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YY/T 0616.7-2020: Medical gloves for single use - Part 7: Test method for the immunological measurement of antigenic protein
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Medical gloves for single use - Part 7: Test method for the immunological measurement of antigenic protein
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YY/T 0616.7-2020
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Basic data | Standard ID | YY/T 0616.7-2020 (YY/T0616.7-2020) | | Description (Translated English) | Medical gloves for single use - Part 7: Test method for the immunological measurement of antigenic protein | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.140.01 | | Word Count Estimation | 10,199 | | Date of Issue | 2020-09-27 | | Date of Implementation | 2021-09-01 | | Regulation (derived from) | Announcement No. 108 (2020) of the National Medical Products Administration | | Issuing agency(ies) | State Drug Administration | YY/T 0616.7-2020: Medical gloves for single use - Part 7: Test method for the immunological measurement of antigenic protein
---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 2020-09-27
Implementation of 2021-09-01
Issued by the National Medical Products Administration
Foreword
The general title of YY/T 0616 is "Disposable Medical Gloves", which consists of the following parts.
---Part 1.Biological evaluation requirements and tests;
---Part 2.Requirements and tests for determining shelf life;
---Part 3.The method of determining the actual time expiration date with the finished gloves in the warehouse;
---Part 4.Test method for puncture resistance;
---Part 5.Test method for resistance to chemical penetration and continuous exposure;
---Part 6.Test method for evaluating penetration performance of anti-chemotherapeutic drugs;
---Part 7.Immunological determination method of antigenic protein content;
This part is part 7 of YY/T 0616.
This section 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. The issuing agency of this document is not responsible for identifying these patents.
This part was proposed by the State Drug Administration.
This part is under the jurisdiction of Shandong Medical Device Product Quality Inspection Center.
Drafting organizations of this section. Shandong Medical Device Product Quality Inspection Center, Shandong University.
The main drafters of this section. Liu Jia, Zhang Jian, Sun Xiaoxia, Han Qiuju, Gai Xiaoxiao, Qu Qiujin.
Introduction
Medical staff may be exposed to some chemicals that are harmful to healthy people at work. To avoid such hazards, medical staff need to
Wear products with corresponding protective properties (such as medical gloves) to achieve effective protection. Medical rubber gloves are made of raw materials
The difference is usually divided into two categories. natural latex gloves and synthetic rubber gloves. Natural latex gloves contain natural latex protein, which can induce type I
Hypersensitivity reactions, manifested as local skin urticaria, allergic rhinoconjunctivitis and asthma and other symptoms. There are many types of products derived from natural rubber latex
A protein that can trigger (type I) allergic reactions. Due to the interference of chemical additives in natural rubber latex gloves, according to GB/T 21870-2008
Quantifying protein levels in natural rubber latex products may produce false positive results. In addition, the protein content of natural rubber latex in the product is often low
The detection limit of standard colorimetric protein analysis.
Disposable medical gloves
Part 7.Antigenic protein content
Immunological determination method
1 Scope
This part of YY/T 0616 specifies the immunological determination of the antigenic protein content in disposable medical natural rubber latex gloves
Test principles, instruments, reagents and consumables, measurement methods and test reports.
This section applies to the quantitative determination of antigenic protein content in disposable medical natural rubber latex gloves.
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 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management
GB/T 16886.20 Biological Evaluation of Medical Devices Part 20.Principles and Methods of Immunotoxicology Tests for Medical Devices
3 Terms and definitions
4 Abbreviations
The following abbreviations apply to this document.
5 Test principle
This part is an immunological method that uses natural rubber latex (NRL) protein-specific antibodies to determine the content of antigen protein in natural rubber latex gloves.
The test sample and the specific antibody specific to the NRL protein are incubated together. Separate the remaining NRL protein antibody and combine it with the pre-coated
The excess NRL protein antigen on the solid phase carrier is bound, and the substrate is added to develop the color. The color change is caused by the color reaction of the substrate, and the OD value is determined.
6 Instruments
And optional computer for data analysis).
7 Reagents and consumables
7.1 Reagents
7.1.1 Buffer
7.1.1.1 Carbonate buffer
Weigh with a balance and combine 0.795g sodium carbonate (Na2CO3), 1.465g sodium bicarbonate (NaHCO3), and 0.100g sodium azide
(NaN3) is dissolved in distilled water and the volume is set to 500mL. Check the pH and adjust if necessary.
Note. The carbonate buffer can be stored at (4 ± 3) ℃ for at least 1 month.
7.1.1.2 PBS buffer
Use a balance to weigh 5.125g sodium dihydrogen phosphate (NaH2PO4·H2O), 45,000g disodium hydrogen phosphate (Na2HPO4·7H2O) and
Dissolve in 1.5L distilled water and adjust the pH to 7.4.Add 175.3g of sodium chloride (NaCl) and dilute to 2L, which is 10 times the stock solution.
Use distilled water to dilute the 10-fold stock solution to PBS working solution before use.
