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National Metrology Verification Regulation of the People's Republic of China JJG 861---2007
Enzyme Label Analyzers
ELISA Analytical Instrmments2007 11 21 Issued
2008 - 05 ~ 21 Implementation
Issued by the General Administration of Quality Supervision, Inspection and Quarantine JJG 861+-2007
Verification Regulation of
ELISA Amalytical Instrumments JJG 861--2007
Replaces JJG 861-—1994
This regulation was approved by the General Administration of Quality Supervision, Inspection and Quarantine on November 21, 2007, and came into effect on May 21, 2008.
Responsible unit: National Physical and Chemical Metrology Technical Committee Drafting unit; National Institute of Metrology Recommended drafting unit: Jilin Institute of Metrology This regulation is entrusted to the National Physical and Chemical Metrology Technical Committee to interpret this regulation. Main drafter:
JFG861-2007
Xie Baomin (China Institute of Metrology) Participating drafter:
Qu Yuanyu (Jilin Institute of Metrology)
2 Overview
3 Metrology performance requirements
4 General technical requirements
4.1 Appearance and toughness inspection
4.2 Insulation resistance
5 Control of measuring instruments
5. 1 Inspection conditions.
5. 2 Inspection items
5.3 Inspection method·
5.4 Processing of inspection results·
5.5 Inspection cycle.
JIG 861--2007
Appendix A Preparation Method of Standard Substances for Sensitive Solutions of ELISA Analyzers Appendix
Verification Record Format
Appendix C
Qualifications in the Verification Certificate
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(2))
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Authorized Standards
JJG861-2007
Verification Procedure for ELISA Analyzers
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1 Scope
National Confidential Product Theory
This procedure is applicable to the initial verification, subsequent verification and in-use inspection of ELISA analyzers. The relevant metrological performance tests in the type evaluation and prototype test of ELISA analyzers can be implemented as a reference. 2 Overview
Aohui Jiandeng
Chunmei Cansheng
Enzyme Label Analyzer (hereinafter referred to as the instrument) is an instrument that can produce a color reaction based on the enzyme-labeled immune complex and the corresponding substrate of the enzyme. The degree of color development is related to the amount of the antibody (or antigen) to be tested in the sample to be tested. The content of the substance to be tested is determined according to the absorbance value of the color-developed substance. Different color-developed substances to be tested have their own characteristic absorption spectra and obey the Lambert-Beer (Lambert-Bee law. The expression of the Lambert-Beer law is as follows:
Where: A
Absorbance of the substance;
Transmittance of the substance;
Absorption coefficient of the substance;
Light path length:
Concentration of the substance.
The instrument mainly consists of a light source system, a monochromator system, a sample chamber, a detector, etc.|| tt||Instrument type
Wavelength/dual wavelength, multi-channel:
Single wavelength
Single channel;
Continuously adjustable wavelength, single channel/multi-channel. Metrological performance requirements
The metrological performance requirements of the instrument are shown in Table 1. Table Instrument metrological performance requirements
Wavelength repeatability
Instrument type
Indication stability
General technical requirements| |tt||Wavelength indication
Error/nm
Appearance and preliminary inspection
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Absorbance weight
Refolding/%
Special use
Sensitivity
（L/mg）
Channel difference
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JJG 861--2007
4.1 The instrument should have the following markings: name, position, manufacturer's name, date of manufacture. 4.1.2 The instrument should be placed stably on a horizontal, motionless workbench. All knobs, buttons and switches should work properly. The cable connectors should have good contact. 4.1.3 The seal should be good without light leakage. 4.1.4 The indicator should work properly, and the digital display should be clear and complete. 4.1.5 The moving parts should be stable, without any jamming, suddenness or obvious gaps. 4.2 Cable insulation
When the instrument is not in contact, the insulation resistance between the power supply line and the shell should not be less than T20Mn when the test voltage is 500V.
5 Control of measuring instruments
Control of measuring instruments includes initial calibration, subsequent calibration and in-use inspection. 5.1 Calibration conditions
5. 1.1 Environmental conditions
The environmental conditions for instrument verification are shown in Table 2. Table 2 Environmental conditions requirements
(15~35)℃
(220±22)V
No direct sunlight
No noise disturbance
No field interference
15%-~85%RH
(50:h:1)Hz
Vibration
No field interference
There should be no strong airflow during operation, and there should be no flammable, explosive and corrosive gases around. 5.1.2 Verification equipment
The equipment for instrument verification is shown in Table 3.
