chinese adult population.
Note 3. C-reactive protein, prealbumin and transferrin test results trace back to internationally recognized reference materials, see Appendix B.
5.1.2 The necessary verification or evaluation should be carried out before using the reference interval of this document.
Note 1. The applicability of the reference interval of this document mainly depends on the comparability of the laboratory test results and the test results when the reference interval is established and the applicability of the population.
Note 2. The laboratory shall ensure that the performance of the analytical system meets the relevant requirements before using the reference interval of this document.
Note 3. The reference interval of this document is based on the results of fresh serum test. If the type of specimen used in clinical laboratory is plasma, appropriate evaluation should be carried out.
Whether to use this reference interval.
5.2 Verification and use of reference intervals
5.2.1 The clinical laboratory should perform the necessary verification before referring to the reference interval. The reference interval verification can be performed as follows.
a) Screening qualified reference individuals not less than 20 (sex and age should be evenly distributed), and the screening criteria are shown in Appendix A, A.2.2;
b) Collect, process and analyze samples according to the laboratory operating procedures, and ensure that the performance of the analytical system meets the relevant requirements before analysis;
c) check and eliminate outliers in an appropriate manner (if there is an outlier, the reference individual is complemented);
Note. The outlier test uses the Dixon method. first sort the test results by size and calculate the range (the difference between the maximum and the minimum) R, and then separately
Calculate the difference D between the maximum and minimum values and their neighboring values; if D/R ≥ 1/3, the maximum or minimum value is treated as an outlier value;
The data is repeated as described above for outlier testing until all outliers are eliminated.
d) If 20 qualified reference individuals are selected, compare 20 test results with the reference interval, if the data outside the reference interval is not
If there are more than 2, the verification will be passed; if there are more than 2, the other 20 qualified reference individuals will be re-according to the above judgment criteria.
verification;
e) If there are more than 20 reference individuals, no more than 10% of the data outside the reference interval is verified; if more than 10% of the data is
In addition to the reference interval, at least 20 qualified reference individuals are selected and re-verified according to the above criteria.
If the verification result meets the requirements, the reference interval can be used, otherwise it should be processed according to 5.2.2.
5.2.2 When the reference interval fails verification, it can be handled as follows.
a) For cases that fail verification, the quality of the analysis should be evaluated first, especially if it is confirmed by the analysis system.
Problem, the analysis system should be improved or replaced. Analytical quality assessment can be (but is not limited to) the following.
1) Analysis of interoperable certified reference materials or other suitable reference materials;
2) Participate in an appropriate correctness verification plan or standardization plan;
3) Compare with other systems or methods with reliable performance.
b) For cases where verification has not been carried out, if it is confirmed to be a population cause, an appropriate reference interval shall be established or referenced as required by WS/T 402.
AA
Appendix A
(informative appendix)
Information about the interval establishment process
A.1 Steps for establishing a reference interval
The reference interval of this document is established in accordance with the requirements of WS/T 402 and mainly includes the following steps.
a) selecting reference individuals to form a reference sample group;
b) collecting and processing the blood sample to obtain a serum sample;
c) analyzing the serum sample to obtain a reference value;
d) statistically process the reference value and establish a reference interval.
A.2 Establishment of reference sample groups
A.2.1 Selection of reference individuals
The reference population is the adult healthy population in China. The reference sample group is selected from the rural areas of Northeast China, North China, Northwest China, East China, South China and Southwest China.
And urban communities. The multi-stage cluster sampling method was used, and the age range of the survey was ≥18 years old. Six centers survey a total of apparently healthy individuals
18,000 people, after a rigorous health check and laboratory screening, determine the reference individuals enrolled.
A.2.2 Selection criteria for reference individuals
Each center collects apparent healthy individuals in their respective regions, and obtains informed consent, through questionnaires, physical examinations, and laboratory tests.
Screening reference individuals to meet the following requirements.
a) Questionnaires and physical examinations include the following.
1) Conscious health;
2) No acute or chronic diseases. no acute or chronic infection, cardiovascular and cerebrovascular diseases, diabetes, respiratory diseases, urinary system diseases,
Thyroid disease, digestive system disease, rheumatic disease, blood system disease, tumor;
3) Blood pressure. systolic blood pressure < 140 mmHg and diastolic blood pressure < 90 mmHg;
4) BMI (body mass index). < 28 kg/m2 and ≥18.5 kg/m2;
5) No operation within 6 months, no blood donation, blood transfusion or massive blood loss within 4 months, no medication within 2 weeks;
6) The woman is not pregnant or breastfeeding;
7) No alcohol or tobacco;
8) There is no obvious abnormality in the ECG.
b) Excluded by laboratory tests.
1) Serum alanine aminotransferase. male >50 U/L, female >40 U/L; or serum gamma-glutamyl transferase.
Male >60 U/L, female >45 U/L; or aspartate aminotransferase. male >40 U/L, female >35 U/L;
2) serum albumin < 40 g/L;
3) Serum creatinine. male (20 years old to 59 years old) >97μmol/L, male (60 years old to 79 years old) >111μmol/L; female
(20 years old to 59 years old) >73μmol/L, female (60 years old to 79 years old) >81μmol/L;
4) Fasting blood glucose ≥7.0 mmol/L;
5) White blood cell count. < 3.5×109/L or >9.5×109/L;
6) Hemoglobin. male < 130 g/L; female < 115 g/L;
7) total cholesterol ≥ 6.22 mmol/L; or triglycerides ≥ 2.26 mmol/L;
8) C-reactive protein > 10 mg/L;
9) HBsAg, anti-HCV antibodies, anti-HIV antibodies are positive for any one of them;
10) RF ≥ 20 IU/ml.
