Cerilliant offers first-ever multi-component solutions for qualitative evaluation of drug interference

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.