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GB/T 26124-2011 (GB/T26124-2011)

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GB/T 26124-2011: PDF in English (GBT 26124-2011)
GB/T 26124-2011
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
In Vitro Diagnostic Reagent (kit) for Clinical Chemistry
ISSUED ON: MAY 12, 2011
IMPLEMENTED ON: NOVEMBER 1, 2011
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of the People’s Republic of
China.
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative References ... 4 
3 Terms and Definitions ... 4 
4 Naming and Classification ... 9 
5 Requirements ... 9 
6 Test Methods ... 11 
7 Markings, Labels and Instructions for Use ... 15 
8 Packaging, Transportation and Storage ... 22 
Bibliography ... 23 
In Vitro Diagnostic Reagent (kit) for Clinical Chemistry
1 Scope
This Standard specifies the general technical requirements for the quality inspection
of in vitro diagnostic reagent (kit) for clinical chemistry [hereinafter referred to as
“reagent (kit)”], including terms and definitions, classification and naming,
requirements, test methods, labels and instructions for use, packaging, transportation
and storage.
This Standard is applicable to in vitro diagnostic reagents (kits) based on the principle
of spectrophotometry used in the quantitative inspection of clinical chemistry items in
medical laboratories.
This Standard does not apply to:
a) Performance evaluation reagents (for example, reagents for research
purposes only);
b) In vitro diagnostic reagents for clinical chemistry in POCT (Point of Care
Testing).
2 Normative References
The following documents are indispensable to the application of this document. In
terms of references with a specified date, only versions with a specified date are
applicable to this document. In terms of references without a specified date, the latest
version (including all the modifications) is applicable to this document.
GB 3100 The International System of Units and Its Application
YY 0466-2003 Medical Devices - Symbols to be Used with Medical Device Labels,
Labelling and Information to be Supplied
YY/T 0638 In Vitro Diagnostic Medical Devices - Measurement of Quantities in
Biological Samples - Metrological Traceability of Assigned Values for Catalytic
Concentration of Enzymes in Calibrators and Control Materials
3 Terms and Definitions
The following terms and definitions are applicable to this Standard.
3.1 In Vitro Diagnostic Reagent
accompanied by the uncertainty of a given confidence level.
NOTE: since some reference materials and certified reference materials cannot be related
to a certain chemical structure, or, due to other reasons, their properties cannot be
determined in accordance with the strictly specified physical and chemical
measurement methods. This type of materials include certain biological materials,
and the World Health Organization has stipulated the corresponding international
units.
[JJF 1001-1998, Definition 8.14]
3.7 Repeatability
Repeatability refers to the consistency among the results obtained from multiple
consecutive measurements of the same measured object under the same
measurement conditions.
[JJF 1001-1998, Definition 5.6]
3.8 Precision of Measurement
Precision of measurement refers to the degree of consistency among mutually
independent measurement results under specified conditions.
NOTE 1: precision of measurement cannot be used to represent the digital value related
to the measurement and can only be described as “sufficient” or “insufficient” for
the specified purpose.
NOTE 2: the degree of precision is usually expressed by the statistics of measurement
imprecision that are opposite to precision, such as: standard deviation and
coefficient of variation.
NOTE 3: the “precision” of a given measurement procedure may be classified in
accordance with specific precision conditions. “Repeatability” is related to
basically unchanged conditions and is often known as “in-sequence precision”
or “within-run precision”. “Reproducibility” is related to condition changes, such
as: time, different laboratories, operators and measurement systems (including
different calibrations and reagent batch numbers).
[GB/T 21415-2008, Definition 3.23]
3.9 Repeatability Conditions
Repeatability conditions refer to the conditions, under which, mutually independent test
results are obtained from the same test object within a short period of time in the same
laboratory, by the same operator using the same instrument and through the same test
method.
Stability refers to the capability of the reagents (kits) to maintain the characteristics
within the limits specified by the manufacturer.
NOTE 1: stability is applicable to: when in vitro diagnostic reagents, calibrators or quality
control materials are stored, transported, and used under the conditions
specified by the manufacturer; freeze-dried materials and / or prepared working
solutions after redissolution; materials to open sealed containers; calibrated
instruments or measurement systems.
NOTE 2: the stability of in vitro diagnostic reagents or measurement systems is usually
quantified by time. Stability may be quantified by the time of a certain quantity of
changes in metrological performance characteristics or the quantity of changes
in characteristics within a certain period of time.
NOTE 3: ISO/FDIS 18113-1, Definition 3.68 is modified.
3.15 Label
Label is printed, written or graphic information on in vitro diagnostic medical devices or
their containers.
[ISO/FDIS 18113-1, Definition 3.33]
3.16 Instructions for Use
Instructions for use refer to information provided by the manufacturer on the safe and
correct use of the reagents (kits).
NOTE: ISO/FDIS 18113-1, Definition 3.30 is modified.
3.17 Immediate Container (primary container)
Immediate container (primary container) refers to packaging that prevents the contents
from being contaminated and other influences from the external environment.
