(267 days)
QUANTA Flash Ro60 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Ro60 autoantibodies in human serum. The presence of anti-Ro60 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus and Sjögren's Syndrome.
QUANTA Flash Ro60 Calibrators are intended for use with the QUANTA Flash Ro60 Reagents for the determination of Ig G anti-Ro60 autoantibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.
QUANTA Flash Ro60 Controls are intended for use with the QUANTA Flash Ro60 reagents for quality control in the determination of IgG anti-Ro60 autoantibodies in human serum.
The QUANTA Flash Ro60 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 Ro60 assay utilizes a reagent cartridge format, which is compatible with the BIO-FLASH instrument.
Purified recombinant Ro60 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-Ro60 antibodies bound to the corresponding beads.
For quantitation, the QUANTA Flash Ro60 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 Ro60 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 Ro60 kit contains the following materials:
One (1) QUANTA Flash Ro60 Reagent Cartridge
One (1) vial of Resuspension buffer
One (1) Transfer pipette
The QUANTA Flash Ro60 reagent cartridge contains the following reagents for 50 determinations:
- a. Ro60 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 Ro60 Calibrators kit contains two vials of Calibrator 1 and two vials of Calibrator 2:
QUANTA Flash Ro60 Calibrators:
- QUANTA Flash Ro60 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL ı prediluted, ready to use reagent. Calibrators contain human antibodies to Ro60 in stabilizers and preservatives.
- -QUANTA Flash Ro60 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro60 in stabilizers and preservatives.
The QUANTA Flash Ro60 Controls kit contains two vials of Negative Control and two vials of Positive Control:
QUANTA Flash Ro60 Controls:
- । QUANTA Flash Ro60 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Ro60 in stabilizers and preservatives.
- i QUANTA Flash Ro60 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Ro60 in stabilizers and preservatives.
The document describes the analytical and clinical performance of the QUANTA Flash® Ro60 chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Ro60 autoantibodies in human serum.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (QUANTA Flash® Ro60) | Reported Device Performance (QUANTA Flash® Ro60) |
|---|---|---|
| Precision (Total %CV) | 85% reactivity after two weeks at 37 ± 3 ℃. | |
| Shelf Life (Beads) (Individual data point recovery) | No individual data point ≤ 75% recovery at 2 weeks | Not explicitly stated, but "pass the acceptance criteria" implies this was met. |
| Shelf Life (Calibrators & Controls) (Lower 95% CI) | ≥ 90% at 2 weeks (accelerated testing) | All Calibrators and Controls maintained > 90% reactivity when stored at 37 ± 3°C for 2 weeks. |
| Shelf Life (Calibrators & Controls) (Individual data point recovery) | No individual data point ≤ 80% recovery at 2 weeks | Not explicitly stated, but "pass the acceptance criteria" implies this was met. |
| Onboard Stability (Calibrators) (RLU recovery) | 90-110% compared to first use | Calibrator RLU values remained within the 90-110% range over 8.5 hours. |
| Onboard Stability (Controls) (Regression line) | Between 85% and 115% at run 15 | Regression line remained between 85% and 115% at run 15 for both Controls. |
| Real-time Stability (Controls) | Results within established acceptable ranges | All results were within the acceptance limits. |
| Real-time Stability (Calibrators) (% Recovery) | 85-115% | All results were within the acceptance limits. |
| Real-time Stability (Calibrators) (%CV) |
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).