Solid-tumor biomarker
Hepatocellular Carcinoma HCC-REAAD
A diagnostic biomarker offering associated with hepatocellular carcinoma on the former site.
Product overview
What it is.
- Restalyst HCC-REAAD™ ERBB3 ELISA: an in-vitro diagnostic for the qualitative and semi-quantitative detection of ERBB3 (HER-3) in human serum or plasma, intended for early detection of hepatocellular carcinoma.
- ERBB3 (patented) is reported to be elevated in the serum or plasma of hepatocellular-carcinoma patients.
- An algorithm (binary logistic regression) combining ERBB3 and AFP is presented as improving on routine screening with AFP alone.
How it works
A sandwich ELISA. Capture antibodies coated on the microwell bind ERBB3 in the sample; biotinylated detection antibodies and HRP-conjugated secondary antibodies are added, and a TMB substrate turns into a colour signal proportional to the antigen present. Wells are read on any suitable spectrophotometer or ELISA reader.
Specifications
Key figures.
- Sensitivity
- 91.1%
- Specificity
- 91.3%
- Inter-assay precision
- 2.16% – 2.87%
- Intra-assay precision
- 6.37% – 8.10%
- Sample type
- Serum / plasma
- Assay duration (approx.)
- 2.0 hours
- Patient sample volume
- <10 µL
- Shelf life
- 9 months
- Certification
- CE-IVD certified; HSA (Singapore) registered
Portfolio information
From the original portfolio.
The legacy description references an ERBB3 ELISA assay and an algorithm involving AFP. The precise intended use needs verification.
This page preserves the former site’s product information for review. It does not establish current Canadian availability, approved indications, performance, or prescribing information. Request verified documentation before relying on it.
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