Instrument Manufacturers
Certify your performance
Modern lab instrumentation is incredibly sophisticated. Advances in technology have automated many processes, boosting productivity and workflow efficiency. However, even the most cutting edge diagnostic equipment and reagent systems require accurate calibration that is traceable to a base of reference.
CEQAL provides instrument manufacturers with CDC Certificates of Traceability for the measurement of lipids to identify patients at risk for coronary artery disease. In addition, we offer fresh human serum samples, target value assignment, as well as troubleshooting and other performance checks to ensure your analytical systems meet the highest level of accuracy.
CDC Manufacturer Certification for TC, HDL, LDL
CEQAL is a member of the CDC’s CRMLN and works with instrument manufacturers to meet the CDC’s accuracy requirements for certification of Total Cholesterol, HDL Cholesterol and LDL Cholesterol. Our fresh and frozen human serum lipid samples can be used for pre-certification assessment of existing systems or evaluation of new systems prior to performing full certification. These commutable samples can also serve as an accuracy base when new lots of calibrators, materials or reagents are introduced. Visit the CDC online to learn more about the Manufacturer Certification Program. Or download the list of analytical systems certified for Total Cholesterol, HDL or LDL.
See how certification can give you a competitive edgeSample procurement
Developing or adapting reagent systems often requires recalibrating to a defined base of reference. CEQAL can source individual patient samples covering the clinical range of interest for a particular analyte. These samples may be used in developing new testing methods, in transferring a method from one instrument to another, or in the performance assessment of an existing method.
Target value assignment
Samples used in the calibration process are often not commutable because they contain artificial substances that lead to matrix effects. We can confirm the transferability of stabilized calibrators and controls by providing individual donor serum samples with target values assigned by our credentialed reference methods or by other means of verification.
Interference studies
Elevated concentrations of biological and non-biological substances can interfere with the measurement of certain analytes. It is therefore important to check your analytical methods using elevated levels of possible interferents, such as bilirubin and triglycerides. CEQAL can provide you with these and other samples for your interference studies.