Simulated Respiratory Secretion for Use in the Development of Influenza Diagnostic Assays. PLoS One 2016;11(11):e0166800
Date
11/22/2016Pubmed ID
27870895Pubmed Central ID
PMC5117718DOI
10.1371/journal.pone.0166800Scopus ID
2-s2.0-84995923573 (requires institutional sign-in at Scopus site) 6 CitationsAbstract
Many assays have been developed for the detection of influenza virus which is an important respiratory pathogen. Development of these assays commonly involves the use of human clinical samples for validation of their performance. However, clinical samples can be difficult to obtain, deteriorate over time, and be inconsistent in composition. The goal of this study was to develop a simulated respiratory secretion (SRS) that could act as a surrogate for clinical samples. To this end, we determined the effects major respiratory secretion components (Na+, K+, Ca2+, cells, albumin IgG, IgM, and mucin) have on the performance of influenza assays including both nucleic acid amplification and rapid antigen assays. Minimal effects on the molecular assays were observed for all of the components tested, except for serum derived human IgG, which suppressed the signal of the rapid antigen assays. Using dot blots we were able to show anti-influenza nucleoprotein IgG antibodies are common in human respiratory samples. We composed a SRS that contained mid-point levels of human respiratory sample components and studied its effect compared to phosphate buffered saline and virus negative clinical sample matrix on the Veritor, Sofia, CDC RT-PCR, Simplexa, cobas Liat, and Alere i influenza assays. Our results demonstrated that a SRS can interact with a variety of test methods in a similar manner to clinical samples with a similar impact on test performance.
Author List
Bose ME, McCaul KC, Mei H, Sasman A, He J, Kramp W, Shively R, Yan K, Henrickson KJAuthors
Michael Bose Research Scientist I in the Pediatrics department at Medical College of WisconsinKelly J. Henrickson MD Professor in the Pediatrics department at Medical College of Wisconsin
Ke Yan PhD Associate Professor in the Pediatrics department at Medical College of Wisconsin
MESH terms used to index this publication - Major topics in bold
A549 CellsAlgorithms
Biomarkers
Early Diagnosis
Humans
Influenza A virus
Influenza B virus
Influenza, Human
Models, Biological
Molecular Diagnostic Techniques
Nasopharynx
Sensitivity and Specificity
Viral Core Proteins