(265 days)
QUANTA Flash® dsDNA is a chemiluminescent immunoassay for the quantitative determination of IgG anti-double stranded deoxyribonucleic acid (dsDNA) antibodies in human serum. The presence of anti-dsDNA antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus.
QUANTA Flash® dsDNA Calibrators are intended for use with the QUANTA Flash® dsDNA chemiluminescent immunoassay for the determination of IgG anti-dsDNA antibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.
QUANTA Flash® dsDNA Controls are intended for use with the OUANTA Flash® dsDNA chemiluminescent immunoassay for quality control in the determination of IgG anti-dsDNA antibodies in human serum.
QUANTA Flash dsDNA is a chemiluminescent microparticle immunoassay for the quantitative determination of IgG anti-double stranded deoxyribonucleic acid (dsDNA) antibodies in human serum. The QUANTA Flash dsDNA 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 dsDNA assay utilizes a reagent cartridge format, which is compatible with the BIO-FLASH instrument.
Synthetic dsDNA is coated onto paramagnetic beads, which are stored in the reagent cartridge in suspension. When the assay cartridge is ready to be used for the first time, the entire cartridge is inverted several times to thoroughly mix the reagents. The sealed reagent tubes are then pierced with the reagent cartridge lid. The reagent cartridge is then loaded onto the BIO-FLASH instrument. Samples are also loaded onto the instrument in sample racks. A patient serum sample is prediluted 1:10 by the BIO-FLASH with system rinse in a 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 antihuman 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(III) 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-dsDNA antibodies bound to the corresponding dsDNA on the beads.
For quantitation, the QUANTA Flash dsDNA 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 dsDNA Calibrators. The Master Curve is created during manufacturing by using in-house standards that are traceable to the First International Standard Preparation for dsDNA (WHO code: Wo/80). 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 international units (U)/mL from the instrument signal (RLU) obtained for each sample.
The QUANTA Flash dsDNA kit contains the following materials:
One (1) QUANTA Flash dsDNA Reagent Cartridge, containing the following reagents for 50 determinations:
- dsDNA antigen coated paramagnetic beads in a suspension. a.
- b. Assay Buffer 3 – buffer containing protein stabilizers and preservatives.
- Tracer IgG 2 Isoluminol labeled anti-human IgG antibodies in buffer, containing protein C. stabilizers and preservative.
The QUANTA Flash dsDNA Calibrators kit contains two vials of Calibrator 1 and two vials of Calibrator 2.
- QUANTA Flash dsDNA Calibrator 1: Two (2) barcode labeled tubes containing 0.7 mL prediluted, ready to use reagent. Calibrators contain human antibodies to dsDNA in stabilizers and preservatives.
- QUANTA Flash dsDNA Calibrator 2: Two (2) barcode labeled tubes containing 0.7 mL prediluted, ready to use reagent. Calibrators contain human antibodies to dsDNA in stabilizers and preservatives.
The QUANTA Flash dsDNA Controls kit contains two vials of Negative Control and two vials of Positive Control.
- QUANTA Flash dsDNA Low Control: Two (2) barcode labeled tubes containing 0.7 mL, ready to use reagent. Controls contain human antibodies to dsDNA in stabilizers and preservatives.
- QUANTA Flash dsDNA High Control: Two (2) barcode labeled tubes containing 0.7 mL, ready to use reagent. Controls contain human antibodies to dsDNA in stabilizers and preservatives.
Here's an analysis of the provided text, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
This table summarizes key acceptance criteria and the performance of the QUANTA Flash® dsDNA device as reported in the document.
| Test Category | Acceptance Criteria (General) | Reported QUANTA Flash® dsDNA Performance |
|---|---|---|
| Analytical Performance | ||
| Precision (Total %CV) | ≤ 10% | All samples had Total %CV values within 10% (ranged from 3.6% to 8.2%). |
| Reproducibility (Between Sites) | ≤ 10% | All %CV values were within 10% (ranged from 0.0% to 6.1%). |
| Reproducibility (Between Lots) | ≤ 10% | All %CV values were within 10% (ranged from 0.7% to 7.5%). |
| Auto-rerun Recovery | 80% - 120% | % Recovery values for auto-rerun vs. manual dilution were between 84% and 106% (average 96%), meeting criteria. |
| Linearity (Recovery) | 80% - 120% (or ± 7 IU/mL) | Percent recovery for all data points ranged from 90.8% to 113.0%. |
| Linearity (Slope) | 0.9 - 1.1 | Combined samples slope: 1.03 (1.02 to 1.05). Individual sample slopes ranged from 0.97 to 1.08, meeting criteria. |
| Linearity (R²) | ≥ 0.95 | All samples R² values were 0.99 or 1.00, meeting criteria. |
| Interference Recovery | 85% - 115% for positive samples; or ± 7 IU/mL for indeterminate/negative samples | No interference detected for bilirubin (86-102%), hemoglobin (88-107%), triglycerides (91-109%), cholesterol (91-109%), and RF IgM (94-114% or 3.6-3.7 IU/mL difference), meeting criteria. |
| Cross-reactivity (% Positive) | Low percentage of positive results in patient groups with other autoimmune/infectious diseases | 26 out of 465 samples (5.6%) tested positive, and 32 (6.9%) indeterminate across various patient groups, demonstrating low cross-reactivity. |
| Sample Stability (Recovery) | 90% - 110% average recovery | All samples fulfilled acceptance criteria for up to 17 days at 2-8°C, up to 48 hours at room temperature, and up to 3 freeze/thaw cycles. |
| Reagent Stability (Accelerated) | Microparticles, Assay Buffer, Tracer IgG: 95% CI regression line 85-115% at 2 weeks, no individual data point 75-125%. Controls & Calibrators: 95% CI regression line 90-110% at 2 weeks, no individual data point 80-120%. | All components fulfilled acceptance criteria for one-year preliminary expiration dating based on accelerated stability (4 weeks at 37°C simulating 6 months at 5±3°C). |
| Reagent Stability (Real-time) | Controls: results within acceptable ranges. Calibrators: QC samples within ranges OR % recovery 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).