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YY/T 1713-2020 (YYT 1713-2020)

YY/T 1713-2020_English: PDF (YYT1713-2020)
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YY/T 1713-2020English260 Add to Cart 0--10 minutes. Auto-delivered. Diagnostic kit for colloidal gold immunochromatographic assay YY/T 1713-2020 Valid YY/T 1713-2020
 

BASIC DATA
Standard ID YY/T 1713-2020 (YY/T1713-2020)
Description (Translated English) Diagnostic kit for colloidal gold immunochromatographic assay
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 16,113
Date of Issue 2020-09-27
Date of Implementation 2022-06-01
Drafting Organization Beijing Medical Device Technology Evaluation Center, Beijing Medical Device Inspection Institute, China Food and Drug Control Research Institute, Zhengzhou Antu Bioengineering Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd., Giddan Biotechnology Co., Ltd.
Administrative Organization National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC 136)
Regulation (derived from) Announcement No. 108 (2020) of the National Medical Products Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

YY/T 1713-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
Diagnostic kit for colloidal gold
immunochromatographic assay
ISSUED ON: SEPTEMBER 27, 2020
IMPLEMENTED ON: JUNE 01, 2022
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Terms and definitions ... 4 
4 Requirements ... 7 
5 Test methods ... 18 
6 Labels and instructions for use ... 24 
7 Packaging, transportation and storage ... 25 
Bibliography ... 26 
Diagnostic kit for colloidal gold
immunochromatographic assay
1 Scope
This Standard specifies relevant terms and definitions, requirements, test
methods, labels and instructions for use, packaging, transportation and storage
of diagnostic kit for colloidal gold immunochromatographic assay.
This Standard is applicable to diagnostic kit that uses the colloidal gold
immunochromatographic assay as the principle to conduct quantitative,
semiquantitative, qualitative examinations to human sample (blood, urine, feces,
saliva and so on).
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 21415, In vitro diagnostic medical devices - Measurement of quantities
in biological samples - Metrological traceability of values assigned to
calibrators and control materials
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 purposes of this document, the following terms and definitions apply.
3.1 qualitative examination
a set of operations that identify or classify substances based on their chemical
or physical properties
NOTE 1: Generally, only two types of examination results are reported (positive/negative,
yes/no, yes/no, etc.).
NOTE 1: The existence of imprecision makes the examination results in this interval not
always consistent.
NOTE 2: The letter c is short for concentration. The subscript (5, 50 or 95) indicates the
percentage of positive results.
NOTE 3: Ideally, repeat the examination with c5 and c95 concentrations of the analyte to
respectively produce about 5% and 95% of the positive results (this is the result of the
diagnostic kit test, not the clinical diagnosis result).
NOTE 4: The c5-c95 interval is usually called the "examination gray zone" during qualitative
inspection. Its width provides information about the precision of the qualitative test (the
narrower the interval, the better the precision of the examination method).
NOTE 5: This interval is sometimes referred to as the "95% interval" of the method. But do
not confuse this term with "95% confidence interval".
NOTE 6: Rewrite EP12-A2, 8.1.
3.6 limit of detection
the measured value obtained from a given measurement program; for this value,
given that the false positive probability of a certain component in the claimed
substance is α, the false positive probability of the non-existent component is β
NOTE 1: IUPAC recommends that the default values of α and β are equal to 0.05.
NOTE 2: It is used to describe a test procedure with a certain level of confidence that can
be reported as the lowest measured value that exists. It is also used to refer to the minimum
detectable concentration.
NOTE 3: It used to be called "lowest examination limit", "lowest examination limit" and
"examination limit".
NOTE 4: Rewrite GB/T 29791.1-2013, definition A.3.14.
3.7 repeatability
the measurement precision under a set of measurement conditions, including
repeated measurement on the same or similar test object with the same
measurement procedure, by the same operator, with the same measurement
system, under the same operating conditions and at the same location and with
a short period of time
[GB/T 29791.1-2013, definition A.3.30]
3.8 analytical specificity
the ability of the examination procedure to only examine or measure the
4.1.1 Appearance
Meet the normal appearance requirements specified by the manufacturer.
4.1.2 Net content (when applicable)
If the kit contains liquid components, the volume shall meet the following
requirements:
a) For liquid components that need to be extracted and used, the net content
shall not be less than the labeled value;
b) For liquid components that do not need to be extracted, the net content
shall specify its deviation requirements.
