YY/T 1178-2010 English PDF (YY/T1178-2010)

YY/T 1178-2010: Carbohydrate antigen CA19-9 quantitative detection reagent(kit) - Chemiluminescent immunoassay
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YY/T 1178-2010 
YY
ICS 11.100
C 44
INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Carbohydrate antigen CA19-9 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 file may involve patents. The issuing organization
of this file does not bear the responsibility to identify these patents.
This standard was proposed by the China Clinical Laboratory Testing and In vitro
Diagnostic Test System of Standardization Administration of China (SAC/TC 136).
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., Johnson and Johnson Medical (Shanghai) Ltd, and Beijing
Office of Switzerland Abbott Co., Ltd.
The main drafters of this standard. Zhang Xinmei, Cheng Yinghao, Qi Xin, and Wang
Xuefeng.
Carbohydrate antigen CA19-9 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 carbohydrate antigen CA19-9
quantitative detection reagent (kit) (chemiluminescent immunoassay).
This standard is applicable to test carbohydrate antigen (CA19-9) reagent (kit) [hereinafter
referred as “CA19-9 reagent (kit)”], based on the principles of chemiluminescent
immunoassay. It includes the enzymatic and non-enzymatic chemiluminescent
immunoassay detection reagent (kit) with the carriers of microwell plates, tubes, magnetic
particles, micro-beads and plastic beads.
This standard is not applicable to.
a) The tumor marker calibrators and tumor marker control materials are intended for
separate sales;
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 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in
biological samples - Metrological traceability of values assigned to calibrators and
control materials
3 Classification
CA19-9 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 carriers of chemiluminescent
4.7 Within-batch difference
Use 3 batches of reagent kits to respectively test the samples with concentrations of
(40±8) U/mL and (150±30) U/mL. The coefficient of variation (CV) among the 3 batches of
kits shall not be greater than 15%.
4.8 Stability
The following methods can be used for verification.
a) Stability within the validity. The manufacturer shall stipulate the validity of reagent
(kit). Use the kits that have been expired to test the accuracy, minimum detection
limit, linearity and repeatability. It shall comply with requirements of .4.3-4.6.
b) Thermal stability test. A kit within the period of validity is placed for 3 days at 37°C.
Test the accuracy, minimum detection limit, linearity and repeatability. The results
shall comply with the requirements of 4.3-4.6.
Note 1. Thermal stability test cannot be used to derive the validity of products, unless it uses the
derivation formula that is established and based on a large number of stability study data.
Note 2. According to the product characteristics, it can choose Method a) and Method b) for arbitrary
combination, but the method selected shall verify the stability of the products, in order to
ensure the product performance to comply with the standard requirements within the validity.
5  Test methods 
5.1 Appearance
Use corrected-visual-acuity to visually inspect, under the natural light. It shall meet the
requirements of 4.1.
5.2 Traceability
Traceability information provided by the manufacturer shall comply with the requirements
of 4.2.
5.3 Accuracy
Accuracy may select one of the following test methods.
a) Prepare the concentration of the reference material. Make its final concentration to
be about 100 U/mL (concentration deviation of ±20% is allowed). Take it as the
sample. Perform the detection according to the procedures of instructions. Repeat
for 3 times repeatedly. Record the average result as M. Calculate the relative
deviation B of the measured concentration according to Formula (1). The result
shall comply with the requirements of 4.3 a).
It shall include 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 (Reference range);
k) Explanation to the inspection results;
l) The limitations of inspection methods;
m) Product performance index;
n) Instructions of analytical interference (hemolysis, lipemia, jaundice, etc.);
o) Instructions for analytical specificity (cross-reactants);
p) Precautions;
q) References;
r) Name, address, contact details of the manufacturer or after-sales service
organization;
s) License number of medical device manufacturer (limited to domestic enterprises);
t) Medical device registration certificate number;
u) Product standard number;
v) Instructions approval and date of modification.
