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YY/T 1523-2017: Bicarbonate Assay Kit (PEPC Enzymatic Method)
YY/T 1523-2017
Bicarbonate assay kit(PEPC enzymatic method)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Carbon dioxide determination kit (PEPC enzymatic method)
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 North Control Biotechnology Co., Ltd., Shenzhen Mindray Biomedical
Subsidiary Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd., Beijing Lidman Biochemical Co., Ltd.
The main drafters of this standard. Bi Chunlei, Jiang Lin, Tang Yi, Tian Wei, Yang Zhong, Ren Yikun.
Carbon dioxide determination kit (PEPC enzymatic method)
1 Scope
This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of carbon dioxide determination kits.
This standard applies to phosphoenolpyruvate carboxylase (PEPC) enzymatic method for human serum
A kit for quantitative detection of carbon dioxide in plasma (hereinafter referred to as. kit), including manual and semi-automatic, fully automated biochemical analysis
The reagents used on the instrument.
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 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents
3 requirements
3.1 Appearance
The appearance of the kit should be consistent with.
a) The components of the kit should be complete and complete, and the liquid should be free of leakage;
b) The packaging label text symbol should be clear.
3.2 Loading
It should be no less than the value indicated.
3.3 Reagent blank absorbance
At the measurement wavelength (light path 1 cm) specified in the kit instructions, the reagent blank absorbance (A) should be ≥ 0.50.
3.4 Analytical sensitivity
For samples with a concentration of 25 mmol/L, the resulting change in absorbance should be in accordance with the manufacturer's specifications.
3.5 linear
The linear range of the kit should cover [10,40] mmol/L.
a) In the [10,40]mmol/L interval, the linear correlation coefficient (r) should be ≥0.990;
b) Within the [10,40] mmol/L interval, the linear relative deviation should not exceed ±10%.
3.6 precision
3.6.1 Repeatability
Repeat the test (25 ± 5) mmol/L of human serum or control substances, the coefficient of variation (CV, %) of the results should be no more than 5%.
3.6.2 Inter-batch difference
Test (25 ± 5) mmol/L of human serum or control substances, the results of the batch-to-batch relative (R) should be no more than 10%.
3.7 Accuracy
You can use one of the following methods to verify.
a) Relative deviation. test reference material or certified reference material, the relative deviation should not exceed ±15%;
b) Recovery test. should not exceed ± 15%.
3.8 Stability
3.8.1 General
Verification of shelf life stability and thermal stability.
3.8.2 Stability of validity
The manufacturer shall specify the period of validity of the product. The product test reagent blank absorbance, analytical sensitivity, and time after a certain period of time
Linearity, repeatability, and accuracy should meet the requirements of 3.3, 3.4, 3.5, 3.6.1, and 3.7.
3.8.3 Thermal stability test
The blank absorbance, analytical sensitivity, linearity, repeatability, and accuracy of the test reagents 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 expiration date of a product unless it is based on a derivation formula based on a large number of stability studies.
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. Any combination of the methods of 3.8.2 and 3.8.3 can be selected according to the product characteristics, but the selected method should be able to verify the stability of the product to ensure that the product is produced during the period of validity.
Product performance meets the standard requirements.
4 Test methods
4.1 Basic requirements of the instrument
Spectrophotometer or biochemical analyzer, the wavelength range should meet the needs of reagent use, biochemical analyzer should be equipped with thermostat (temperature value is set
In the fixed value of ±0.3 °C, the fluctuation is not more than ± 0.2 ° C), and the absorbance measurement resolution is above 0.001.
4.2 Appearance
Visual inspection with normal or corrected visual acuity under natural light shall comply with the requirements of 3.1.
4.3 Loading
Measurement with a universal gauge shall comply with the requirements of 3.2.
4.4 Reagent blank absorbance
Test the blank sample with the kit and record the absorbance value at the main wavelength of the reading point specified in the kit parameters, which should meet the requirements of 3.3.
Note. The blank sample can be a pure water sample, saline, zero calibration solution, and the like.
4.5 Analytical sensitivity
A sample with a known concentration of carbon dioxide at (25 ± 5) mmol/L was tested with a kit, and the difference in absorbance under the parameters specified in the kit was recorded.
The value, converted to absorbance difference of 25mmol/L carbon dioxide, should meet the requirements of 3.4.
4.6 linear
4.6.1 Dilute high-concentration samples close to the upper limit of the linear interval with low-concentration samples near the lower limit of the linear interval, and mix them into at least 5 dilutions.
Concentration (xi). The above samples were tested separately with the kit, and each dilution concentration was tested 3 times, and the results of each dilution concentration were determined.
