We have been developing proficiency testing exercises in the field of efficacy testing of antiseptic products and chemical disinfectants since 2021.
| Program of proficiency tests performed | ||
| Method | ID | |
| EN 1500:2013 | PT-1500-2-0921 | |
| EN 1656:2019 & EN 1657:2017 | PT-1656-1657-2.1-0222 | |
| EN 14476:2013+A:2019 | PT-14476-2,1-0822 | |
| EN 1499:2013 | PT-1499-2,2-0223 | |
| EN 1276:2019 & EN 1650:2019 | PT-1276-1650-2,1-0523 | |
| EN 13727:2012+A2:2015 & EN 13624:2021 | PT-13727-13624-2,1-0823 | |
By 2024 we will realize:
| 2024 proficiency testingprograms | ||
| Method | ID | |
| EN 1040 y EN 1275 | PT-1040-1275-1-0324 | |
| EN 14675 | PT-14675-2.1-0624 | |
| EN 16777 | PT-16777-2.2-0924 | |
Are you interested in knowing how we organize our proficiency testing?
- For testing under the requirements of EN14675 Quantitative suspension test for the evaluation of the virucidal activity of chemical antiseptics and disinfectants used in the veterinary area (phase 2 / stage 1).
Test background: A sample of the product as supplied and/or diluted with hard water is added to a test suspension of virus in a solution of interfering substance. The mixture is maintained at 10°C ± 1 °C for 30 min ± 10s. Finally, virus inactivation values are calculated from the differences in virus titres before and after treatment with the product.
The test will be performed in two phases the ring trial:
- Phase I of the program consists of proposing at least 3 concentrations including one concentration in the active range and one concentration in the non-active range. The maximum range between two tested concentrations must be sufficiently low for reasons related to the exploitation of the results. The ratio between two tested concentrations must be strictly less than 2. (examples; 0.75%, 1% and 1.5% or 15%, 20% and 25%).
- Phase II consists of analysing at 3 concentrations of the product sent by SHAPYPRO. These will be determined after the results of phase I.
Test Ring Trial condition:
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- For testing under the requirements of EN16777 quantitative non-porous surface test without mechanical action for the evaluation of the virucidal activity of chemical disinfectants used in medicine (phase 2 / step 2).
Test Background: A test suspension of viruses in a solution of interfering substance is inoculated onto a test surface and dried. The prepared sample of the test product is applied in a manner that covers the dried film.
The test surface is maintained at a specified temperature for a set period. The surface is transferred to a cell maintenance medium in a manner that immediately neutralizes the action of the disinfectant. The titre of virus recovered from the test surface is determined.
Finally, the titre of the inoculum on a test surface treated with hard water instead of disinfectant is also determined and the virus reduction attributed to the product is calculated by difference.
Test Ring Trial condition:
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Description of the expected value range EN 14675
The analytical requirements established in the standard shall be followed, considering for the validation of the test:
- The logarithmic decimal detectable reduction of the titre must be at least 4.
- The difference between the decimal logarithm titre of the virus control and the decimal logarithm of the virus titre in the reference inactivation test must be between 0.5 and 2.5 after 30 min.
- Cytotoxicity of the product solution does not affect cell morphology and virus growth and susceptibility at dilutions necessary to demonstrate a decimal log reduction of 4.
- Comparative virus titration on cells cultures inoculated with dilutions of the test mixture or with dilutions of virus in MEM +2% FCS, results in a difference <1 of the logarithmic titre of virus.
- Efficacy control for suppression of activity the product should be ≤ 0.5 of the log virus titres.
- At least one of the three concentrations tested must demonstrate a log reduction of less than 4.
Description of the expected value range EN 16777
The analytical requirements established in the standard shall be followed, considering for the validation of the test:
- The detectable decimal log reduction of the titre must be at least 4. (virus control).
- The difference between the decimal logarithm of the virus control titre and the decimal logarithm of the virus titre in the reference inactivation test must be <3 log in the presence of 50ppm glutaraldehyde after 5 min.
- Cytotoxicity of the product solution does not affect cell morphology and virus growth and susceptibility at dilutions necessary to demonstrate a log decimal reduction of 4.
- Comparative titration of virus on cells inoculated with dilutions of the test mixture or with dilutions of virus in PBS results in a difference of <1 log virus titre.
- Efficacy control for suppression of activity the product should be ≤ 0.5 of the log titres of the virus.
- At least one of the three concentrations tested must demonstrate a log reduction of less than 4.
Proposed Timeline our proficiency testing
A description of the information provided to participants and the schedule for the various phases;
Calendar (dd.mm.yyyy) for EN14675:
- End of registrations: 03.05.2024
- Sample submission: 06.05.2024
- Start of phase I: 03.06.2024
- Collection of results phase I: 16.08.2024
- Start of phase II: 16.08.2024
- Collection of results phase II: 29.11.2024
- Start of phase I: 03.06.2024
- Final report: 14.01.2025
Calendar (dd.mm.yyyy) for EN16777:
- End of registrations: 02.08.2024
- Sample submission: 05.08.2024
- Start of test 02.09.2024
- Collection of results: 15.11.2024
- Start of test 02.09.2024
- Final report: 31.01.2025
If you are accredited in the above-mentioned standards or are thinking of doing so and need to perform an intercomparison, Shapypro can help you. Do not hesitate to contact us.
Do you want to get access to our 2024 agenda? Download it here.