YY/T 1578-2018 English PDF (YYT1578-2018)

Delivery: 3 seconds. Download true-PDF + Invoice.
Get Quotation: Click YY/T 1578-2018 (Self-service in 1-minute)
Historical versions (Master-website): YY/T 1578-2018
Preview True-PDF (Reload/Scroll-down if blank)

YY/T 1578-2018: Glycated albumin assay kit (enzymatic method)
YY/T 1578-2018
Glycated albumin assay kit(enzymatic method)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Glycated albumin determination kit (enzymatic method)
2018-02-24 released
2019-03-01 Implementation
Issued by the State Food and Drug Administration
Preface
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that certain contents of this document may involve patents. Publication of this document
The agency 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 In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
Drafting organizations of this standard. Beijing Institute of Medical Device Inspection, Beijing Jiuqiang Biotechnology Co., Ltd., Sichuan Mike Technology Biological Stock
Co., Ltd., Ningbo Meikang Biotechnology Co., Ltd., Shanghai Fosun Long March Medical Science Co., Ltd.
The main drafters of this standard. Bi Chunlei, Chen Yang, Long Tengxiang, Zou Bingde, Dai Leiying, Jin Huihong.
Glycated albumin determination kit (enzymatic method)
1 Scope
This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of glycated albumin determination kits.
Claim.
This standard applies to kits for the quantitative detection of glycated albumin in human serum or plasma by enzymatic methods, including manual, semi-automatic, and complete
Reagents used on the automatic biochemical analyzer.
If the glycated albumin determination kit contains albumin test components, the technical requirements of the albumin determination reagent refer to the corresponding standards.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents
3 requirements
3.1 Appearance
The appearance of the kit should conform to.
a) The components of the kit should be complete and complete, with no liquid leakage;
b) The text symbols on the packaging label should be clear.
3.2 Quantity
Should not be less than the marked value.
3.3 Absorbance of reagent blank
At the measurement wavelength (light path 1cm) specified in the kit instructions, the reagent blank absorbance (A) should be less than or equal to 0.30.
3.4 Analysis sensitivity
When the concentration of glycated albumin sample is 15g/L, the absorbance change is between 0.02 and 0.20.
3.5 Linear
The linearity of glycated albumin should meet the following requirements.
a) The linear interval of glycosylated albumin concentration should cover. [3.8,28.8]g/L;
b) The linear correlation coefficient (r) should not be less than 0.990;
c) In the interval of [3.8,14.4]g/L, the linear absolute deviation should not exceed ±1.4g/L; within the interval of (14.4,28.8)g/L, the linear relative
The deviation should not exceed ±10%.
3.6 Precision
3.6.1 Repeatability
Repeat the test of the glycated albumin 7.0g/L±3.0g/L sample, and the coefficient of variation (CV) of the result should be no more than 8%.
3.6.2 Difference between batches
Test the sample of glycated albumin 7.0g/L±3.0g/L, the relative range (R) of the results obtained should not be greater than 10%.
3.7 Accuracy
You can choose one of the following methods for verification.
a) Relative deviation. the relative deviation should not exceed ±10% for testing reference materials or certified reference materials;
b) Comparison test. The analysis system with traceability specified by the manufacturer is used for comparison, the correlation coefficient (r) is not less than 0.975, and the slope should be
Within [0.9,1.1]; when the sample concentration is ≤14.4g/L, the absolute deviation should not exceed ±2.2g/L; the sample concentration>14.4g/L
When, the relative deviation should not be more than 15%. 95% of the tested samples should meet the above requirements.
3.8 Stability
3.8.1 General
The validity period stability and thermal stability can be verified.
3.8.2 Stability of validity period
The manufacturer shall stipulate the validity period of the product. Take the product within a certain time after the expiration date, and detect the blank absorbance of the reagent and the analysis is sensitive
Degree, linearity, repeatability and accuracy shall meet the requirements of 3.3, 3.4, 3.5, 3.6.1, and 3.7.
3.8.3 Thermal stability test
The test reagent blank absorbance, analytical sensitivity, linearity, repeatability, and accuracy should meet the requirements of 3.3, 3.4, 3.5, 3.6.1, and 3.7.
Note 1.Thermal stability cannot be used to derive the expiry date of the product, unless it is a derivation formula based on a large amount of stability research data.
Note 2.Generally, when the validity period is 1 year, choose products that do not exceed 1 month, when the validity period is half a year, choose products that do not exceed half a month, and so on. but if
It is acceptable if the product meets the requirements beyond the specified time.
Note 3.Any combination of 3.8.2 and 3.8.3 methods can be selected according to product characteristics, but the selected method should be able to verify the stability of the product to ensure that the product is produced within the validity period.
Product performance meets standard requirements.
4 Test method
4.1 Basic requirements for instruments and materials
4.1.1 Spectrophotometer or biochemical analyzer, the wavelength range should meet the needs of reagent use. The biochemical analyzer should be equipped with a constant temperature device (temperature value
Within ±0.3℃ of the set value, the fluctuation is not more than ±0.2℃), and the absorbance measurement resolution is above 0.001.
4.1.2 The albumin concentration of the samples used in 4.5~4.7 is 40g/L~50g/L.
4.2 Appearance
Visual inspection with normal vision or corrected vision under natural light should meet the requirements of 3.1.
4.3 Quantity
Measured with a universal measuring tool, it should meet the requirements of 3.2.
4.4 Absorbance of reagent blank
Use the kit to test the blank sample, and record the absorbance value (A) at the main wavelength of the reading point specified by the kit parameters, which should meet 3.3
Claim.
Note. The blank sample can be pure water sample, physiological saline, zero calibration solution, etc.
