Complement system Classical Pathway WIESLAB®

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The increased awareness and interest in the complement system has augmented the need for a simple and objective method to assess the function of complement activity.

With the Euro Diagnostica complement assay solution a complete picture of the complement function is provided.

Complement System Website

Read more about the complement system, details related to the diagnostics, treatment and multiple applications on our new dedicated Complement System Website!

 

Product code
COMPL CP310
Format
ELISA
Tests
Break apart microtitration strips (12x8) 96 wells
Calculation
Qualitative
Calibrators
Refer
Incubation time
60+30+30 min
Detection system
405 nm
Availability
CE marked. Available in US only for research use, not for IVD use

Intended use

The Wieslab® COMPL CP310 is an enzyme immunoassay for the qualitative determination of functional classical complement pathway in human serum.

FOR IN VITRO DIAGNOSTIC USE.

This product is also available as research use only. Product code: COMPL CP310 RUO

For complete product description, claims and use, please refer to the Instructions For Use. Contact your local representative for availability in your country.

Background

The complement system plays an essential role in chronic, autoimmune and infectious disease. There are three pathways of complement activation, namely the classical, the alternative and the MBL pathway.

Impaired complement activity causes humans to become susceptible to repetitive fulminant or severe infections and may contribute to development of autoimmune disease. Inappropriate activation of complement contributes to chronic inflammation and tissue injury.

Technical information

The Wieslab® Complement assay combines principles of the hemolytic assay for complement activation with the use of labeled antibodies specific for neoantigen produced as a result of complement activation. The amount of neoantigen generated is proportional to the functional activity of complement pathways.

In the Complement Screen CP kit, the wells of the microtitre strips are coated with specific activators of the classical pathway. Patient serum is diluted in diluent containing specific blocker to ensure that only the Classical pathway is activated. During the incubation of the diluted patient serum in the wells, complement is activated by the specific coating.

The wells are then washed and C5b-9 is detected with a specific alkaline phosphatase labelled antibody to the neoantigen expressed during MAC formation.

After a further washing step, detection of specific antibodies is obtained by incubation with alkaline phosphatase substrate solution. The amount of complement activation correlates with the colour intensity and is measured in terms of absorbance (optical density (OD)).

Kit components and storage of reagents

- One frame with blue coloured break-apart wells (12x8) sealed in a foil pack with a desiccation sachet. The wells have been coated with human IgM.

- 35 mL Diluent CP (Dil CP), labelled blue.

- 13 mL conjugate containing alkaline phosphatase-labelled antibodies to C5b-9 (blue colour).

- 13 mL Substrate solution ready to use.

- 30 mL wash solution 30x concentrated.

- 0,2 mL negative control (NC) containing human serum. (to be  diluted as for a patient serum sample).

- 0,2 mL positive control (PC) containing freezed dried human serum, see “Reconstitution of positive control”, in the IFU.

 

All reagents in the kit are ready for use except washing solution and controls. The reagents should be stored at 2-8° C except the positive control. The positive control should be stored at -20° C.