NOTE 1: Common liquid components include sample diluent, sample treatment liquid and
so on.
NOTE 2: Under normal circumstances, the diluent or treatment liquid in single serving
packaging does not need to be extracted for use. Multi-serving packaging needs to be
extracted before use.
4.1.3 Film strip width
The manufacturer shall specify the width of the film strip (lower limit or deviation).
The random test shall be no less than the manufacturer's claim.
4.1.4 Liquid moving speed
The manufacturer shall specify the moving speed requirements (lower limit or
deviation). The random test shall be no less than the manufacturer's claim.
4.1.5 Limit of detection
The manufacturer shall specify the limit of detection level of the kit. Separately
examine reference products/samples of different concentrations/level gradients.
The result shall meet the manufacturer's claim.
The concentration/level setting and preparation of the reference
product/sample shall follow the following principles:
a) The reference product/sample shall cover the concentration/level near c5
and c95 on both sides of the critical value;
b) The setting of cutoff and gray zone shall consider whether it accords with
the clinical diagnosis significance. The same test substance can be set
with different cutoffs according to the sensitivity/specificity requirements
for different clinical application situations such as screening reagents and
confirmation reagents;
b) The positive reference/sample shall be determined, and/or tested by
recognized methods, and/or clinically confirmed positive samples. It is
recommended to use national reference materials. If prepared by the
manufacturer, the matrix, preparation method and value assignment
method shall be specified.
4.1.8 Analytical specificity (when applicable)
Examine the negative reference product/sample containing a certain
concentration/level of cross-reactant 3 times. The examination result shall not
be positive.
The analyte kit with a clear cross-reactant shall be applicable. Its setting shall
follow the following principles:
a) The selection of cross-reactants and their concentrations shall be scientific
and reasonable. And it shall be possible to exist in the sample to be tested.
The acceptable degree of cross-reaction mainly depends on the relative
content of the analyte and the cross-reactant in the human body;
b) Negative reference materials/samples shall be determined, and/or tested
by recognized methods, and/or clinically confirmed negative samples. If it
is prepared by the manufacturer, the matrix, preparation method and
assignment method shall be clarified.
NOTE: If there are relevant requirements for cross-reactants in the "negative/positive
reference product compliance rate", this item may not be applicable (such as pathogenic
microorganism diagnostic kit).
4.1.9 High dose hook effect (when applicable)
Examine the high concentration/level positive reference product/sample
claimed by the manufacturer 3 times. There shall be no false negatives in the
examination results.
The double-antibody sandwich one-step examination kit shall generally be
applicable. Its setting shall follow the following principles:
a) The high concentration/level claimed here shall be the higher
concentration level of the analyte that is clinically visible;
b) This is not a requirement to claim that the concentration/level of the hook
effect has occurred. In fact, at the examination concentration/level, the
hook effect has not yet occurred or although the hook effect has occurred,
no false negatives have occurred.
NOTE: This high concentration/level can also be regarded as the upper limit of the
diagnostic kit claimed by the manufacturer.
on. However, if the specified time is exceeded, the product can be accepted if it meets
the requirements.
NOTE 2: Thermal stability test cannot be used to derive product expiration date, unless
it is a deduced formula based on a large amount of stability research data.
NOTE 3: A combination of a) and b) methods can be selected according to product
characteristics. However, the selected method shall be able to verify the stability of the
product, so as to ensure that the product performance meets the standard requirements
within the validity period.
NOTE4: When the kit needs to be used multiple times after opening (for example, the
initial packaging for multiple servings) or when it is not used immediately after opening,
c) applies.
4.2 Diagnostic kit for semiquantitative examination
4.2.1 Appearance
Meet the normal appearance requirements specified by the manufacturer.
4.2.2 Net content (when applicable)
If the kit contains liquid components, the number of liquid components shall
meet the following requirements:
a) For the liquid components that need to be extracted and used, the net
content shall not be less than the labeled value;
b) For the liquid components directly used without extraction, the net content
shall specify its deviation requirements.
NOTE 1: Common liquid components include sample diluent, sample treatment liquid
and so on.
NOTE 2: Under normal circumstances, the diluent or treatment solution in the single-
serving package does not need to be extracted for use, and the multi-serving package
needs to be extracted before use.
