YY/T 1582-2018 (YY/T1582-2018, YYT 1582-2018, YYT1582-2018) & related versions
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Colloidal gold immunochromatography reader
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YY/T 1582-2018
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YYT 1582-2018
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YY/T 1582-2018
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
Colloidal gold immunochromatography reader
ISSUED ON: FEBRUARY 24, 2018
IMPLEMENTED ON: MARCH 01, 2019
Issued by: State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Requirements ... 5
4 Test method ... 7
5 Labels and instructions for use ... 11
6 Packaging, transportation and storage ... 12
Appendix A (Informative) Preparation and measurement calibration method of
quality control strip ... 14
References ... 19
Colloidal gold immunochromatography reader
1 Scope
This standard specifies the requirements, test methods, labels and instructions
for use, packaging, transportation and storage of colloidal gold
immunochromatography analyzers.
This standard is applicable to instruments that interpret the results of samples
by measuring the reflectivity of the bands in the reaction zone of the colloidal
gold reagent card (hereinafter referred to as analyzers).
This standard does not apply to instruments that use fluorescent labels or other
labeling methods for rapid immunoassay.
2 Normative references
The following documents are indispensable for the application of this document.
For dated reference documents, only the dated version applies to this document.
For undated references, the latest version (including all amendments) applies
to this document.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB 4793.1 Safety requirements for electrical equipment for measurement,
control, and laboratory use - Part 1: General requirements
GB 4793.9 Safety requirements for electrical equipment for measurement,
control and laboratory use - Part 9: Particular requirements for automatic
and semi-automatic laboratory equipment for analysis and other purposes
GB/T 14710 Environmental requirement and test methods for medical
electrical equipment
GB/T 18268.1 Electrical equipment for measurement, control and laboratory
use - EMC requirements - Part 1: General requirements
GB/T 18268.26 Electrical equipment for measurement, control and
laboratory use - EMC requirements - Part 26: Particular requirements - In
vitro diagnostic (IVD) medical equipment
GB/T 29791.3 In vitro diagnostic medical devices - Information supplied by
3.4 Repeatability
It may choose one of the following methods:
a) Test quality control strips: Test three quality control strips with high,
medium and low reflectivity in the range of [0.20, 0.80], respectively; the
coefficient of variation (CV) shall not be greater than 3%.
b) Use of matching reagent test sample: Test samples with high, medium and
low concentrations in the linear range, the coefficient of variation (CV)
shall not be greater than 20%.
3.5 Linearity
It may choose one of the following methods:
a) Test quality control strip: Within the linear range of reflectivity [0.20, 0.80],
the linear correlation coefficient (r) shall not be less than 0.990.
b) Use of matching reagent test sample: Within the linear range declared by
the manufacturer, the linear correlation coefficient (r) shall not be less than
0.950.
3.6 Channel consistency (if applicable)
Test the quality control strip, the relative range (Rp) of the measurement results
of each channel shall not be greater than 5%.
3.7 Stability
Test the quality control strip, the relative range (R) shall not exceed 5%.
3.8 Function
At least the following functions shall be included; the enterprise shall also
determine other functions according to the characteristics of the product:
a) Self-check function;
b) Function of input calibration information;
c) Function of result storage and query;
d) Fault prompt function.
3.9 Safety requirements
It shall meet the requirements of applicable clauses in GB 4793.1, GB 4793.9,
YY 0648.
A2 - The reflectivity of quality control strip 2;
S2 - The response value of quality control strip 2.
4.3.2 Use of matching reagent test sample
Test a pair of samples which has a concentration difference not greater than
15% at the medical decision level (i.e., ); repeat the
measurement 10 times; if each measurement meets S1 - S2 < 0, then it meets
the requirements of 3.2b).
Where:
X1 - The concentration of sample 1;
S1 - The measurement result of sample 1;
X2 - Sample with medical decision level concentration;
S2 - The measurement result of sample 2.
