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YY/T 1163-2009 English PDF (YYT1163-2009)

YY/T 1163-2009 English PDF (YYT1163-2009)

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YY/T 1163-2009: Total Prostate Specific Antigen (t-PSA) Quantitative Detection Reagent (Kit) (Chemiluminescent Immunoassay)

This Standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, marks, labels, operating instructions, packaging, transportation, and storage of total prostate specific antigen (t-PSA) quantitative detection reagent (kit) (chemiluminescent immunoassay).
YY/T 1163-2009
YY
ICS 11.100
C 44
Pharmaceutical Industry Standard
of the PEOPLE Republic of China
Total Prostate Specific Antigen (t-PSA)
Quantitative Detection Reagent (Kit)
(Chemiluminescent Immunoassay)
ISSUED ON. DECEMBER 30, 2009
IMPLEMENTED ON. JUNE 1, 2011
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Classification ... 6
5 Requirements ... 6
6 Test methods ... 8
7 Product inspection rules ... 10
8 Marking, labeling, and instructions ... 12
9 Packaging, transportation, and storage ... 13
References ... 14
Foreword
The preparation of this Standard follows the basic specifications of GB/T 1.1-2000 Directives for Standardization. Part 1. Standard Structure and Compilation Rules. It is the basis for evaluating the product quality of total prostate specific antigen (t-PSA) quantitative detection reagent (kit) (chemiluminescent immunoassay).
This Standard was proposed by the State Food and Drug Administration.
This Standard shall be under the jurisdiction of the National Medical Clinical Testing Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC 136).
Drafting organizations of this Standard. Beijing Institute of Medical Device Testing, Beijing Yuande Medical Engineering Co., Ltd., Beijing Chemclin Biotech Co., Ltd., Roche Diagnostic Products (Shanghai) Co., Ltd., and Shanghai Abbott Laboratories Co., Ltd.
Main drafters of this Standard. Zhang Xinmei, Sun Xudong, Cheng Yinghao, Yang Xiaolin, Cai Xiaorong, and Wang Xuefeng.
Prostate Specific Antigen (t-PSA) Quantitative Detection
Reagent (Kit) (Chemiluminescent Immunoassay)
1??Scope
This Standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, marks, labels, operating instructions, packaging, transportation, and storage of total prostate specific antigen (t-PSA) quantitative detection reagent (kit) (chemiluminescent immunoassay).
This Standard applies to the quantitative detection of total prostate specific antigen (t-PSA) quantitative detection reagent (kit) (herein after referred to as ?€?t-PSA reagent (kit)?€?) of the human blood matrix or other body fluid components based on the principle of chemiluminescent immunoassay. It includes the enzymatic and non-enzymatic chemiluminescence immunoassay detection reagent (kit) with carriers such as microplates, tubes, magnetic particles, microbeads, and plastic beads. This Standard does not apply to the requirements of the calibrator and quality control material in reagent kits.
2??Normative??references
The provisions in following documents become the provisions of this Standard through reference in this Standard. For dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this Standard, however, parties who reach an agreement based on this Standard are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies.
GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrator and control materials (ISO 17511.2003, IDT)
3??Terms??and??definitions
The following terms and definitions apply to this Standard.
3.1
Chemiluminescence, CL
C0 ?€? Detection concentration of serum sample B;
Cs ?€? Concentration of solution A.
6.4 Minimum detection limit
USE zero-concentration calibrator or sample diluent as the sample to perform the detection. REPEAT measurement for 20 times. OBTAIN the RLU value (relative luminescence value) of the 20 measurement results. CALCULATE the mean (M) and standard deviation (SD). OBTAIN the M+2SD. CONDUCT two-points regression fitting, based on the concentration ?€? RLU value result BETWEEN zero-concentration calibrator AND adjacent calibrator, to obtain the linear formula. SUBSTITUTE the RLU value of M+2SD into the above formula. OBTAIN the corresponding concentration value, that is, the minimum detection limit. The result shall comply with the requirements of 5.4.
6.5 Linearity
DILUTE the samples with high-value close to the upper limit of linear range INTO at least 5 concentrations according to certain proportion. In which, the samples with low-value concentration shall be close to the lower limit of the linear range. OPERATE according to the instructions of reagent (kit). For each concentration, repeatedly DETECT for 2 times. CALCULATE the mean. USE the least square method to
perform the straight-line fitting FOR result?€?s mean and dilution proportion. And CALCULATE the linear correlation coefficient r. The result shall comply with the requirements of 5.5.
6.6 Repeatability
USE samples of 4ng/ML ?? 0.8ng/mL and 30ng/mL ?? 6ng/mL to repeatedly detect for 10 times. CALCULATE the mean M and standard deviation SD of 10-time measured results. CALCULATE coefficient of variation CV according to the formula CV = SD/M ?? 100%. The results shall comply with the requirements of 5.6.
6.7 Between-batch difference
USE 3 batches of reagent kits to detect one sample with concentration of (30??6) ng/mL respectively. REPEAT for 10 times. CALCULATE the mean M and standard deviation SD of 30-time measured results. CALCULATE coefficient of variation CV according to the formula CV = SD/M ?? 100%. The results shall comply with the requirements of 5.7.
6.8 Stability
a) Stability within the period of validity. TAKE the expired sample to inspect according to the methods of 6.3, 6.4, 6.5, and 6.6. It shall comply with the requirements of 5.8 a).
7.4.1 Amount of sampling
The amount of sampling of factory-exit inspection shall be three times of the amount of inspection items, including the amount of inspection, amount of re-inspection and the amount of sample.
7.4.2 Inspection items
The items of factory-exit inspection shall be clarified.
7.4.3 Conformance determination
During the process of inspection, if there is 1 item unqualified, then it shall conduct re-inspection. If there is 1 item unqualified in the re-inspection, then this batch of reagent (kit) is deemed as unqualified.
7.4.4 The retained sample reagent (kit) is used for re-inspection in special cases, such as quality complaints from users. If it is not used in re-inspection, then the reagent (kit) shall be destroyed in two months after the period of validity.
7.5 Type inspection
7.5.1 When there is one of the following conditions, it shall conduct type inspection.
a) Launch of new products;
b) When there is significant changes to the material, formula and process; c) Not less than once a year in continuous production;
d) When production is resumed after the long-term shutdown;
e) When it is required by the contract provisions or the administrative department. 7.5.2 Amount of sampling
The amount of sampling of type inspection shall be three times of the amount of inspection items, including the amount of inspection, amount of re-inspection and the amount of sample.
7.5.3 Inspection items
When conducting type inspection, it shall conduct full-inspection. All inspection results shall be qualified.
7.5.4 Conformance determination
If all inspection items are qualified, the type inspection is passed. If the type inspection References
[1] GB/T 191 Packaging - Pictorial marking for handling of goods
[2] GB/T 9969 General principles for preparation of instructions for use of industrial products
[3] YY 0466 Medical devices - Symbols to be used with medical device labels labeling and information to be supplied (ISO 15223-2000, IDT)
[4] GB/T 19702-2005 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193.2002, IDT)
[5] ISO/DIS 18113-1 Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labeling) - Part 1. Terms, definitions and general requirements

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