YY/T 1513-2017 English PDF (YYT1513-2017)

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YY/T 1513-2017: C-reactive protein testing kit
YY/T 1513-2017
C-reactive protein testing kit
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
C-reactive protein assay kit
Released on.2017-03-28
2018-04-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. Publication of this document
The organization is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This standard was drafted. Beijing Medical Device Inspection Institute, Zhongsheng Beikong Biotechnology Co., Ltd., Beijing Jiuqiang Biotechnology Unit
Co., Ltd., Xisen Meikang Biotechnology (Wuxi) Co., Ltd., Shanghai Rongsheng Biological Pharmaceutical Co., Ltd.
The main drafters of this standard. Wang Ruixia, Xia Shuangchao, Zhang Xiaorui, Dai Leiying, Zhang Jie, Zhang Zhengqiang.
C-reactive protein assay kit
1 Scope
This standard specifies the classification, requirements, test methods and signs, labels, instructions for use, packaging, and transportation of C-reactive protein assay kits.
Loss and storage.
This standard applies to the kit for the quantitative determination of C-reactive protein in blood samples based on the antigen-antibody reaction (hereinafter referred to as.
CRP kit), including quantitative labeling immunoassay [eg (electro) chemiluminescence] and immunoturbidimetry (eg immunoturbidimetry, latex increase)
Strong immune turbidimetry).
This standard does not apply to.
a) Evaluation of C-reactive protein calibrators and controls.
b) Various types of colloidal gold-labeled test strips.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
GB/T 21415 in vitro diagnostic medical device biological sample medium quantity measurement calibrator and control substance evaluation
Source
GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents
3 classification
3.1 Different classifications according to methodology
Can be divided into immunoturbidimetric method, quantitative labeling immunoassay [such as enzyme-linked immunosorbent assay (ELISA), time-resolved fluorescence immunoassay,
(Electrical) chemiluminescence method, etc.].
3.2 Different classification according to measurement range and/or detection limit
It can be divided into a conventional C-reactive protein assay kit, a hypersensitive (high-sensitivity) C-reactive protein assay kit, and a full-range C-reactive protein assay kit.
4 requirements
4.1 Appearance
The manufacturer shall specify the appropriate appearance requirements according to the packaging characteristics of the product. Generally, there should be components and traits of each component of the kit; internal and external
Requirements for packaging, labeling, etc. as follows.
a) The kit should be complete in composition, the inner and outer packaging should be complete, and the label should be clear;
b) The liquid reagent has no leakage, the lyophilized component is loose, and the liquid is uniform after reconstitution (no visible particles, no precipitation).
4.2 Traceability
The source, assignment process and measurement uncertainty of the CRP calibrator used shall be provided in accordance with GB/T 21415-2008 and related regulations.
And so on.
4.3 Reagent blank absorbance
When applicable, the manufacturer shall specify the absorbance of the reagent blank and meet the corresponding requirements.
Note. Only applicable to immunoturbidimetric turbidity.
4.4 Analytical sensitivity
The manufacturer shall specify the analytical sensitivity of the reagents and meet the following requirements.
a) Routine C-reactive protein assay kit, full-range C-reactive protein assay kit, specified wavelength in the production enterprise (light path)
1cm), the absolute value of the absorbance difference (ΔA) corresponding to CRP at a concentration of 40mg/L should be 0.05~0.50
In the range.
b) Hypersensitive (high-sensitivity) C-reactive protein assay kit, specified wavelength in the manufacturer (light path 1cm), corresponding to a concentration of 5mg/L
The absolute value of the absorbance difference (ΔA) caused by CRP should be in the range of 0.05 to 0.50.
Note. Only applicable to immunoturbidimetric turbidity.
4.5 Detection limit
The manufacturer shall provide the detection limit of the CRP kit. The detection limit of the conventional C-reactive protein assay kit is not higher than 5 mg/L.
