Shape 21 Experience

    Atellica® POC Cardiac Solution

    How would a hs-cTnI testing at the point of care impact operational workflow?

    Rapid disposition of cardiac patients is vital.

    Providing acute care facilities with tools to confidently disposition potential cardiac patients quickly and accurately could improve patient experiences. Fast, confident dispositions could alleviate ED congestion and improve cost and operational outcomes in these settings. Making accurate, cardiac testing readily available at the point of care is a crucial first step in this ambitious but important goal.

    Each year millions of patients enter emergency departments presenting with symptoms of acute coronary syndrome (ACS).1 Determining the differential diagnosis of these patients takes time, and that time comes at a human cost: the anxiety felt by patients and their families as they wait for answers and pressure on the medical staff to identify the problem as quickly and accurately as possible.2 Our development goal is to provide high-sensitive troponin testing where it matters most—at the point of care. The design goal of the Atellica POC system is to enable ED staff to allocate resources to patients quicker and with more confidence.

    Atellica CardiacPlanned Designed WorkflowPlanned Cartridge DesignPlanned Testing MethodologyClinical Value of hsTnIcTn and hsTnI
    1. Planned designed of an intuitive, prompt-based workflow: just scan, test, and send
      • Blood testing directly at patient’s bedside
      • Design goal of ~30 µL of blood required to perform the test
      • Results automatically collected in patient history file of part of the POC Ecosystem™ Solution
    2. Planned unique cartridge design
      As a design goal the Radio Frequency Identification tag (RFiD tag) on the cartridge:
      • Contains information on the type of test and calibration data
      • Instructs the instrument to automatically start the correct assay protocol
      • The RFiD tag on each disposable cartridge contains lot-specific calibration information
      • Integrated assay control in every cartridge
    3. Signal Chart

      1. The system detects when the cartridge is inserted. This triggers cartridge validation and starts temperature control of the cartridge.

      2a. The system detects when the sample is added and instructs the operator to close the lid.

      2b. The system detects when the liquid enters the measurement chamber. Assay timing is well-controlled.

      3. The system measures a reference value. The optical system is calibrated with each measurement, so there is no need for optical calibration cartridges.

      4. The system uses magnetic force to remove any unbound magnetic particles. The magnetic wash replaces liquid washing steps, so no wet reagents are required.

      5. The end result is detected and related to the reference obtained in step 3. The design goal is to have results available in less than 10 minutes.

    4. Atellica Cardiac

      Compared with conventional troponin assays:3

      • Higher NPV for AMI

      • Reduced “troponin-blind” interval leading to earlier detection of AMI

      • Result in ~4% absolute and ~20% relative increases in the detection of type 1 MI and corresponding decrease in the diagnosis of unstable angina

      • Associated with 2-fold increase in the detection of type 2 MI

      Rising and/or falling cardiac troponin levels differentiate acute from chronic cardiomyocyte damage.

    5. atellica cardiac

      • Contemporary assays must detect cTn in 20% to <50% of healthy individuals.

      • High-sensitivity assays must detect cTn in at least 50% of healthy individuals and must have <10% CV at the 99th percentile of normal.

      • Units of measure:

           – Contemporary: ng/mL

           – High-sensitivity: ng/L