Sigma-Aldrich Corporation (NASDAQ: SIAL) today announced that the Cerilliant® brand within its Applied Diagnostics and Testing business segment now offers the first-ever reference solutions for qualitative evaluation of drug interferences in a testing laboratory's analytical methods. These seven multi-component solution mixes contain more than 50 of the most routinely monitored over-the-counter (OTC) and prescription drugs. Cerilliant offers the seven mixes separately or as a kit for added convenience.
Regulations for drug bioanalysis, including the Clinical Laboratory Improvement Amendments (CLIA), as well as the US FDA Bioanalytical Method Validation Guidance, state that manufacturers of laboratory-developed tests (LDTs) must determine the effect of interfering substances during design, development, and validation of an analytical method.1,2 The presence of interfering substances, which often includes drugs and their metabolites, impacts measurement accuracy of the analyte of interest.1,2 Interfering compounds originate from many sources including sample matrix, contaminants inadvertently introduced during handling or sample preparation, and samples from patients on multiple drug regimens.1,2
The importance of identifying interfering substances is critical for numerous testing applications ranging from therapeutic drug monitoring (TDM), confirmatory drug testing, and forensic analysis to bioavailability (BA)/bioequivalence (BE) and pharmacokinetic (DMPK) studies.