(High-sensitivity) C-reactive protein assay kit, full-range C-reactive protein assay kit detection limit is not higher than 0.5mg/L.
4.6 Accuracy
Accuracy should meet one of the following requirements.
a) Relative Deviation. Tested with a Certified Reference Material (CRM) that can be used to evaluate conventional methods, the results of which are measured
The relative deviation should not exceed ±15%.
b) Enterprise reference product test. the detection of traceable enterprise reference products, the relative deviation of the measurement results should not exceed
±10%.
4.7 linear
The manufacturer shall specify the linear range of the CRP kit and meet the following requirements.
a) Within the linear interval, the linear correlation coefficient |r| should be not less than 0.990;
b) The linear range of the high-sensitivity C-reactive protein assay kit is not narrower than [0.5,10] (mg/L);
c) The linear interval of the conventional C-reactive protein assay kit is not narrower than [8,80] (mg/L);
d) The linear range of the full-scale C-reactive protein assay kit is not narrower than [0.5, 80] (mg/L);
e) Linear deviations within the linear interval should be specified, depending on the actual situation, with relative or absolute bias in different segments of the linear interval
Poor expression.
4.8 repeatability
In the range of linear interval, select 2~3 samples with different concentration levels. The concentration selection can refer to the medical decision level, which represents the normal value.
And outlier levels. Each test is repeated 10 times, and its coefficient of variation (CV) should be no more than 10%.
4.9 batch difference
Use 3 CRP batch kits to select 2~3 different concentrations of samples, then batch between 3 batches of CRP kits
The relative extreme difference should be no more than 15%.
4.10 Stability
4.10.1 General
Verification of shelf life stability and thermal stability.
4.10.2 Stability of validity
The manufacturer shall specify the validity period of the CRP kit. The reagent at the end of the period of time is used to detect the reagent blank absorbance, analytical sensitivity,
The detection limit, accuracy, linearity and repeatability should meet the requirements of 4.3~4.8.
4.10.3 Thermal stability test
Take the CRP kit within the valid period and leave it at 37 °C for a certain period of time to detect the reagent blank absorbance, analytical sensitivity, detection limit, and accuracy.
The accuracy, linearity and repeatability should meet the requirements of 4.3~4.8.
Note 1. The thermal stability test cannot be used to derive the expiration date of the product, unless a derivation formula based on a large number of stability study data is used;
Note 2. Generally, products with a validity period of 1 year are selected for products not exceeding 1 month, products with a validity period of not more than half a month are selected for half a year, and so on. But as super
After the specified time, the product is acceptable when it meets the requirements;
Note 3. According to the product characteristics, any combination of methods 4.10.2 and 4.10.3 can be selected, but the selected method should be able to verify the stability of the product to ensure the validity period.
Product performance meets standard requirements.
5 Test methods
5.1 Appearance
Visual inspection with normal or corrected visual acuity under natural light shall comply with the requirements of 4.1.
5.2 Traceability
The traceability information provided by the manufacturer shall meet the requirements of 4.2.
5.3 Reagent blank absorbance
When applicable, repeat the determination twice with purified water or blank sample to calculate the blank absorbance (A) of the reagent. The mean value of the determination should be in accordance with 4.3.
Requirements. Or according to the test methods provided by the manufacturer, the measurement results should meet the requirements of 4.3.
5.4 Analytical sensitivity
The analytical sensitivity can be verified by the following methods.
a) Determine a sample with a concentration close to 40 mg/L and repeat the measurement twice to calculate the absorbance change and blank suction produced by the sample.
The difference in luminosity change (ΔA), taking the mean of the two results, and converting the equivalent of the CRP produced by the concentration of 40 mg/L.
The luminosity difference (ΔA), the result should meet the requirements of 4.4a).
b) Determine a sample with a concentration close to 5 mg/L and repeat the measurement twice to calculate the absorbance change and blank absorbance produced by the sample.
The difference in degree change (ΔA), taking the mean of the two results, and converting the absorbance produced by CRP at a concentration of 5 mg/L.