Example: sealed bottles, ampoules or bottles, tin foil bags, sealed plastic bags.
[ISO/FDIS 18113-1, Definition 3.24]
3.18 Outer Container
Sales Packaging
Outer container / sales packaging refers to materials used for the packaging of the
immediate container (primary container) of the reagents (kits).
NOTE: ISO/FDIS 18113-1, Definition 3.49 is modified.
3.19 Intended Use (intended purpose)
5.3 Reagent Blank
5.3.1 Absorbance of reagent blank
When the designated blank solution is added to the reagent as a sample for the test,
the absorbance of the reagent blank shall comply with the range provided by the
manufacturer.
5.3.2 Absorbance change rate of reagent blank
For the reagent tested by the rate method, when the designated blank solution is added
to the reagent as a sample for the test, the change rate of the absorbance of the
reagent blank (A/min) shall not exceed the value provided by the manufacturer.
5.4 Analytical Sensitivity
When the reagents (kits) are used to test n units of tested object, the difference in
absorbance (A) or the change rate of absorbance (A/min) shall comply with the
range provided by the manufacturer.
5.5 Linearity Range
The analytical performance within the linearity range of the reagents (kits) shall comply
with the following requirements:
a) Linear correlation coefficient r ≥ 0.990;
b) The linear deviation does not exceed the value provided by the manufacturer.
5.6 Precision of Measurement
5.6.1 Repeatability
The repeatability (coefficient of variation, CV) of the results obtained from repeated
tests with control serum shall not exceed the value provided by the manufacturer.
5.6.2 Within-run difference between bottles (dry powder or freeze-dried reagent)
The within-run difference between bottles of the reagents (kits) shall not exceed the
value provided by the manufacturer.
5.6.3 Between-run difference
The between-run difference of the reagents (kits) shall comply with the requirements
specified by the manufacturer.
5.7 Accuracy
The accuracy of the reagents (kits) shall comply with the requirements specified by the
6.4.1 Use the designated blank samples to test the reagents (kits). At the main
wavelength of the test, record the absorbance (A1) at the start of the test and the
absorbance (A2) after about 5 min (t). The test result of A2 is the measured value of the
absorbance of reagent blank, which shall comply with the requirements of 5.3.1.
6.4.2 Calculate the absorbance change value (A2 - A1 / t), which is the change rate of
the absorbance of reagent blank (A/min), which shall comply with the requirements
of 5.3.2.
6.5 Analytical Sensitivity
Use samples with already-known concentration or activity to test the reagents (kits);
record the absorbance change generated under the specified parameters of the
reagents (kits). Convert it to the difference in absorbance (A) of n units, or, the change
rate of absorbance (A/min) of n units, which shall comply with the requirements of 5.4.
6.6 Linearity Range
6.6.1 Use high-concentration (activity) samples close to the upper limit of the linearity
range and low-concentration (activity) samples close to the lower limit of the linearity
range to mix into at least 5 dilution concentrations (xi). Respectively test the reagents
(kits); for each dilution concentration, test 1 ~ 3 times; respectively calculate the
average value (yi) of the test results. Take the dilution concentration (xi) as the
independent variable; take the average value (yi) of the test results as the dependent
variable; obtain the linear regression equation. Calculate the correlation coefficient (r)
of linear regression, which shall comply with the requirements of 5.5 a).
6.6.2 Substitute the dilution concentration (xi) in Method 6.6.1 into the linear regression
equation to calculate the estimated value of yi, and the relative deviation or absolute
deviation of yi from the estimated value, which shall comply with the requirements of
5.5 b).
6.7 Precision of Measurement
6.7.1 Repeatability
Under repeatability conditions, use the control materials to test the reagents (kits);
repeat the test for at least 10 times (n ≥ 10). Respectively calculate the average value
(x) and standard deviation (s) of the measured values. In accordance with Formula
(1), calculate the coefficient of variation (CV), which shall comply with the requirements
of 5.6.1.
Where,
Where,
R---recovery rate;
V---volume of added standard solution;
V0---volume of anthropogenic samples;
c---detected concentration of anthropogenic samples after adding standard
solution;
c0---detected concentration of anthropogenic samples;
cs---concentration of standard solution.
6.9 Stability
The following methods may be selected for the verification of stability:
a) Stability of expiry date: take samples beyond the expiry date, in accordance
with the methods of 6.4, 6.5, 6.6, 6.7.1, 6.7.2 and 6.8, conduct the test, which
shall comply with the requirements of 5.8 a);
b) Thermal stability test: take samples within the expiry date, in accordance with
the thermal stability conditions claimed by the manufacturer, and the methods
of 6.4, 6.5, 6.6, 6.7.1, 6.7.2 and 6.8, conduct the test, which shall comply with
the requirements of 5.8 b).
