In general, Rapid Microbial Methods (RMM) allow users to obtain results more early compared to conventional methods. Most of current RMMs rely on microbial growth to enable earlier detection. The next generation RMM focuses on the direct detection and enumeration of microbes, without limiting sensitivity and specificity. In this ground-breaking field of RMMs the most advanced and powerful method that meets these high demands is the MuScan^(TM) technology. The MuScan^(TM) technology relies on solid phase cytometry. In combination with our dedicated Sieve-ID^(TM) kits a rapid and sensitive direct detection and quantification of microbes in a sample is allowed, even within 1 hour. The MuScan^(TM) technology is validated for total viable count analysis according to USP[1223] and performance is non-inferior to the compendial reference method.

The MuScan^(TM) technology principle relies on 3 steps.

• Step 1:

  A fast and efficient sample preparation is performed to provide a reliable analysis. The purpose is mainly to separate the microbes from eventual clogging agents in the sample.

• Step 2:

  The sample is processed using our Sieve-ID^(TM) protocol based on solid phase cytometry. The microbes are retained on the dedicated membrane, washed and stained for subsequent analysis.

• Step 3:

  The membrane with stained microbes is analysed using the automated optical scanning device, the MuScan^(TM). The GMP software provides a report presenting the number of found viable microbes.

The Sieve-ID^(TM) diagnostic platform of Innosieve offers a new generation of rapid sample testing. The Sieve-ID^(TM) diagnostic tests are easy to use, user friendly and allow rapid and robust analysis with a sensitivity of 1-5 FFU and high accuracy in quantification.

The platform has proven to efficiently collect and concentrate low levels of cells from a large volume suspension. Dependent on user demands, the collected cells can be either specifically detected, quantified, tested for cell viability, subjected to nucleic acid extraction or recovered again from the platform. Using the Sieve-ID^(TM) diagnostic platform of Innosieve, in most cases a sample can be analyzed directly without the need for time-consuming bacterial enrichments. The complete test can be performed in 1 hour (from sample to result). All Sieve-ID^(TM) diagnostic kits are fully compatible with the automated MuScan^(TM) device, giving reliable quantitative results within minutes.

Using the Sieve-ID^(TM) kits, microbial cells can be visualized using different approaches:

• Generic staining dyes
• Selective staining dyes
• Fluorescently labelled DNA/RNA/PNA probes
• Fluorescently labelled antibodies

Due to the generic nature of the Sieve-ID^(TM) diagnostics, organisms can be detected using different specific labels or generic cell staining dyes. Even combinations of different labels are possible. Which staining principle to use mainly depends on the custom demands for detection and quantification. At Innosieve we have different diagnostic kits available, ranging from specific detection to generic detection of microbial cells. Next to that, Innosieve often performs contract-based projects to develop a custom diagnostic kit for customers.

Many different matrices have been evaluated, ranging from pharmaceutical compounds to high density yeast matrices. Or matrices that are viscuous, acidic or with high protein content, each can be processed using our Rapid Microbial Method.

Complex matrices can require a sample pretreatment step to separate the microbes from the matrix components. At Innosieve we have large expertise in rapid and efficient sample pretreatment solutions to allow application of our Rapid Microbial Method for your laboratory. This is often the key to success. Would you like to know more?