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Proficiency, Run - control Panels

 
 

Founding of bioQControl

Since 1992 Sanguine (CLB) Diagnostic services, DDL Diagnostic Laboratory (DDL) and SKML (dutch foundation for quality assurance in medical laboratories) have been involved in a scientific program for quality control on nucleic acid testing and serology as manufacturing site, co-author scientific papers and neutral office for proficiency testing. By the end of 2004 the scientific collaboration was stopped. We believe there is a need for a science based quality control program in blood banks and medical laboratories. The former organizers of the collaboration have decided to continue the scientific program under the name bioQControl to relate to history but also broaden the scope of the program to all infectious disease agents. We strongly believe in the concept combining data analysis, proficiency testing, validation testing and daily control of performance into one system. The results of a continuous program will be instrumental in defining the performance of assays and laboratories.

Product and services

  • Sensitivity panels for validation of assays and batch release control of IVDs. A typical nucleic acid sensitivity panel starts at 3000 copies/ml and end at 0.1 copy/ml and comprises 10 different dilutions. The concentration range is suitable for defining the analytical sensitivity of both quantitative and qualitative nucleic acid tests. The product is available for all blood borne viruses covering the common genotypes. For serology we are developing meaningful panels that can control both analytical and diagnostic sensitivity.

  • Run controls for monitoring sensitivity and accuracy of nucleic acid assays. Run controls should be dedicated to your assay system. Using our knowledge we can create valuable run controls. The bioQControl run controls are custom made products. For quantitative assays a concentration should be chosen which is in the linear range of the assay or represent a clinical decision point. Controls to monitor the sensitivity of qualitative assays have concentrations at 3 times 95% hit rate for the check control and at the 95 % hit rate as trend control.

  • Run controls for monitoring consistency of serological assays. The bioQControl run controls are custom made products dedicated for your test systems. Concentrations have a level with an expected result at 2-3 times the cut-off value. We can provide the controls in a liquid or lyophilized serum matrix. Serological run controls for HBsAg, HIV-Ag and HCV-Ag can also be used for controlling the sensitivity of the assay. Antigen controls do not contain the corresponding antibodies.

  • Quantification panels for validation of assays, training and batch release control of IVDs. Depending on the natural history we have chosen 5 quantitated concentrations that are valuable for controlling quantitative assays. The panels should not be used to replace internal calibrators. Quantification is done in copies/ml and a relation to the International standards is given. The genotypes used for the panels are common in the western world. We can prepare custom made panels based on other genotypes.

  • Internet accessible databases are made available for peer review of test results using appropriate statistics.

  • We are involved in development of quality control measures in the field of Human Papilloma virus testing. Diagnostic tools needs to be harmonized to ensure results of different studies are commutable. The panels will enable the community to compare assays and to establish algorithms for diagnosis.
 

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