{"id":16664,"date":"2022-09-12T07:00:48","date_gmt":"2022-09-12T14:00:48","guid":{"rendered":"https:\/\/admin.acceleratingscience.com\/clinical-conversations\/?p=16664"},"modified":"2022-09-13T15:39:12","modified_gmt":"2022-09-13T22:39:12","slug":"introducing-ugentecs-fastfinder-assay-plugins","status":"publish","type":"post","link":"https:\/\/www.thermofisher.com\/blog\/clinical-conversations\/introducing-ugentecs-fastfinder-assay-plugins\/","title":{"rendered":"Introducing UgenTec’s FastFinder Assay Plugins"},"content":{"rendered":"

UgenTec’s FastFinder Assay Plugin, for use with the TaqPath\u2122 COVID 19 CE IVD RT PCR Kit, and TaqPath\u2122 COVID-19, Flu A\/B, RSV Combo Kit, is now available as a CE-marked device.<\/p>\n

Applied Biosystems\u2122 TaqPath\u2122 COVID\u201119 CE\u2011IVD RT\u2011PCR Kit<\/h4>\n

The TaqPath COVID\u201119 CE\u2011IVD RT\u2011PCR Kit enables clinical and public health laboratories to quickly diagnose COVID-19, by the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens. This test uses a multi-target design which may be useful for identifying emerging variants.<\/p>\n

Applied Biosystems\u2122 TaqPath\u2122 COVID-19, Flu A\/B, RSV Combo Kit<\/h4>\n

The CE-IVD-marked, TaqPath COVID-19, Flu A\/B, RSV Combo Kit detects and differentiates between SARS-CoV-2, influenza A\/B, and RSV in a single sample. This test enables laboratories to expand their respiratory sample testing menu, ensuring proper patient care with timely and accurate diagnoses.<\/p>\n

UgenTec’s FastFinder plugin is easy to use in conjunction with the TaqPath kits. Once the specimens are received by a lab, RNA is purified, reverse-transcribed into cDNA, and amplified on a real-time PCR instrument using the TaqPath kit and corresponding workflow. Raw PCR data are then transferred to the FastFinder software (rather than the Applied Biosystems Interpretive Software), which analyzes the data.<\/p>\n

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UgenTec’s FastFinder Analysis platform successfully hosts, processes, and displays the results of assay-specific plugins. FastFinder uses an assay-specific algorithm and decision mechanism to convert PCR raw data into test results. Cq values of each PCR curve are determined using a static model trained by machine learning technology, with cut-off Cq values built into the algorithm which are based off each TaqPath assay’s IFU. The software flags samples with suspicious amplification (such as a weak-positive sample with a strong-positive neighbor, or a cluster of positive samples) for manual review, and authorization is blocked until a trained professional has confirmed or rejected the suggested sample status.<\/p>\n

To provide additional safeguards, plugins are self-contained and encrypted, and all assay-specific information (device type, assay type, used channels and targets, algorithm, and decision tree) is fixed within the assay plugin. The assay plugin offers full sample traceability across workflow steps, and all changes in the FastFinder software are audit trailed to maintain full data integrity.\u00a0 Upon final review and authorization, results may be exported as input for an external software system such as LIMS.<\/p>\n

A detailed overview of the performance validation performed by UgenTec can be found in the following white papers:<\/p>\n