YY/T 1529-2017 English PDF (YYT1529-2017)

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YY/T 1529-2017: ELISA Analytical Instruments
YY/T 1529-2017
ELISA analytical instruments
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Enzyme immunoassay analyzer
2017-05-02 released
2018-04-01 implementation
State Food and Drug Administration released
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of this document may be patentable. The release of this document
The agency does not assume responsibility for identifying these patents.
This standard proposed by the State Food and Drug Administration.
This standard by the National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Beijing Medical Device Testing Institute, Shanghai Branch of China Experimental System Co., Ltd., Jiangsu Sino Novartis Medical Technology Co., Ltd.
Company, Shenzhen Aikang Biological Technology Co., Ltd., Yantai Orth State Biological Engineering Co., Ltd.
The main drafters of this standard. Wang Ruixia, Li Dong, Zhou Qiang, Zhang Chuanguo, Liu Yanchun, Zhuang Chuangling.
Enzyme immunoassay analyzer
1 Scope
This standard defines the terms and definitions of enzyme-linked immunoassay analyzer (hereinafter referred to as analyzer), provides the classification, requirements, test methods, standard
Chi, labels and instructions for use and packaging, storage and transportation.
This standard applies to enzyme-linked immunosorbent analyzer, automatic enzyme-linked immunosorbent reader module.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements
GB/T 14710 medical appliances environmental requirements and test methods
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements
GB/T 18268.26 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use - Part 26. Particular requirements
External diagnostic (IVD) medical equipment
GB/T 29791.3 Information provided by manufacturers of in vitro diagnostic medical devices (LABELING) - Part 3. Professional in vitro diagnostic instruments
JJG861-2007 enzyme analyzer
YY 0648 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101. In vitro diagnostic (IVD) medical equipment
The special requirements
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
ELISA-enzyme-linked immunosorbentassay; ELISA
The ELISA method is an immunoassay developed on the basis of immunoenzymatictechniques
Surgery. The ELISA process includes adsorption of the antigen or antibody on a solid support (referred to as coating), test sample (including antibody or antigen to be tested) and enzyme label
Antibodies or antigens, according to a certain procedure with the solid phase carrier antigen or antibody reacts to form a complex of antigen and antibody, solid phase
The amount of enzyme label bound to the body is proportional to the amount of analyte in the sample. After adding enzyme reaction substrate, the substrate is catalyzed by enzymes
Into a colored product. Through the color reaction of the substrate to determine whether the corresponding immune response, the depth of the color reaction with the corresponding antibody in the specimen or
The amount of antigen is proportional.
3.2
Using enzyme-linked immunosorbent assay (ELISA) and Lambert-Beer's law, the substance to be tested is quantified or characterized
Analysis of the equipment known as enzyme-linked immunoassay analyzer, also known as microplate reader.
4 categories
4.1 instrument composition and principle
The instrument mainly consists of power supply, light source system, monochromator system, sample chamber, detector, microcomputer and operating software.
Light emitted by the light source after parallel processing, through the filter/grating into the sample chamber, after the test solution, the transmitted light signal is detected
Detection, amplification and analog/digital conversion by the computer to calculate, process, and display, printer and print out the final determination results.
4.2 Instrument Type
Commonly used enzyme-linked immunosorbent can be divided into the following three types.
a) single wavelength, single channel;
b) Single/dual wavelength, multi-channel;
c) continuously adjustable wavelength, single/multi-channel.
5 requirements
5.1 appearance
Should meet the following requirements.
a) The words and signs shall be clearly visible and the signs shall be firmly attached and shall not be loosened or curled;
b) the surface should be smooth, smooth, uniform color, no bumps, scratches and uneven bump defects;
c) The fastener connection should be firm and reliable, without looseness;
d) moving parts should be smooth, should not be stuck, sudden jump and significant empty back, the key group should be flexible bounce.
5.2 Performance Requirements
5.2.1 Wavelength accuracy
The wavelength of the instrument filter should not exceed ± 2nm.
5.2.2 Absorbance accuracy
The accuracy of the instrument at the corresponding wavelength should meet the requirements of Table 1.
