title: Comparative analytical evaluation of the respiratory TaqMan Array Card with real-time PCR and commercial multi-pathogen assays.
abstract: 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.
authors.affiliation: Battelle Technical On-Site Professional Services, Atlanta, GA, 30329 USA; Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA, 30329-4027 USA. Electronic address: xba6@cdc.gov.
authors.forename: John J
authors.initials: JJ
authors.lastname: Harvey
authors.affiliation: Association of Public Health Laboratories, Silver Spring, MD, 20904 USA.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Chester
authors.affiliation: Battelle Technical On-Site Professional Services, Atlanta, GA, 30329 USA; Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA, 30329-4027 USA.
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Burke
authors.affiliation: Battelle Technical On-Site Professional Services, Atlanta, GA, 30329 USA; Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA, 30329-4027 USA.
authors.forename: Marisela
authors.initials: M
authors.lastname: Ansbro
authors.affiliation: Battelle Technical On-Site Professional Services, Atlanta, GA, 30329 USA; Association of Public Health Laboratories, Silver Spring, MD, 20904 USA.
authors.forename: Tricia
authors.initials: T
authors.lastname: Aden
authors.affiliation: Hawaii Department of Health State Laboratories, Pearl City, HI, 96782 USA.
authors.forename: Remedios
authors.initials: R
authors.lastname: Gose
authors.affiliation: Hawaii Department of Health State Laboratories, Pearl City, HI, 96782 USA.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Sciulli
authors.affiliation: Iowa State Hygienic Laboratory, Coralville, IA, 52241 USA.
authors.forename: Jing
authors.initials: J
authors.lastname: Bai
authors.affiliation: Iowa State Hygienic Laboratory, Coralville, IA, 52241 USA.
authors.forename: Lucy
authors.initials: L
authors.lastname: DesJardin
authors.affiliation: Iowa State Hygienic Laboratory, Coralville, IA, 52241 USA.
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Benfer
authors.affiliation: William A. Hinton State Laboratory Institute, Jamaica Plain, MA, 02130 USA.
authors.forename: Joshua
authors.initials: J
authors.lastname: Hall
authors.affiliation: William A. Hinton State Laboratory Institute, Jamaica Plain, MA, 02130 USA.
authors.forename: Sandra
authors.initials: S
authors.lastname: Smole
authors.affiliation: William A. Hinton State Laboratory Institute, Jamaica Plain, MA, 02130 USA.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Doan
authors.affiliation: Wadsworth Center, New York State Department of Health, Albany, NY, 12201-0509 USA.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Popowich
authors.affiliation: Wadsworth Center, New York State Department of Health, Albany, NY, 12201-0509 USA.
authors.forename: Kirsten
authors.initials: K
authors.lastname: St George
authors.affiliation: Wadsworth Center, New York State Department of Health, Albany, NY, 12201-0509 USA.
authors.forename: Tammy
authors.initials: T
authors.lastname: Quinlan
authors.affiliation: Wadsworth Center, New York State Department of Health, Albany, NY, 12201-0509 USA.
authors.forename: Tanya A
authors.initials: TA
authors.lastname: Halse
authors.affiliation: Washington State Public Health Laboratories, Shoreline, WA, 98155-7224 USA.
authors.forename: Zhen
authors.initials: Z
authors.lastname: Li
authors.affiliation: Washington State Public Health Laboratories, Shoreline, WA, 98155-7224 USA.
authors.forename: Ailyn C
authors.initials: AC
authors.lastname: Pérez-Osorio
authors.affiliation: Washington State Public Health Laboratories, Shoreline, WA, 98155-7224 USA.
authors.forename: William A
authors.initials: WA
authors.lastname: Glover
authors.affiliation: Washington State Public Health Laboratories, Shoreline, WA, 98155-7224 USA.
authors.forename: Denny
authors.initials: D
authors.lastname: Russell
authors.affiliation: Wisconsin State Laboratory of Hygiene, Madison, WI, USA.
authors.forename: Erik
authors.initials: E
authors.lastname: Reisdorf
authors.affiliation: Wisconsin State Laboratory of Hygiene, Madison, WI, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Whyte
authors.affiliation: Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA, 30329-4027 USA.
authors.forename: Brett
authors.initials: B
authors.lastname: Whitaker
authors.affiliation: Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA, 30329-4027 USA.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Hatcher
authors.affiliation: Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA, 30329-4027 USA.
authors.forename: Velusamy
authors.initials: V
authors.lastname: Srinivasan
authors.affiliation: Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA, 30329-4027 USA.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Tatti
authors.affiliation: Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA, 30329-4027 USA.
authors.forename: Maria Lucia
authors.initials: ML
authors.lastname: Tondella
authors.affiliation: Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA, 30329-4027 USA.
authors.forename: Xin
authors.initials: X
authors.lastname: Wang
authors.affiliation: Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA, 30329-4027 USA.
authors.forename: Jonas M
authors.initials: JM
authors.lastname: Winchell
authors.affiliation: Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA, 30329-4027 USA.
authors.forename: Leonard W
authors.initials: LW
authors.lastname: Mayer
authors.affiliation: Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA, 30329-4027 USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Jernigan
authors.affiliation: Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Atlanta, GA, 30329-4027 USA.
authors.forename: Alison C
authors.initials: AC
authors.lastname: Mawle
mesh_terms: D001419:Bacteria / Q000235:genetics / Q000302:isolation & purification; D002487:Centers for Disease Control and Prevention, U.S.; D006801:Humans; D044085:Microfluidics / Q000379:methods / Q000592:standards; D020411:Oligonucleotide Array Sequence Analysis / Q000592:standards*; D060888:Real-Time Polymerase Chain Reaction / Q000295:instrumentation / Q000379:methods* / Q000592:standards*; D015203:Reproducibility of Results; D012141:Respiratory Tract Infections / Q000175:diagnosis / Q000382:microbiology / Q000821:virology; D012680:Sensitivity and Specificity; D014481:United States; D014780:Viruses / Q000235:genetics / Q000302:isolation & purification
keywords: Analytical techniques; Comparative studies; Microfluidics; PCR; Respiratory pathogens