Value (yi). The linear regression equation was obtained by taking the dilution concentration (xi) as the independent variable and the mean value of the test result (yi) as the dependent variable. Calculating linear regression
The correlation coefficient (r) should meet the requirements of 3.5a).
4.6.2 Substituting the dilution concentration (xi) in the 4.6.1 method into the linear regression equation to calculate the relative deviation of the yi test mean from the corresponding estimate.
Should meet the requirements of 3.5b).
4.7 precision
4.7.1 Repeatability
Repeat the test 10 with human serum or control substance at a concentration of (25 ± 5) mmol/L under repeated conditions.
The average value (x) and standard deviation (s) of the measured values are calculated. Calculating the coefficient of variation (CV) according to equation (1) shall comply with the requirements of 3.6.1.
CV=
x
×100% (1)
In the formula.
CV --- coefficient of variation;
s --- standard deviation;
x --- The average of the measured values.
4.7.2 Inter-batch difference
Human serum or control substances in the range of (25 ± 5) mmol/L were tested with 3 different batches of kits, each batch
Test 3 times, 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).
Requirements of 3.6.2.
xT =
x1 x2 x3
(2)
R=
xmax-xmin
xT
×100% (3)
In the formula.
xmax---the maximum value in xi;
xmin---the minimum value in xi;
xT --- total mean.
4.8 Accuracy
4.8.1 General
The accuracy of the kit can be tested by one of the two methods of relative deviation and recovery test, which should meet the requirements of 3.7;
Use the method of relative deviation.
4.8.2 Relative deviation
Kit testing can be used to evaluate a certified method reference material (CRM) or other recognized reference material for routine methods 3 times.
For (Xi), the relative deviation (B) is calculated according to equation (4), and if all three results meet the requirements of 3.7a), it is judged as qualified. If greater than or
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 (4). If the result of greater than or equal to 19 tests meets the requirements of 3.7a), the accuracy is in accordance with 3.7a).
Claim.
Bi=
Xi-T
T × 100%
(4)
In the formula.
Bi --- relative deviation;
Xi---measuring concentration;
T --- Reference substance calibration concentration.
4.8.3 Recovery test
Add a volume of standard solution to the human sample (the ratio of the standard solution volume to the human sample volume should not change the matrix, plus
After entering the standard solution, the total concentration of the sample must be within the linear range of the kit detection) or pure product, repeat the detection for each concentration 3 times, calculate the mean value, press
The recovery rate calculated by equation (5) shall be in accordance with 3.7b).
R=
C × (V0 V) - C0 × V0
V×CS ×
100% (5)
In the formula.
R --- recovery rate;
V --- the volume of the standard solution added;
V0 --- the volume of the human sample;
C --- the average concentration of the detected concentration of the human sample after adding the standard solution;
C0 --- the average concentration of the detected concentration of the human sample;
CS --- The concentration of the standard solution.
4.9 Stability
4.9.1 Stability of validity
The sample after the expiration date is 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 according to the methods of 4.4, 4.5, 4.6, 4.7.1, 4.8.
Should 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
Packaging should meet the following requirements.
a) The kit should be packaged to protect against natural and mechanical damage;
b) If applicable, the package shall be accompanied by the instruction manual and the product inspection certificate.
6.2 Transportation
Transport according to the conditions stipulated in the contract.
6.3 Storage
Store according to the specified conditions.
references
[1] GB/T 191-2008 packaging storage and transportation icon
[2] GB/T 3358.1-2009 Statistical vocabulary and equals Part 1. General statistical terms and terms used for probability
[3] GB/T 26124-2011 Clinical Chemistry In Vitro Diagnostic Reagent (Box)
[4] YY/T 0316-2008 Medical Device Risk Management for Medical Devices
[5] YY/T 0466.1-2009 Symbols for medical devices for labeling, marking and providing information on medical devices - Part 1.
General requirements (ISO 15223-1.2007, IDT)
[6] Ye Yingqi. National Clinical Laboratory Procedures (3rd Edition) [M]. Nanjing. Southeast University Press,.2006.
[7] CLSIEP05-A2evaluationofprecisionperformanceofquantitativemeasurementmethods;
Approvedguideline-secondedition.
[8] CLSIEP06-Aevaluationofthelinearityofquantitativemeasurementprocedures.astatisti-
Calapproach;approvedguideline.
[9] CLSIEP09-A2methodcomparisonandbiasestimationusingpatientsamples;approved
Guideline.
