Product Manual (.pdf)

Description

This ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative determination of human anti-human IgG antibody (HAHA) levels in patient serum or plasma samples. It detects both HAHA-IgG and HAHA-IgM subtypes. This test might be used as an aid in the detection of patients with positive HAHA that may affect prescribed diagnosis and treatment involving humanized monoclonal antibody.

This ELISA kit is for in-vitro diagnostic use.

Background

Clinically, humanized monoclonal antibodies (IgG) and their fragments are used in treatment for patients with various diseases. In patients, even a single dose injection of humanized monoclonal antibody may induce immune response directed against this foreign protein (immunogen).

Individuals with autoimmune diseases, such as rheumatoid arthritis, lupus, etc. produce autoantibodies against human IgG. In circulation, the presence of human antibody against human IgG would bind to the injected humanized antibody therapeutics and therefore diminish the efficacy of either in-vivo diagnosis or treatment. HAHA is likely to increase the risk of anaphylactic complications to subsequent administration of the humanized monoclonal antibody-based therapy.

The presence of HAHA in patient serum or plasma specimens causes both false positive and false negative immunoassay test results depending on assay principles and monoclonal antibodies used in the assay system.

Specifications

Catalog no.

Target:

Species

Method

Tests Per Kit

Detection

Sensitivity / LLOD

Dynamic Range

Total Incubation Time

Sample Type

Sample Volume

Storage Temperature

KT-806

Human anti-human IgG/IgM

Human

Sandwich ELISA

96 tests

Colorimetric

0.1 µg/mL

0 - 27 µg/mL

1 hours, 50 minutes

Serum, plasma

25 µL

2-8 °C