(253 days)
The EUROIMMUN IFA 40: HEp-20-10 is an indirect immunofluorescence antibody test for the qualitative or semi-quantitative detection of antibodies against cell nuclei (ANA) in human serum. This test system is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings.
The test system consists of BIOCHIPs coated with HEp-20-10 cells. It includes a fluorescein-labeled goat anti-human IgG, a positive and negative control, salt for PBS, Tween 20, embedding medium, cover glasses and instruction booklet. Reagent trays for the TITERPLANE technique are required but ordered separately.
Here's a breakdown of the acceptance criteria and study information for the EUROIMMUN IFA 40: HEp-20-10 device, based on the provided text:
Acceptance Criteria and Device Performance
| Criteria | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance and Confidence Intervals |
|---|---|---|
| Qualitative Agreement with Predicate Device | Not explicitly stated as a numerical target in the provided text. However, the study aims to demonstrate substantial equivalence, implying high agreement. The predicate device is ImmunoConcepts® HEp-2000 ANA-Ro IFA. | Overall Agreement: 94.5% (95% C.I.: 90.4% - 97.2%) |
| Positive Agreement: 92.4% (95% C.I.: 83.2% - 97.5%) | ||
| Negative Agreement: 95.5% (95% C.I.: 90.5% - 98.3%) | ||
| Semi-Quantitative Agreement with Predicate Device (Positive/Negative) | Not explicitly stated as a numerical target. The study aims to demonstrate substantial equivalence. | Overall Agreement: 100.0% (95% C.I.: 97.7% - 100.0%) |
| Positive Agreement: 100.0% (95% C.I.: 96.7% - 100.0%) | ||
| Negative Agreement: 100.0% (95% C.I.: 92.3% - 100.0%) | ||
| Semi-Quantitative Agreement with Predicate Device (Pattern Agreement) | Not explicitly stated as a numerical target. Implicitly, high agreement is desired. | Overall Pattern Agreement: 91.4% |
| (Individual pattern agreements range from 66.7% (Nuclear Membrane) to 100.0% (Homogenous, Centromere, Nuclear Dot)) | ||
| Precision/Reproducibility | Fluorescence Intensity: The results should not exceed an acceptable deviation of +/- 1 intensity level. Positive samples should not be found negative and vice versa. Observed patterns should not change. | |
| Endpoint Titer: Endpoint titer should not deviate more than +/- 1 titer level. | Intra-Assay, Inter-Assay, Inter-Lot, Inter-Observer, Semi-quantitative Reproducibility: All studies met the criteria; results did not exceed +/- 1 intensity level deviation, positive/negative status remained consistent, and patterns did not change. Semi-quantitative reproducibility also showed endpoint titer did not deviate more than +/- 1 titer level. | |
| Linearity/Assay Reportable Range | Mixed patterns should be distinguishable in every dilution. Samples should show a decrease in fluorescence intensity with increasing dilutions. The pattern of the samples should not change with dilution. Acceptable deviation of fluorescence intensity: ± 1 intensity level. | Mixed patterns were distinguishable in every dilution. Samples showed a decrease in fluorescence intensity with dilution. The pattern did not change with dilution. Acceptable deviation of fluorescence intensity (± 1 intensity level) was met. |
| Analytical Specificity (Cross-Reactivity) | No significant cross-reactivity with ANCA-associated vasculitis, Crohn's disease, ulcerative colitis, celiac disease, Chlamydia pneumoniae, and Epstein-Barr virus samples. CDC reference panel results should be in line with CDC characterization. | No significant cross-reactivity observed with the tested clinical samples. Results for the CDC reference panel were in line with CDC characterization (with one exception, CDC sample No. 12, which was negative across all three test systems). |
| Analytical Specificity (Interfering Substances) | Deviation in fluorescence intensity level should not exceed +/- 1. No significant interference. | Hemoglobin (up to 1000 mg/dL), bilirubin (up to 40 mg/dL), triglyceride (up to 2000 mg/dL), HAMA, and RF at indicated concentrations had no effect on assay results. Deviation in fluorescence intensity level did not exceed +/- 1. No significant interference observed. |
| Assay Cut-off Verification | Prevalence of ANAs in healthy individuals should be within the range of 3.0% - 15% as per the American College of Rheumatology. | A prospective study with 138 samples (routine health screening) found a prevalence of 11.6% (95% C.I.: 6.8% - 18.6%) for ANA positivity at the 1:40 dilution, which falls within the 3.0% - 15% range. |
| Expected Values/Reference Range | Prevalence of ANAs in healthy individuals should be about 3.0% - 15% as per the American College of Rheumatology. Reference range determined as titer |
§ 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).