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The VisiQuant™ Anti-Nuclear Antibody Test System is intended for the visual determination of anti-nuclear antibodies (ANA's) immunofluorescence pattern(s) and the semiquantitative measurement of ANA's in human serum with a single dilution as an aid in the in-vitro diagnosis of auto-immune and connective tissue diseases such as systemic lupus erythematosus (SLE) and Sjogren Syndrome.

The proposed VisiQuant™ ANA Test System uses the same VisiQuant™ ANA Test Kit as was previously cleared. Hyperion is now proposing to supply the VisiQuant™ Microscope as an additional reader for use with the VisiQuant™ ANA Test Kit. The reading of the samples remains the same except that the software will now generate the calibration curve and interpolate the titer. The prepared slide is placed onto the stage of the microscope. The microscope focuses on the images of each well and the CCD camera collects the images. The software captures and stores the images. The operator views the images to determine if the sample is positive and identifies the pattern. For the samples determined to be positive by the operator, the software calculates a fluorescence intensity unit (FIU) value. The proposed software will now generate a 4-parameter curve using the FIUs and ANA titers of Calibrators assayed in the same run, from which the VisiQuant titer of the test sample is interpolated. The proposed software now has the capability of generating calibration curve reports and laboratory reports.

The Hyperion VisiQuant™ ANA Test Kit is intended for the visual determination of anti-nuclear antibodies (ANA's) immunofluorescence pattern(s) and the semiquantitative measurement of ANA's in human serum with a single dilution as an aid in the invitro diagnosis of auto-immune and connective tissue diseases such as systemic lupus erythematosus (SLE) and Sjogren Syndrome.

VisiQuant™ ANA is a unique ANA IFA. The test samples are assayed with a single dilution as in the traditional qualitative procedure to determine positive and pattern while obtaining a VisiQuant titer from the same image. The stained slides are read objectively with a digital camera through the FAN microscope to measure the fluorescence intensity of reacted substrate (Hip-2 calls). The Visiguant tive of the test sample is interpolated from a standard curve. VisiQuant ANA uses a unique fluorophore, La Jolla Blue (LJB), which has a longer fluorescence life (photostability) than fluorescent. LJJP has nearinfrared peak excitation and emission wavelengths to minimize autofluoresconce commonly present in biological substances.