The difference (ΔA), the result should meet the requirements of 4.4b).
5.5 Detection limit
The manufacturer shall provide relevant information such as the blank limit, detection limit and reference interval of the CRP kit. According to the information provided by the manufacturer,
Five low-value samples with a minimum detection limit (LOD) were tested, and each sample was tested 5 times.
Row sorting, in line with the following conditions, can be considered that the setting of the blank limit and the detection limit provided by the manufacturer is basically reasonable, and the result is in line with 4.5.
Claim.
a) The number of test results below the blank limit value provided by the manufacturer shall be less than or equal to 3;
b) When applicable, there is no test result higher than the lower limit of the reference interval provided by the manufacturer.
5.6 Accuracy
5.6.1 General
The accuracy of the CRP kit can be tested using one of the relative deviation and the enterprise reference test, which should meet the requirements of 4.6;
First adopt the method of relative deviation.
5.6.2 Relative deviation
According to the linear interval of the CRP kit provided by the manufacturer, the reference material that can be used to evaluate the conventional method is taken as a sample, and is reasonably set.
Set 2~3 concentrations, use it as a sample according to the instructions of the test kit instructions, and repeat the test 3 times for each sample.
If the result is (Xi), the relative deviation (Bi) is calculated according to the formula (1). If the three results meet the requirements of 4.6a), it is judged as qualified. If greater than
If the result equals 2 times does not match, it is judged as unqualified. If one result does not meet the requirements, it should be tested continuously 20 times and separately
Calculate the relative deviation according to formula (1). If the result of 19 tests or more meets the requirements of 4.6a), it is judged as qualified and the accuracy is consistent.
4.6a) Requirements.
Bi=(Xi-T)/T ×100% (1)
In the formula.
Bi --- relative deviation;
Xi---measuring concentration;
T --- calibration concentration.
5.6.3 Enterprise Reference Test
The enterprise reference product is provided by the manufacturer, and the test is carried out according to the routine sample. Each sample is measured 3 times, and the test result is recorded as (Xi).
Equation (1) calculates the relative deviation (Bi), and the result should meet the requirements of 4.6b).
5.7 linear
A high-value sample close to the upper limit of the linear interval is diluted to a concentration of at least 5 concentrations, wherein the sample of the low-value concentration is close to the line
The lower limit of the sexual interval. Repeat the measurement at least twice for each concentration of the sample, calculate the average value, and measure the average and theoretical concentration of the concentration.
Or the dilution ratio is straight-line fitted by the least squares method to obtain a linear regression equation, and calculate the linear correlation coefficient r and the absolute deviation or relative
Deviation, the result should meet the requirements of 4.7.
5.8 repeatability
Using the same batch of CRP kit, repeat the determination of 2~3 samples of different concentrations for 10 times, and calculate the flattening results of 10 times.
Mean (M) and standard deviation (SD), the coefficient of variation (CV) is obtained according to formula (2), and the result should meet the requirements of 4.8.
CV=SD/M ×100% (2)
In the formula.
CV --- coefficient of variation;
SD - the standard deviation of the results of -10 measurements;
The average of M - 10 measurements.
5.9 batch-to-batch difference
Repeat the determination of 2 to 3 samples of different concentrations using three different batches of CRP kits, and calculate each concentration sample.
The average of 10 measurements per batch (Xi, i = 1, 2, 3) and the total average of 30 measurements for each batch of 3 batches
(XT), according to formula (3), the relative extreme difference (R) between batches is obtained, and the result should meet the requirements of 4.9.
R=(Xmax-Xmin)/XT×100% (3)
In the formula.
R --- relatively poor between batches;
The maximum value of Xmax---Xi, i=1, 2, 3;
The minimum value of Xmin---Xi, i=1, 2, 3;
XT --- The average of 30 measurements for each concentration sample.
5.10 Stability
5.10.1 Stab...