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The Dimension Vista® High-Sensitivity Troponin I (TNIH) assay is for in vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma using the Dimension Vista system. The assay can be used to aid in the diagnosis of acute myocardial infarction (AMI).

Device Description

The Dimension Vista® TNIH assay is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI® technology. The LOCI reagents include two synthetic bead reagents and two biotinylated anti-cardiac troponin I monoclonal antibody fragments. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitizer dye. The second bead reagent (Chemibeads) is coated with a third anticardiac troponin I monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibodies to form bead-cardiac troponin Ibiotinylated antibody sandwiches. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the cardiac troponin I concentration in the sample. Lithium heparin plasma specimens may be used. The reagent is stored unopened at 2 – 8 °C, is stable sealed on system for 30 days and opened on the system for 7 days. Calibration is performed every 30 days for a reagent lot.

AI/ML Overview

The provided document describes the Siemens Healthcare Diagnostics Dimension Vista High-Sensitivity Troponin I (TNIH) Assay. The following information regarding its acceptance criteria and a study proving its performance is extracted:

Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Detection Limit
- Limit of Blank (LoB)	95th percentile of all values, measured using a non-parametric approach.	1.0 pg/mL
- Limit of Detection (LoD)	Non-parametric approach following CLSI EP17-A2.	2.0 pg/mL (consistent with range of 0.7 - 1.9 pg/mL)
Limit of Quantitation (LoQ)	Analyte level with a within-lab CV of ≤ 20.0%.	3.0 pg/mL (Lot-1: 1.2 pg/mL, Lot-2: 2.4 pg/mL, Lot-3: 2.2 pg/mL)
10% CV Limit	Analyte level with a within-lab CV of ≤ 10.0%.	Consistent with 10.0 pg/mL (Lot-1: 2.7 pg/mL, Lot-2: 5.7 pg/mL, Lot-3: 5.4 pg/mL)
Precision	All precision goals were met. (Specific goals for SD and %CV not explicitly detailed but implied by "All precision goals were met" statement).	Repeatability: Plasma 1 (48.9 pg/mL): 1.12 SD, 2.3% CV; Plasma 2 (157.7 pg/mL): 1.55 SD, 1.0% CV; QC (8088.5 pg/mL): 99.54 SD, 1.2% CV.
Within-Lab: Plasma 1: 3.05 SD, 6.2% CV; Plasma 2: 2.60 SD, 1.6% CV; QC: 200.36 SD, 2.5% CV.
Linearity	The p values of nonlinear terms in the quadratic and cubic fit equations are non-significant (p ≤ 0.05). If p-value > 0.05, then allowable bias is ≤ 10% or 3 pg/mL, whichever is greater.	Confirmed linearity from 3.0 - 25,000.0 pg/mL.
Interferences	Bias exceeding 10% is considered interference.	Exogenous Compounds: No interference detected from Hemoglobin (400 mg/dL), Bilirubin (conjugated 30 mg/dL, unconjugated 40 mg/dL), Lipemia (3000 mg/dL) at approximately 40 pg/mL and 1350 pg/mL cTnI.
Numerous therapeutic/toxic substances: No interference detected at specified low/therapeutic and high/toxic concentrations (details in document for each substance).
High Dose Hook Effect	Not explicitly stated as a numerical criterion, but implies absence of hook effect.	No hook effect found at 1,000,000 pg/mL troponin.
Dilution Recovery	Supported use of diluent for over-range samples. (Specific numerical criteria not explicitly stated).	Testing supported use of the diluent for over-range samples.
Calibration Stability	P-value of regression slope ≥ 0.05 OR drift ≤ LoQ OR drift ≤ 10% for values up to 20,000 pg/mL OR drift ≤ 13% for values > 20,000 pg/mL.	Calibration interval measured to be 30 days.
Open Well Stability	P-value of regression slope ≥ 0.05 OR drift ≤ LoQ OR drift ≤ 10% for values up to 20,000 pg/mL OR drift ≤ 13% for values > 20,000 pg/mL.	Stability of reagents opened onboard the instrument was 7 days per well set.
Sample Stability	Lower bound of the one-sided 95% confidence interval of the regression line must be ≤ -10% AND all individual data points must have a bias of ≤ -20% when compared to time zero.	Separated samples stable for 8 hours at room temperature, 24 hours at 2-8 °C, up to 40 days at or below -20 °C (non-frost free), and up to 1 year at or below -70 °C.
Clinical Performance (Sensitivity)	Not explicitly stated as acceptance criteria, but clinical performance is assessed for diagnostic accuracy.	Pooled Gender (58.9 pg/mL 99th percentile): ranged from 79.0% (0-24h).
Male (78.5 pg/mL 99th percentile): ranged from 74.0% (0-24h) to 92.5% (0-24h) to 94.4% (0-

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