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YY/T 1729-2020: (Fungus (1-3)-β-D glucan assay kit)
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1729-2020 | English | 149 |
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(Fungus (1-3)-β-D glucan assay kit)
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YY/T 1729-2020
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PDF similar to YY/T 1729-2020
Basic data | Standard ID | YY/T 1729-2020 (YY/T1729-2020) | | Description (Translated English) | (Fungus (1-3)-��-D glucan assay kit) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 8,857 | | Date of Issue | 2020-06-30 | | Date of Implementation | 2021-06-01 | | Regulation (derived from) | Announcement No. 76 (2020) of the National Medical Products Administration | | Issuing agency(ies) | State Drug Administration | YY/T 1729-2020: (Fungus (1-3)-β-D glucan assay kit)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
People's Republic of China Pharmaceutical Industry Standards
Released on 2020-06-30
Implementation of 2021-06-01
Issued by the National Medical Products Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. Publication of this document
The agency is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
Drafting organizations of this standard. Beijing Jinshanchuan Technology Development Co., Ltd., Beijing Medical Device Inspection Institute, Beijing Medical Device Technical Review
Evaluation Center, Clinical Laboratory Center of National Health Commission, Tianjin Sino Biomedical Co., Ltd.
The main drafters of this standard. Hu Jihong, Yang Zhong, Sun Rong, Guo Lili, He Yongsheng, Yuan Qinghua, Zang Danrong.
Fungus (1-3)-β-D glucan determination kit
1 Scope
This standard specifies the requirements, test methods, identification, labeling and instructions for use, packaging, transportation and storage of the fungus (1-3)-β-D glucan determination kit.
This standard applies to kits for the quantitative determination of fungal (1-3)-β-D glucan in human serum and plasma by spectrophotometry based on the principle of chromogenic matrix method.
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 article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.In vitro diagnostic reagents for professional use
3 requirements
3.1 Appearance
Should meet the following requirements.
a) The components of the kit should be complete, the inner and outer packaging should be complete, and the label should be clear;
b) The liquid reagent has no leakage; the freeze-dried components are loose bodies, and the liquid has no visible particles or precipitation after reconstitution.
3.2 Quantity
Should meet one of the following requirements.
a) For single-serving liquid reagents that do not need to be extracted and directly added for testing, the deviation of the net content of the liquid reagent should not exceed ±5%;
b) For multi-person liquid reagents, the net content of the liquid reagent should not be less than the labeled value.
3.3 Accuracy
Should meet one of the following requirements.
a) Relative deviation. should not exceed ±20%;
b) Recovery rate. 80%~120%.
3.4 Linearity
The manufacturer should specify the linear interval of the kit and meet the following requirements.
a) The upper limit of the linear interval of the kit should not be lower than 500 pg/mL, and the lower limit should not be higher than 50 pg/mL;
3.5 Blank limit
The blank limit should not be higher than 30 pg/mL.
3.6 Detection limit
The detection limit should not be higher than 40pg/mL.
3.7 Repeatability
Repeat the test for samples with at least two concentration levels, and the coefficient of variation of the results obtained should not be greater than 15%.
3.8 Difference between bottles within batch (dry powder or lyophilized reagent)
There is no significant difference in the test values between 10 bottles of reagents in the same batch.
3.9 Difference between batches
The difference between batches should not be more than 20%.
3.10 Analysis of specificity
Preparation of common clinical concentration levels of endotoxin or gram-negative bacterial lipopolysaccharide as interfering substances, detection before and after adding interfering substances
The absolute value of the concentration difference should not exceed the blank limit.
3.11 Stability
You can choose one of the following methods for verification.
a) Stability of validity period. The manufacturer shall stipulate the validity period of the kit. Take the kit within a certain period of time after the expiration date to test its accuracy
Degree, linearity, blank limit, detection limit, repeatability, bottle-to-batch difference, analytical specificity, etc., should meet the requirements of 3.3~3.8 and 3.10;
b) Thermal stability. take the kit within the validity period and place it at 37°C for a certain period of time to detect its accuracy, linearity, blank limit, and detection
Limits, reproducibility, bottle-to-batch differences, analysis specificity, etc. should meet the requirements of 3.3 to 3.8 and 3.10.
Note 1.Thermal stability cannot be used to derive the expiry date of the product, unless a derivation formula based on a large amount of stability research data is used;
Note 2.Any combination of a) and b) methods can be selected according to product characteristics, but the selected method should be able to verify the stability of the product to ensure product performance within the validity period
meet the standards.
4 Test method
4.1 Appearance
Visual inspection with normal vision or corrected vision under natural light should meet the requirements of 3.1.
4.2 Quantity
Measured with a universal measuring tool, it should meet the requirements of 3.2.
4.3 Accuracy
It is recommended to use one of the following methods to test the accuracy of the kit according to the following priority order, which should meet the requirements of 3.3.
a) Relative deviation
The reagent (kit) test can be used to evaluate the certified reference material (CRM) or other recognized reference material of the conventional method for 3 times, according to formula (1)
Calculate the relative deviation B (%). If all three results meet the requirements of 3.3a), it is deemed qualified. If the result of greater than or equal to 2 times is not
If it meets, it is judged as unqualified. If there is one result that does not meet the requirements, the test should be repeated 20 times continuously, and the phases should be calculated according to formula (1).