Note. Exclusion criteria are based on health industry standards, reference authoritative books and literature, comprehensive tests and clinical expert opinions, and statistical analysis results.
A.3 Blood sample collection and processing
The principle of blood sample collection and processing is carried out in accordance with the relevant requirements of WS/T 225, the specific requirements are as follows.
a) Reference individual preparation. maintain normal living habits three days before blood collection, do not exercise vigorously and heavy physical labor; dinner the day before blood collection
After the second day of the morning, fasting before blood collection, fasting time 8 h ~ 14 h;
b) Blood collection. the subject takes a sitting position, rests for 15 minutes before blood collection, uses a serum separation hose, and adopts a vacuum blood collection method, from the front of the elbow
Venous blood collection;
c) Blood sample processing. The sample is separated in time within 2 hours after collection, and the hemolysis, jaundice or chyle sample is checked and eliminated. Serum
Analysis was performed within 2 h after separation.
A.4 Analysis of serum samples
A.4.1 Analysis system. use a variety of analytical systems commonly used in clinical laboratories in China and their respective supporting reagents and calibrators.
Note. The analytical methods used in the establishment of this reference interval and the metrological traceability of the test results are given in Appendix B. Verification of the correctness of the test results of each analysis system
See A.4.2. There is no internationally recognized traceability system for serum β2-microglobulin, but the reference interval established based on multiple detection systems is consistent.
A unified reference interval is provided.
A.4.2 Analytical system performance assessment. Analytical performance assessment is performed prior to analysis of individual serum samples.
a) Precision assessment. Determination of quality control at both normal and abnormal levels, 1 batch per day, 3 replicates, continuous measurement
For 5 days, the minimum standard of precision derived from biological variation is used as the criterion;
b) Correctness verification. Analyze the reference substance ERM-DA470K/IFCC to verify the correctness of PA and TRF and analyze the reference substance
ERM-DA474/IFCC performs correctness verification on CRP;
c) Conformance assessment. assessing the same analysis across laboratories using multiple concentrations (including normal and abnormal levels) of human mixed serum
System consistency and comparability of all analytical systems, based on the minimum standard of total error derived from biological variation
standard.
A.4.3 Analysis of serum samples. Analyze serum samples after the performance of the system meets the requirements, and analyze each serum sample once.
A.4.4 Quality control of sample analysis. use third-party quality control at both normal and abnormal levels and a normal concentration level
Precision control was performed with serum control substances, and quality control analysis was performed for each analysis batch.
A.5 Reference value processing and reference interval establishment
A.5.1 Outlier test. After each packet data is normalized, data other than the mean ± 4 standard deviations is excluded.
A.5.2 Group judgment. After the data is normalized, the three factors of gender, age and region are analyzed by using the nested ANOVA method.
When the SDR (SD ratio, the SD of a given factor divided by between-individual SD) ≤ 0.3, the packet is not prompted; SDR
When >0.3, the prompt is grouped by this factor. If you need to group, use the Z test method recommended by Harris and Boyd to subgroup the factors.
A pairwise comparison is made to determine how the reference intervals are grouped.
Note. According to the results of statistical analysis, combined with clinical observations, prealbumin is grouped by sex, and β2-microglobulin is grouped by age.
A.5.3 Reference limits and reference interval establishment. Calculate the reference interval using a non-parametric method. PA, TRF, and β2-MG take the reference value of 2.5
The percentile and the 97.5th percentile are used as the reference lower limit and the reference upper limit; CRP takes the 97.5th percentile of the reference value as the reference upper limit.
Thereby determining the reference interval.
Note. C-reactive protein concentration has clinical significance, the reference interval is expressed as ≤ reference upper limit.
BB
Appendix B
(informative appendix)
Metrology traceability
The metrological traceability of serum C-reactive protein, prealbumin, transferrin, β2-microglobulin analysis methods and test results are shown in Table B.1.
Table B.1 Evidence traceability of serum C-reactive protein, prealbumin, transferrin, β2-microglobulin analysis methods and test results
Project measurement method metrology traceability
C-reactive protein (CRP) immunoturbidimetric method ERM-DA474/IFCC
Prealbumin (PA) immunoturbidimetric method ERM-DA470/IFCC
Transferrin (TRF) immunoturbidimetric method ERM-DA470/IFCC
Β2-microglobulin (β2-MG) immunoturbidimetric manufacturer internal standard
references
[1] Wang Jiyao. Internal Medicine. 2nd Edition. Beijing. People's Medical Publishing House,.2010
[2] Donald S. Young. Influence of pre-analytical factors on clinical test results. 3rd edition. Li Yan, et al., Beijing. People's Military Medical Press,.2009
[3] Clinical and Laboratory Standards Institute (CLSI). Defining, establishing, and verifying reference
Intervals in the clinical laboratory. Approved Guideline -Third Edition.CLSI document C28-A3c.CLSI,
Wayne, PA, USA,.2010
[4] Ichihara K, Boyd JC.An appraisal of statistical procedures used in derivation of reference intervals.
Clin Chem Lab Med,.2010, 48 (11). 1537-1551
[5] Clinical and Laboratory Standards Institute (CLSI). Method Comparison and Bias Estimation Using
Patient Samples; Approved Guideline-Second Edition.CLSI document EP9-A2.CLSI, Wayne, PA, USA,
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