(60 days)
The LIAISON® Aldosterone assay uses chemiluminescent immunoassay (CLIA) technology and is intended for the quantitative determination of Aldosterone in human serum. EDTA plasma and treated urine samples. Aldosterone measurements are intended for use in the diagnosis and treatment of primary aldosteronism (a disorder caused by excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states and other conditions of electrolyte imbalance. The test has to be performed on the LIAISON® Analyzer.
The DiaSorin LIAISON® Aldosterone Control Set is intended for use as assayed quality control samples to monitor the accuracy of the DiaSorin LIAISON® Aldosterone assay on the LIAISON® Analyzer.
The DiaSorin LIAISON® Aldosterone Calibration Verifiers are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the LIAISON® Aldosterone assay when performed on the LIAISON® Analyzer.
The LIAISON® Aldosterone assay is a competitive modified 2 step chemiluminescent assay that uses sheep monoclonal antibody for capture of the Aldosterone molecule. Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal is measured by a photomultiplier as relative light units (RLU) and is inversely proportional to the concentration of aldosterone present in the calibrators, controls or samples.
Here's a breakdown of the acceptance criteria and study details for the LIAISON® Aldosterone assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with specific pass/fail thresholds for the LIAISON® Aldosterone assay. However, it provides performance data that would implicitly be compared against desired clinical or analytical requirements. Below is a table summarizing the reported performance, which serves as evidence of the device meeting its intended analytical characteristics.
| Performance Metric | Reported Device Performance (LIAISON® Aldosterone) | Clinical Context / Implied Acceptance |
|---|---|---|
| Method Comparison (vs. Predicate RIA) | High correlation and agreement with established method | |
| - Serum Samples (n=144) | Slope: 0.98 (95% CI: 0.94 to 1.02) | Slope near 1.0, indicating proportional agreement. |
| Intercept: 1.10 ng/dL (95% CI: 0.43 - 1.49) | Intercept near 0, indicating minimal constant bias. | |
| R: 0.988 | High correlation (close to 1). | |
| - Urine Samples (n=104) | Slope: 0.98 (95% CI: 0.91 to 1.05) | Slope near 1.0, indicating proportional agreement. |
| Intercept: 34 ng/dL (95% CI: 11.43 to 56.7) | Intercept near 0 (though 34 ng/dL for urine is noted). | |
| R: 0.948 | High correlation (close to 1). | |
| Limit of Blank (LoB) | Serum: 0.97 ng/dL | Ability to distinguish analyte absence from presence. |
| Urine: 1.26 ng/dL | ||
| Limit of Detection (LoD) | Serum: 1.45 ng/dL | Lowest concentration detectable with reasonable certainty. |
| Urine: 2.00 ng/dL | ||
| Limit of Quantitation (LoQ) | Serum: 3.0 ng/dL | Lowest concentration quantifiable with acceptable precision and accuracy. |
| Urine: 2.80 ng/dL | ||
| Precision (20-Day Reproducibility) | Consistent and reproducible results across runs, days, sites, and reagent lots. | |
| - Serum (Aldo-S1 to Aldo-S6, n=480 each) | Total %CV: 5.6% - 10.5% | Low Coefficient of Variation (CV) indicating high precision. |
| - Urine (Aldo-U1 to Aldo-U3, n=480 each) | Total %CV: 8.6% - 9.8% | Low Coefficient of Variation (CV) indicating high precision. |
| Dilution Linearity | Serum: Observed = 0.994(Expected) + 0.71, R = 1.000 | Linear response across dilution range. (Slope near 1, intercept near 0, R near 1) |
| EDTA Plasma: Observed = 1.01(Expected) + 1.43, R = 0.998 | ||
| Urine: Observed = 0.996(Expected) + 0.69, R = 0.999 | ||
| Interfering Substances | No interference observed at specified concentrations for various substances. | Robustness against common physiological and therapeutic interferences. |
| Cross-Reactivity |
§ 862.1045 Aldosterone test system.
(a)
Identification. An aldosterone test system is a device intended to measure the hormone aldosterone in serum and urine. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by the excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.(b)
Classification. Class II.