Analytical characterization of an assay designed to detect and identify diverse agents of disseminated viral infection.
BACKGROUND
Diverse viruses often reactivate in or infect cancer patients, patients with immunocompromising infections or genetic conditions, and transplant recipients undergoing immunosuppressive therapy. These infections can disseminate, leading to death, transplant rejection, and other severe outcomes.


OBJECTIVE
To develop and characterize an assay capable of inclusive and accurate identification of diverse potentially disseminating viruses directly from plasma specimens.


METHODS
We developed a PCR/electrospray ionization mass spectrometry (PCR/ESI-MS) assay designed to simultaneously detect and identify adenovirus, enterovirus, polyomaviruses JC and BK, parvovirus B19, HSV-1, HSV-2, VZV, EBV, CMV, and herpesviruses 6-8 in plasma specimens. The assay performance was characterized analytically, and the results from clinical plasma samples were compared to the results obtained from single-analyte real time PCR tests currently used in clinical practice.


RESULTS
The assay demonstrated sensitivity and specificity to diverse strains of the targeted viral families and robustness to interfering substances and potentially cross reacting organisms. The assay yielded 94% sensitivity when testing clinical plasma samples previously identified as positive using standard-of-care real-time PCR tests for a single target virus (available samples included positive samples for 11 viruses targeted by the assay).


CONCLUSIONS
The assay functioned as designed, providing simultaneous broad-spectrum detection and identification of diverse agents of disseminated viral infection. Among 156 clinical samples tested, 37 detections were made in addition to the detections matching the initial clinical positive results.
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States. Electronic address: david.l.metzgar@abbott.com.
David
D
Metzgar
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.
Robert
R
Lovari
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.
Keith
K
Ray
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.
Darcie
D
Baynes
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.
Darren
D
Drapp
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.
Mark
M
Frinder
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.
Roy
R
Vijesurier
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.
Michelle
M
Stemler
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.
Reuben
R
Ofsaiof
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.
Heather
H
Carolan
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.
Joseph
J
Welk
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.
Donna
D
Toleno
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.
Raymond
R
Ranken
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.
Thomas A
TA
Hall
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.
Christian
C
Massire
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.
Rangarajan
R
Sampath
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.
Lawrence B
LB
Blyn
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.
Jon
J
Goveia
Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.
George
G
Schneider
D006801:Humans; D057230:Limit of Detection; D057089:Pathology, Molecular / Q000379:methods*; D016133:Polymerase Chain Reaction; D015203:Reproducibility of Results; D014766:Viremia / Q000175:diagnosis* / Q000821:virology*; D014773:Virology / Q000379:methods*; D014780:Viruses / Q000145:classification / Q000235:genetics / Q000302:isolation & purification
Antiviral; Clinical virology; Disseminated infection; Immunocompromised; Molecular diagnostics; Viremia