HYDRAGEL URINE PROFIL(E)

The most complete “all-in-one” solution for proteinuria investigation by electrophoresis

Test presentation

Protein immunofixation is a well-established technique for typing any suspected monoclonal component on urine electrophoresis. It also allows the characterization of the proteinuria.

The HYDRAGEL URINE PROFIL(E) kit is used for proteinuria investigation by immunofixation on agarose gel in order to:

Detect and type Bence Jones proteins (monoclonal kappa and/or lambda free light chains) or any other monoclonal full immunoglobulin.
Type renal lesions (tubular, glomerular or mixed lesion).
Quantify the monoclonal peak.

The detection of any Bence Jones proteins or renal damage is essential for patients with multiple myeloma or other plasma cell dyscrasias.

The semi-automated HYDRASYS instrument performs the migration, the immunofixation and the staining of the agarose gels, in order to obtain protein profiles for qualitative analysis. The sensitivity of HYDRAGEL URINE PROFIL(E) permits the detection of very small monoclonal components.

A recent development on GELSCAN offers the quantification of the monoclonal protein on the ELP (Protein Electrophoresis) track.

Test principle

The HYDRAGEL URINE PROFIL(E) assay is based on the principle of agarose gel electrophoresis followed by immunofixation. After separation of urine proteins according to their charge, the gel is incubated with different specific antisera targeted against:

Low molecular weight serum proteins revealing tubular damage:
- ß2 microglobulin,
- Retinol Binding Protein (RBP)
- α1 microglobulin

High molecular weight serum proteins revealing glomerular damage:
- Heavy chains Gamma, Alpha & Mu (with a trivalent antiserum),
- Heavy chains Delta & Epsilon (with a divalent antiserum) (SM*)
- Albumin

α2 macroglobulin revealing blood contamination
Kappa (κ) and Lambda (λ) free and bound light chains
Kappa (κ) and Lambda (λ) free light chains.

The gel is then processed in order to remove unbound proteins before the final staining step. The gel is inspected visually and the monoclonal peak can be quantified by scanning the ELP track.

Performances

Sensitivity:
- The minimal detection limit is about:
  - 6 mg/L for tubular proteins
  - 3 mg/L for glomerular proteins
  - 6 mg/L for Ig D
  - 12 mg/L for Ig E
- The detection limit of the Bence Jones protein is about:
  - 20 mg/L with anti-free and bound light chains antisera
  - 50 mg/L with anti-free light chains antisera.
- According to the mobility of the monoclonal component and polyclonal background, the sensitivity may vary.
Full traceability and positive ID are obtained by connecting the HYDRASYS to the ASSIST pipetting station