4.2.3 Film strip width
The manufacturer shall specify the width of the film strip (lower limit or deviation).
The random test shall be no less than the manufacturer's claim.
4.2.4 Liquid moving speed
The manufacturer shall specify the moving speed requirements (lower limit or
deviation). The random test shall be no less than the manufacturer's claim.
4.2.9 Batch-to-batch difference
Extract 3 batches of diagnostic kits. Repeat the examination for each batch of
different concentrations/levels of reference products (at least contain two orders
of magnitude, weak positive and positive) at least 10 times each. The
consistency rate of the measurement results of each magnitude shall not be
less than 95%.
4.2.10 Stability
Stability shall meet the following requirements:
a) Stability of validity period
The diagnostic kit is stored under the specified storage conditions until the
end of the validity period. If tested within a certain period of time after the
expiry date, the performance of the product shall at least meet the
requirements of 4.2.5, 4.2.6, 4.2.7, and 4.2.8.
b) Thermal stability
Take the kit within the validity period and place it at the temperature
specified by the manufacturer for a specified time. The performance of the
product shall at least meet the requirements of 4.2.5, 4.2.6, 4.2.7, and
4.2.8.
c) Opening stability
After the kit is opened, store under the specified storage conditions until
the end of the expiry date of opening. The performance of the product
shall at least meet the requirements of 4.2.5, 4.2.6, 4.2.7, and 4.2.8.
NOTE 1: Validity period stability test: Under normal circumstances, when the validity
period is 1 year, select products that do not exceed 1 month for testing. When the validity
period is half a year, choose a product that does not exceed half a month for testing,
and so on. However, if the specified time is exceeded, the product can be accepted if it
meets the requirements.
NOTE 2: Thermal stability test cannot be used to derive product expiration date, unless
it is a deduced formula based on a large amount of stability research data.
NOTE 3: A combination of a) and b) methods can be selected according to product
characteristics. However, the selected method shall be able to verify the stability of the
product, so as to ensure that the product performance meets the standard requirements
within the validity period.
NOTE 4: When the kit needs to be used multiple times after opening (for example, the
initial packaging for multiple servings) or when it is not used immediately after opening,
Add the analyte of known concentration to the clinical sample matrix. The
recovery rate shall be 80%~120%.
c) Comparison test
Conduct comparison test between the kit and the designated analysis
system. The correlation coefficient (r) shall not be less than 0.95.
4.3.7 Limit of detection
The manufacturer shall provide the limit of detection of the kit. The test result
shall conform to its claimed value.
4.3.8 Linear
The manufacturer shall provide the linear interval of the kit. In its given linear
interval, the correlation coefficient (r) shall not be lower than 0.95.
4.3.9 Analytical specificity (when applicable)
Examine the negative reference product/sample containing a certain
concentration/level of cross-reactant 3 times. The examination result shall
conform to its claimed value.
4.3.10 Repeatability
Repeat the test 10 times with high and low concentration/level reference
products/samples respectively. The coefficient of variation (CV) shall not be
greater than 15%.
The concentration/level setting and preparation of the reference
product/sample shall follow the following principles:
a) The concentration of the tested reference product/sample shall be
selected near the medically determined level.
b) If the reference/sample used is prepared by the manufacturer, the matrix,
preparation method and assignment method shall be clarified.
NOTE: High and low concentration/level can also choose different coefficient of variation
(CV) requirements. For example, high concentration requires CV not greater than 8%; low
concentration requires CV not more than 12%.
4.3.11 Batch-to-batch difference
Use 3 lot number kits to examine high and low concentrations/levels of
reference products/samples 10 times. The inter-assay coefficient of variation
(CV) shall not be greater than 20%.
5 Test methods
5.1 Diagnostic kit for qualitative examination
5.1.1 Appearance
Visually inspect with normal vision or corrected vision under natural light, which
shall be in accordance with the requirements in 4.1.1.
5.1.2 Net content (when applicable)
Use a universal measuring tool to measure the number of liquid reagents, which
shall be in accordance with the requirements in 4.1.2.
5.1.3 Film strip width
Use a Vernier caliper to measure the width of the test strip, which shall be in
accordance with the requirements in 4.1.3.
