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YY/T 1247-2014 (YY/T1247-2014)

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YY/T 1247-2014: PDF in English (YYT 1247-2014)
YY/T  1247‐2014 
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Hepatitis B virus surface antigen (HBsAg)
detection reagent (kit)
(Chemiluminescent immunoassay)
ISSUED ON. JUNE 17, 2014
IMPLEMENTED ON. JULY 1, 2015
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3 
1  Scope ... 4 
2  Normative references ... 4 
3  Requirements ... 4 
4  Test methods ... 8 
5  Marks, labels and instructions ... 11 
6  Packaging, transportation and storage ... 13 
Bibliography ... 14 
Foreword 
This Standard is drafted according to the rules specified in GB/T 1.1-2009.
Please note that some contents of this Document may involve patents. The issuing
authority of this Document does not undertake the responsibility of identifying these
patents.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee (SAC/TC
136) on System of Medical Clinical Test Lab and in Vitro Diagnostic System of
Standardization Administration of China.
Drafting organizations of this Standard. National Institutes for Food and Drug Control,
Beijing Institute of Medical Device Testing, Beijing Chemclin Biotech Co., Ltd, Beijing
Yuande Bio-Medical Engineering Co., Ltd, Roche Diagnostics (Shanghai) Ltd., and Abbott
Trading (Shanghai) Co., Ltd.
The main drafters of this Standard. Zhou Cheng, Wang Ruixia, Du Haiou, Cheng Yinghao,
Cai Xiaorong, Wang Yunfeng, and Wang Xuefeng.
Hepatitis B virus surface antigen (HBsAg) detection
reagent (kit)
(Chemiluminescent immunoassay)
1  Scope 
This Standard specifies the technical requirements, test method, marks, labels,
instructions, packaging, transportation, and storage of the hepatitis B virus surface
antigen (HBsAg) detection reagent (kit) (chemiluminescent immunoassay).
This standard is applicable to the reagent (kit) that utilizes the chemiluminescent analysis
technique, and adopts the double antibody sandwich method to qualitatively or
quantitatively measure the hepatitis B virus surface antigen (hereinafter referred as
“HBsAg”) reagent (kit) in human’s serum and plasma. It includes chemiluminiscence,
electrochemiluminescence and time-resolved fluorescence etc.
This Standard does not apply to.
a) The calibrator of surface antigen of hepatitis B virus that is marketed independently,
and the quality control materials of surface antigen of hepatitis B virus;
b) Biochip in 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 In vitro diagnostic medical devices - Measurement of quantities in
biological samples - Metrological traceability of values assigned to calibrators and
control materials
3  Requirements 
3.1 Quantitative determination reagent (kit)
3.1.1 Appearance
The linear range specified by the manufacturing enterprise shall at least cover 5.9
IU/mL-100.0 IU/mL. Within the linear range specified by the manufacturing enterprise, the
correlation coefficient r shall not be lower than 0.9900.
3.1.8 Precision
3.1.8.1 Repeatability
USE national reference materials or precision reference materials (1 IU/mL) that has been
calibrated by national reference materials to repeatedly test for 10 times. Its coefficient of
variation (CV) shall not be higher than 15%.
3.1.8.2 Between-batch difference
USE national reference materials or precision reference materials (1 IU/mL) that has been
calibrated by national reference materials to test 3 batches of kit. Its coefficient of variation
(CV) between batches shall not be higher than 15%.
3.1.9 Stability
The following methods can be used for verification.
a) Stability within the validity. The manufacturing enterprise shall stipulate the validity
of reagent (kit). TAKE the expired-sample to perform the test. The test result shall
meet the requirement of 3.1.3-3.1.8.1.
b) Thermal stability. Test result shall meet the requirement of 3.1.3-3.1.8.1.
Note 1. The thermal stability cannot be used to derive the validity of products, unless it use the
derivation formula that is established based on a large number of stability study data;
Note 2. Any arbitrary combination of a) and b) can be selected according to the product
characteristics. However, the selected method shall be capable of verifying the stability of the product,
so as to ensure that the performance of the product can meet the standard requirements within valid
period.
3.2 Qualitative determination reagent (kit)
3.2.1 Appearance
The following requirements shall be met.
a) Liquid components shall be clear and colorless;
b) Each component of reagent (kit) shall be complete, intact and no leakage of liquid;
Chinese packaging labels shall be clear and without wear and tear.
4.2.5.2 Between-batch difference
USE 2 batches of reagent (kit) to respectively test the national reference materials HBsAg
or precision reference materials (1 IU/mL) that has been calibrated by national reference
materials. Repeat the test for 10 times respectively. USE the luminescent signal value of
the sample OR the ratio (S/CO) of sample signal and Cut-off to calculate the average
value (x ) and standard deviation (SD) of the 30 times measurement results. Calculate
the coefficient of variation (CV) according to formula (2). The result shall meet the
requirements of 3.2.5.2.
4.2.6 Stability
4.2.6.1 Stability within the validity. Take the expired-sample to perform the test according
to the methods of 4.2.2-4.2.5.1. It shall meet the requirements of 3.2.6 a).
4.2.6.2 Thermal stability test. The sample within the period of validity, according to
thermal stability conditions provided by the manufacturing enterprise, shall be tested
according to methods of 4.2.2-4.2.5.1. It shall meet the requirements of 3.2.6 b).
5  Marks, labels and instructions 
5.1 Marks and labels for outer packing
It shall contain at least the following contents.
a) Product names and packaging specifications;
b) Name, address, contact information of manufacturing enterprises or after-sales
service unit;
c) Medical Device Registration Certificate Number;
d) Product standard number;
e) Product batch number;
f) Expiration date;
g) Storage conditions.
5.2 Packaging marks and labels of each component
It shall contain at least the following contents.
a) Product names and packaging specifications;
b) Name or trademark of manufacturing enterprise;
c) Product batch number;
d) Expiration date;
e) Storage conditions.
5.3 Operating instructions
It shall contain at least the following contents.
a) Product name;
b) Packaging specifications;
c) Intended use;
d) Inspection principle;
e) Main compositions;
f) Storage conditions and expiration date;
g) Applicable instrument;
h) Sample requirements;
i) Inspection methods;
j) Reference value (threshold value);
k) Explanation to the inspection results;
l) The limitations of inspection methods;
m) Product performance indicators;
n) Instructions to analytical interference (hemolysis, lipemia, jaundice, etc.);
o) Instructions for analytical specificity (cross-reactants);
p) Precautions;
q) References;
r) Name, address and contact details of the manufacturing enterprise or after-sales
service organization;
s) Medical device manufacturing enterprise license number (limited to domestic
enterprises);
Bibliography 
1) YY/T 0316 Medical devices - Application of risk management to medical devices
2) YY/T 0466.1 Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1.General requirements
3) GB/T 191 Packaging - Pictorial marking for handling of goods
4) GB/T 9969 General principles for preparation of instructions for use of industrial
products
5) Chinese Pharmacopoeia Commission. Pharmacopoeia of the People's Republic.
Edition 2010, Volume 3
......
 
(Above excerpt was released on 2015-02-05, modified on 2021-06-07, translated/reviewed by: Wayne Zheng et al.)
Source: https://www.chinesestandard.net/PDF.aspx/YYT1247-2014