CAPI 3 IMMUNOTYPING 

Fully automated immunological identification of monoclonal proteins by capillary electrophoresis

Test presentation

CAPI 3 IMMUNOTYPING kit allows the immunological identification of monoclonal components in human serum. This test is fully automated on CAPILLARYS 3 TERA instruments.

CAPILLARYS 3 TERA instruments perform all sequences automatically, from sample dilution to migration, in order to obtain protein profiles for qualitative analysis. Profiles are visually interpreted to screen for any pattern abnormalities.

The combination of the CAPI 3 IMMUNOTYPING kit with the CAPI 3 PROTEIN(E) 6 buffer allows the detection and identification of monoclonal components.

 

Test principle

The CAPI 3 IMMUNOTYPING assay is based on the principle of capillary electrophoresis in free solution. Serum proteins are separated in silica capillaries by their electrophoretic mobility and electroosmotic flow at high voltage in an alkaline buffer. Proteins are directly detected during migration by UV absorbance.

Serum proteins are mixed with specific antisera directed against:

  • Gamma- (IgG),  Alpha- (IgA),  Mu- (IgM) heavy chains
  • Kappa (κ) and Lambda (λ) free and bound light chains

Immunoglobulins specifically react with their corresponding antiserum. At the end of the analysis, each antiserum pattern (IgG, IgA, IgM, κ and λ) is automatically overlaid with the ELP (Protein Electrophoresis) curve.

Disappearance of the abnormality in the antiserum-treated pattern indicates the presence of a monoclonal protein.

Performances

  • Throughput: from 11 immunotyping tests/h for CAPILLARYS 3 TERA stand alone to 33 immunotyping tests/h with CAPILLARYS 3 TERA MC configuration
  • Sensitivity:
    • Internal study has demonstrated that a monoclonal protein can be detected at a concentration as low as 12.5 mg/dL in serum. According to the mobility of the monoclonal component and polyclonal background, the sensitivity may vary.
  • Full traceability and positive sample ID for primary tube samples
  • Full traceability and reagent management through RFID tags for both reagents and antisera
  • On board antisera vials kept at cool temperature
  • Full automation
  • Color-coded backlit reagent containers 

Kit description

CAPI 3 IMMUNOTYPING (PN 2600) kit content:

  • RFID sample diluent vial
  • RFID rack holding with ELP solution and antiserum tubes:
    • color-coded anti-IgG, -IgA, -IgM, -κ (free and bound), –λ (free and bound)
    • 60 immunotyping tests

Related products and accessories not provided in the kit:

  • Quality controls:
    • Normal control serum (PN 4785)
    • Hypergamma control (PN 4787)
    • IT/IF control (PN 4788)
  • CAPI 3 DISPOSABLES KIT (PN 2580)
  • CAPI 3 PROTEIN(E) 6 (PN 2503)
  • FLUIDIL (PN 4587)
  • CAPICLEAN CAPILLARYS 3 (PN 2060)
  • CAPIprotect (2 x 5L) (PN 2061)

compatible Instruments

CAPILLARYS 3 TERA

CAPILLARYS 3 TERA MC*

CAPILLARYS 3 TERA TLA*

CAPILLARYS 3 OCTA*

* Under development

NOTE: Contact your Sebia representative to verify the product availability in your country.