pt01.jpg (12562 bytes)Intelligent process control that enables full monitoring and operator feedback for specimen processing, reagent processing and results integrity has been developed by Ortho-Clinical Diagnostics, a Johnson & Johnson Company. The new system software enhancement for the Vitros ECi Immunodiagnostic System, called Intellicheck, was launched about a month ago. The software monitors sample and result integrity without sacrificing workflow productivity or continuous processing.

According to recent publications on laboratory performance in proficiency testing, erroneous results caused by sample mishandling or instrument malfunctions continue at high levels. In response to this, Ortho has made it a priority to address laboratorian concerns about result integrity with product enhancements to improve sample and reagent process control. Intellicheck is specifically designed to establish confidence in results at every sample and assay processing step. A number of new patented processes have been combined with other Vitros technologies such as Smart Metering and Save-the Sample Clot Detection to optimize performance and deliver a level of result integrity not previously attainable.

Intellicheck is intelligent process control. It provides full monitoring and operator feedback for specimen processing, reagent processing and results integrity. Specimen processing begins with Vitros’ patented Smart Metering technology, which integrates several key elements that ensure sample integrity and optimize sampling performance. Automated sample status checks performed during sample aspiration and dispensing use a pressure transducer. Anomalies or exceptions to expected parameters that may impact the quality of an assay result are identified and immediately reported. Those anomalies include, bubble detection, short-sample detection, high-viscosity sample detection and clot detection. There also is a Save-the-Sample feature that returns sample to the original container after a clot is detected. Disposable probe tips eliminate carryover contamination concerns, which may effect results in systems with fixed-probe designs.

Automatic sample dilutions are verified by measuring sample and diluent volumes in the reaction well. Result integrity is ensured by confirming the proper dilution factor was performed as requested.

Reagent processing and signal reagent dispensing into the reaction wells are critical steps in achieving a quality test result from an enhanced chemiluminescence reaction.

Using level-sensing technology, elements of the subsystem, which perform aspiration and dispensing of reagents, are verified. The Reagent Metering subsystem performance is monitored to ensure proper pump operation and to detect obstructions in the probe, tubing or valves. Any detected exception or error condition with the potential to effect result integrity is immediately recognized by the error-recovery software, and the operator is notified both visually and audibly. An automatic analysis determines the next process required for error resolution and if sample and assay processing can proceed. For example, if Intellicheck detects a bubble in a particular sample, only the affected assay would be noted with a flag, and processing would continue for other samples awaiting processing. If all processing is paused due to a system error, it can automatically be resumed without operator intervention or loss of sample programming once the error condition has been resolved. To minimize waste and cost, reagents are only dispensed when integrity checks are complete.

Intellicheck provides on-screen guidance through diagnostic decision trees. Detailed messages and condition codes, with prioritized corrective-action steps, help the operator identify what needs to be done to resolve the reported condition.

The addition of Intellicheck software to the Vitros ECi represents a new standard for monitoring sample and result integrity without sacrificing workflow productivity and continued system processing. Through sophisticated methods of error management, interruptions or delays to processing performance have all but been eliminated, providing the user with added confidence in overall system operations. The full complement of Intellicheck software applications and hardware components are now standard features on the Vitros ECi Immunodiagnostic System.

The Vitros ECi Immunodiagnostic System uses enhanced chemiluminescence detection technology that supports assay precision and extended low-end sensitivity. Other chemiluminescence assays typically have a short-lived flash as their endoints. However, the Vitros ECi amplifies and prolongs the duration of light output by the chemiluminscent reaction, providing high signal to noise. Light output is increased over other methods by a factor of 1 million.

In addition, the Vitros ECi System provides convenient and cost-effective automated assay technology through its true random access, continuous processing and state-of-the-art sample clot management. Operators have complete access to samples, reagents and supplies, even during full operation.

The Vitros ECi System’s test menu is built around disease state management in thyroid, reproductive/fertility, metabolic, bone metabolism, cardiac and oncology disciplines. The third and final module of the Premarket Approval Application for an Anti-HBs hepatitis assay recently has been completed and sent to the U.S. Food & Drug Administration for review. The Vitros Anti-HBs assay is the first infectious disease assay for the random access Vitros ECi Immunodiagnostic System submitted to the FDA. Once approved, the assay will expand the System’s menu as an addition to the more than 30 current analytes. Other hepatitis and HIV tests are in different phases of development or the PMA Modular Submission process.

Tim Vesling is product manager of Immunodiagnostic System for Ortho Clinical Diagnostics.

For more information about Intellicheck, call 800-828-6316. The Web site is