BACKGROUND: Virologic surveillance is a key and complex component of the influenza surveillance s... more BACKGROUND: Virologic surveillance is a key and complex component of the influenza surveillance system, informed by a variety of independent but related elements. Specific objectives of virologic surveillance include seasonal situational awareness and determination of virus strain prevalence, early detection of novel viruses or novel events, annual vaccine strain selection, and antiviral resistance monitoring. The CDC-APHL Right Size Influenza Virologic Surveillance project was undertaken to develop a statistical, systematic approach to determining the amount of testing and system requirements needed to support disease response and control efforts and policy decisions. METHODS: A “road map” to achieving an effective virologic surveillance system has been drafted; the Influenza Virologic Surveillance Requirements Roadmap document describes the system requirements for sampling strategies, including sample size and representativeness, laboratory testing, quality systems and specimen re...
In this study, a multicenter evaluation of the Life Technologies TaqMan(®) Array Card (TAC) with ... more In this study, a multicenter evaluation of the Life Technologies TaqMan(®) Array Card (TAC) with 21 custom viral and bacterial respiratory assays was performed on the Applied Biosystems ViiA™ 7 Real-Time PCR System. The goal of the study was to demonstrate the analytical performance of this platform when compared to identical individual pathogen specific laboratory developed tests (LDTs) designed at the Centers for Disease Control and Prevention (CDC), equivalent LDTs provided by state public health laboratories, or to three different commercial multi-respiratory panels. CDC and Association of Public Health Laboratories (APHL) LDTs had similar analytical sensitivities for viral pathogens, while several of the bacterial pathogen APHL LDTs demonstrated sensitivities one log higher than the corresponding CDC LDT. When compared to CDC LDTs, TAC assays were generally one to two logs less sensitive depending on the site performing the analysis. Finally, TAC assays were generally more sensitive than their counterparts in three different commercial multi-respiratory panels. TAC technology allows users to spot customized assays and design TAC layout, simplify assay setup, conserve specimen, dramatically reduce contamination potential, and as demonstrated in this study, analyze multiple samples in parallel with good reproducibility between instruments and operators.
BACKGROUND: Virologic surveillance is a key and complex component of the influenza surveillance s... more BACKGROUND: Virologic surveillance is a key and complex component of the influenza surveillance system, informed by a variety of independent but related elements. Specific objectives of virologic surveillance include seasonal situational awareness and determination of virus strain prevalence, early detection of novel viruses or novel events, annual vaccine strain selection, and antiviral resistance monitoring. The CDC-APHL Right Size Influenza Virologic Surveillance project was undertaken to develop a statistical, systematic approach to determining the amount of testing and system requirements needed to support disease response and control efforts and policy decisions. METHODS: A “road map” to achieving an effective virologic surveillance system has been drafted; the Influenza Virologic Surveillance Requirements Roadmap document describes the system requirements for sampling strategies, including sample size and representativeness, laboratory testing, quality systems and specimen re...
In this study, a multicenter evaluation of the Life Technologies TaqMan(®) Array Card (TAC) with ... more In this study, a multicenter evaluation of the Life Technologies TaqMan(®) Array Card (TAC) with 21 custom viral and bacterial respiratory assays was performed on the Applied Biosystems ViiA™ 7 Real-Time PCR System. The goal of the study was to demonstrate the analytical performance of this platform when compared to identical individual pathogen specific laboratory developed tests (LDTs) designed at the Centers for Disease Control and Prevention (CDC), equivalent LDTs provided by state public health laboratories, or to three different commercial multi-respiratory panels. CDC and Association of Public Health Laboratories (APHL) LDTs had similar analytical sensitivities for viral pathogens, while several of the bacterial pathogen APHL LDTs demonstrated sensitivities one log higher than the corresponding CDC LDT. When compared to CDC LDTs, TAC assays were generally one to two logs less sensitive depending on the site performing the analysis. Finally, TAC assays were generally more sensitive than their counterparts in three different commercial multi-respiratory panels. TAC technology allows users to spot customized assays and design TAC layout, simplify assay setup, conserve specimen, dramatically reduce contamination potential, and as demonstrated in this study, analyze multiple samples in parallel with good reproducibility between instruments and operators.
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