The use of external positive controls has become an essential tool for quality systems in diagnostic and blood screening laboratories. bioQControl (multi-marker) positive controls are calibrated in proficiency testing and will react at approximately 2-3 times the cut off value. Such controls have proved to be instrumental in the independent monitoring of the technical performance of assay runs and the quality of IVD reagent batches. A wide range of (multi-marker) run controls can be manufactured for meaningful use in different test systems and reagent combinations. Serological run controls are safe for laboratory workers. The methods used to inactivate the serum standards proved to be efficacious in the vaccine and plasma industry. The run controls are available in liquid format. The applied matrix is negative human serum with merthiolate as preservative. The HBsAg concentrations in the run controls are calibrated in IU (WHO standard) and nanograms (PEI standard) to be compatible with the regulatory requirements for IVDs.
The run controls are custom made. You can use the enquiry form for the definition of the control the turnaround time for is around 12 weeks after the issuing of your order when the control is not yet defined. For the major blood screening automates we have defined list products.
Summary products characteristics.
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Available for HBsAg, anti-HBc, anti-HCV, anti-HIV-1, anti-HTLV-I and anti-Treponema pallidum (other markers on request)
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Expected reactivity at 2-3 times the cut-off
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Matrix is equal to human serum
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Available in custom made formats
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Serum standards are available in sufficient quantities to guarantee long term supply of run controls
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All serum standards are effectively inactivated
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Should not be used for evaluation of diagnostic sensitivity
