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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.

Device Description

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.

AI/ML Overview

This document describes the QUANTA Flash® Ro52, QUANTA Flash® Ro52 Calibrators, and QUANTA Flash® Ro52 Controls, which are chemiluminescent immunoassays for the semi-quantitative determination of IgG anti-Ro52 autoantibodies in human serum. The presence of these autoantibodies aids in the diagnosis of Systemic Lupus Erythematosus, Sjögren's Syndrome, Systemic Sclerosis, and Idiopathic Inflammatory Myopathies.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents several acceptance criteria and results for various analytical performance characteristics. Below is a compilation of these, focusing on the ones directly stating "Acceptance criteria".

Test Type	Acceptance Criteria (Set by Manufacturer)	Reported Device Performance
Precision	Total %CV: 85% reactivity (considering the 95% CI) after two weeks at 37 ± 3°C, and therefore pass the acceptance criteria for one year expiration date.
Shelf Life (Cal/Controls)	Lower 95% CI of regression line ≥ 90% at 2 weeks AND no individual data point ≤ 80% recovery at 2 weeks.	All Calibrators and Controls maintained > 90% reactivity (considering the 95% CI) when stored at 37 ± 3°C for 2 weeks, and therefore pass the acceptance criteria for one year expiration dating.
In-use Stability (Calibrators)	All five calibrations successful; Average Calibrator RLU recovery 90-110% compared to first use.	5 successful calibrations over 8.5 hours. Calibrator RLU values remained within 90-110% range. Controls and patient panel samples ran within expected range, supporting 4 calibrations over 8 hours.
In-use Stability (Controls)	All values run within established range; linear regression line for %recovery between 85-115% at run 15.	All controls ran within acceptable ranges for all runs. Regression line remained between 85-115% at run 15 for both Controls, supporting up to 15 uses at 10 minutes per use.
Real-time Stability (Controls)	Results fall within their acceptable ranges as established at release.	All results were within the acceptance limits.
Real-time Stability (Calibrators)	% recovery of average of triplicates 85-115% AND %CV of triplicates

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