Analytical characteristics of a qPCR-based molecular diagnostic assay-conceptual considerations for laboratory personnel
Tanuj Shukla
Prabhakar Rao Kaipa
Shesheer K Munpally
Rachana Tripathi
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[1].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.They are tested for proficiency using the College of American Pathologists (CAP) guidelines and Quality Control for Molecular Diagnostics (QCMD).
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论文发表日期：2014-01-01
在线出版日期：2025-08-15（本平台首次上网日期，不代表文献的发表时间）