Principles of the xTAG™ respiratory viral panel assay (RVP Assay)

Abstract

Multiplexed nucleic assays enable the simultaneous detection of multiple analytes and minimize the cost per result while maintaining high analytical and clinical sensitivity and specificity. The Luminex bead microarray based Universal array platform delivers on these desirable characteristics for both genotyping and infectious disease based assays. The platform utilizes a validated array comprised of 100 spectrally distinct beads, each of which is coupled to a unique oligonucleotide primer sequence comprising the Luminex Universal array (Bortolin et al., 2004). The use of this array for clinical genotyping has been well documented (Bortolin et al., 2004; Strom et al., 2005; Zhu et al., 2007) and most recently its utility for infectious disease testing has been exemplified (Mahony et al., 2007). Generally genotyping assays require the amplification and interrogation of all alleles present in the test. Infectious disease testing on the other hand, as is the case for the Luminex xTAGTM RVP assay, generally detects the presence of one or more target sequences when present in a clinical sample. The xTAGTM RVP assay provides clinicians with new tools with greater sensitivity and specificity and improved positive and negative predictive values in detecting respiratory viruses compared to current infectious disease diagnostic laboratory standards which rely upon culture and fluorescence techniques. By providing broader target coverage in the same assay, multiplexing methods obviate the diagnostic doubt that occurs when a symptomatic patient tests negative by less comprehensive methods. The Luminex Molecular Diagnostics (LMD) Respiratory Viral Panel (xTAGTM RVP) is a multiplexed nucleic acid assay covering almost all viruses and some subtypes associated with respiratory or influenza-like-illness. It is based on LMD’s proprietary universal array platform and allows detection of 20 distinct respiratory viruses and subtypes