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
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
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
YY/T 1178-2010 
YY
ICS 11.100
C 44
INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Carbohydrate antigen CA19-9 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 file may involve patents. The issuing organization
of this file does not bear the responsibility to identify these patents.
This standard was proposed by the China Clinical Laboratory Testing and In vitro
Diagnostic Test System of Standardization Administration of China (SAC/TC 136).
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., Johnson and Johnson Medical (Shanghai) Ltd, and Beijing
Office of Switzerland Abbott Co., Ltd.
The main drafters of this standard. Zhang Xinmei, Cheng Yinghao, Qi Xin, and Wang
Xuefeng.
Carbohydrate antigen CA19-9 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 carbohydrate antigen CA19-9
quantitative detection reagent (kit) (chemiluminescent immunoassay).
This standard is applicable to test carbohydrate antigen (CA19-9) reagent (kit) [hereinafter
referred as “CA19-9 reagent (kit)”], based on the principles of chemiluminescent
immunoassay. It includes the enzymatic and non-enzymatic chemiluminescent
immunoassay detection reagent (kit) with the carriers of microwell plates, tubes, magnetic
particles, micro-beads and plastic beads.
This standard is not applicable to.
a) The tumor marker calibrators and tumor marker control materials are intended for
separate sales;
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 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in
biological samples - Metrological traceability of values assigned to calibrators and
control materials
3 Classification
CA19-9 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 carriers of chemiluminescent
4.7 Within-batch difference
Use 3 batches of reagent kits to respectively test the samples with concentrations of
(40±8) U/mL and (150±30) U/mL. The coefficient of variation (CV) among the 3 batches of
kits shall not be greater than 15%.
4.8 Stability
The following methods can be used for verification.
a) Stability within the validity. The manufacturer shall stipulate the validity of reagent
(kit). Use the kits that have been expired to test the accuracy, minimum detection
limit, linearity and repeatability. It shall comply with requirements of .4.3-4.6.
b) Thermal stability test. A kit within the period of validity is placed for 3 days at 37°C.
Test the accuracy, minimum detection limit, linearity and repeatability. The results
shall comply with the requirements of 4.3-4.6.
Note 1. Thermal stability test cannot be used to derive the validity of products, unless it uses the
derivation formula that is established and based on a large number of stability study data.
Note 2. According to the product characteristics, it can choose Method a) and Method b) for arbitrary
combination, but the method selected shall verify the stability of the products, in order to
ensure the product performance to comply with the standard requirements within the validity.
5  Test methods 
5.1 Appearance
Use corrected-visual-acuity to visually inspect, under the natural light. It shall meet the
requirements of 4.1.
5.2 Traceability
Traceability information provided by the manufacturer shall comply with the requirements
of 4.2.
5.3 Accuracy
Accuracy may select one of the following test methods.
a) Prepare the concentration of the reference material. Make its final concentration to
be about 100 U/mL (concentration deviation of ±20% is allowed). Take it as the
sample. Perform the detection according to the procedures of instructions. Repeat
for 3 times repeatedly. Record the average result as M. Calculate the relative
deviation B of the measured concentration according to Formula (1). The result
shall comply with the requirements of 4.3 a).
It shall include 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 (Reference range);
k) Explanation to the inspection results;
l) The limitations of inspection methods;
m) Product performance index;
n) Instructions of analytical interference (hemolysis, lipemia, jaundice, etc.);
o) Instructions for analytical specificity (cross-reactants);
p) Precautions;
q) References;
r) Name, address, contact details of the manufacturer or after-sales service
organization;
s) License number of medical device manufacturer (limited to domestic enterprises);
t) Medical device registration certificate number;
u) Product standard number;
v) Instructions approval and date of modification.
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
2. YY/T 0466.1-2009 Devices — Symbols to be used with medical device labels,
labelling and information to be supplied — Part 1. General requir...