Analytical characteristics of a qPCR-based molecular diagnostic assay-conceptual considerations for laboratory personnel

摘要

Dear Editor:Quantitative real-time PCR has revolutionized molecular diagnostics with its ease of use,increased sensitivity and specificity and low turnaround time.PCR/quantitative PCR(qPCR)-based assays offer a distinct advantage over other serological/conventional diagnostic approaches^([7-10]).The ability to diagnose infectious diseases has benefited from the availability of US FDA approved and Conformite Europeenne(CE)-marked qPCR-based in-vitro diagnostic kits from international companies.The high-quality kits are calibrated with the World Health Organization(WHO)reference standards and the National Institute for Biological Standards and Control(NIBSC)standards.