YY/T 1200-2024 English PDF (YY/T1200-2024)

YY/T 1200-2024: Glucose assay kit (Enzymic method)
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YY/T 1200-2024
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100.10
CCS C 44
YY/T 1200-2024
Replacing YY/T 1200-2013
Glucose assay kit (Enzymic method)
ISSUED ON: FEBRUARY 07, 2024
IMPLEMENTED ON: MARCH 01, 2025
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Requirements ... 5
5 Test methods ... 7
6 Labels, markings and instructions for use ... 10
7 Packaging, transportation and storage ... 10
Bibliography ... 12
Foreword
This document was drafted in accordance with the provisions of GB/T 1.1-2020
“Directives for standardization - Part 1: Rules for the structure and drafting of
standardizing documents”.
This document replaces YY/T 1200-2013 “Glucose assay kit (Enzymic method)”.
Compared with YY/T 1200-2013, in addition to structural adjustments and editorial
changes, the main technical changes are as follows:
- MODIFY the requirements for regent blank absorbance (see 4.3 of this document,
4.3 of the 2013 edition);
- MODIFY the requirements for linearity (see 4.4 of this document, 4.4 of the 2013
edition);
- MODIFY the requirements and test methods for accuracy (see 4.5 of this document,
4.5 of the 2013 edition);
- MODIFY the applicable range of analytical sensitivity (see 4.6 of this document,
4.6 of the 2013 edition);
- MODIFY the requirements for repeatability (see 4.7.1 of this document, 4.7.1 of
the 2013 edition);
- MODIFY the requirements for batch difference (see 4.7.2 of this document, 4.7.2
of the 2013 edition).
Attention is drawn to the possibility that some of the elements of this document may be
the subject of patent rights. The issuing authority of this document shall not be held
responsible for identifying any or all such patent rights.
This document was proposed by National Medical Products Administration.
This document shall be under the jurisdiction of National Technical Committee on
Medical Clinical Laboratory and In Vitro Diagnostic System of Standardization
Administration of China (SAC/TC 136).
Drafting organizations of this document: China Institutes for Food and Drug Control,
Beijing Jiuqiang Biotechnology Co., Ltd., Maccura Biotech Co., Ltd., Shenzhen
Mindray Bio-Medical Electronics Co., Ltd., Beijing Leadman Biochemistry Co., Ltd.,
Abbott Trading (Shanghai) Co., Ltd., Siemens Medical Diagnostics Products (Shanghai)
Co., Ltd., BIOSINO Bio-technology and Science Co., Ltd., Roche Diagnostics Products
(Shanghai) Co., Ltd.
Glucose assay kit (Enzymic method)
1 Scope
This document specifies the requirements, labeling and instructions for use, packaging,
transportation and storage of glucose assay kits (enzymatic method), and describes the
corresponding test methods.
This document applies to determination of assay kits by hexokinase method and glucose
oxidase method, which are used in clinical tests to quantitatively analyze the glucose
concentration in body fluids such as serum, plasma, urine, and cerebrospinal fluid.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
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 Terms and definitions
For the purpose of this document, there are no terms and definitions that need to be
defined.
4 Requirements
4.1 Appearance
The manufacturer shall specify appropriate appearance requirements based on the
packaging characteristics of its own products, and it should have requirements for the
composition and properties of each component of assay kits.
4.2 Net content
The net content of liquid reagents shall not be less than the labeled amount.
4.3 Reagent blank absorbance
The reagent blank absorbance shall not be greater than 0.6 (wavelength given by the
manufacturer, light path 1.0 cm).
NOTE: Not applicable to dry analyzer assay reagents.
4.4 Linearity
The linearity shall meet the following requirements:
a) the linear range of glucose concentration shall cover: [0.6, 25.0] mmol/L;
b) the linear correlation coefficient (r) shall not be less than 0.9900;
c) in the range of [0.6 ~ 5.0] mmol/L, the absolute linear deviation shall be within
the range of ±0.50 mmol/L; in the range of (5.0~25.0] mmol/L, the relative linear
deviation shall be within the range of ±10.0 %.