Get Quotation: Click YY/T 1523-2017 (Self-service in 1-minute)
Historical versions (Master-website): YY/T 1523-2017
Preview True-PDF (Reload/Scroll-down if blank)
YY/T 1523-2017: Bicarbonate Assay Kit (PEPC Enzymatic Method)
YY/T 1523-2017
Bicarbonate assay kit(PEPC enzymatic method)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Carbon dioxide determination kit (PEPC enzymatic method)
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 North Control Biotechnology Co., Ltd., Shenzhen Mindray Biomedical
Subsidiary Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd., Beijing Lidman Biochemical Co., Ltd.
The main drafters of this standard. Bi Chunlei, Jiang Lin, Tang Yi, Tian Wei, Yang Zhong, Ren Yikun.
Carbon dioxide determination kit (PEPC enzymatic method)
1 Scope
This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of carbon dioxide determination kits.
This standard applies to phosphoenolpyruvate carboxylase (PEPC) enzymatic method for human serum
A kit for quantitative detection of carbon dioxide in plasma (hereinafter referred to as. kit), including manual and semi-automatic, fully automated biochemical analysis
The reagents used on the instrument.
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 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents
3 requirements
3.1 Appearance
The appearance of the kit should be consistent with.
a) The components of the kit should be complete and complete, and the liquid should be free of leakage;
b) The packaging label text symbol should be clear.
3.2 Loading
It should be no less than the value indicated.
3.3 Reagent blank absorbance
At the measurement wavelength (light path 1 cm) specified in the kit instructions, the reagent blank absorbance (A) should be ≥ 0.50.
3.4 Analytical sensitivity
For samples with a concentration of 25 mmol/L, the resulting change in absorbance should be in accordance with the manufacturer's specifications.
3.5 linear
The linear range of the kit should cover [10,40] mmol/L.
a) In the [10,40]mmol/L interval, the linear correlation coefficient (r) should be ≥0.990;
b) Within the [10,40] mmol/L interval, the linear relative deviation should not exceed ±10%.
3.6 precision
3.6.1 Repeatability
Repeat the test (25 ± 5) mmol/L of human serum or control substances, the coefficient of variation (CV, %) of the results should be no more than 5%.
3.6.2 Inter-batch difference
Test (25 ± 5) mmol/L of human serum or control substances, the results of the batch-to-batch relative (R) should be no more than 10%.
3.7 Accuracy
You can use one of the following methods to verify.
a) Relative deviation. test reference material or certified reference material, the relative deviation should not exceed ±15%;
b) Recovery test. should not exceed ± 15%.
3.8 Stability
3.8.1 General
Verification of shelf life stability and thermal stability.
3.8.2 Stability of validity
The manufacturer shall specify the period of validity of the product. The product test reagent blank absorbance, analytical sensitivity, and time after a certain period of time
Linearity, repeatability, and accuracy should meet the requirements of 3.3, 3.4, 3.5, 3.6.1, and 3.7.
3.8.3 Thermal stability test
The blank absorbance, analytical sensitivity, linearity, repeatability, and accuracy of the test reagents 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 expiration date of a product unless it is based on a derivation formula based on a large number of stability studies.
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. Any combination of the methods of 3.8.2 and 3.8.3 can be selected according to the product characteristics, but the selected method should be able to verify the stability of the product to ensure that the product is produced during the period of validity.
Product performance meets the standard requirements.
4 Test methods
4.1 Basic requirements of the instrument
Spectrophotometer or biochemical analyzer, the wavelength range should meet the needs of reagent use, biochemical analyzer should be equipped with thermostat (temperature value is set
In the fixed value of ±0.3 °C, the fluctuation is not more than ± 0.2 ° C), and the absorbance measurement resolution is above 0.001.
4.2 Appearance
Visual inspection with normal or corrected visual acuity under natural light shall comply with the requirements of 3.1.
4.3 Loading
Measurement with a universal gauge shall comply with the requirements of 3.2.
4.4 Reagent blank absorbance
Test the blank sample with the kit and record the absorbance value at the main wavelength of the reading point specified in the kit parameters, which should meet the requirements of 3.3.
Note. The blank sample can be a pure water sample, saline, zero calibration solution, and the like.
4.5 Analytical sensitivity
A sample with a known concentration of carbon dioxide at (25 ± 5) mmol/L was tested with a kit, and the difference in absorbance under the parameters specified in the kit was recorded.
The value, converted to absorbance difference of 25mmol/L carbon dioxide, should meet the requirements of 3.4.
4.6 linear
4.6.1 Dilute high-concentration samples close to the upper limit of the linear interval with low-concentration samples near the lower limit of the linear interval, and mix them into at least 5 dilutions.
