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The Atellica IM High-Sensitivity Troponin I (TnIH) assay is for in the quantitative measurement of cardiac troponin I in human serum or plasma (lithium heparin) using the Atellica IM Analyzer. The assay can be used to aid in the diagnosis of acute myocardial infarction (AMI).

Device Description

The Atellica IM TnIH assay components include the Atellica IM TnIH Primary Reagent ReadyPack (containing Lite Reagent and Solid Phase Reagent) and the Atellica IM TnIH Calibrator (containing High Calibrator (Cal H) and Low Calibrator (Cal L)). The Lite Reagent contains Bovine serum albumin (BSA) conjugated to a recombinant monoclonal (sheep) Fab anti-human cTnl labeled with acridinium ester in HEPES buffer; stabilizers; preservatives. The Solid Phase Reagent contains Streptavidin-coated magnetic latex particles with 2 biotinylated (mouse and sheep) monoclonal anti-troponin I antibodies in buffer; stabilizers; preservatives. The High Calibrator contains Human serum; human cTnl; preservatives. The Low Calibrator contains HEPES buffer; bovine serum albumin (BSA); surfactants; preservatives. The methodology is Chemiluminescence and the assay protocol is a Sandwich immunoassay.

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Here's an analysis of the provided text, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a structured table. However, implied acceptance criteria are based on CLSI (Clinical and Laboratory Standards Institute) guidelines and the reported performance of the device. The "High-Sensitivity Designation" section (10.10) presents criteria for classification as a high-sensitivity troponin test.

Category	Criterion (Implied Acceptance)	Reported Device Performance (Atellica IM TnIH)
High Sensitivity Designation (as per IFCC Task Force)
%CV at 99th percentile	≤10%	Meets Criterion: The assay meets this criterion (explicitly stated: "The Atellica IM TnIH assay meets both of these criteria."). Specific %CV values not explicitly provided for the 99th percentile in the summary.
Measurable Conc. for 50%+ Healthy Individuals	Attainable above LoD for at least 50% of healthy individuals	Meets Criterion: The assay meets this criterion (explicitly stated: "The Atellica IM TnIH assay meets both of these criteria."). Specific data not provided in the summary.
Precision (CLSI EP5-A3)	Demonstrated acceptable repeatability and within-lab precision for various concentrations. (Specific numerical thresholds not stated as AC)
Serum Samples:
12.72 pg/mL		Repeatability %CV: 4.3; Within-Lab %CV: 4.7
127.93 pg/mL		Repeatability %CV: 1.8; Within-Lab %CV: 2.4
1334.97 pg/mL		Repeatability %CV: 1.7; Within-Lab %CV: 2.1
13815.89 pg/mL		Repeatability %CV: 1.4; Within-Lab %CV: 1.9
Lithium Heparin Plasma Samples:
12.03 pg/mL		Repeatability %CV: 4.1; Within-Lab %CV: 5.3
131.21 pg/mL		Repeatability %CV: 1.7; Within-Lab %CV: 2.1
1363.38 pg/mL		Repeatability %CV: 2.0; Within-Lab %CV: 2.3
12862.97 pg/mL		Repeatability %CV: 1.7; Within-Lab %CV: 2.3
Linearity (CLSI EP06-A)	Demonstrated acceptable deviation from linear fit. (Specific numerical thresholds not stated as AC)	Deviations from linear fit generally low, with largest reported as 7.47% (Serum Full Range, Sample I).
Dilution Recovery	Individual sample recoveries within 20% (implied)	Meets Implied Criterion: All individual sample recoveries were within 20%. Mean of 1:2 dilutions: 99.6%; Mean of 1:5 dilutions: 91.6%.
Hook Effect	No hook effect up to a specified concentration. (Implied AC)	Meets Implied Criterion: No hook effect up to 500,000 pg/mL.
Detection Limit (CLSI EP17-A2)	Defined LoB, LoD, and LoQ. (Implied AC)	LoB: 0.50 pg/mL; LoD: 1.60 pg/mL; LoQ: 2.50 pg/mL (at 20% total CV).
Endogenous Interference (CLSI EP07-A2)	Typically

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