4.4 Accuracy
4.4.1 Relative deviation
Use matching reagents to test certified reference materials. The measured
value is recorded as (Xi). Use the formula (1) to respectively calculate the
relative deviation B. If the three measurement results meet the requirements of
3.3a), it is deemed qualified. If more than or equal to 2 measurement results do
not meet, it is judged as unqualified. If one measurement does not meet the
requirements, it shall make 20 tests continuously again; use the formula (1) to
calculate the relative deviation. If greater than or equal to 19 measurement
results meet the requirements of 3.3a), it is judged as qualified.
Where:
Xi - Each measured value;
T - The labeled value of the reference material.
4.4.2 Comparison test
Use matching reagents; refer to the method of CLSI EP09-A2; use no less than
40 clinical samples with different concentrations within the measurement
d) The name, residence, production address, contact information and
production license number of the production enterprise. In case of
entrusted production, the name, residence, production address,
production license number of the entrusted enterprise shall also be
marked;
e) Production date, use period or expiration date;
f) Power connection conditions and input power;
g) Graphics, symbols and other related content that shall be marked
according to product characteristics;
h) Necessary warnings and precautions;
i) Special storage, operating conditions or instructions.
Note: If it is not possible to indicate all the above content due to location or size
limitation, at least the product name, model, specification, production date and
expiration date shall be indicated, meanwhile the label shall clearly indicate that "see
the instruction manual for other contents".
5.3 Instruction manual
The instruction manual shall meet the requirements of the Provisions on the
Administration of Medical Device Instructions and Labels; it shall at least
include the following:
a) Descriptions for normal operation of the product;
b) Description of normal working conditions;
c) Handling methods for common faults;
d) Descriptions of product structure;
e) Description of product consumables and accessories;
f) Recommended service life of key components;
g) Descriptions for matching reagents.
6 Packaging, transportation and storage
6.1 Packaging
The packaging shall meet the following requirements:
Where:
Rn - The reflectivity value of the measurement gray block for metering
calibration which has a serial number n;
Rstd - The standard reflectivity value of the standard reflectivity whiteboard;
Ln - The measured brightness value of the gray scale block for metering
calibration which has a serial number n;
Lstd -The measured brightness value of the standard reflectivity whiteboard.
According to the above method, the number of measurements must be greater
than 2; take the arithmetic mean as the final result.
A.2.4 Reflectivity value of quality control strip
Calculate the reflectivity value of the cut-out measurement grey-scale block for
metering calibration according to the method in A.2.3. This series of reflectivity
values is the reflectivity value of the required quality control strip.
A.2.5 Traceability method
Trace the source in the following ways:
a) The reflection optical densitometer has the measurement calibration
report of the national measurement institutions at all levels;
b) For the preparation of the reflectivity measurement card by itself, the state
measurement institutions at all levels shall make measurement according
to the method A.2 and issue a metering calibration report;
c) Entrust national measurement institutions at all levels to prepare quality
control strips and issue measurement calibration reports in accordance
with A.1.
A.2.6 Validity period and storage method of measurement traceability of
quality control strip
The quality control strip shall be properly stored after being cut and measured
to prevent moisture, pollution, or long-term strong light exposure. It is
recommended that the validity period of the quantity measurement of a properly
kept quality control strip is 1 year.
......
| Standard ID | YY/T 1582-2018 (YY/T1582-2018) | | Description (Translated English) | Colloidal gold immunochromatography reader | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 13,130 | | Date of Issue | 2018-02-24 | | Date of Implementation | 2019-03-01 | | Quoted Standard | GB/T 191; GB 4793.1; GB 4793.9; GB/T 14710; GB/T 18268.1; GB/T 18268.26; GB/T 29791.3; YY 0648 | | Drafting Organization | Beijing Medical Device Technology Review Center | | Administrative Organization | National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee | | Regulation (derived from) | China Food and Drug Administration announced No. 27 of 2018 | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the requirements, test methods, labels, and instructions for use, packaging, transportation, and storage of colloidal gold immunochromatographic analyzers. This standard is applicable to instruments that interpret the sample results by measuring the reflectance of the reaction zone of the colloidal gold reagent card (hereinafter referred to as the analyzer). This standard does not apply to instruments that perform rapid immunoassays using fluorescent labels or other labeling methods. |
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