4.5 Accuracy
Select one of the following methods for verification in the following order of priority.
a) Use recognized reference materials or certified reference materials that can be
used to evaluate conventional methods as samples for determination, and the
relative deviation shall be within the range of ±7.0 %.
b) The recovery rate of assay kits shall be within the range of 93.0 % ~ 107.0 %.
c) Compare with the traceable analytical system specified by the manufacturer. If it
is in the range of [0.6, 25.0] mmol/L, the correlation coefficient (r) shall be no
less than 0.9900, and the slope shall be within the range of [0.9, 1.1]; if the sample
concentration is in the range of [0.6 ~ 5.0] mmol/L, the absolute deviation shall
be within the range of ±0.35 mmol/L; if the sample concentration is in the range
of (5.0 ~ 25.0] mmol/L, the relative deviation shall be within the range of ±7.0 %.
95 % of the test samples shall meet the above requirements.
4.6 Analytical sensitivity
When the reagent (kit) tests n units of the analyte, the absorbance difference (ΔA) or
the absorbance change rate (ΔA/min) shall comply with the range given by the
manufacturing enterprise.
NOTE: Not applicable to dry analyzer assay reagents.
4.7 Precision
4.7.1 Repeatability
The coefficient of variation (CV, %) shall not be greater than 3.0 %.
4.7.2 Batch difference
The batch relative range (R) shall not exceed 5.0 %.
4.8 Stability
Expiration date stability and thermal stability can be verified.
a) Expiration date stability: The manufacturing enterprise shall specify the expiration
date of the product. Take products within a certain period of time after the
expiration date to test the reagent blank absorbance, linearity, accuracy, analytical
sensitivity, and repeatability, determine whether the results meet the requirements
of 4.3 ~ 4.6 and 4.7.1.
b) Thermal stability: Under the accelerated conditions specified by the manufacturer,
test the reagent blank absorbance, linearity, accuracy, analytical sensitivity, and
repeatability, determine whether the results meet the requirements of 4.3 ~ 4.6
and 4.7.1.
NOTE 1: Generally, when the expiration date is 1 year, select products that do not exceed 1 month,
when the expiration date is half a year, select products that do not exceed half a month, and so on.
However, if the specified time is exceeded, the product can be accepted if it meets the requirements.
NOTE 2: Thermal stability cannot be used to derive the expiration date of the product unless a
derivation formula based on a large amount of stability research data is used.
NOTE 3: According to the characteristics of the product, any combination of methods a) and b) can
be selected for verification, but the selected method can verify the stability of the product to ensure
that the product performance complies with this document within the expiration date.
5 Test methods
5.1 Appearance
Visually inspect with normal or corrected vision under natural light, determine whether
the results meet the requirements of 4.1.
5.2 Net content
Measure with a universal measuring instrument, determine whether the results meet the
requirements of 4.2.
5.3 Reagent blank absorbance
Use designated blank samples to test the assay kit. Different methods have different
wavelengths. Using the wavelength given by the manufacturer, 1 cm light path, test 2
times in a row, and calculate the average value, which is the blank absorbance.
Determine whether the results meet the requirements of 4.3.
5.4 Linearity
YY/T 1200-2024
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100.10
CCS C 44
YY/T 1200-2024
Replacing YY/T 1200-2013
Glucose assay kit (Enzymic method)
ISSUED ON: FEBRUARY 07, 2024
IMPLEMENTED ON: MARCH 01, 2025
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Requirements ... 5
5 Test methods ... 7
6 Labels, markings and instructions for use ... 10
7 Packaging, transportation and storage ... 10
Bibliography ... 12
Foreword
This document was drafted in accordance with the provisions of GB/T 1.1-2020
“Directives for standardization - Part 1: Rules for the structure and drafting of
standardizing documents”.
This document replaces YY/T 1200-2013 “Glucose assay kit (Enzymic method)”.
