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AOAC 965.12
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Quick understanding of the test
AOAC 965.12 - Tuberculocidal Activity of Disinfectants
Application
Mandatory test strains
- Mycobacterium bovis
- Test suspension with an interfering substance is inoculated onto a test surface and dried.
- The surface is then treated with the disinfectant sample and left to interact for predetermined contact times.
- After contact time, the test surface is transferred to neutralizing solution, followed by plating and microbial enumeration.
- Helps manufacturers meet regulatory standards for disinfectant products claiming tuberculocidal properties.
- Critical for compliance with regulatory standards set by the EPA.
Turnaround Time
Passing criteria
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Abstract
AOAC 965.12 – AOAC Tuberculocidal Activity of Disinfectants Test is a standardized laboratory method developed for evaluating the effectiveness of disinfectants against Mycobacterium tuberculosis. AOAC 965.12 is a modified version of the Use-dilution method (AOAC 955.14, 955.15, 964.02 ) and is recognized by the U.S. Environmental Protection Agency (EPA) for supporting claims that a disinfectant product can kill tuberculosis-causing bacteria.
While both Mycobacterium tuberculosis (Mtb) and Mycobacterium bovis can cause tuberculosis in humans, M. bovis is often used in testing because it’s safer to handle in lab environments. It carries a significantly lower risk of aerosol transmission compared to M. tuberculosis, reducing the danger to lab personnel. For this reason, EPA accepts M. bovis as a suitable surrogate organism when evaluating disinfectants for tuberculocidal claims.
AOAC 965.12 Test Method
- A 21-day-old culture of Mycobacterium bovis BCG is used for the experiment.
- 10 carrier surfaces are required for this experiment.
- A test suspension of the bacteria with interfering substance is inoculated onto small, cylindrical, porcelain test surfaces called penicylinders (carriers) and allowed to dry.
- Each of the dried contaminated surfaces is transferred to a container containing the 10ml disinfectant solution using a sterilized wire hook and allowed to interact for a specified contact time.
- At the end of contact times, the treated test surfaces are transferred to a neutralizing solution to halt further antimicrobial action by disinfectants.
- Following neutralization, the treated test surfaces are placed into the bacterial growth medium and incubated at controlled laboratory conditions for 60 days.
- After the incubation period, test surfaces are observed for bacterial growth. The number of tubes showing bacterial growth is recorded.
- To pass the test (a 10-carrier test), the product must demonstrate complete disinfection. This means no detectable growth of the target microorganism in the test tubes. If no bacterial growth is detected after 60 days, the tubes shall be incubated for an additional 30 days.
Importance of AOAC 965.12 Test
Mycobacteria are microorganisms that can survive on inanimate surfaces for extended periods and remain infectious. This poses a significant risk of acquiring nosocomial infections in places like hospitals, laboratories, and other environments.
Due to their complex cell wall structure, mycobacteria exhibit resistance to regular disinfectants. Therefore, specialized disinfectants containing tuberculocidal agents are necessary to effectively eliminate them.
In the US, Environmental Protection Agency (EPA) regulates disinfectant products labeled
as tuberculocidal and recommends employing AOAC 965.12 test method to validate product efficacy claims.
Strengths of AOAC 965.12 Test
- The EPA recognizes the AOAC 965.12 Tuberculocidal Activity of Disinfectants Test as an acceptable test method for assessment of disinfectants’ efficacy and can be used to generate reliable data required for submission when registering tuberculocidal disinfectants for sale in the United States.
- This test is considered a “high-level” assessment as it requires a disinfectant to demonstrate significant antimicrobial action within a short contact time (typically less than 10 minutes) to meet the passing criteria.
Conclusion
Looking for AOAC 965.12 testing services, a team of MIS experts is here to help you!
At MIS, we offer a comprehensive range of AOAC testing solutions that are tailored as per clients requirements.
We completely understand the significance of microbiology analysis in the process of development of high quality products. Therefore, our experts follow standard guidelines to ensure quality and accuracy in their testing procedures.
In addition to evaluating tuberculocidal activity of disinfectants, we perform AOAC 965.13 test for pool and spa disinfectants and field testing.
To get a quote on AOAC 965.12 test or want to know more about our testing services, contact our experts here.
Frequently Asked Questions
DR. Martinoz Scholtz
AOAC 965.12 test is used to validate tuberculocidal activity of disinfectants sold in US markets. Mycobactericidal efficacy of product samples is tested on porcelain test surfaces (referred as carriers) against Mycobacterium bovis.
AOAC 965.12 testing is applicable to non – porous surface disinfectants that claim to possess tuberculocidal activity.
AOAC 965.12 test takes 4-5 months to complete.
At Microbe Investigations Switzerland, we test for AOAC 965.12 using the following microbial strains – Mycobacterium bovis.
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