(260 days)
QUANTA Flash Jo-1 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Jo-1 antibodies in human serum. The presence of antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myopathy.
QUANTA Flash Jo-1 Calibrators are intended for use with the QUANTA Flash Jo-1 Reagents for the determination of Ig G anti-Jo-1 antibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.
QUANTA Flash Jo-1 Controls are intended for use with the OUANTA Flash Jo-1 Reagents for quality control in the determination of IgG anti-Jo-1 antibodies in human serum.
The QUANTA Flash Jo-1 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 Jo-1 assay utilizes a reagent cartridge format, which is compatible with the BIO-FLASH instrument.
Recombinant Jo-1 antigen is coated onto paramagnetic beads, which is stored in the reagent cartridge as a suspension. When the cartridge is ready to be used for the first time, the entire cartridge is inverted several times to thoroughly mix the reagent cartridge is then loaded onto the BIO-FLASH instrument. Samples are also loaded onto the instrument in sample racks. Serum samples are diluted 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 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 (urea-hydrogen 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-Jo-1 antibodies bound to the corresponding beads.
For quantitation, the QUANTA Flash Jo-1 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 Jo-1 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 Jo-1 kit contains the following materials:
One (1) QUANTA Flash Jo-1 Reagent Cartridge
The QUANTA Flash Jo-1 reagent cartridge contains the following reagents for 50 determinations:
- a. Jo-1 coated paramagnetic beads, in a suspension containing buffer, protein stabilizers and preservative.
- b. Assay buffer - colored pink, containing buffer, 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 Jo-1 Calibrators kit contains two vials of Calibrator 1 and two vials of Calibrator 2:
QUANTA Flash Jo-1 Calibrators:
- І QUANTA Flash Jo-1 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Jo-1 in buffer, stabilizer and preservative.
- QUANTA Flash Jo-1 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Jo-1 in buffer, stabilizer and preservative.
The QUANTA Flash Jo-1 Controls kit contains two vials of Negative Control and two vials of Positive Control:
QUANTA Flash Jo-1 Controls:
- -QUANTA Flash Jo-1 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Jo-1 in buffer, stabilizer and preservative.
- QUANTA Flash Jo-1 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Jo-1 in buffer, stabilizer and preservative.
The provided text describes the analytical and clinical performance characteristics of the QUANTA Flash® Jo-1 chemiluminescent immunoassay. This device is intended for the semi-quantitative determination of IgG anti-Jo-1 antibodies in human serum to aid in the diagnosis of idiopathic inflammatory myopathy.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:
Acceptance Criteria and Reported Device Performance
Note: The document provides detailed analytical performance characteristics and clinical performance characteristics. For acceptance criteria, the document explicitly states them for:
- **Precision (Total %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).