(265 days)
QUANTA Flash SS-B is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-SS-B autoantibodies in human serum. The presence of anti-SS-B autoantibodies, in conjunction with clinical findings and other laboratory tests is an aid in the diagnosis of Sjögren's Syndrome and Systemic Lupus Erythematosus.
QUANTA Flash SS-B Calibrators are intended for use with the QUANTA Flash SS-B Reagents for the determination of IgG anti-SS-B autoantibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.
QUANTA Flash SS-B Controls are intended for use with the QUANTA Flash SS-B reagents for quality control in the determination of IgG anti-SS-B autoantibodies in human serum.
The QUANTA Flash SS-B 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 SS-B assay utilizes a reagent cartridge format, which is compatible with the BIO-FLASH instrument.
Purified recombinant SS-B 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-SS-B antibodies bound to the corresponding beads.
For quantitation, the QUANTA Flash SS-B 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 SS-B 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 SS-B kit contains the following materials:
One (1) QUANTA Flash SS-B Reagent Cartridge One (1) vial of Resuspension buffer One (1) Transfer pipette
The QUANTA Flash SS-B reagent cartridge contains the following reagents for 50 determinations:
- a. SS-B antigen coated paramagnetic beads, lyophilized.
- Assay buffer colored pink, containing Tris-buffered saline, Tween 20, protein b. stabilizers and preservatives.
- C. Tracer IgG - Isoluminol labeled anti-human IgG antibodies in buffer, containing protein stabilizers and preservative.
The QUANTA Flash SS-B Calibrators kit contains two vials of Calibrator 1 and two vials of Calibrator 2:
QUANTA Flash SS-B Calibrators:
- । QUANTA Flash SS-B Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to SS-B in stabilizers and preservatives.
- QUANTA Flash SS-B Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL - prediluted, ready to use reagent. Calibrators contain human antibodies to SS-B in stabilizers and preservatives.
The QUANTA Flash SS-B Controls kit contains two vials of Negative Control and two vials of Positive Control:
QUANTA Flash SS-B Controls:
- । QUANTA Flash SS-B Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to SS-B in stabilizers and preservatives.
- QUANTA Flash SS-B Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to SS-B in stabilizers and preservatives.
The document describes the QUANTA Flash® SS-B assay and its performance characteristics. This device is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-SS-B autoantibodies in human serum, used as an aid in diagnosing Sjögren's Syndrome and Systemic Lupus Erythematosus.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
This section focuses on the analytical performance characteristics and clinical performance.
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | Total %CV: 85% at 2 weeks, no individual data point ≤ 75% recovery at 2 weeks. Controls/Calibrators: Lower 95% CI of regression line ≥ 90% at 2 weeks, no individual data point ≤ 80% recovery at 2 weeks. | Achieved. All three lots of beads retained > 85% reactivity. All calibrators and controls maintained > 90% reactivity. |
| In-use (onboard) Stability | Calibrators: 5 successful calibrations over 8.5 hours, average RLU recovery 90-110%, all controls/patient samples within expected range. Controls: All replicates within established range, linear regression line of %recovery 85-115% at run 15. Reagent Cartridge: Stability claim established when 95% CI of regression line reaches 85% or 115% recovery, or when 2 data points or ≥2% of recovery data is ≤ 75% or ≥ 125%. | Achieved. Calibrators: 5 successful calibrations over 8.5 hours, RLU values within 90-110%, controls/patient panel within expected range. Controls: All controls ran within acceptable ranges, regression line remained between 85% and 115% at run 15. Reagent Cartridge: In-use stability for reagent cartridge was set at 57 days based on the criteria. |
| Real Time Stability | Controls: Results fall within acceptable ranges. Calibrators: % recovery of average triplicates between 85-115%, %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).