New methodology validates Immunoassay cell functionality data

Guava Technologies, a leading supplier of integrated cellular analysis systems, has announced a new customer technical paper describing a methodology that can be used in validating enzyme-linked immunospot (ELISpot) assays.

The technical paper describes the development of a library of donors with characterised responses that can be used as controls for ELISpot and multiple immune monitoring assay validations for use in clinical trials. The ELISpot assay is one of the most useful techniques for the immunological monitoring of vaccine trials and has increasing application as a measure of specific T-cell activation.

Post-cryopreservation cell recovery and viability counts for the research described was determined using a Guava Personal Cell Analyser (Guava PCA). Its ultra-compact size and ease of use makes the Guava PCA system indispensable to all scientists who need immediate access to fast and simple cell monitoring and screening assays. Intuitive in operation, the Guava PCA provides precise, accurate and easy-to-read results with often less than one day of training. Increased cell counting accuracy on the Guava PCA translates into more accurate evaluation of vaccine efficacy. Benefiting from a patented self-aligning, user-replaceable microcapillary flow cell - assays on the Guava PCA need less cells (< 20 µl), less reagents and generate minimal waste. Using a proprietary viability protocol the Guava PCA can determine the percentage of dead or apoptotic cells that will not respond in an ELISpot assay. The same protocol enables the Guava PCA to determine the amount of debris in a sample, which can affect the clarity of an ELISpot read out. All these advantages combine to enable the Guava PCA to undertake sensitive ELISpot assays with unmatched reproducibility and precision.

The study demonstrates that, using the Guava PCA, frozen peripheral blood mononuclear cell (PBMC) donor samples can be used as a convenient control tool for improving standardisation of protocols and reagents in obtaining reliable and reproducible cell functionality data among different laboratories. Such standardisation of data may support immunogenicity studies, vaccine regulatory submissions, and aid in designing validation studies for immunoassays, including ELISpot assays.

Guava Technologies, Inc. is a leading provider of integrated, fully optimised microcytometry and cell counting systems. Guava serves the worldwide life science, biotechnology and pharmaceutical industries, offering a state-of-the-art, comprehensive portfolio of products designed to accelerate discovery and increase productivity with accessible, easy-to-use solutions to the biologist's testing problems available right at the lab bench. Guava's products have broad applications in scientific research, drug discovery, cell counting, and optimisation of commercial bioproduction. Guava's technology also offers potential for use in clinical testing and blood processing, as well as other areas where single cell counting is important.

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