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QUANTA Flash® Ro52 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Ro52 autoantibodies in human serum. The presence of anti-Ro52 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus, Systemic Sclerosis, Idiopathic Inflammatory Myopathies. QUANTA Flash Ro52 Controls are intended for use with the QUANTA Flash Ro52 Reagents for quality control in the determination of IgG anti-Ro52 autoantibodies in human serum. QUANTA Flash Ro52 Calibrators are intended for use with the OUANTA Flash Ro52 Reagents for the determination of Ig G anti-Ro52 autoantibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.

The QUANTA Flash Ro52 assay is designed to run on the BIO-FLASH® instrument. This platform is a fully automated closed system with continuous load and random access capabilities that automatically processes the samples, runs the assay and reports the results. It includes liquid handling hardware, luminometer and computer with software-user interface. The QUANTA Flash Ro52 assay utilizes a reagent cartridge format, which is compatible with the BIO-FLASH instrument. Purified recombinant Ro52 antigen is coated onto paramagnetic beads. The bead suspension is lyophilized and stored in the bead tube. Prior to use in the BIO-FLASH system, the sealed reagent tubes are pierced with the reagent cartridge lid and the beads are rehydrated and resuspended using resuspension buffer by pipetting up and down with a transfer pipette. The reagent cartridge is then loaded onto the BIO-FLASH instrument. Samples are also loaded onto the instrument in sample racks. Serum samples are prediluted by the BIO-FLASH with system rinse in a small disposable plastic cuvette. Small amounts of the diluted patient serum, the beads, and assay buffer are all combined into a second cuvette, and mixed. This cuvette is then incubated at 37°C. The beads are magnetized and washed several times. Isoluminol conjugated anti-human IgG antibodies are then added to the cuvette, and again incubated at 37°C. The beads are magnetized and washed repeatedly. The isoluminol conjugate is oxidized when Trigger 1 (Fe(II)coproporphyrin in sodium hydroxide solution) and Trigger 2 (ureahydrogen peroxide in sodium chloride solution) are added to the cuvette, and the flash of light produced from this reaction is measured as Relative Light Units (RLU) by the BIO-FLASH optical system. The RLU are proportional to the amount of isoluminol conjugate that is bound to the human IgG, which is in turn proportional to the amount of anti-Ro52 antibodies bound to the corresponding beads. For quantitation, the QUANTA Flash Ro52 assay utilizes a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge barcode. Every new lot number of reagent cartridge must be calibrated before first use, with the QUANTA Flash Ro52 Calibrators. Based on the results obtained with the two Calibrators included in the Calibrator Set (sold separately), an instrument specific Working Curve is created, which is used to calculate chemiluminescent units (CU) from the instrument signal (RLU) obtained for each sample. The QUANTA Flash Ro52 kit contains the following materials: One (1) QUANTA Flash Ro52 Reagent Cartridge One (1) vial of Resuspension buffer One (1) Transfer pipette The QUANTA Flash Ro52 reagent cartridge contains the following reagents for 50 determinations: a. Ro52 antigen coated paramagnetic beads, lyophilized. b. Assay buffer colored pink, containing Tris-buffered saline, Tween 20, protein stabilizers and preservatives. c. Tracer IgG - Isoluminol labeled anti-human IgG antibodies in buffer, containing protein stabilizers and preservative. The QUANTA Flash Ro52 Calibrators kit contains two vials of Calibrator 1 and two vials of Calibrator 2: QUANTA Flash Ro52 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro52 in buffer, protein stabilizer and preservative. QUANTA Flash Ro52 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro52 in buffer, protein stabilizer and preservative. The QUANTA Flash Ro52 Controls kit contains two vials of Negative Control and two vials of Positive Control: QUANTA Flash Ro52 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Ro52 in buffer, protein stabilizer and preservative. QUANTA Flash Ro52 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Ro52 in buffer, protein stabilizer and preservative.

The QUANTA Lite™ SS-A 52 ELISA is a semiquantitative enzymelinked immunosorbent assay for the detection of IgG anti-SS-A 52 antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.

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