The Indian Pharmacopoeia Commission (IPC) has released draft chapter on “Approach to alternative rapid microbiological methods” for stakeholder comments for effective diagnostic practices.
The purpose of this chapter is to provide guidance for selection and validation of methods for use as alternatives to the official compendial microbiological methods.
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Traditional methods of microbial detection tend to be labor-intensive and take more than a day to yield results. Alternative methods for microbial detection can be sensitive, precise, quick and reproducible test results when compared with conventional, growth-based methods.
For microbial recovery and identification, microbiological testing laboratories sometimes use alternative test methods to those described in the general chapters of Indian Pharmacopoeia (IP) for a variety of reasons.
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Alternative microbiological methods also known as Rapid Microbial Methods (RMMs) are the technologies that allow the user to get microbiology test results faster compared with traditional culture-plate methods.
In general, rapid methods can be grouped into three distinctive categories in accordance with their application. These categories include qualitative, quantitative and identification methods.
Qualitative rapid methods provide a presence or absence result that indicates microbial contamination in a sample. Quantitative methods provide a numerical result that indicates the total number of microbes present in the sample. Identification methods provide us with a species or genus name for the microbial contaminant in a sample.
Since RMMs may produce sensitive, accurate results, however while using RMMs, acceptance criteria will change in comparison to conventional methods (Quantitative / Qualitative tests), if this is the case, the responsibility lies with the manufacturer / user to produce / show the similarity / equivalence of the results / acceptance criteria while using RMMs. Since the acceptance criteria mentioned for microbiological quantitative / qualitative tests in IP is conclusive.
Rapid methods normally involve some form of automation, and the methods often capture data electronically.
Alternative microbiological methods tend to be based on various technology platforms. The more common technologies include nucleic-acid-based detection, which uses DNA or RNA targets, antibody-based detection, biochemical, enzymatic detection such as adenosine triphosphate (ATP) methods, impedance methods and flow-cytometry-based methods.
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