For the deviation, if the result of 19 tests meets the requirements of 3.3a), the accuracy meets the requirements of 3.3a).
M --- test result;
T --- Labeled value of certified reference material.
b) Recovery test
Add a certain volume of (1-3)-β-D glucan standard solution of known concentration to the negative sample matrix (the volume ratio between the added standard solution and the negative sample matrix should not be greater than 1.20, add the standard solution The concentration of the latter sample is near the critical value), and the test is repeated 3 times. root
Calculate the recovery rate R according to formula (2), and the result should meet the requirements of 3.3b).
Where.
R ---Recovery rate;
C --- The concentration of the negative sample matrix after adding the standard solution;
V0 --- the volume of the negative sample matrix;
V---the volume of the standard solution added;
C0 --- The detection concentration of the negative sample matrix;
CS ---The concentration of the standard solution.
4.4 Linearity
Dilute the high-concentration sample close to the upper limit of the linear interval with a low-concentration sample close to the lower limit of the linear interval, and mix into at least 5 dilution concentrations
4.5 Blank limit
Use the kit to test the blank sample (including buffer, etc.), repeat the test 20 times, get 20 measurement results, and calculate the average value (x)
And the standard deviation (x), x + 2x should not be greater than the blank limit.
4.6 Detection limit
The manufacturer shall provide relevant information such as the blank limit, detection limit and reference interval of the kit. According to the information provided by the manufacturer,
The low-value samples with a degree similar to the detection limit are tested, and each sample is tested 5 times. The test results are sorted by size and meet the following conditions, namely
It can be considered that the blank limit and detection limit provided by the manufacturer are basically reasonable, and the result should meet the requirements of 3.6.
a) The number of test results lower than the blank limit value provided by the manufacturer should be less than or equal to 3;
b) There is no value higher than the test result of the reference interval provided by the manufacturer.
4.7 Repeatability
Use the kit to test samples with at least 2 concentration levels, repeat the test 10 times each, and calculate the average (x) and standard deviation of the measured values
(S). Calculate the coefficient of variation (CV) according to formula (4), and the result should meet the requirements of 3.7.
Where.
CV---coefficient of variation;
S --- the standard deviation of the results of 10 measurements;
X --- the average of 10 measurements.
The selection of the sample can refer to the critical value, which represents the normal value and the abnormal value level.
Note. The normal value selects the detection concentration to be within the range of 30% lower than the critical value, and the abnormal value selects the detection concentration to be within the range of 30% higher than the critical value.
4.8 The difference between batches of bottles
According to the specifications of the kit, test according to the following methods.
a) Not applicable for single serving reagents;
b) For multi-person reagents, 10 samples are taken, and each sample is tested 3 times under repeated conditions, taking into account factors such as the measurement system over time
The random variation caused by the element, the 3 measurements are carried out in a different order, such as 1, 3, 5, 7, 9, 2, 4, 6, 8, 10, 10, 9, 8, 7, 6,
5, 4, 3, 2, 1, 2, 4, 6, 8, 10, 1, 3, 5, 7, 9.Calculate F according to formula (5) ~ formula (11), and the result should meet the requirements of 3.8.
4.9 Difference between batches
Use 3 kits of different batch numbers to test samples near the critical value, and test each batch number 3 times, and calculate the average value of each batch of 3 tests.
Claim.
4.10 Analysis of specificity
Prepare endotoxin or gram-negative bacterial lipopolysaccharide at common clinical concentration levels as interfering substances, and calculate the before and after adding interfering substances
Detect the absolute value of the concentration difference, and the result should meet the requirements of 3.10.
4.11 Stability
The following methods can be used for verification.
a) Stability of expiration date. test kits within a certain period of time after expiration date should be tested according to the methods of 4.3 to 4.8 and 4.10.
3.11a) requirements;
b) Thermal stability test. take the kit within the validity period and place it at 37°C for a certain period of time, and proceed in accordance with the methods of 4.3 to 4.8 and 4.10
Testing should meet the requirements of 3.11b).
5 Marks, labels and instructions for use
Should meet the requirements of GB/T 29791.2.
6 Packaging, transportation and storage
6.1 Packaging
The packaging should meet the following requirements.
a) The packaging of the kit should be able to protect it from natural and mechanical damage;
b) If applicable, the instruction manual and product inspection certificate should be enclosed in the package, and the kit should be packaged according to the requirements of the manufacturer.
6.2 Transportation
The kit should be transported according to the requirements of the manufacturer.
6.3 Storage
The kit should be stored under the conditions specified by the manufacturer.
references
[1] GB/T 26124-2011 Clinical chemistry in vitro diagnostic reagents (kits)
[2] GB/T 29791.1 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 1.Terms, definitions and communication
Use requirements
[3] YY/T 04666.1 Medical devices used in medical device labeling, marking and providing information symbols Part 1.General
Claim
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