Controls and Standards

Infectious Disease Immunoassay Control and Calibration

Infectious diseases remain among the most important threats to public health. The role of IVD manufacturers in developing trustworthy assays for diagnosing infections has never been more critical. Reliable calibration and quality control materials are essential in this effort.

Conventional techniques of quality control and calibration of infectious disease immunoassays require collecting and processing large volumes of blood from previously infected individuals, which is costly and time-consuming. To help overcome these challenges we have developed a line of human monoclonals as sustainable and reliable substitute for antibodies found in source plasma or patient samples.

Our human monoclonal antibodies can free you from the effort and expense of

• Continually searching for plasma or serum units with desired antibodies
• Titration and validation of plasma or serum pools
• Defibrination, filtration and other processing steps

  Enjoy security of supply and minimal processing costs by relying on human monoclonals made under cGMP in industrial cell culture volumes.

Toxoplasma p30 antigen IgM
Toxoplasma p30 antigen IgG
Rubella E1 antigen IgM
Rubella E1 antigen IgG
CMV p65 antigen IgM
Hepatitis A VP1 antigen IgM
Hepatitis B p22 antigen IgM

For more information please refer to our data sheet.

Human Infectious Disease Antibodies From Cell Culture

View our scientific poster presented at AACC 2014

New materials for Hepatitis A and Hepatitis B IgM Immunoassay Calibration and Quality Control

BIOSCOT® FFMU Intermediates

We offer human monoclonal antibodies for further manufacturing use (FFMU) which can be used in the formulation of both calibrators and positive controls by manufacturers of diagnostic kits for the detection of IgM or IgG disease state antibodies. These in vitro-produced, standardized products offer an unlimited and consistent raw material supply of antibody which requires no pre-production processing.