YY/T 1516-2017 English PDF (YYT1516-2017)

Delivery: 3 seconds. Download true-PDF + Invoice.
Get Quotation: Click YY/T 1516-2017 (Self-service in 1-minute)
Historical versions (Master-website): YY/T 1516-2017
Preview True-PDF (Reload/Scroll-down if blank)

YY/T 1516-2017: Prolactin Quantitative Labelling Immunoassay Kit
YY/T 1516-2017
Prolactin quantitative labelling immunoassay kit
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Prolactin quantitative labeling immunoassay 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.
This standard is the basis for evaluating the prolactin quantitative labeling immunoassay kit.
Please note that some of the contents of this document may involve patents. The issuing organization of this document 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. China Food and Drug Control Research Institute.
The main drafters of this standard. Yu Ting, Qu Shoufang, Huang Jie, Sun Nan, Zhang Juanli, Zhang Xiaoyan, Gao Shangxian.
Prolactin quantitative labeling immunoassay kit
1 Scope
This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and prolactin quantitative immunoassay kits.
Storage.
This standard applies to the kit for quantitative determination of prolactin by the double antibody sandwich method.
This standard does not apply to semi-quantitative determination of prolactin reagents (such as test strips, etc.) labeled with colloidal gold or other methods;
Various types of prolactin radioimmunoassay or immunoradiometric kits for radioisotope labeling.
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 191-2008 packaging storage and transportation icon
GB/T 29791.2-2013 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional use for external diagnosis
Broken reagent
3 classification
According to different labeling methods, it can be divided into enzyme label, (electro) chemiluminescent label, (time-resolved) fluorescent label, etc.
The same can be divided into microplate type, tube type, magnetic particles, microspheres and plastic beads; according to different operating procedures can be divided into manual methods and instruments
Automatic operation method.
4 requirements
4.1 Appearance
Manufacturers should specify appropriate appearance requirements based on the packaging characteristics of their products. Generally, there should be components and traits of each component of the kit; internal and external
Requirements for packaging, labeling, etc.
4.2 Blank limit
Should not be higher than 20.0 μIU/mL.
4.3 Linear
The correlation coefficient (r) should be no less than 0.9900 within the linear range given by the manufacturer.
Note. The lower limit of the dose-response curve range is not higher than 40 μIU/mL, and the upper limit is not lower than 3000 μIU/mL.
4.4 Accuracy
Accuracy should meet one of the following requirements.
a) The calibrator in the kit is simultaneously analyzed with the corresponding concentration of prolactin national (or international) standard, using double logarithm or
His appropriate mathematical model fit requires that the two dose-response curves do not significantly deviate from parallel (t-test); in prolactin countries (or
The international standard curve is the control, and the potency ratio of the measured value of the calibrator in the kit to the labeled value should be between 0.900 and 1.100;
b) Detection of prolactin national (or international) standards within the dose-response curve specified in the kit, the relative bias of the measurements
The difference should be within ±10.0%;
c) A known concentration of prolactin is added to normal serum and the recovery should be in the range of 85% to 115%.
4.5 Precision
4.5.1 In-batch precision
Within the range of the dose-response curve of the kit, set up 2~3 different concentrations of quality control products, and manually change the measurement results of the kit.
The coefficient of variation (CV) should not be higher than 10.0%, and the coefficient of variation (CV) of the fully automated operation kit should not be higher than 8.0%.
4.5.2 Inter-assay precision
Between 3 different batches of products, within the dose-response curve range of the kit, set 2~3 different concentrations of quality control products, measure
The coefficient of variation (CV) of the determined results should be no more than 15.0%.
4.6 Specificity
A human growth hormone (GH) sample having a concentration of.200 ng/mL was measured, and the measurement result should be no more than 20.0 μIU/mL.
4.7 Stability
4.7.1 Stability at the end of the period
The kit is stored under the specified conditions until the end of the validity period. The test results should meet the requirements of 4.2, 4.3, 4.4, and 4.5.1.
4.7.2 Thermal stability
The kit should be placed at 37 ° C for a certain period of time. The test results should meet the requirements of 4.2, 4.3, 4.4, and 4.5.1.
4.7.3 Stability after lyophilization reagent reconstitution
After the lyophilized component in the kit is reconstituted according to the specified conditions, it shall be placed under the conditions specified by the manufacturer for a certain period of time, and the test results shall be consistent.
4.2, 4.3, 4.4, 4.5.1.
Note 1. 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 if
Exceeding the specified time, the product is acceptable when it meets the requirements.
Note 2. 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 3. According to the product characteristics, one of the above methods can be selected for verification in 4.7.1 or 4.7.2, but the selected method should be able to verify the stability of the product to ensure
Product performance meets the standard requirements during the validity period.
Note 4. If the kit contains components such as lyophilized calibrators and is stable after being reconstituted for a certain period of time, verification of 4.7.3 is required.
5 Test methods
5.1 Appearance
Visual inspection, visual inspection in bright natural light, should comply with the provisions of 4.1.
