Search Results

Lipids is part of the TruWellness Panel™ and is intended for use on the TruVerus™. Lipids (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to be used for the quantitative determination of Total Cholesterol (TChol) and Triglycerides (TRIG) in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings. From the TRIG determination, Very Low-Density Lipoprotein Cholesterol (VLDL) is calculated by the analyzer.

Lipids (part of the TruWellness Panel™) is an in vitro diagnostic test system that aids the physician in the diagnosis and treatment of the following disorders in adults 18 years of age or older:

Total Cholesterol (TChol): Excess cholesterol in the blood and lipid and lipoprotein disorders.

Triglyceride (TRIG): Diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism; various endocrine disorders.

Device Description

The TruSystem is an automated, integrated in vitro diagnostic platform consisting of the TruVerus™ and the TruWellness Panel™, a Single-Use Consumable Kit that includes a Disc and a Support Pack. Designed for point-of-care and clinical laboratory use, the system enables the simultaneous measurement of clinical chemistry, immunoassay, and hematology parameters from a lithium-heparinized venous whole blood sample in a single run. The TruSystem delivers quantitative results for routine clinical chemistry and immunoassay analytes as well as a complete blood count (CBC) with a 3-part differential, all without the need for specialized operating skills, external calibration, or complex infrastructure.

The TruVerus™ is a benchtop instrument that fully automates sample processing, assay execution, and result reporting. Its touchscreen interface allows operators to control workflows, initiate tests, and review results with minimal training. The Single-Use Consumable Kit and blood sample are loaded into the analyzer drawer, where all necessary processing takes place. Internally, the TruVerus™ integrates:

A high-precision pipettor for automated sample and reagent handling.
An onboard centrifuge to separate whole blood into plasma.
A closed-loop thermal control system to maintain precise assay temperatures.
A motion control system to fully automate sample processing.
Dedicated detection modules for clinical chemistry, immunoassay, and hematology testing.
A high-definition camera used to collect assay readings, image capture, and instrument quality control checks.
An electronics board to manage individual module boards and associated firmware.
An integrated computer running the instrument software, accessible via the touchscreen user interface.

The TruVerus™ is factory-calibrated and continuously monitors its performance using optical sensing and electronic feedback mechanisms. Every time the analyzer is powered on or a Single-Use Consumable Kit (TruWellness Panel™) is loaded, the system runs an automated self-test to verify that it remains within calibration and is functioning properly. Internal quality control (QC) checks occur throughout the testing process to ensure the integrity of the analyzer, Disc, and Support Pack. If any self-test or QC check fails to meet system specifications, the TruVerus™ will display an error code and next steps on the touchscreen interface.

The Single-Use Consumable Kit (TruWellness Panel™) houses all the components needed to process as well as analyze samples on the TruVerus™, including dried reagents, internal process control solutions, barcodes that manage the identity of the kit lot (e.g., Disc and Support Pack ID), calibration information, dilution buffers, and single-use plastic pipette tips. It also serves as a waste container which the user discards of at the end of the run.

AI/ML Overview

N/A

Ask a Question

Ask a specific question about this device

Page 1 of 1