Table 3 Equipment for instrument verification
5.1.3 Standard substances
AC voltmeter
Frequency meter
Driving ohmmeter
Microwell ELISA plate
Spectrophotometer
Standard interference filter
5. 1. 3.13
Specifications and technical indicators
Square meter (4-control semi-digital)
(4565)Hz, 0.5 level
Test voltage 500V, 1.0 velvet
Wavelength indication error better than ±0.5mm
JIG 861-2007
The peak value in the material certificate is marked with a wavelength of (405, 450, 492 (or 490), 620 (or 630 ± 2)) and the standard interference filter is added, or 4 standard filters are selected within the wavelength range of the instrument. 5.1.3.2 Spectral neutral filter
The nominal absorbance values are 0.2, 0.5, 1.0, 3.5 (uncertainty ≤ 0.01)° 5.1.3.B Standard solution for alcohol standard analyzer (uncertainty ≤ 5%. 5.2 Verification items
Table 4 Verification items
Verification items
Appearance inspection
Value stability
Wavelength indication error
Restoration of wavelength
Absorbance indication error
Absorbance spot reproducibility
Gel sensitivity
Channel difference
Insulation resistance
Note: 1
Retest times
“+” means items to be inspected, “-” means items to be inspected No inspection is required. Subsequent calibration
2 When the instrument may be greatly affected after repair, its subsequent calibration shall be carried out according to the initial calibration. 5.3 Calibration method
5.3.1 Appearance and preliminary inspection shall be carried out according to the requirements of 4.1. The calibration instrument should be preheated for 20 minutes. 5.3.2 Qualitative calibration of indication
Convenient inspection
Select a wavelength of 492nm or a specific wavelength unique to the instrument, and place a spectral non-radiative filter with a nominal absorbance value of 1.0 flat on the empty plate rack of the microwell ELISA plate. With air as the reference, measure and record the initial indication of the instrument. After min, record the indication of the instrument. After 10 mm, record the value of the instrument again. Calculate the maximum value of the last two absorbance indications. For various instruments, follow the formula (1) to calculate the indication stability: r = Amax Amax
Where: A and Amax
are the initial and maximum absorbance values of the instrument. 5.3.3 Verification of wavelength indication error and wavelength repeatability ()
5.3.3.1 For Class 1 instruments, use 4 standard optical filters with wavelengths of 405, 450, 492, and 620 nm. Evenly select 4 standard optical filters within the wavelength range of the instrument and place them in front of the light exit hole of the instrument or at a certain position of the microplate (the standard optical filters must be perpendicular to the incident light beam). Measure the wavelength of the filter point by point from short wave to long wave - absorbance indication (for example: measure the wavelength of 4051n standard optical filter When measuring the wavelength of the optical film, the wavelength will be adjusted to 20nm below the standard wavelength, i.e. 385nm. Then, the wavelength will be measured with a change of 1mm to a wavelength above the standard wavelength. The wavelength of the optical film needs to be set on the spectrometer with a wavelength indication adjustment of 0.01nm. The standard material of the national cumulative measurement department should be used. 3
JJG861—2007
wavelength 20nm, i.e. 425nm), and the corresponding peak wavelength should be calculated. Repeat the measurement 3 times and take the average value. The difference between the measured wavelength average and the standard wavelength is the wavelength indication error. The wavelength indication error 4 is calculated according to formula (2). The difference between the maximum and minimum values is the wavelength repeatability. Use the same method to calibrate the other 3 points: the instrument wavelength indication error and wavelength repeatability. The report of the results should be given by measuring and calculating the wavelength indication error and wavelength repeatability at each wavelength (405, 450, 492, 620nm) or the specific wavelength of the instrument. 5.3.3.2 For Class I and Class II instruments, use a spectrophotometer with a wavelength indication error better than ±0.5mm to verify the transmittance of the interference filter attached to the instrument at each nominal wavelength (the plane of the interference filter must be perpendicular to the incident light beam), and draw a wavelength transmittance characteristic curve (as shown in the figure). The calculation formula for the peak wavelength error of the interference filter is: S
Wherein: I
Nominal value of the peak wavelength of the filter;
Peak transmittance T, corresponding wavelength
Maximum dimensional
Tested
Figure 1 Wavelength transmittance characteristic curve
5.3.4 Verification of absorbance indication error
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5.3.4.1 Select 405, 4509/520mm wavelength or the specific wavelength of the instrument in turn; Place four optical filters with nominal absorbance values of 0.2, 0.5, 1.0, and 1.5 on the empty plate rack of the microwell ELISA plate at the same time, take air as the reference, measure continuously for 3 times, record the instrument indications in turn, and calculate the average value. 5.3.4.2 For instruments with fixed absorption cells, first adjust the instrument zero point with an empty absorption cell, then place the spectral neutral filter in the sample chamber, measure three times in succession, record the instrument indication, and calculate the average value.
5.3.4.3 The absorbance indication error AA is calculated according to formula (5): Where: A is the absorbance value measured for the first time:
A is the absorbance standard value.