5.2 Blank limit
Use a zero-concentration calibrator or sample dilution as a sample for testing, repeat the measurement 20 times, calculate the average value (M) of the signal value and the standard
Quasi-difference (SD), based on the concentration-signal value between the zero-concentration calibrator and the adjacent calibrator, a two-point regression fit yields a first-order equation.
Bring the signal value of (M 2SD) into the above equation and find the corresponding concentration value, which is the blank limit. The result should meet the requirements of 4.2.
5.3 Linear
Dilute high-value samples close to the upper limit of the linear interval to at least 5 concentrations, where the diluted minimum concentration sample must be connected
The lower limit of the near linear interval. Repeat the measurement at least twice for each concentration of the sample, calculate the average value, and measure the average and concentration of the concentration.
The concentration or dilution ratio is straight-line fitted by the least squares method, and the linear correlation coefficient r is calculated. The result should meet the requirements of 4.3.
5.4 Accuracy
Accuracy can be selected as one of the following test methods.
a) Use the kit buffer system to formulate the prolactin national (or international) standard to correspond to the calibrator in the kit (generally should not
Less than 5) concentration points, no more than 2 times in parallel, and fitted with double logarithms or other appropriate mathematical models to calculate two
The slope of the dose-response curve requires that the two dose-response curves do not significantly deviate from parallel (t-test); to the prolactin country (or country)
The standard curve is the control. Calculate the potency ratio of the measured value of the calibrator in the kit to the labeled value, which should meet the requirements of 4.4a).
b) The prolactin national (or international) standard is formulated into a certain concentration of accuracy samples for testing, repeated 3 times, according to formula (1)
Calculating the relative deviation shall comply with the provisions of 4.4b).
B=
Xi-T
T × 100%
(1)
In the formula.
B --- relative deviation;
Xi --- the measured concentration of the sample;
T --- target value of the sample.
c) adding a known concentration of prolactin to normal human serum, the volume ratio between the added prolactin and normal human serum is
1.9, the calculation result according to formula (2) shall comply with the provisions of 4.4c).
R=
C × (V0 V) - (C0 × V0)
(V×Cs) ×
100% (2)
In the formula.
R --- recovery rate;
C --- The concentration of the serum sample after adding the A solution;
V0 --- the volume of serum sample B;
V --- the volume of the liquid A added;
C0 --- serum sample B detection concentration;
The concentration of Cs ---A solution.
5.5 precision
5.5.1 Intra-assay precision
Using the same batch of kits, repeat the determination of different concentrations of quality control products 10 times, calculate the average value (x) and standard of the measurement results.
Difference (s), the coefficient of variation (CV) is obtained according to formula (3), and the result should meet the requirements of 4.5.1.
CV=
􀭺x
×100% (3)
In the formula.
CV --- coefficient of variation;
s -- the standard deviation of the results of -10 measurements;
􀭺x -- The average of the results of -10 measurements.
5.5.2 Inter-assay precision
The test was repeated 10 times for different concentrations of the control products using 3 different batch kits, and the average value (􀭺x) of the measured results was calculated.
The standard deviation (s), the coefficient of variation (CV) is obtained according to formula (4), and the result should meet the requirements of 4.5.2.
CV=
􀭺x
×100% (4)
In the formula.
CV --- coefficient of variation;
s -- the standard deviation of the results of -30 measurements;
􀭺x -- The average of -30 measurements.
5.6 Specificity
Using the kit buffer system, the specific sample is formulated into the specified concentration, and the measurement is performed twice in parallel, and the measurement result should conform to 4.6.
Provisions.
5.7 Stability
After the kit is stored in accordance with the conditions specified in 4.7, it shall be tested according to the methods of 5.2, 5.3, 5.4, and 5.5.1. The results shall be in accordance with 4.7.
Provisions.
6 Labels and instructions for use
Should comply with the provisions of GB/T 29791.2-2013.
7 Packaging, transportation and storage
7.1 Packaging
The packaging and transportation pictorial signs shall comply with the provisions of GB/T 191-2008. The packaging container should ensure good sealing, completeness and no leakage.
No damage.
7.2 Transportation
The kit should be shipped at the manufacturer's request. During transportation, it should be protected from moisture, and heavy loads should be prevented from direct sunlight and rain and snow.
Leach, prevent contact with acid and alkali substances, and prevent damage to the inner and outer packaging.
7.3 Storage
The kit should be stored under the conditions specified by the manufacturer.
references
[1] GB/T 1.1-2009 Standardization work guide Part 1. Standard structure and preparation
[2] GB/T 21415-2008 In vitro diagnostic medical devices biological samples of the amount of measurement of calibrators and control substances assigned
Metrology traceability (ISO 17511.2003, IDT)
[3] GB/T 3358.1-2009 Statistical vocabulary and symbols Part 1. General statistical terms and terms used for probability
[4] GB/T 9969-2008 General instructions for the use of industrial products
[5] YY/T 0316-2008 Medical Device Risk Management for Medical Devices (ISO 14971.2007, IDT)
[6] JJF1001-2011 General measurement terms and definitions
[7] Medical Device Specification and Label Management Regulations
[8] Department of Health, Ministry of Health, People's Republic of China. National Clinical Laboratory Practices (3rd Edition) [M]. Nanjing. Southeast University Publishing
Society,.2006