Controls, Linearity & Proficiency Panels
To expand manufacturing capabilities, Bioresource Technology has recently increased the size of our production facility. Bioresource Technology has also expanded our services to the diagnostic industry. Our R & D, technical, and quality assurance staff assists in the development of products based on your specifications and needs, including custom and OEM formulations of controls, calibrators, linearity and proficiency testing materials. Click on any of the product links to see a sample Certificate Of Analysis.
With two 510K approved control products and several others in the pipeline, BRT offers an excellent OEM opportunity for control development and manufacture. Our control products have been developed with the knowledge we have gained working with human plasma, serum and other control matrices over the past 25 years. BRT has the capability to make small validation batches or large manufacturing runs filled, capped, and labeled with our in house fully automated filling line.
Linearity & Proficiency Panels
In addition to manufacturing serum pools for use as base materials for controls and calibrators, BRT has the personnel, expertise, and experience needed to provide proficiency testing materials and related services to CMS approved Interlaboratory Comparison Proficiency Testing Programs (“PT Programs”). Proficiency testing materials are unknown samples that are used in evaluating the performance of laboratories in testing for those analytes included in the PT Program surveys. Proficiency materials available from BRT include serum chemistry, Therapeutic Drug Monitoring (TDM), immunoassay, urinalysis, cardiac markers, lipids, glycated hemoglobin, and other specialty samples.
The Bioresource Technology Linearity Sets satisfy the requirements for semiannual assessment of linearity and calibration verification required by CLIA. Verification of the analytical measurement range is required for laboratory accreditation. CLIA requires calibration verification for most analytes. Linearity and calibration verification materials provide a means to identify linearity and precision problems with automated systems before a failure in a graded proficiency testing survey occurs.
BRT Linearity sets are liquid and easy to use and cover broad ranges to cover the assay range from near zero to the top of the analytical measurement range for most clinical analyzers. Linearity sets are available for Cardiac markers, Lipids, Serum Chemistry, TDM, Urine Chemistry including microalbumin, HbA1c, Ammonia and Ethanol.
Linearity sets are available as OEM products and not held in stock.