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The Inanovate Lyme-ID IgG Test is an in vitro qualitative microarray assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease. It is intended to detect antibodies to VlsE and multiple other B.burgdorferi antigens following a modified two-tier test methodology. Positive results from the Lyme-ID IgG Test are supportive evidence for the presence of antibodies and exposure to B. burgdorferi, the causative agent for Lyme disease. Negative results do not preclude infection with B. burgdorferi. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures as an aid in diagnosis of Lyme disease.

The Inanovate Lyme-ID IgG Test must be used with Inanovate's Bio-ID800 instrument and Lyme-ID Software.

Designed as a modified solid-phase ELISA, the Lyme-ID IgG Test is a protein microarray assay. A whole cell lysate sample of B. burgdorferi, along with antigens Outer Surface Protein C (OspC) and Variable Lipoprotein Surface-Exposed (VlsE) are bound to the glass surface of the Lyme-ID IgG Test cartridge. The antigens are immobilized as individual spots onto the glass surface. Positions of the spots are exactly defined and can be assigned to each antigen reliably. A negative control spot, positive control spot, and six signal control spots are applied to each microarray to ensure that the assay performs properly and to verify the reliability of individual sample results.

The Bio-ID800 Instrument is a bench-top analyzer which contains an optics system for detecting and reading fluorescence produced during the assay, pressure system for flowing reagents through the microfluidics channels in the cartridge, and a manifold for clamping the cartridge and aligning the cartridge over the optics scan area. The optics system excites the fluorescent reagent for analyte detection using a 532nm wavelength laser projected through a series of mirrors and expanders to a scan lens located directly under the stage for the cartridge. This enables the assay area of the cartridge to be scanned for fluorescence through an aperture and read as it returns down an optics path to a photomultiplier tube (PMT). The PMT converts the collected fluorescent light into a corresponding output voltage that is read by a high-speed data acquisition card. Reagent and sample flow rates are pulsed using high-speed valves connected to externally sourced compressed air through a series of regulators and sensors. Assay reaction temperature is controlled using filtered fans and vents to maintain the chamber at room temp with a negative pressure at the cartridge loading door.

The cartridge contains up to six patient samples and two controls (positive and negative), detection reagent, and blocking buffer wells all connected by microfluidic channels to an assay array field. As reagents or samples flow through the field, they are collected in waste wells, so that no waste leaves the cartridge. Each cartridge consists of a glass plate (containing the protein and cell lysate antigens, along with positive and negative control spots), a PDMS polymer assay reservoir which contains the microfluidic flow paths molded into the bottom, and a protective frame that aids in the alignment.

The Lyme-ID Software controls the Bio-ID800 and communicates with the instrument to collect data into a database, enabling both storage of the assay data and analysis. The software enables self-tests of the instrument and communication through the user interface with the user and instrument for warnings, errors, and prompts. During assay performance, the control of the valves for pressurizing cartridges is controlled by the software. Signal generated through the PMT is interpreted using a statistical average function and stored by the software as an image file. The software then analyzes the image files to ensure the test was performed without error and analyzes the data collected from the analytes to compute the positive or negative status of the sample. Results are then printed from the computer with a standalone printer.

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