HCC-REAAD™ ERBB3 ELISA Kit

HCC-REAAD™ ERBB3 ELISA (Hepatocellular Carcinoma -Recombinant Antigen-Antibody Detection) is intended for qualitative and semi-quantitative detection of human epidermal growth factor receptor 3 (ERBB3) proteins in human plasma/serum samples. The test utilizes sandwich ELISA using two layers of antibodies (i.e, capture and detection antibody) to determine a subject’s ERBB3 proteins levels in plasma/serum samples.

HCC-REAAD™ ERBB3 ELISA incorporating the use of algorithm, is for hepatocellular carcinoma research. Combining the levels of ERBB3 protein determined using HCC-REAAD™ ERBB3 ELISA and levels of AFP (e.g. Elecsys AFP) together with the age of the individual into a mathematical algorithm (binary logistic regression), which enables as a better aid in the determination of HCC as comparing to using AFP alone.

Liver Cancer is the sixth most common cancer malignancy in the world with 83% of cases occurring in less developed countries. Liver Cancer is the second leading cause of cancer death worldwide. The highest estimated mortality rates are in Eastern and South-Eastern Asia. Hepatocellular Carcinoma (HCC) is the most common type of liver cancer, accounting for at least 70% of the total liver cancer cases. HCC was once prevalently only in Southeast Asia and Africa due to dietary intake of aflatoxin contaminated food grains. However, in recent years, an increase of HCC incidences is discovered in Europe and United States. Higher levels of ERBB3 proteins were detected in subjects with HCC as compared to non-HCC subjects.

The number of reagents is sufficient for 4 optimal runs.

• Ready to use, 12 strips x 8 microwells coated with Human ERBB3 capture antibody
• Wash Buffer Concentrate
• Ready to use Diluent
• Recombinant ERBB3 protein Standard
• Detection Ab
• Streptavidin conjugated with horseradish peroxidase
• Positive Control
• Negative Control
• TMB
• Stop solution
• Reseal-able bag for unused microwells

MEASURING RANGE 195.31 ‑ 20,000.00 RU (defined by the Limit of Quantification and the maximum of the master curve). Values below the Limit of Quantification are reported as < 195.31 RU. Values above the measuring range are reported as > 20,000.00 pmol/L.

The detection limits stated above define the lowest and highest quantifiable analyte concentration using the calibration curve. ERBB3 concentration of 195.31 RU or 20,000.00 RU should be incorporated into the algorithm if results fall below or above the calibration curve, respectively, and could not be quantifiable.