4.5 Analysis sensitivity
Use the kit to test a sample with a known concentration of glycated albumin at 15g/L±3g/L, and record it under the reading point specified by the kit parameters
The absorbance change (ΔA), converted to a 15g/L sample absorbance change, should meet the requirements of 3.4.
4.6 Linearity
4.6.1 Dilute the high-concentration sample close to the upper limit of the linear interval with a low-concentration sample close to the lower limit of the linear interval, and mix into at least 5 dilutions
Concentration (xi). Use the kit to test the above samples separately, test each dilution concentration 3 times, and find the average of the detection results of each dilution concentration.
Value (yi). Take the dilution concentration (xi) as the independent variable and the mean value of the test results (yi) as the dependent variable to find the linear regression equation. Calculate linear regression
The correlation coefficient (r) should meet the requirements of 3.5b).
4.6.2 Substitute the dilution concentration (xi) in the method 4.6.1 into the linear regression equation to calculate the relative deviation or the relative deviation between the mean value of the yi test and the corresponding estimated value.
The absolute deviation should meet the requirements of 3.5c).
4.7 Precision
4.7.1 Repeatability
Under repeatable conditions, use the kit to test human serum or control substances within the range of 7.0g/L±3.0g/L of glycated albumin, and repeat the test.
Try 10 times and calculate the average (x) and standard deviation (s) of the measured values. Calculate the coefficient of variation (CV) according to formula (1), which should meet the requirements of 3.6.1.
CV=
×100% (1)
Where.
CV --- coefficient of variation;
s ---standard deviation;
x --- the average of the measured values.
4.7.2 Difference between batches
Use 3 kits of different batch numbers to test human serum or control substances of glycated albumin 7.0g/L±3.0g/L, each batch number
Test 3 times, respectively calculate the mean value xi (i=1,2,3) of each batch of 3 tests, and calculate the relative range (R) according to formula (2) and formula (3), which should conform to 3.6.2.
Requirements.
xT=
x1 x2 x3
(2)
R=
xmax-xmin
xT
×100% (3)
Where.
xmax---the maximum value in xi;
xmin---the smallest value in xi.
4.8 Accuracy
4.8.1 General
One of the relative deviation or comparison tests can be used to test the accuracy of the kit, which should meet the requirements of 3.7; if applicable, relative
Methods of deviation.
4.8.2 Relative deviation
The kit test can be used to evaluate the certified reference materials (CRM) or other recognized reference materials of conventional methods for 3 times, and the test results are recorded
Is (Xi), calculate the relative deviation Bi according to formula (4), if the three results all meet the requirements of 3.7a), it is judged as qualified. If greater than or
If the result equal to 2 times does not meet, it is judged as unqualified. If there is 1 result that does not meet the requirements, it should be retested 20 times continuously and separately
Calculate the relative deviation according to formula (4). If the result of 19 tests meets the requirements of 3.7a), the accuracy meets the requirements of 3.7a)
Claim.
Bi=
Xi-T
T ×100%
(4)
Where.
Bi---relative deviation;
Xi---measure concentration;
T ---The calibration concentration of the reference substance.
4.8.3 Comparison test
Use no less than 40 human samples covering different concentrations within the detection concentration range to specify a traceable analysis system by the manufacturer
Conduct a comparison test. Each sample is tested separately according to the requirements of the reagent box to be tested and the selected analysis system, and each sample is tested once, with thread
The linear regression method performs linear fitting on the two sets of results, obtains the correlation coefficient (r) and slope of the linear regression equation, and calculates the
The absolute or relative deviation between the measured value of the test kit and the measured value of the control system should meet the requirements of 3.7b).
4.9 Stability
4.9.1 Stability of validity period
The samples taken after the expiry date are tested according to the methods of 4.4, 4.5, 4.6, 4.7.1, 4.8, and should meet the requirements of 3.8.2.
4.9.2 Thermal stability test
Take samples within the validity period according to the thermal stability conditions claimed by the manufacturer, and test them according to the methods of 4.4, 4.5, 4.6, 4.7.1, and 4.8.
Meet the requirements of 3.8.3.
5 Labels and instructions for use
Should meet the requirements of GB/T 29791.2.
6 Packaging, transportation and storage
6.1 Packaging
The packaging should meet the following requirements.
a) The packaging of the kit should be able to protect against natural and mechanical damage;
b) If applicable, the instruction manual and product inspection certificate should be enclosed in the package.
6.2 Transportation
Transport in accordance with the conditions stipulated in the contract.
6.3 Storage
Store in accordance with the specified conditions.
references
[1] GB/T 191-2008 Graphical signs for packaging, storage and transportation
[2] GB/T 3358.1-2009 Statistics vocabulary and symbols Part 1.General statistical terms and terms used in probability
[3] GB/T 26124-2011 Clinical chemistry in vitro diagnostic reagents (kits)
[4] YY/T 0316-2008 Application of medical device risk management to medical devices
[5] YY/T 0466.1 Medical devices used for labeling, marking and providing information symbols for medical devices. Part 1.General
Claim
[6] Ye Yingwu. National Clinical Laboratory Procedures. 3rd Edition. Nanjing. Southeast University Press,.2006
[7] CLSIEP05-A2 EvaluationofPrecisionPerformanceofQuantitativeMeasurementMeth-
ods;ApprovedGuideline-SecondEdition
[8] CLSIEP06-A EvaluationoftheLinearityofQuantitativeMeasurementProcedures.A
StatisticalApproach;ApprovedGuideline
[9] CLSI EP09-A2 Method Comparison and Bias Estimation Using PatientSamples;
ApprovedGuideline