National Physical Laboratory

Immunoassay development and verification

Bio-diagnostics 

NPL has expertise in the development and validation of immunoassays for various applications including biopharmaceutical production and clinical chemistry. Currently the immunoassay laboratories are run at Category 2 safety level in which we routinely analyse blood, serum and plasma samples. In the future we plan to be able to offer this service at Category 3 safety level subject to prior consultation.

Immunoassays can be developed for various applications using many detection methods including:

  • Absorbance
  • Fluorescence
  • Chemiluminescence
  • Electrochemistry
  • SERS

Where required, uncertainty analysis can be performed on the immunoassay technique to provide an uncertainty budget for the assay and give confidence in the final concentration estimations of the method.

Examples of work carried out for external customers in the immunoassay area include:

  • NPL carried out a comparison of a number of commercial Protein A ELISA kits for the detection of carry-over materials in biopharmaceutical quality control. This contract was carried out for the US Pharmacopoeia to analyse candidate Protein A reference material.

  • NPL is currently developing the cardiac Troponin I (cTnI) Reference Measurement Procedure for the IFCC. This is an important part of the international drive to improve standardisation of this important cardiac biomarker.

Contact

Customer Service tel: +44 20 8943 8637
E-mail: biodiagnostics_enquiries@npl.co.uk

Last Updated: 18 Aug 2015
Created: 7 May 2009

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