Compared with YY/T 1200-2013, in addition to structural adjustments and editorial
changes, the main technical changes are as follows:
- MODIFY the requirements for regent blank absorbance (see 4.3 of this document,
4.3 of the 2013 edition);
- MODIFY the requirements for linearity (see 4.4 of this document, 4.4 of the 2013
edition);
- MODIFY the requirements and test methods for accuracy (see 4.5 of this document,
4.5 of the 2013 edition);
- MODIFY the applicable range of analytical sensitivity (see 4.6 of this document,
4.6 of the 2013 edition);
- MODIFY the requirements for repeatability (see 4.7.1 of this document, 4.7.1 of
the 2013 edition);
- MODIFY the requirements for batch difference (see 4.7.2 of this document, 4.7.2
of the 2013 edition).
Attention is drawn to the possibility that some of the elements of this document may be
the subject of patent rights. The issuing authority of this document shall not be held
responsible for identifying any or all such patent rights.
This document was proposed by National Medical Products Administration.
This document shall be under the jurisdiction of National Technical Committee on
Medical Clinical Laboratory and In Vitro Diagnostic System of Standardization
Administration of China (SAC/TC 136).
Drafting organizations of this document: China Institutes for Food and Drug Control,
Beijing Jiuqiang Biotechnology Co., Ltd., Maccura Biotech Co., Ltd., Shenzhen
Mindray Bio-Medical Electronics Co., Ltd., Beijing Leadman Biochemistry Co., Ltd.,
Abbott Trading (Shanghai) Co., Ltd., Siemens Medical Diagnostics Products (Shanghai)
Co., Ltd., BIOSINO Bio-technology and Science Co., Ltd., Roche Diagnostics Products
(Shanghai) Co., Ltd.
Glucose assay kit (Enzymic method)
1 Scope
This document specifies the requirements, labeling and instructions for use, packaging,
transportation and storage of glucose assay kits (enzymatic method), and describes the
corresponding test methods.
This document applies to determination of assay kits by hexokinase method and glucose
oxidase method, which are used in clinical tests to quantitatively analyze the glucose
concentration in body fluids such as serum, plasma, urine, and cerebrospinal fluid.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
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 Terms and definitions
For the purpose of this document, there are no terms and definitions that need to be
defined.
4 Requirements
4.1 Appearance
The manufacturer shall specify appropriate appearance requirements based on the
packaging characteristics of its own products, and it should have requirements for the
composition and properties of each component of assay kits.
4.2 Net content
The net content of liquid reagents shall not be less than the labeled amount.
4.3 Reagent blank absorbance
The reagent blank absorbance shall not be greater than 0.6 (wavelength given by the
manufacturer, light path 1.0 cm).
NOTE: Not applicable to dry analyzer assay reagents.
4.4 Linearity
The linearity shall meet the following requirements:
a) the linear range of glucose concentration shall cover: [0.6, 25.0] mmol/L;
b) the linear correlation coefficient (r) shall not be less than 0.9900;
c) in the range of [0.6 ~ 5.0] mmol/L, the absolute linear deviation shall be within
the range of ±0.50 mmol/L; in the range of (5.0~25.0] mmol/L, the relative linear
deviation shall be within the range of ±10.0 %.
4.5 Accuracy
Select one of the following methods for verification in the following order of priority.
a) Use recognized reference materials or certified reference materials that can be
used to evaluate conventional methods as samples for determination, and the
relative deviation shall be within the range of ±7.0 %.
b) The recovery rate of assay kits shall be within the range of 93.0 % ~ 107.0 %.
c) Compare with the traceable analytical system specified by the manufacturer. If it
is in the range of [0.6, 25.0] mmol/L, the correlation coefficient (r) shall be no
less than 0.9900, and the slope shall be within the range of [0.9, 1.1]; if the sample
concentration is in the range of [0.6 ~ 5.0] mmol/L, the absolute deviation shall
be within the range of ±0.35 mmol/L; if the sample concentration is in the range
of (5.0 ~ 25.0] mmol/L, the relative deviation shall be within the range of ±7.0 %.
95 % of the test samples shall meet the above requirements.
4.6 Analytical sensitivity
When the reagent (kit) tests n units of the analyte, the absorbance difference (ΔA) or
the absorbance change rate (ΔA/min) shal...