7 Markings, Labels and Instructions for Use
7.1 General Requirements
The markings, labels and instructions for use shall comply with the following
requirements:
a) The format and content of the markings, labels and instructions for use shall
be suitable for the intended use of the reagents (kits);
b) The markings, labels and instructions for use shall be in the language of the
country where the reagents (kits) are sold. However, the product name, and
the name and address of the manufacturer do not need to be in multiple
languages;
c) The symbols specified in YY 0466-2003 shall be used; if there is no
corresponding standard, or the used symbols cannot be understood by the
7.2 Markings and Labels of Outer Container
The markings and labels of the outer container shall include the following information:
a) Name and address of the manufacturer;
NOTE 1: when applicable, the address may include province, city, prefecture, county
and town.
NOTE 2: the outer container may also provide the name and address of authorized
representative, distributor or importer.
b) Name of reagents (kits). If the reagents (kits) cannot be uniquely identified by
the name alone, additional identification modes shall be provided;
c) Batch number. If the reagents (kits) contain components with different batch
numbers, then, the batch number of the outer container shall be able to ensure
that the batch number of each component can be traced from the
manufacturer’s production records;
d) Composition. It shall include the mass, volume, and the volume and (or)
inspection number after the redissolution;
e) Intended use. If the name of the reagents (kits) cannot reflect the intended
use of the reagents (kits), then, a brief description of the intended use shall
be provided;
f) In vitro diagnostic purposes;
g) Storage and disposal conditions:
---Necessary storage conditions that can ensure the stable state of the
reagents, calibrators and control materials in the unopened state shall be
provided;
---Other conditions affecting the stability shall be specified;
---All the other special measures taken during product disposal shall be
specified.
h) Expiry date:
---The expiry date under the specified storage conditions shall be clearly
indicated;
---The expiry date shall be expressed in year and month, and day when
applicable;
---If only the year and month are provided, then, the expiry date shall be the
h) Expiry date. The expiry date under the specified storage conditions shall be
clearly indicated; see the mode of expression in 7.2 h);
i) Warnings and precautions:
---If the in vitro diagnostic reagents (kits) are considered to be hazardous (for
example, chemical, radioactive or biological hazards), the immediate
container shall be marked with appropriate texts or symbols for hazard
warning; the requirements of YY/T 0316 apply;
---For chemical hazards, if the reagents (kits) do not come with instructions
that contain appropriate instructions of the hazards and safety, then, they
shall be stated on the labels of the immediate container; when applicable,
it shall be clearly indicated the reagents are intended for single use only.
7.4 Instructions for Use
The instructions for use shall provide the following information:
a) The manufacturer’s name and complete address or contact information;
b) Identification. The name of the reagents (kits) shall be provided. If the
reagents (kits) cannot be uniquely identified by the name alone, additional
identification modes shall be provided;
c) Intended use. The intended use (including the measured) and use restrictions
shall be described. When applicable, the medical indications for use shall be
explained;
d) Principle of measurement procedure. The principle of the measurement
procedure shall be explained, including the type of reaction (for example,
chemical, microbiological or immunochemical), indicator or monitoring system,
and (or) other appropriate details;
e) Traceability of calibrators and authenticity control materials:
---The metrological traceability of the assignment of calibrators and
authenticity control materials shall be explained, including available
reference materials and (or) a higher level of reference measurement
procedures;
NOTE: GB/T 21415-2008 and YY/T 0638 stipulate the requirements for the
traceability of reference materials and (or) reference measurement
procedures.
---When applicable, relevant scientific literatures or other available literatures
on reference measurement procedures or reference materials shall be
provided.
---The samples to be used, and special requirements for the collection, pre-
treatment and (or) storage conditions shall be specified in detail;
---Special instructions shall be provided for the preparation that patients shall
be made before sample collection.
l) Inspection procedures:
---A complete and detailed description of the inspection procedures to be
followed shall be provided;
---All procedures necessary for sample preparation, and steps of
implementing inspection and obtaining results shall be included;
---When applicable, a dilution scheme shall be provided.
m) Control process:
---Sufficient information on the performance of the in vitro diagnostic reagents
(kits) and methods to ensure that they work correctly in accordance with
the instructions shall be provided;
---If a specific recommendation of the quality control procedures is provided,
then, the actions that the user needs to take and the requirements shall be
described.
n) Calculation of inspection results. The mathematical methods used to calculate
the inspection results shall be explained;
o) Interpretation of results:
---The criteria for acceptance and rejection of the inspection results shall be
stated; if special results are obtained, then, it shall be stated whether
additional inspections shall be performed;
---The significance of the obtained inspection results shall be explained.
p) Performance characteristics:
---The characteristics of analytical performance related to the intended use
shall be described;
---The characteristics of diagnostic performance related to the intended use
shall be described.
q) If applicable, a description of the reference interval and reference population,
as well as relevant bibliography shall be provided;
r) The limitations of the inspection procedures shall be stated, including:
......
 
(Above excerpt was released on 2020-12-20, modified on 2021-06-07, translated/reviewed by: Wayne Zheng et al.)
Source: https://www.chinesestandard.net/PDF.aspx/GBT26124-2011