5.1.4 Liquid moving speed
Follow the instructions for use. Use a stopwatch to start timing when the test
paper is added to the sample liquid. Stop timing until the liquid reaches the end
of the observation area (shall cover the detection area, quality control area and
other reaction areas). The time used is recorded as t. Use a Vernier caliper to
measure the length from the sample application area to the end of the
observation area, recorded as L. Calculate L/t as the moving speed, which shall
be in accordance with the requirements in 4.1.4.
5.1.5 Limit of detection
Respectively examine the reference product/sample of different gradients with
the indicated concentration/level once each. The result shall meet the
requirements of 4.1.5.
5.1.6 Negative coincidence rate (when applicable)
Respectively examine different reference products/samples used to evaluate
the specificity of reagents once each. The result shall meet the requirements of
4.1.6.
5.1.7 Positive coincidence rate (when applicable)
Respectively examine different reference products/samples used to evaluate
the sensitivity of reagents once each. The result shall meet the requirements of
4.1.7.
5.1.8 Analytical specificity (when applicable)
5.2.2 Net content (when applicable)
Use a universal measuring tool to measure the number of liquid reagents, which
shall meet the requirements in 4.2.2.
5.2.3 Film strip width
Use a Vernier caliper to measure the width of the test strip, which shall meet
the requirements in 4.2.3.
5.2.4 Liquid moving speed
Follow the instructions for use. Use a stopwatch to start timing when the test
paper is added to the sample liquid. Stop timing until the liquid reaches the end
of the observation area (shall cover the detection area, quality control area and
other reaction areas). The time used is recorded as t. Use a Vernier caliper to
measure the length from the sample application area to the end of the
observation area, recorded as L. Calculate L/t as the moving speed, which shall
meet the requirements of 4.2.4.
5.2.5 Accuracy
Respectively examine the concentration/level of each level of concentration
reference product/sample once each. The result shall meet the requirements of
4.2.5.
5.2.6 Analytical specificity (when applicable)
Examine the negative reference product/sample containing the indicated
concentration/level of the cross-reactant 3 times. The result shall meet the
requirements of 4.2.6.
5.2.7 High dose hook effect (when applicable)
Examine the strong positive reference product/sample 3 times according to the
concentration/level claimed by the manufacturer. The result shall meet the
requirements of 4.2.7.
5.2.8 Repeatability
Respectively examine the concentration/level of different levels of
concentration reference products/samples at least 10 times each. The result
shall meet the requirements of 4.2.8.
5.2.9 Batch-to-batch difference
Extract 3 batches of kits. Each batch shall be tested respectively at least 10
times for the reference product/sample with the indicated concentration/level.
according to the kit instructions. Repeat the examination twice for each
concentration of the sample. Calculate its average. Use the least square
method to fit the result average and dilution ratio to a straight line. Calculate the
linear correlation coefficient r. The result shall meet the requirements of 4.3.8.
5.3.9 Analytical specificity (when applicable)
Examine the negative reference product/sample containing the indicated
concentration/level of the cross-reactant 3 times. The result shall meet the
requirements of 4.3.9.
5.3.10 Repeatability
Respectively examine the high and low two reference products/samples with
indicated concentrations/levels 10 times each. Calculate the coefficient of
variation CV. The result shall meet the requirements of 4.3.10.
5.3.11 Batch-to-batch difference
Extract 3 batches of diagnostic kits. Each batch is tested for 10 times each of
the high and low concentration reference products/samples with the indicated
concentration/level. Calculate the coefficient of variation CV of 30 test results.
The result shall meet the requirements of 4.3.11.
5.3.12 Stability
5.3.12.1 Stability of validity period
The diagnostic kit is stored under the specified storage conditions until the end
of the validity period. Examine according to 5.3.6, 5.3.7, 5.3.8, 5.3.9, 5.3.10.
The result shall meet the requirements of 4.3.12a).
5.3.12.2 Thermal stability
Take the diagnostic kit within the validity period and place it at the temperature
specified by the manufacturer for a specified time. Examine according to 5.3.6,
5.3.7, 5.3.8, 5.3.9, 5.3.10. The result shall meet the requirements of 4.3.12b).
5.3.12.3 Opening stability
After the diagnostic kit is opened, store it under the specified storage conditions
until the end of the expiry date of opening. Examine according to 5.3.6, 5.3.7,
5.3.8, 5.3.9, 5.3.10. The result shall meet the requirements of 4.3.12c).
6 Labels and instructions for use
Shall meet the requirements of GB/T 29791.2.