IMMULITE^® Turbo
Cardiac Biomarker Assays:
Results in Less Than 15 Minutes!

DPC is pleased to announce the release of the IMMULITE Turbo cardiac biomarker assays for CK-MB, myoglobin, and troponin I. The IMMULITE Turbo platform, building on the proven performance of the IMMULITE immunoassay analyzer, offers sample processing with assay incubation times reduced by half.

A vast need
Cardiovascular disease is the leading cause of morbidity and mortality in developed nations. Each year, coronary artery disease consumes billions of healthcare dollars, yet still claims hundreds of thousands of lives. Cardiac biomarkers are quickly assuming a critical role in directing and confirming physicians' diagnostic, prognostic and therapeutic options. The increasing use of thrombolytic therapy, angioplasty and new antiplatelet drugs will improve patient outcomes. Clearly, high-quality immunoassays will enhance diagnosis and, therefore, the effectiveness of therapeutic intervention by emergency room (ER) physicians and cardiologists who incorporate these life-saving options.

The laboratorian needs to select a testing platform capable of managing the acute coronary syndrome continuum-silent ischemia, unstable angina pectoris and, finally, acute myocardial infarction (AMI). ER physicians and cardiologists are requesting that cardiac biomarker results be made available faster than ever before. Decisions about treatment options and assessment of therapeutic efficacy are time dependent. The National Academy of Clinical Biochemistry (NACB) recommends that STAT cardiac biomarker testing be done on ". . . a continuous random-access basis, with a target turnaround time (TAT) of 1 hour or less. The TAT is defined as the time from blood collection to the reporting of results."¹

IMMULITE Turbo features
With that healthcare challenge defined, DPC has introduced the IMMULITE Turbo platform with cardiac biomarker assays. The Turbo platform delivers cardiac biomarker results in less than 15 minutes, with consecutive results reported every 45 seconds. Maximum throughput is 80 tests per hour. The IMMULITE Turbo package includes the IMMULITE Test Unit Organizer, a dehumidifying accessory designed to improve productivity by conveniently storing and organizing Test Units near the IMMULITE analyzer. An ultracentrifuge that completely spins standard primary serum or plasma tubes in 2 minutes is also available, to reduce turnaround time an additional 8 to 10 minutes.

A "window on the system" is provided by way of a color-coded screen, which displays real-time sample tracking for instantaneous result status. Barcoded sample cups allow immediate sample testing with a worklist generated for an LIS interface. The robust system design and simplicity of operation make IMMULITE Turbo ideal for STAT testing in core laboratories or chest pain centers. The Turbo software offers easy switching between standard and Turbo mode.

IMMULITE Turbo assay performance
The results obtained with the IMMULITE Turbo and standard IMMULITE assays demonstrate excellent correlation. Cutoff points and extended calibration curves are equivalent in both formats-a critical feature allowing flexibility in different workflow environments. Over 4000 IMMULITE units have now been placed worldwide. Current IMMULITE system customers can improve the quality of cardiac results reported by moving cardiac testing from other systems over to the IMMULITE and adding Turbo performance with a simple software upgrade.

False-positive results due to heterophilic antibodies and rheumatoid factor (RF) have been reported with some troponin assays. DPC utilizes a blocking agent in the diluent that guards against such interference; therefore, results can be reported with confidence.

The DPC IMMULITE Turbo Troponin I assay uses a monoclonal antibody directed at a very stable portion of the troponin I protein. The resulting analytical response to these troponin complexes yields consistent sample results. As the troponin is degraded by proteases, the IMMULITE assay detects the troponin concentrations of the shifting complexes, which is important in the context of monitoring for clinically significant changes in levels.

The clinical ramifications of poor assay performance are therefore compelling and warrant cardiac biomarker selection independent of purchasing contracts or "package deals."

The IMMULITE Turbo cardiac biomarker platform represents a collaborative research and production effort involving many DPC departments. The resulting technology platform provides the highest performing cardiac biomarker system available on the market today. DPC backs the cardiac biomarker results you report to your physicians with 28 years of immunodiagnostic research and manufacturing expertise.

Consistent with the philosophy of DPC founder and CEO, Dr. Sigi Ziering, we at DPC are proud to introduce our newest application in the IMMULITE family of chemiluminescent analyzer platforms which, we hope, will truly contribute to better healthcare worldwide.

Reference

1. Wu AHB, Apple FS, Gibler WB, Jesse RL, Warshaw MM, Valdes R Jr. National Academy of Clinical Biochemistry Standards of Laboratory Practice: Recommendations for the use of cardiac markers in coronary artery diseases. Clin Chem 1999;45:1104-21.