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YY/T 1581-2018 PDF in English


YY/T 1581-2018 (YY/T1581-2018, YYT 1581-2018, YYT1581-2018)
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YY/T 1581-2018: PDF in English (YYT 1581-2018)

YY/T 1581-2018
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
Allergy-specific IgE detection kit
ISSUED ON. FEBRUARY 24, 2018
IMPLEMENTED ON. MARCH 01, 2019
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Requirements ... 4 
4 Test methods ... 10 
5 Label and instructions for use ... 17 
6 Packaging, transportation, and storage ... 17 
Bibliography ... 18 
Allergy-specific IgE detection kit
1 Scope
This Standard specifies the requirements, test methods, label and instructions
for use, packaging, transportation, and storage of allergy-specific IgE detection
kit.
This Standard is applicable to the kit in the medical laboratory for
quantitative/semi-quantitative/qualitative detection of allergy-specific IgE in
human serum or plasma using enzyme-linked immunosorbent assay,
chemiluminescence, fluorescence immunoassay, colloidal gold method,
immunoblotting as the principle (hereinafter known as “kit” for short).
2 Normative references
The following documents are indispensable for the application of this document.
For the dated references, only the editions with the dates indicated are
applicable to this document. For the undated references, the latest edition
(including all the amendments) are applicable to this document.
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 Requirements
3.1 Requirements for quantitative detection kit
3.1.1 Appearance
The components of the kit shall be complete and free of liquid leakage.
3.1.2 Value assignment to calibrators
The manufacturing enterprise shall, according to GB/T 21415 and relevant
regulations, provide the source, value assignment process, measurement
uncertainty, and other contents of calibrators.
IU/mL and no specific IgE, IgA sample with a concentration of not less than 700
μg/mL, IgM sample of 500 μg/mL, and IgG sample of 7000 μg/mL. The
determination results shall not be higher than the detection limit.
3.1.9 Stability
The expiration date stability and thermal stability can be verified.
a) Expiration date stability. The manufacturing enterprise shall specify the
expiration date of the kit. TAKE the product within a certain period of time
after the expiration date to detect accuracy, detection limit, linearity,
repeatability, etc.. It shall meet the requirements of 3.1.3, 3.1.4, 3.1.5,
3.1.6;
b) Thermal stability test. Detect the accuracy, detection limit, linearity,
repeatability, etc.. It shall meet the requirements of 3.1.3, 3.1.4, 3.1.5,
3.1.6.
Note 1. Thermal stability cannot be used to derive the expiration date of a product, unless
a derivation formula based on a large amount of stability study data is used.
Note 2. Generally, when the expiration date is 1 year, SELECT the product which has
expired no more than 1 month; when the expiration date is half a year, SELECT
the product which has expired no more than half a month, and so on. However, if
the specified time is exceeded, but the product meets the requirements, it can also
be accepted.
Note 3. According to the product characteristics, any combination of the methods of 3.1.9a)
and 3.1.9b) can be selected. But the selected method shall be able to verify the
stability of product, to ensure that the product performance during the expiration
date meets the standard requirements.
3.2 Requirements for semi-quantitative detection kit
3.2.1 Appearance
The components of the kit shall be complete and free of liquid leakage.
3.2.2 Negative reference material coincidence rate
Detect negative national reference materials, or negative reference materials
provided by the manufacturing enterprise. The results shall be negative.
3.2.3 Positive reference material coincidence rate
Detect national reference materials, or positive reference materials provided by
the manufacturing enterprise. The results shall be positive. The results are
TAKE the product within a certain period of time after the expiration date
to detect negative reference material coincidence rate, positive reference
material coincidence rate, detection limit, correlation, repeatability, etc.. It
shall meet the requirements of 3.2.2, 3.2.3, 3.2.4, 3.2.5, 3.2.6;
b) Detect negative reference material coincidence rate, positive reference
material coincidence rate, detection limit, correlation, repeatability, etc.. It
shall meet the requirements of 3.2.2, 3.2.3, 3.2.4, 3.2.5, 3.2.6.
Note 1. Thermal stability cannot be used to derive the expiration date of a product, unless
a derivation formula based on a large amount of stability study data is used.
Note 2. Generally, when the expiration date is 1 year, SELECT the product which has
expired no more than 1 month; when the expiration date is half a year, SELECT
the product which has expired no more than half a month, and so on. However, if
the specified time is exceeded, but the product meets the requirements, it can also
be accepted.
Note 3. According to the product characteristics, any combination of the methods of 3.2.8a)
and 3.2.8b) can be selected. But the selected method shall be able to verify the
stability of product, to ensure that the product performance during the expiration
date meets the standard requirements.
3.3 Requirements for qualitative detection kit
3.3.1 Appearance
The components of the kit shall be complete and free of liquid leakage.
3.3.2 Negative reference material coincidence rate
Detect negative national reference materials, or negative reference materials
provided by the manufacturing enterprise. The results shall be negative.
3.3.3 Positive reference material coincidence rate
Detect national reference materials, or positive reference materials provided by
the manufacturing enterprise. The results shall be positive.
3.3.4 Detection limit
It shall be less than or equal to 0.35 IU/mL.
3.3.5 Repeatability
One of the following methods can be used to verify.
kit. According to the information provided by the manufacturing enterprise,
detect 5 low-value samples with approximate detection limits of concentration.
