Search Results

The IDS Cortisol assay is an in vitro diagnostic device intended for the quantitative determination of cortisol in human serum and plasma on the IDS system. Results are to be used in conjunction with other clinical and laboratory data to assist clinicians in the diagnosis and treatment of disorders of the adrenal gland.

The IDS Cortisol assay consists of a reagent cartridge. The reagent cartridge contains multiple reagents:

• MPE1:Magnetic particles coated rat anti-mouse monoclonal antibody in a phosphate buffer with Proclin as preservative.
• CONJ: Cortisol coupled with an acridinium ester derivative in = phosphate buffer with Proclin as a preservative.
• mAb: Mouse anti-cortisol monoclonal antibody in phosphate buffer with Proclin as a preservative .;
• BUF: HEPES buffer containing Proclin as preservative .

This document describes the analytical performance of the IDS Cortisol assay, an in vitro diagnostic device, and demonstrates its substantial equivalence to a predicate device (Roche Elecsys Cortisol II). The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this in vitro diagnostic device are primarily based on demonstrating analytical performance that is comparable to, or meets specified standards relative to, established laboratory methods and a predicate device.

• 0.94 µg/dL: 7.8% CV
• 1.84 µg/dL: 4.6% CV
• 5.75 µg/dL: 2.4% CV
• 13.06 µg/dL: 2.4% CV
• 19.94 µg/dL: 1.8% CV
• 44.63 µg/dL: 1.9% CV
  |
  | | Intermediate Precision (Within-System/Total): Lower CV% | Within-System (n=80 per sample, 1 lot, 1 system):
• 0.94 µg/dL: 16.2% CV
• 1.84 µg/dL: 10.9% CV
• 5.75 µg/dL: 5.2% CV
• 13.06 µg/dL: 3.9% CV
• 19.94 µg/dL: 5.1% CV
• 44.63 µg/dL: 4.2% CV
  Total (Combind 3 lots, 3 systems, n=240 per sample):
• 0.88 µg/dL: 15.3% CV
• 1.78 µg/dL: 10.1% CV
• 5.75 µg/dL: 4.5% CV
• 13.09 µg/dL: 3.3% CV
• 20.22 µg/dL: 4.8% CV
• 44.48 µg/dL: 5.0% CV |
  | Linearity/Reportable Range | Data should demonstrate linearity across the claimed measuring range. | Measuring Range: 0.59 to 45.00 µg/dL.
  Regression: Observed = 1.01 * Expected + 0.01 µg/dL; R²: 1.00
  (Accepted based on R² close to 1 and slope ~1, intercept ~0) |
  | Detection Limits (LoB, LoD, LoQ) | Specific quantifiable low limits. | LoB: 0.10 µg/dL
  LoD: 0.24 µg/dL
  LoQ: 0.59 µg/dL |
  | Analytical Specificity (Interference) | Non-significant bias (

Ask a specific question about this device

Immunoassay for the in vitro quantitative determination of cortisol in human serum, and plasma. The determination of cortisol is used for the recognition and treatment of functional disorders of the adrenal gland. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.

Cortisol II CalSet is used for calibrating the quantitative Elecsys Cortisol II assay on the Elecsys and cobas e immunoassay analyzers.

The Elecsys Cortisol II assay makes use of a competition test principle using a monoclonal antibody which is specifically directed against cortisol. Endogenous cortisol which has been liberated from binding proteins with danazol competes with exogenous cortisol derivative in the test which has been labeled with ruthenium complex for the binding sites on the biotinylated antibody.

Results are determined via a calibration curve which is instrument specifically generated by 2point calibration and a master curve provided via reagent barcode.

The reagent working solutions include:

• rackpack (kit placed on instrument) .
  • Streptavidin coated microparticles, ş
  • Reagent 1 (Anti-cortisol-Ab~biotin) and ş
  • Reagent 2 (Cortisol-peptide~Ru(bpy)2+3). ş

The Cortisol II CalSet is a lyophilized human serum with added cortisol in two concentration ranges.

The CalSet includes:

• Cal 1 (approximately 12.5 nmol/L cortisol in a human serum matrix) .
• Cal 2 (approximately 1000 nmol/L cortisol in a human serum matrix) .

The provided document describes the Elecsys Cortisol II immunoassay and its associated calibrator, Cortisol II CalSet. It details various non-clinical performance evaluations and one clinical performance evaluation.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a dedicated table for each technical performance study. Instead, it presents the results of these studies and implies that these results demonstrate the device's performance is acceptable and supports substantial equivalence to the predicate device. For analytical specificity and method comparison, the document includes tables comparing some key characteristics with the predicate device. For other studies like precision, linearity, and sensitivity, it reports the performance without directly listing a pre-defined acceptance criterion.

However, I can extract the reported performance directly from the document for key metrics.

Ask a specific question about this device