Lateral flow immunoassays (LFIA) used in rapid quantitative point of care testing require an accurate, reliable and easy to operate instrument to read the LFIA kit and calculate the quantitative result value. We present iQuant® Analyser, an immunoassay reader designed for reading the Quanti® range of LFIA test kits for key markers such as HbA1C, Vitamin D, TSH etc. The instrument utilizes a laser based confocal optics system to capture the test and control lines from the LFIA kit, digitizes the fluorescent signal with high spatiotemporal resolution, computes necessary peak area ratios, applies calibration curves and declares the final result in an automated manner with minimal operator input. The instrument uses kit specific calibration information embedded on each LFIA test kit, to compute the final clinical parameter without using any external calibration chip. An intuitive icon based interface enables easy operation with minimal key presses, suited for point of care applications. The technology is designed in a modular manner to enable the instrument to perform tests on various parameters such as HbA1C, TSH, and Vitamin D etc without any hardware changes, using test-specific LFIA kits. The functional performance of the iQuant Analyser was verified over the range of expected area ratio values with standard reference cartridges that provided stable fluorescent lines. Repeatability of the instrument was found to be excellent with coefficient of variation (CoV) of area ratios found to be less than 1%. The inter-instrument reproducibility was also found to be good with CoV less than 4 %. Tests using blood samples with Quanti LFIA kits verified the accuracy of HbA1C results to be acceptable as per international standards with errors <; 4 %. The iQuant Analyser is a portable, easy to use rapid quantitative immunoassay reader best suited for point of care applications.

Fluorescence immunoassays (FIA) have strong potential in enabling rapid quantitative immunological testing at point of care. Existing state of the art instruments employ laser scanning of FIA test kits, which require the use of electromechanical systems, making the instrument bulky, heavy and less reliable in the long term. There is a growing need for an extremely compact and reliable, motion-free, automated reader for accurate quantification of immunoassays. Here, we present ImQuant, an image based FIA reader with integrated monochromatic excitation source, optical filtering and real time image capture, assisted with an intuitive graphical user interface. A 12bit dynamic range RAW ouput CMOS camera with 1/3" sensor format and a sharp cut off wideband filter were utilized to ensure improved accuracy. A laboratory prototype was constructed and tested using a set of stable reference cartridges that provided repeatable fluorescent lines. The ImQuant could capture the lines and measure area ratios with coefficient of variation (CV) less than 2%. Further, tests with blood samples on Quanti HbA1C test kits also demonstrated good repeatability with CV<;2%. The ImQuant is a novel platform of motion-free fluorescent scanning of FIA immunoassays and is being used for developing a variety of test kits and instruments.

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