YY/T 1176-2010 (YY/T1176-2010, YYT 1176-2010, YYT1176-2010)
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| YY/T 1176-2010 | English | 150 |
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Cancer antigen CA 15-3 quantitative detection reagent (kit) - Chemiluminescent immunoassay
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YY/T 1176-2010
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Standards related to: YY/T 1176-2010
| Standard ID | YY/T 1176-2010 (YY/T1176-2010) | | Description (Translated English) | Cancer antigen CA 15-3 quantitative detection reagent (kit) - Chemiluminescent immunoassay | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 10,181 | | Date of Issue | 2010-12-27 | | Date of Implementation | 2012-06-01 | | Quoted Standard | GB/T 21415-2008 | | Drafting Organization | Beijing Medical Device Testing | | Administrative Organization | National Standardization Technical Committee of Medical clinical testing laboratories and in vitro diagnostic systems | | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | | Proposing organization | National Medical Clinical Laboratory Laboratory and Standardization Technical Committee for In Vitro Diagnostic System (SAC/TC 136) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the cancer antigen CA15-3 Quantitative Assay (box) (chemiluminescent immunoassay) classification, requirements, test methods, marking, labeling, instructions, packaging, transportation and storage. This standard applies to chemiluminescence immunoassay for the quantitative determination of cancer antigen principle CA15-3 reagent (box) [ hereinafter referred to as "CA15-3 reagent (boxes) ]. Including microplates, tubes, magnetic particles, beads and plastic beads as the carrier of enzymatic and non- enzymatic chemiluminescence immunoassay reagent (box) this standard does not apply to: a) intended to be used tumor markers sold separately tumor marker substance calibrators and control products. b) by chemiluminescence immunoassay for the principle of bio- chips. | YY/T 1176-2010
YY
ICS 11.100
C 44
INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Cancer antigen CA15-3 quantitative detection
reagent (kit) - Chemiluminescent immunoassay
ISSUED ON. DECEMBER 27, 2010
IMPLEMENTED ON. JUNE 1, 2012
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Classification ... 4
4 Requirements ... 5
5 Test methods ... 6
6 Marks, labels and instructions ... 9
7 Packaging, transportation and storage ... 11
Bibliography ... 12
Foreword
This standard was drafted in accordance with the rules specified in GB/T 1.1-2009.
Please note that some contents in this document may involve patents. The issuing
organization of this document does not bear the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard shall be under the jurisdiction of the China Clinical Laboratory Testing and
In vitro Diagnostic Test System of Standardization Administration of China (SAC/TC 136).
Drafting organization of this standard. Beijing Institute of Medical Device Testing, Beijing
Chemclin Biotech Co., Ltd., Roche Diagnostic Products (Shanghai) Co., Ltd., and
Beckman Coulter Commercial Enterprise (China) Co., Ltd.
The main drafters of this standard. Zhang Xinmei, Cheng Yinghao, Du Haiou, Huang
Baixing, and Zhang Jinwen.
Cancer antigen CA15-3 quantitative detection reagent
(kit) - Chemiluminescent immunoassay
1 Scope
This standard specifies the classification, requirements, test method, identification, labels,
instructions, packaging, transportation and storage of the cancer antigen CA15-3
quantitative detection reagent (kit) (chemiluminescent immunoassay).
This standard is applicable to test cancer antigen CA15-3 reagent (kit) [hereinafter
referred to as “CA15-3 reagent (kit)”], based on the principles of chemiluminescent
immunoassay. It includes the enzymatic and non-enzymatic chemiluminescent
immunoassay detection reagent (kit) with carriers of microwell plates, tubes, magnetic
particles, micro-beads and plastic-beads.
The Standard is not applicable to.
a) The tumor marker calibrators and tumor marker control materials that are intended
for separate sales.
b) Biochip that uses the principle of chemiluminescent immunoassay.