Table 1 Absorbance accuracy requirements
Absorbance range accuracy
[0.000 ~ 1.000] ± 0.02
(1.000 ~ 2.000] ± 0.03
5.2.3 Linear
In the range of absorbance value of 0 ~ 3.000, the linear correlation coefficient of not less than 0.990.
5.2.4 absorbance repeatability
The coefficient of variation CV of the instrumental repeatability measurement should not exceed 1.0%.
5.2.5 absorbance stability
The stability of the instrument absorbance should not exceed ± 0.005.
5.2.6 Sensitivity
Use the concentration of 5mg/L ELISA instrument with the sensitivity of the standard material, the instrument measured absorbance value should not be less than 0.01.
5.2.7 Channel differences
Take the air as reference, measure the difference of absorbance of 8 channels, the result should not be more than 0.02.
5.3 Electrical Safety Requirements
Should be consistent with the applicable provisions of GB 4793.1, YY 0648 requirements.
5.4 Environmental test requirements
Should comply with the applicable provisions of GB/T 14710 requirements.
5.5 Electromagnetic compatibility requirements
Should be consistent with the applicable provisions of GB/T 18268.1, GB/T 18268.26 requirements.
5.6 Software Features
Enzyme immunoassay analyzer should have at least the following functions.
a) with data display function;
b) Flexible setting of test items, test methods and test dates;
c) can be continuously saved in succession to test the project and the results;
d) Test items, test data and test time can be displayed and printed.
6 experimental methods
6.1 working conditions
6.1.1 Power Requirements. Voltage 220V ± 22V (AC); Frequency 50Hz ± 1Hz.
6.1.2 Ambient temperature. 10 ℃ ~ 40 ℃.
6.1.3 Relative humidity. 30% ~ 80%.
6.1.4 The following items are stable after the instrument is turned on for 30min, the instrument in the following experiments, the amount of influence should be in the normal working bar
Under the piece.
6.1.5 Spectral Neutral Filters There is a certified reference material or a spectrophotometric neutral filter with absorbance values of about 0.2,
0.5, 1.0, 1.5, 2.0, 3.0 (uncertainty no greater than 0.005).
6.1.6 enzyme-linked immunosorbent sensitivity standard solution.
Note. The conditions in 6.1.2 and 6.1.3 are not the same as those specified by the manufacturer. The product specifications shall prevail. Manufacturers should be described in product standards.
6.2 Appearance
Visual inspection under normal light or normal vision should meet the requirements of 5.1.
6.3 Wavelength accuracy
Wavelength accuracy test method is as follows.
a) Wavelength continuously adjustable enzyme-linked immunoassay analyzer, test method see JJG0861-2007 5.2.1, or by the manufacturer
Scientific and reasonable test methods.
b) Using a spectrophotometer with an optical wavelength error of better than ± 0.5 nm to perform wavelength-to-transmittance spectroscopy
The description of the curve (Figure 1), and according to equation (1), equation (2) were calculated center wavelength error, should meet the requirements of 5.2.1.
Figure 1 wavelength - transmittance spectral characteristics
λ0 =
λ1 λ2
(1)
Where.
λ0 --- measured center wavelength;
λ1, λ2 - the corresponding wavelength when the transmittance is 0.5τmax.
Δλ = λ0-λ (2)
Where.
Δλ --- center wavelength error;
λ0 --- measured center wavelength;
λ --- filter standard wavelength.
6.4 Absorbance accuracy test
Followed by selection of 405nm, 450nm, 492nm and 630nm wavelength or instrument-specific wavelength, the nominal absorbance of about
The four spectral neutral filters of 0.2, 0.5, 1.0, 1.5, or the instrument-specific wavelength-specific filters, are placed flat on a microplate microtiter plate
Rack, air as a reference, continuous measurement of 3 times, record the value of the instrument.
Absorbance accuracy ΔA according to equation (3) Calculated.
ΔA =
3Σ
i = 1
Ai-AS (3)
Where.
ΔA --- the neutral filter absorbance accuracy;
Ai --- sheet neutral filter at a wavelength i measured the absorbance value;
AS --- The neutral filter at this wavelength of the standard value.
