YY/T 1524-2017 (YY/T1524-2017, YYT 1524-2017, YYT1524-2017)
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α-L-Fucosidase(AFU) assay kit(CNPF substrate method)
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YY/T 1524-2017
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Standards related to: YY/T 1524-2017
| Standard ID | YY/T 1524-2017 (YY/T1524-2017) | | Description (Translated English) | ��-L-Fucosidase(AFU) assay kit(CNPF substrate method) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 8,868 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Beijing Medical Device Testing Institute, Shanghai Kehua Bioengineering Co., Ltd., Shandong Brocade Biological Industry Co., Ltd., Shenzhen Kangmei Biotechnology Co., Ltd., Wuhan Mayor Li Biotechnology Co., Ltd. | | Administrative Organization | National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC 136) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 38 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1524-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
α-L-Fucosidase (AFU)
Assay Kit (CNPF Substrate Method)
ISSUED ON. MARCH 28, 2017
IMPLEMENTED ON. APRIL 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Requirements ... 4
4 Test Methods ... 6
5 Label and Use Instructions ... 10
6 Package, Transportation and Storage ... 10
Bibliography ... 11
α-L-Fucosidase (AFU)
Assay Kit (CNPF Substrate Method)
1 Scope
This Standard specifies the requirements, test methods, label and use instructions,
package, transportation and storage of α-L-fucosidase (AFU) assay kit.
This Standard is applicable to reagent (kit) (hereinafter referred to as kit) performing
quantitative detection by CNPF (2-chloro-4-nitrophenyl-α-L-fucoylpyranoside)
substrate method against the α-L-fucosidase in human serum or plasma; including the
reagents used on the manual and semi-automatic, fully automated biochemical
analyzers.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
GB/T 29791.2 In Vitro Diagnostic Medical Devices - Information Supplied by the
Manufacturer (Labelling) - Part 2. In Vitro Diagnostic Reagents for Professional
Use
3 Requirements
3.1 Appearance
The appearance of kit shall meet the following requirements.
a) The components of kit shall be complete and intact; there is no liquid leakage;
b) The text and symbols of package label shall be clear.
3.2 Loading amount
It shall be no less than the marked value.
4.2 Appearance
Take visual examination with normal or corrected visual acuity under natural light, the
results shall meet the requirements of 3.1.
4.3 Loading amount
Use general measuring gauge to measure; it shall meet the requirements of 3.2.
4.4 Reagent blank
4.4.1 Reagent blank absorbance
Use reagent kit to test the blank sample; record the absorbance value (A) at the
dominant wavelength of the reading point specified in the reagent kit parameters;
which shall meet the requirements of 3.3.1.
4.4.2 Reagent blank absorbance change rate
Test the blank sample with kit; record the absorbance value (A) of the reading point
specified in the kit parameters; calculate the absorbance change rate (ΔA/min), which
shall meet the requirements of 3.3.2.
NOTE. The blank sample can be pure water sample, saline, zero calibration solution, and the
like.
4.5 Analytical sensitivity
Test the sample with a known concentration (30±10) U/L of α-L-fucosidase by a kit;
record the absorbance value (A) at the reading point specified in the kit parameters;
convert into 30 U/L sample’s absorbance change rate (ΔA/min), which shall meet the
requirements of 3.4.
4.6 Linear
4.6.1 Use the low-concentration sample near the lower limit of the linear interval to
dilute the high-concentration sample near the upper limit of the linear interval; mix into
at least 5 dilution concentrations (xi). Use kit to separately test the above samples;
each dilution concentration shall be tested for 3 times; separately calculate the mean
value (yi) of each dilution concentration test results. Obtain the linear regression
equation by taking the dilution concentration (xi) as the independent variable and the
mean value of test result (yi) as the dependent variable. Calculate the correlation
coefficient (r) of the linear regression, which shall meet the requirements of 3.5a).
4.6.2 Substitute the dilution concentration (xi) of the 4.6.1 method into the linear
regression equation; calculate the relative deviation or absolute deviation between yi
test mean and the corresponding estimate, which shall meet the requirements of 3.5b).
4.8.2 Relative deviation
The kit test can be used to evaluate a certified reference material (CRM) of
conventional method or other recognized reference materials for 3 times; the test
results can be recorded as (Xi); separately calculate the relative deviation (B) as per
Formula (4); if all the 3 results meet the requirements of 3.7a), then it can be judged
qualified. If the result of greater than or equal to 2 times are not qualified, then it is
judged disqualified. If one result does not meet the requirements, then retest for 20
times; separately calculate the relative deviation as per the Formula (4); if the results
of greater than or equal to 19 times meet the requirements of 3.7a), then the accuracy
shall meet the requirements of 3.7a).
Where.
Bi – relative deviation;
Xi – measurement concentration;
T – calibrated concentration of reference material.
4.8.3 Enterprise reference product test
The manufacturer shall provide the enterprise reference product; test according to the
routine sample; each sample shall be tested for 3 times; calculate the average value
of the measurement results, which shall meet the requirements of 3.7b).
4.8.4 Comparison test
Use no less than 40 human samples of different concentrations within the detection
concentration range to conduct a comparison test with a traceable analysis system
designated by the manufacturer. Each sample shall be tested according to the
requirements of to-be-tested kit and selected analysis system; each sample shall be
tested once; use the linear regression method to linearly fit the two sets of results; then
obtain the correlation coefficient (r) and slope of linear regression equation; calculate
the absolute deviation or relative deviation between the measured value of the to-be-
tested kit and the measured value of control system for each sample, which shall meet
the requirements of 3.7c).
4.9 Stability
4.9.1 Shelf life stability
Take the sample after the expiration date, test as per the method specified in 4.4, 4.5,
4.6, 4.7.1, 4.8, which shall meet the requirements of 3.8.2.
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