2 Normative references
The articles contained in the following documents have become part of this document
when they are quoted herein. For the dated documents so quoted, all the modifications
(Including all corrections) or revisions made thereafter shall be applicable to this
document.
GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in
biological samples - Metrological traceability of values assigned to calibrators and
control materials
3 Classification
CA15-3 reagent (kit) can be divided into enzymatic and non-enzymatic chemiluminescent
immunoassay reagent (kit), according to different chemiluminescent principles. According
to different solid-phase carriers, it can be divided into microwell plates, tubes, magnetic
particles, micro-beads and plastic-beads as the carrier of chemiluminescent
immunoassay reagent (kit). According to different operation processes, it can be divided
into manual operation method and instrument-automatic operation method.
4 Requirements
4.1 Appearance
The appearance shall comply with the following requirements.
a) Each component of reagent (kit) shall be complete, intact and no leakage of liquid;
b) The packaging labels shall be clear and easy to be identified.
4.2 Traceability
The manufacturer shall provide the contents such as source, assignment procedure and
measurement uncertainty of the applied CA15-3 calibrators in accordance with
GB/T21415-2008 and relevant regulations.
4.3 Accuracy
The accuracy shall comply with one of the following requirements.
a) Use the reference materials as the sample for detection. The relative deviation of
the measurement results shall be within the range of ± 10%;
b) The recovery rate shall be within the range of (85% to 115%).
Note. If CA15-3 has the international reference materials or national standard products, detect in
accordance with Term a); if there are no international reference materials or national standard
products, then in accordance with b) for detection.
4.4 Minimum detection limit
The minimum detection limit shall not be greater than 1.0 U/mL.
4.5 Linearity
The upper limit of linear range shall not be less than 5 times the reference value. The
lower limit shall not be greater than 1/5 times the reference value. The correlation
coefficient r shall not be less than 0.9900 within the linear range prescribed by the
manufacturer.
4.6 Repeatability
Use the samples with the concentrations of (30±6) U/mL and (150±30) U/mL to repeatedly
and respectively test for 10 times. The coefficient of variation (CV) shall not be greater
than 10% (instrument-automatic operation) or not be greater than 15% (manual
operation).
SD — Standard deviation of 30-times measurement results;
M — Mean of 30-times measurement results.
5.8 Stability
The following methods can be used for verification.
a) Stability within the validity. Take the kit that has been expired to perform the
detection in accordance with methods of 5.3-5.6. It shall comply with the
requirements in 4.8 a);
b) Thermal stability test. A kit within the validity is placed for 3 days at 37°C. Perform
the test according to methods of 5.3-5.6. The result shall comply with
requirements of 4.8 b).
6 Marks, labels and instructions
6.1 Marks, labels for outer package of reagent (kit)
a) Product name and packaging specifications;
b) Name, address, contact details of the manufacturer or after-sales service
organization;
c) Medical device registration certificate number;
d) Product standard number;
e) Product batch number;
f) Expiration date;
g) Storage conditions.
6.2 Marks and labels on each component packing of reagent (kit)
It shall contain at least the following contents.
a) Product name and packaging specifications;
b) Name or trademark of the manufacturer;
c) Product batch number;
d) Expiration date;
e) Storage conditions.
7 Packaging, transportation and storage
7.1 Packaging
Reagent (kit) shall be packaged according to the requirements of the manufacturer.
7.2 Transportation
Reagent (kit) shall be transported according to the requirements of the manufacturer.
7.3 Storage
Reagent (kit) shall be stored under the conditions specified by the manufacturer.
Bibliography
1. YY/T 0316-2008 Medical devices — Application of risk management to medical
devices (ISO 14971. 2007, IDT)
2. YY/T 0466.1-2009 Devices — Symbols to be used with medical device labels,
labelling and information to be supplied — Part 1.General requirements (ISO
15223.1-2009, IDT)
3. GB/T 191-2008 Packaging - Pictorial marking for handling of goods
4. GB/T 9969-2008 General principles for preparation of instructions for use of
industrial products
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