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The report of the instrument absorbance indication error result is given by the maximum value of the absorbance indication error obtained by measurement and calculation at each wavelength (405, 450, 492, 620nm) or the specific wavelength unique to the instrument. 5.3.5 Verification of absorbance repeatability
Choose a wavelength of 450 nm or a wavelength specific to the instrument, place a spectral neutral filter with a nominal absorbance value of 0.5 or 1.0 flat on the empty plate rack of the microwell ELISA plate, use air as a reference, repeat the measurement 6 times at a fixed well position, record the instrument indication, and calculate the average value. Calculate the RSD value according to formula (6). The relative standard S
deviation value (RSD value) of the experimental result is used to express the absorbance repeatability of the instrument: Li Ren Test Sea
RSagoR
Where:
the result of the nth measurement
the average absorbance value of the nth measurement result:||tt ||Measurement data
5.3.6 Sensitivity verification
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wavelength or instrument-specific specific wavelength, use a Class A sample adder with a suitable range and qualified by verification, choose 450
instrument, add 350uL of 5mg/L enzyme HO
standard analyzer sensitivity solution standard substance into a well of the microwell ELISA plate not coated with antigen or antibody, and measure the absorbance value. 5.3.7 Verification of channel differences For Class I instruments, select a wavelength of 450 nm or a wavelength specific to the instrument, place a spectral neutral filter with a nominal photometric value of 1.0 flat on the empty plate rack of the microwell ELISA plate, and place it in the corresponding positions of the multiple channels (for example, for an 8-channel instrument, A1 to H1 or A2 to H2 can be used as the starting position). Use air as a reference and measure (1+6 or A2 to A7). Measure and record each channel. At least 6 absorbance values of the channel (for example, channel A can measure the difference of A1 channels) are reported as the range of all measurement data. The channel difference is calculated according to formula (7):
Wherein: Amax
The maximum absorbance value of the measurement results in multiple channels The minimum absorbance value of the measurement results in multiple channels SA—channel difference.
5.3.8 Insulation resistance inspection
Use a 500V megohmmeter to measure the insulation resistance between the power supply terminal of the instrument and the casing or grounding terminal). VAMETROL
5.4 Processing of verification results
5.4.1 All the above verification data must be recorded on the verification record paper, and the results of the relevant items should be filled in completely or indicated on the verification certificate or verification result notice. 5.4.2 For instruments that pass the verification according to this regulation, a verification certificate shall be issued; for instruments that fail the verification, a verification result notice shall be issued, and the data of the failed items shall be indicated. 5.5 Calibration cycle
The calibration cycle is generally not more than 1 year. During this period, the instrument should be calibrated in time if it is repaired or there is any question about the measurement result. 5
Appendix A
JJG861-2807
Method for preparing standard material for enzyme marker sensitivity solution Standard material for enzyme marker sensitivity solution Use pure potassium carbonate to prepare standard material with a mass concentration of m, using 0.00/1.34 as the matrix, A, 10.05/.34. Preparation of sulfuric acid solution
Pour 400ml of distilled water into a 500ml beaker and use a pipette arm to take 2.7ml of concentrated sulfuric acid and spread it into a beaker. Stir well before placing in a 10ml container and dilute to the scale line with distilled water for later use. A.2 Preparation of chromium-containing acid solution A.2.1 Accurately weigh 0.282 g potassium dichromate using an analytical balance. Place a 100 mL beaker with 0.05 mL sulfuric acid solution to dissolve the bottom. Transfer to a 500 mL container. Add 0.05 mL/L sulfuric acid solution to wash the beaker. Add the previous washing solution to a container. Dilute the sulfuric acid solution to the full scale line and shake. The concentration of this solution is 200 mL. tmag/i.1
A.2.2 Use a pipette to draw 2.5ml of potassium chromate solution with a concentration of 200mg/1. Put it into a 100ml volumetric flask, dilute it with 0.05ml/1 sulfuric acid to the mark mark, about, the maximum concentration of this paint liquid is 5H, and it is a solution standard material for the sensitivity of the calibration instrument. Appendix B
Calibration unit
Only instrument
Instrument type
Certification number
Calibrator
Model scanning period
"Appearance:
, Physical stability:
, Wavelength value misinstallation and wavelength correction:
IV. Absorbance indication error:
Filter film is!
Value-holder
UG 861--20
Verification record format
Name of instrument
Instrument certificate number
Uncertainty (or degree)
Standard instrument within validity period
Correction:RH
Verifier
Drug Dream
Wavelength/nm
Filter label
Value A
Absorbance repeat
VI. Sensitivity
VII. Channel difference:
VIII. Insulation resistance:
JJG8612007
Table (continued)
ETROTOGY PU
Channel difference A-
Hongjuyuan
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