Concentration (xi). The above samples were tested separately with the kit, and each dilution concentration was tested 3 times, and the results of each dilution concentration were determined.
Value (yi). The linear regression equation was obtained by taking the dilution concentration (xi) as the independent variable and the mean value of the test result (yi) as the dependent variable. Calculating linear regression
The correlation coefficient (r) should meet the requirements of 3.5a).
4.6.2 Substituting the dilution concentration (xi) in the 4.6.1 method into the linear regression equation to calculate the relative deviation of the yi test mean from the corresponding estimate.
Should meet the requirements of 3.5b).
4.7 precision
4.7.1 Repeatability
Repeat the test 10 with human serum or control substance at a concentration of (25 ± 5) mmol/L under repeated conditions.
The average value (x) and standard deviation (s) of the measured values are calculated. Calculating the coefficient of variation (CV) according to equation (1) shall comply with the requirements of 3.6.1.
CV=
x
×100% (1)
In the formula.
CV --- coefficient of variation;
s --- standard deviation;
x --- The average of the measured values.
4.7.2 Inter-batch difference
Human serum or control substances in the range of (25 ± 5) mmol/L were tested with 3 different batches of kits, each batch
Test 3 times, 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).
Requirements of 3.6.2.
xT =
x1 x2 x3
(2)
R=
xmax-xmin
xT
×100% (3)
In the formula.
xmax---the maximum value in xi;
xmin---the minimum value in xi;
xT --- total mean.
4.8 Accuracy
4.8.1 General
The accuracy of the kit can be tested by one of the two methods of relative deviation and recovery test, which should meet the requirements of 3.7;
Use the method of relative deviation.
4.8.2 Relative deviation
Kit testing can be used to evaluate a certified method reference material (CRM) or other recognized reference material for routine methods 3 times.
For (Xi), the relative deviation (B) is calculated according to equation (4), and if all three results meet the requirements of 3.7a), it is judged as qualified. If greater than or
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 (4). If the result of greater than or equal to 19 tests meets the requirements of 3.7a), the accuracy is in accordance with 3.7a).
Claim.
Bi=
Xi-T
T × 100%
(4)
In the formula.
Bi --- relative deviation;
Xi---measuring concentration;
T --- Reference substance calibration concentration.
4.8.3 Recovery test
Add a volume of standard solution to the human sample (the ratio of the standard solution volume to the human sample volume should not change the matrix, plus
After entering the standard solution, the total concentration of the sample must be within the linear range of the kit detection) or pure product, repeat the detection for each concentration 3 times, calculate the mean value, press
The recovery rate calculated by equation (5) shall be in accordance with 3.7b).
R=
C × (V0 V) - C0 × V0
V×CS ×
100% (5)
In the formula.
R --- recovery rate;
V --- the volume of the standard solution added;
V0 --- the volume of the human sample;
C --- the average concentration of the detected concentration of the human sample after adding the standard solution;
C0 --- the average concentration of the detected concentration of the human sample;
CS --- The concentration of the standard solution.
4.9 Stability
4.9.1 Stability of validity
The sample after the expiration date is 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 according to the methods of 4.4, 4.5, 4.6, 4.7.1, 4.8.
Should 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
Packaging should meet the following requirements.
a) The kit should be packaged to protect against natural and mechanical damage;
b) If applicable, the package shall be accompanied by the instruction manual and the product inspection certificate.
6.2 Transportation
Transport according to the conditions stipulated in the contract.
6.3 Storage
Store according to the specified conditions.
references
[1] GB/T 191-2008 packaging storage and transportation icon
[2] GB/T 3358.1-2009 Statistical vocabulary and equals Part 1. General statistical terms and terms used for probability
[3] GB/T 26124-2011 Clinical Chemistry In Vitro Diagnostic Reagent (Box)
[4] YY/T 0316-2008 Medical Device Risk Management for Medical Devices
[5] YY/T 0466.1-2009 Symbols for medical devices for labeling, marking and providing information on medical devices - Part 1.
General requirements (ISO 15223-1.2007, IDT)
[6] Ye Yingqi. National Clinical Laboratory Procedures (3rd Edition) [M]. Nanjing. Southeast University Press,.2006.
[7] CLSIEP05-A2evaluationofprecisionperformanceofquantitativemeasurementmethods;
Approvedguideline-secondedition.
[8] CLSIEP06-Aevaluationofthelinearityofquantitativemeasurementprocedures.astatisti-
Calapproach;approvedguideline.
[9] CLSIEP09-A2methodcomparisonandbiasestimationusingpatientsamples;approved
Guideline.
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