IVDT_In Vitro Diagnostics Technology

IVD Technology, November/December 2012

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Building block Hardware Detector Firmware Workflow (GUI) Lateral Flow Studio Software Other software solutions Table I. The ESEQuant lateral fl ow system consists of the generic modules and customized components shown here. and-play tool for R&D staff that enables generation of assay-specifi c method fi les, which contain all information and parameter settings to do the following: 1. Introduce product name/article number and lot num- ber of the test. 4. Process the data acquired from the scan. 5. Calculate analyte concentration from a lot-specifi c calibration curve. 3. Identify reactivity in predefi ned areas—test line(s), control line(s). 2. Scan a given rapid test cassette after the defi ned incu- bation time. Description of modules Generic Customized reflectometric fluorescence 6. Interpret the test results using diagnostics. 7. Report the diagnostic fi nding to the rapid test user. After setting all necessary test parameters, the corre- sponding lot-specifi c assay method fi le is downloaded to the lateral fl ow reader. Up to 15 bands per test strip can be processed indepen- dently, representing one parameter each. Th e PLM can choose from qualitative and quantitative interpretation of the assay based on various curve-fi tting algorithms, such as four-parameter logistic function (Rodbard), logarithmic, exponential, or linear. In addition, the results of the diff er- ent parameters on one test strip can be summarized in an overall result. Th e individual results, as well as the overall results, are displayed in the menu. During rapid test development, the lateral fl ow reader is connected to a PC via a USB interface. After completing an assay-specifi c method, the accompanying fi le is down- loaded to the reader (Figure 1). Th e assay-specifi c instruc- tions for the processing of a given rapid test are integrated into a corresponding section of the reader's fi rmware. Th is allows the reader to work in stand-alone mode, indepen- dent of a computer and, because of its internal rechargeable power cells, also independent of an external power supply. Th e reader can be updated while located at the user's point-of-need site through 2-D bar code and RFID tech- nologies (Figure 1). An assay- or lot-specifi c method fi le is ivdtechnology.com IVD TECHNOLOGY | NOVEMBER/DECEMBER 2012 31

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