March 2009: Volume 35, Number 3
Master Curve Calibration
Master curve calibration applications are now available for the quantitative determination of immuno-turbidimetric reagents on the Olympus AU680 chemistry system. Two-dimensional barcodes on reagent vials allow for automatic uploading of multi-point, lot-specific master calibration curves. The master curve calibration is currently available for use with C3, C4, transferrin, and anti-streptolysin O, immunoglobulin-A, and immunoglobulin-M reagents.
Enzymatic Lithium Test
A new, liquid-stable enzymatic lithium test is now available for the quantitative determination of lithium levels in blood samples. This lithium assay provides improved reagent stability and reduced cost-per-test, and also demonstrates no significant interference from indigenous ions and other interfering substances. The assay is compatible with most common clinical chemistry analyzers.
The new VITROS 3600 Immunodiagnostic System is a high-capacity immunoassay system featuring a broad menu of assays covering major disease states. The VITROS 3600 combines MicroWell, MircoSensor, and Intellicheck technologies into one system for high quality and reproducible results.
ORTHO CLINICAL DIAGNOSTICS
MicroRNA-Based Diagnostic Test for NSCLC
miRview squamous is a new microRNA-based diagnostic test that measures the expression level of a microRNA squamous biomarker to differentiate squamous from non-squamous cancer cells in non-small cell lung cancer patients. Current methods for differentiating squamous from non-squamous cell lung carcinomas only have accuracy in the 30% to 40% range. miRview squamous has a reported sensitivity of 97% and a specificity of 91%.
Hemoglobin A1c APT Assay
The Hemoglobin A1c APT Reagent OSR 61177 is now available for the determination of glycated hemoglobin in whole-blood samples. The assay is designed for use on the Olympus AU 680 chemistry analyzer system, featuring enhanced whole blood sampling.
Tissue of Origin Test
A new Tissue of Origin Test is now available for analyzing formalin-fixed, paraffin-embedded tissue specimens. Using microarray technology, the test measures the expression pattern of more than 1,500 genes in tumors of uncertain origins and compares the results to the expression patterns of a panel of 15 known tumor types, representing 90% of all solid tumors. In clinical validation studies, the test demonstrated 89% sensitivity and 99% specificity.
POC Test for Recurrent Bladder Cancer
The BTA stat test uses the latest POC technology for the early detection of recurrent bladder cancer. Monoclonal antibodies detect the presence of the bladder tumor-associated antigen in urine in a single-step, rapid immunochromatographic assay. The test has a specificity of 93% to 95% and a sensitivity higher than voided urine cytology. The BTA stat test is CLIA waived and available for prescription home use.