(437 days)
The ADVIA Centaur® High-Sensitivity Troponin I (TNIH) assay is for in vitro diagnostic use in the quantitative measurement of cardiac troponin I in human serum or plasma (lithium heparin) using the ADVIA Centaur XP system. The assay can be used to aid in the diagnosis of acute myocardial infarction (AMI).
The ADVIA Centaur TNIH assay kit includes the ADVIA Centaur TNIH Primary Reagent ReadyPack and the ADVIA Centaur TNIH Calibrator. The Primary Reagent ReadyPack contains ADVIA Centaur TNIH Lite Reagent (Bovine serum albumin (BSA) conjugated to a recombinant monoclonal Fab anti-human cTnl (~0.2-0.4 µg/mL) labeled with acridinium ester in HEPES buffer with stabilizers and preservatives) and ADVIA Centaur TNIH Solid Phase Reagent (0.45 mg/mL streptavidin-coated magnetic latex particles with 2 biotinylated (mouse and sheep) monoclonal anti-troponin I antibodies in buffer with stabilizers and preservatives). The Calibrator kit contains ADVIA Centaur TNIH High Calibrator (Human serum with human cTnl and preservatives (lyophilized)) and ADVIA Centaur TNIH Low Calibrator (HEPES buffer with bovine serum albumin (BSA), surfactants, and preservatives (liquid)). The assay uses a chemiluminescence sandwich immunoassay methodology.
The Siemens Healthcare Diagnostics Inc. ADVIA Centaur High-Sensitivity Troponin I (TNIH) assay is an in vitro diagnostic device used for the quantitative measurement of cardiac troponin I in human serum or plasma to aid in the diagnosis of acute myocardial infarction (AMI).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for each performance characteristic in a table format. However, it indicates expected outcomes based on standard guidelines (CLSI protocols) and high-sensitivity troponin definitions. The performance data presented demonstrates that the device meets these implied criteria.
| Performance Characteristic | Implied Acceptance Criteria (Based on CLSI & IFCC) | Reported Device Performance |
|---|---|---|
| Precision | CVs within acceptable ranges for clinical assays; demonstrating consistent results. (Based on CLSI EP5-A3) | Repeatability (%CV): Serum samples ranged from 0.7% to 4.8%. Lithium Heparin Plasma samples ranged from 0.8% to 3.6%. |
| Within-Lab (%CV): Serum samples ranged from 0.9% to 5.4%. Lithium Heparin Plasma samples ranged from 1.1% to 4.9%. | ||
| These values are generally considered acceptable for clinical assays, especially within the context of troponin measurement. | ||
| Linearity | Deviation from linear fit within acceptable limits across the assay's measuring range. (Based on CLSI EP06-A) | Deviation from Linear Fit: For full range, Li Hep and Serum samples showed deviations up to 6.57%. For ~150 pg/mL range, deviations up to 3.5% were observed. |
| While specific acceptance limits for deviation are not given, these results are presented as representative and implied to be acceptable. | ||
| Dilution Recovery | Recoveries for diluted samples should be within a reasonable percentage of expected values. | Recoveries for individual samples were all within 20%. Mean of 1:2 dilutions was 102.6%. Mean of 1:5 dilutions was 91.8%. |
| This indicates acceptable recovery for diluted samples. | ||
| Hook Effect | No Hook Effect detected within the specified concentration range. | No hook effect observed up to 500,000 pg/mL. |
| This is a positive finding, indicating reliability at high concentrations. | ||
| Detection Limit | LoB, LoD, and LoQ determined as per CLSI protocol EP17-A2. | LoB: 0.50 pg/mL. LoD: 1.60 pg/mL. LoQ: 2.50 pg/mL (at 20% total CV). |
| These values describe the analytical sensitivity of the assay. | ||
| Endogenous Interference | Interferents should not cause >10% interference at tested concentrations. (Based on CLSI EP07-A2) | Most endogenous substances showed less than 10% interference. For substances causing >10% interference (none explicitly highlighted as such in the table, all shown are below), serial measurements were taken and analyzed by linear regression (though specific results for such cases are not provided in the table). |
| The presented data indicates minimal endogenous interference. | ||
| Drug Interference | At tested concentrations, drugs should cause |
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.