Each sample is detected 5 times. SORT the detection results by size. If the
following conditions are met, it can be considered that the setting of blank limit
and detection limit provided by the manufacturing enterprise is basically
reasonable. The result shall meet the requirements of 3.1.4.
a) The number of the detection results below the blank limit value provided
by the manufacturing enterprise shall be less than or equal to 3;
b) There is no detection result higher than the lower limit of the reference
interval provided by the manufacturing enterprise.
4.1.5 Linearity
Detect each of the allergy items in the mixed/combined/multivalent allergy
detection items. USE low-concentration sample or sample diluent near the
lower limit of linear interval to dilute high-concentration sample near the upper
limit of linear interval; and MIX them into at least 5 dilution concentrations (xi).
USE the kit to test the above samples separately. Each dilution concentration
is tested 3 times. The mean value (yi) of each dilution concentration detection
result is calculated respectively. USE the dilution concentration (xi) as the
independent variable; USE the mean value (yi) of the detection result as the
dependent variable; and obtain the linear regression equation. Calculate the
correlation coefficient (r) of linear regression. It shall meet the requirements of
3.1.5.
4.1.6 Repeatability
USE samples of at least two concentration levels of 0.35 IU/mL~0.7 IU/mL and
3.5 IU/mL~17.5 IU/mL for repeated detection 10 times respectively. Calculate
the mean value M and standard deviation SD of the 10 measured concentration
results. According to formula (3), the coefficient of variation CV is obtained. The
result shall meet the requirements of 3.1.6.
Where.
CV - Coefficient of variation;
SD - Standard deviation of measured values;
M - Mean value of measured values.
4.2.3 Positive reference material coincidence rate
Detect each of the allergy items in the mixed/combined/multivalent allergy
detection items. Detect positive national reference materials, or positive
reference materials provided by the manufacturing enterprise. Reference
materials provided by the manufacturing enterprise shall contain strongly
positive, positive, weakly positive reference materials. Operate according to the
instructions of the kit. The results shall meet the requirements of 3.2.3.
4.2.4 Detection limit
Detect each of the allergy items in the mixed/combined/multivalent allergy
detection items. SET the product detection limit. Detect the national reference
materials of detection limit, or the series of reference materials provided by the
manufacturing enterprise. If the concentration is higher than the detection limit,
the reference material shall be detected positive. If the concentration is lower
than the detection limit, the reference material shall be detected negative. The
detection limit reference materials can be detected negative or positive. The
detection limit shall meet the requirement of 3.2.4.
4.2.5 Correlation
Detect the reference material at each concentration level of all detection items
(The preparation method of reference material is based on the information
provided by the manufacturer). Each concentration level is repeatedly detected
3 times. Calculate the difference between the magnitude of the detection result
and the reference solution labelling concentration. It shall meet the
requirements of 3.2.5.
4.2.6 Repeatability
4.2.6.1 USE at least 2 different levels of positive and weakly positive samples
for repeated detection 10 times respectively. Calculate the mean value M and
standard deviation SD of the 10 measured results. According to formula (3), the
coefficient of variation CV is obtained. The result shall meet the requirements
of 3.2.6a).
4.2.6.2 USE repetitive national reference materials or repetitive reference
materials provided by the manufacturing enterprise for repeated detection 10
times. The enterprise’s reference materials shall contain at least 2 levels of
positive and weakly positive reference materials. The result shall meet the
requirements of 3.2.6b).
4.2.7 Inter-batch difference
4.2.7.1 USE kits of 3 batch numbers to detect 2 levels of positive and weakly
reference materials provided by the manufacturing enterprise. Reference
materials provided by the manufacturing enterprise shall contain strongly
positive, positive, weakly positive reference materials. Operate according to the
instructions of the kit. The results shall meet the requirements of 3.3.3.
4.3.4 Detection limit
Detect each of the allergy items in the mixed/combined/multivalent allergy
detection items. SET the product detection limit. Detect the national reference
materials of detection limit, or the series of reference materials provided by the
manufacturing enterprise. If the concentration is higher than the detection limit,
the reference material shall be detected positive. If the concentration is lower
than the detection limit, the reference material shall be detected negative. The
detection limit reference materials can be detected negative or positive. The
detection limit shall meet the requirement of 3.3.4.
4.3.5 Repeatability
4.3.5.1 USE at least 2 different levels of positive and weakly positive samples
for repeated detection 10 times respectively. Calculate the mean value M and
standard deviation SD of the 10 measured results. According to formula (3), the
coefficient of variation CV is obtained. The result shall meet the requirements
of 3.3.5a).
4.3.5.2 USE repetitive national reference materials or repetitive reference
materials provided by the manufacturing enterprise for repeated detection 10
times. The enterprise’s reference materials shall contain at least 2 levels of
positive and weakly positive reference materials. The result shall meet the
requirements of 3.3.5b).
4.3.6 Inter-batch difference
4.3.6.1 USE kits of 3 batch numbers to detect 2 levels of positive and weakly
positive samples. REPEAT 10 times respectively. Calculate the mean value M
and standard deviation SD of the 30 measured results. According to formula (3),
the coefficient of variation CV is obtained. The result shall meet the
requirements of 3.3.6a).
4.3.6.2 USE kits of 3 batch numbers to detect repetitive national reference
materials or repetitive reference materials provided by the manufacturing
enterprise respectively. The enterprise’s reference materials shall contain at
least 2 levels of positive and weakly positive reference materials. Repeatedly
detect 10 times respectively. The results of the 30 detections shall meet the
requirements of 3.3.6b).
4.3.7 Stability
......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.