7.1.1.3 T-PBS washing solution
Add 0.5mL Tween 20 (Tween 20) to 1LPBS working solution and mix well.
7.1.2 Blocking solution and antibody diluent
7.1.2.1 Sealing fluid
T-PBS containing 3g/mL skimmed milk powder, 100mL (used for the sealing treatment of the measuring plate and the dilution plate).
7.1.2.2 Diluent
T-PBS with 0.2g/mL skimmed milk powder, 100mL (used for blocking in antibody dilution and competitive inhibition steps).
7.1.3 Reference reagents
A NRL protein solution with a concentration of 1 mg/mL prepared with distilled water. The polypropylene tube is stored in (-20±10)℃, after thawing
Store at (4±3)℃.
Note. The commercially available StAg standard solution is optional for IRM-913.
7.1.3.2 Coating antigen
The StAg solution was formulated into a solution with a concentration of 3μg/mL with carbonate buffer, which was used to coat the assay plate.
7.1.3.3 Reference standard
The StAg solution was formulated into a solution with a concentration of 2μg/mL with the diluent for competitive inhibition. In order to reduce possible protein loss, all steps involving protein-containing solutions should be performed in polypropylene tubes or containers. Avoid using polystyrene or glass containers.
7.1.4 Antibodies
7.1.4.1 Primary antibody
The commercially available anti-NRL antibody IRM-914 can be used.
7.1.4.2 Secondary antibodies
Horseradish peroxidase (HRP)-conjugated anti-rabbit IgG is used to detect the primary antibody bound to NRL protein on the solid phase. Recommended diluent
Dilute 1.5 and store in aliquots at (-20±10)°C.
7.1.5 Substrate color developing solution
O-phenylenediamine (OPD) and hydrogen peroxide (H2O2) can be used for yellow color reaction. Dissolve commercially available OPD tablets in distilled water,
And add an appropriate amount of H2O2 according to the operating instructions. For example, dissolve 10mgOPD tablets in 10ml distilled water and add it before use
30μL30% H2O2.
Note. TMB kit can also be used for color development.
7.2 Consumables
96-well microassay plate; dilution plate, 96-well plate with low protein binding for sample dilution and antibody reaction; multi-channel pipette; ELISA
Plate sealing tape or plastic cover.
8 Measurement method
8.1 Sample preparation
8.1.1 It is advisable to use the PBS working solution of 7.1.1.2 as the extract.
8.1.2 Weigh the natural rubber latex gloves, and record the mass and surface area; 5 mL of extraction medium should be added to each gram of natural rubber latex gloves. Extraction temperature
The temperature is (25 ± 5) ℃; the extraction time is (120 ± 5) min. The extraction process should be agitated continuously to ensure that the sample is in full contact with the extraction medium.
Or oscillate 3 times at the beginning, middle and end stages of the extraction process, with an interval of 15s/time.
Filter the low-protein binding 0.45μm filter to collect the extract into a polypropylene tube.
Note 1.The extraction is carried out in a polypropylene container to reduce the possibility of protein loss due to adsorption to the inner surface of the container wall.
Note 2.Generally, the obtained extract can be used immediately, but it can be stored at (4 ± 3) ℃ for up to 2 days.
8.2 Test procedure
8.2.1 Closure of the dilution plate
Add 300μL of blocking solution to each well of the 96-well dilution plate, and incubate overnight at (4±3)°C.
8.2.2 Coating of the measuring plate
Add 100μL of coating antigen (StAg, 3μg/mL) to each well of the 96-well assay plate, and seal the plate with ELISA plate sealing tape or plastic lid.
Incubate at (37±1)℃ for (120±5)min. Wash the plate once with T-PBS and discard the supernatant. Or coat the antigen at (4±3)℃ overnight, and in the follow-up
T-PBS washes the plate once before the start of the test. Add 300μL of blocking solution to each well and seal the plate, and incubate at (37±1)°C in a thermostat for 1h.
8.2.3 Inhibition steps
8.2.3.1 In the 96-well dilution plate, wash the plate twice with T-PBS; as shown in Table 1, except for row A, add 100μL of dilution buffer to each well; add wells A1 and A2 to row A Add.200 μL of antigen standard (StAg, 2 μg/mL) to each well, and add.200 μL of test sample to wells A3 to A12 (at least 2 replicate wells for each sample); by taking 100 μL/well from row A to each well of row B, and then Sequentially from row B to row G, perform 7 serial dilutions of the antigen standard or sample to be tested (mix by pipetting up and down 5 times each time, and finally discard it after mixing in row G)
100μL/well); H behavior has no inhibition, and each well contains 100μL diluent.
Note. Each sample to be tested has 3 dilution multiples (at least 2 dilution multiples), and each 1 dilution multiple has 2 replicates.
8.2.3.2 Prepare an appropriate dilution of the primary antibody so that the maximum OD value of the "uninhibited" well is 0.8 to 2.0.According to Table 1, add the primary antibody
100μL/hole, none...
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