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VIDAS Troponin I Assay is an automated quantitative test for use on the VIDAS instruments for the determination of human cardiac troponin 1 in serum or plasma (lithium heparinate) using the ELFA (Enzyme-Linked Fluorescent Assay) technique

The VIDAS Troponin I (TNI) Assay is an enzyme-linked fluorescent immunoassay (ELFA) performed in an automated VIDAS® instrument. All assay steps and assay temperature are controlled by the instrument. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as the solid phase as well as a pipettor for the assay. Reagents for the assay are in the sealed TNI Reagent Strips.

The sample is transferred into the wells containing anti-cardiac troponin I antibodies labeled with alkaline phosphatase (conjugate). The sample/conjugate mixture is cycled in and out of the SPR for a specified length of time. Troponin I present in the specimen will bind to the anti-cardiac troponin I immunoglobulin coating the interior of the SPR. Unbound sample components are washed away.

A fluorescent substrate, 4-methylumbelliferyl phosphate, is introduced into the SPR. Enzyme remaining on the SPR wall will catalyze the conversion of the substrate to the fluorescent product 4-methylumbelliferone. The optical scanner in the instrument measures the intensity of fluorescence. When the VIDAS TNI assay is completed, the results are analyzed automatically by the computer, a test value is generated, and a report is printed for each sample.

Here's a breakdown of the acceptance criteria and study details for the VIDAS Troponin I (TNI) Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined column. Instead, it presents performance data for both the VIDAS TNI assay and its predicate device, the Stratus CS Cardiac Troponin I Testpak, implying that the VIDAS TNI assay needed to demonstrate comparable performance to the predicate. The "Reported Device Performance" column reflects the performance of the VIDAS TNI assay.

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