The absorbance accuracy of each neutral filter at each wavelength shall meet the requirements of 5.2.2.
6.5 Linear
You can choose one of the following methods to verify.
a) Select the spectral neutral filter certified reference material or qualified by the spectral neutral filter, indicating values of about 0.2,
0.5,1.0,1.5,2.0,3.0 (uncertainty of not more than 0.005), each filter measured 2 times, the measured mean and the calibration value of the line
Sex fitting, calculation of linear correlation coefficient, the results should be consistent with the requirements of 5.2.3.
b) the use of selective spectral neutral filter certified reference material or certified by the spectral neutral filter, indicating the value of about
0.2, 0.5, 1.0, 1.5, 2.0 filters, alone or in combination, were used (0.2 0.5), (0.5 1.5), (1.0 2.0)
Addition, the measured value and the theoretical value of a linear fit, calculate the linear correlation coefficient, the result should be consistent with the requirements of 5.2.3.
Note. It is not recommended to overlay two or more filters.
6.6 Absorbance repeatability test
Select a wavelength of 450nm or instrument specific wavelength, the absorbance of the nominal value of about 0.5 or 1.0 Spectral neutral filter flat
In the microporous ELISA plate empty rack, air as a reference, fixed in a hole repeated measurements at least 6 times, record the value of the instrument, and then according to equation
(4) Calculate the CV value of absorbance repeatability, should meet the requirements of 5.2.4.
CV =
× 100% (4)
Where.
CV --- coefficient of variation;
s --- standard deviation, s =
i = 1
(xi-x) 2
n-1
among them,
xi --- the i measured absorbance value;
n --- the number of measurements;
x --- arithmetic average of n measurements.
6.7 absorbance stability test
Select 450nm wavelength or instrument-specific wavelength, the absorbance of the nominal 1.0 spectral neutral filter, flat on the microporous enzyme
Standard board empty shelf, the air as a reference, measure and record the initial indication of the instrument, record the instrument after 5min value, once again after 10min
Record the value of instrument, and calculate the maximum value (r) of absorbance value and initial value according to formula (5). The result should meet the requirements of 5.2.5.
r = | A max-A initial | (5)
Where.
A maximum --- instrument maximum absorbance value;
A initial --- instrument initial absorbance value.
6.8 Sensitivity test
Use 450nm or instrument-specific wavelength, using the appropriate range and qualified test sampler, not coated with antigens or antibodies
Microporous ELISA plates in a hole 350μL concentration of 5mg/L ELISA solution with standard reference material (preparation
Method see Appendix A), the measured absorbance value meets the requirements of 5.2.6.
6.9 channel difference test
Use 450nm wavelength or instrument-specific wavelength, the absorbance of the nominal value of 1.0 spectral neutral filter placed in the microporous enzyme
On the empty shelf of the target board, it is placed in the corresponding position of the 8 lanes one after another (for example, from A1 to H1 or A2 to H2 for the 8-channel instrument
Start position), with air as reference, repeat measurement at least 5 times per channel (neutral filter same position), record 5 absorbance values,
The difference report of 8 channels is represented by the difference of all measurement data (48 results in all), and the channel difference δA is calculated according to formula (6)
Meet the requirements of 5.2.7.
δA = Amax-Amin (6)
Where.
δA --- channel difference;
Amax --- maximum absorbance measurement of 8 channels;
Amin --- 8 channels in the absorbance measurement of the minimum.
6.10 safety performance test
In accordance with the provisions of GB 4793.1, YY 0648 test method should be consistent with the requirements of 5.3.
6.11 Environmental testing
According to GB/T 14710 in the test conditions, the results should be consistent with the requirements of 5.4.
6.12 Electromagnetic compatibility test
In accordance with the method specified in GB/T 18268.1, GB/T 18268.26 test should meet the requirements of 5.5.
6.13 software function test
Through the software operation to be verified, the results should be consistent with the requirements of 5.6.
7 signs, labels and instructions
Should comply with the relevant provisions of GB/T 297...