Proficiency Testing

As a manufacturer of clinical diagnostic products, Binding Site is aware of the need for a high standard of quality in the laboratory. The IMMPROVE™ Quality Assurance Schemes, also referred to as proficiency testing, allows the laboratory to monitor the standard of their own results over time and compare them to other methods available. Participants in the scheme are located in more than 15 countries worldwide.  Binding Site offers two QA Schemes, one for Subclass testing and one for Paraprotein testing.

Laboratories may join a scheme at any time during the year. Each laboratory is allocated a reference number on registration and all reports are generated against the relevant number in order to preserve confidentiality.   

 

Binding Site IMMPROVE™ Serum Paraprotein QA Scheme - QA003

It is essential that all laboratories participate in external quality control schemes when performing monoclonal protein analysis.

Around 300 laboratories worldwide currently participate in the IMMPROVE™ Paraprotein QA Scheme. Methodologies include Serum Protein Electrophoresis (SPE), Immunofixation Electrophoresis (IFE), and a large range of nephelometric and turbidometric free light chain assays.

This scheme provides a single human serum sample six times a year for analysis of the following analytes:
·         IgG, IgA, IgM
·         Beta 2-Microglobulin
·         Free Kappa
·         Free Lambda
·         Determination of Kappa/Lambda ratio

Freelite® Serum Free Light Chain Analysis

Four samples are issued per year and results can be returned via the IMMPROVE website. A comprehensive report is returned to each laboratory, and includes photocopies of electrophoresis gels, comparisons with other laboratories' results, and an expert opinion regarding the sample and results. Participants will be able to view their Bias Index Score (BIS), Variable Index Score (VIS), Mean Running Bias Index Score (MRBIS), and Mean Running Variable Index Score (MRVIS) for both the specific method and the overall statistics. 

Example results are shown for the serum sample in QA003 distribution number 111.

Binding Site IMMPROVE™ Urine Paraprotein QA Scheme - QA006 

Two urine samples are issued per year for quality assurance of quantitative results for Freelite® Free Kappa, Free Lambda, and Free Kappa/Lambda ratio in Urine on a range of nephelometric and turbidimetric assays. In addition, qualitative paraprotein results for urine protein electrophoresis and urine immunofixation electrophoresis can be quality assured.

 

Ordering Information for the Paraprotein QA Scheme

Description Code
Paraproteins
QA Scheme Registration (4 issues)
QA003
QA Scheme Registration (2 issues) QA006
Paraproteins
Individual Serum Sample (2.0 mL)
 
BP152

 

 

More than 170 laboratories worldwide participate in the IMMPROVE™ Subclass Quality Assurance Scheme.

This scheme provides a single human serum sample six times a year for analysis of the following analytes:

  • IgG, IgA, IgM
  • IgG1, IgG2, IgG3 and IgG4
  • IgA1 and IgA2
  • Tetanus toxoid IgG
  • Diphtheria toxoid IgG
  • Pneumococcal capsular polysaccharide IgG
  • Haemophilus influenzae type b IgG

The participating laboratory is asked to run the sample provided using their routine assays and report the results obtained.

Following analysis of the results, a personalized report is sent to each laboratory. The report includes full statistical analysis of results and high quality graphical representation of the data for each analyte.

Ordering Information for the Subclass QA Scheme

Description Code

Subclass

QA Scheme Registration (6 issues)

QA001

Subclass

Individual Sample (2.0 mL)

BP150

IMMPROVE™ is a trademark of The Binding Site Group Ltd, Birmingham, UK.