CDC STACKS serves as an archival repository of CDC-published products including scientific findings, journal articles, guidelines, recommendations, or other public health information authored or co-authored by CDC or funded partners.
As a repository, CDC STACKS retains documents in their original published format to ensure public access to scientific information.
i
Analytical evaluation of the microarray-based FluChip-8G Influenza A+B Assay
-
July 02 2019
-
-
Source: J Virol Methods. 2019; 273:113686
[PDF-959.59 KB]
Details:
-
Alternative Title:J Virol Methods
-
Personal Author:
-
Description:Background
Influenza causes a significant annual disease burden, with characterization of the infecting virus important in clinical and public health settings. Rapid immunoassays are fast but insensitive, whereas real-time RT-PCR is sensitive but susceptible to genetic mutations and often requires multiple serial assays. The FluChip-8G Influenza A+B Assay provides type and subtype/lineage identification of influenza A and B, including non-seasonal A viruses, in a single microarray-based assay with same day turnaround time.
Objective
To evaluate key analytical performance characteristics of the FluChip-8G Influenza A+B Assay.
Study design
Analytical sensitivity, cross-reactivity, and multi-site reproducibility were evaluated.
Results
The limit of detection (LOD) for the FluChip-8G influenza A+B Assay ranged from 5.8 × 102–1.5 × 105 genome copies/mL, with most samples ∼2 × 103 genome copies/mL (∼160 genome copies/reaction). Fifty two (52) additional strains were correctly identified near the LOD, demonstrating robust reactivity. Two variant viruses (H1N1v and H3N2v) resulted in dual identification as both “non-seasonal influenza A” and A/H1N1pdm09. No reproducible cross-reactivity was observed for the 34 organisms tested, however, challenges with internal control inhibition due to crude growth matrix were observed. Lastly, samples tested near the LOD showed high reproducibility (97.0% (95% CI 94.7–98.7)) regardless of operator, site, reagent lot, or testing day.
Conclusion
The FluChip-8G Influenza A+B Assay is an effective new method for detecting and identifying both seasonal and non-seasonal influenza viruses, as revealed by good sensitivity and robust reactivity to 52 unique strains of influenza virus. In addition, the lack of cross-reactivity to non-influenza pathogens and high lab-to-lab reproducibility highlight the analytical performance of the assay as an alternative to real-time RT-PCR and sequencing-based assays. Clinical validation of the technology in a multi-site clinical study is the subject of a separate investigation.
-
Subjects:
-
Source:
-
Pubmed ID:31271790
-
Pubmed Central ID:PMC6779046
-
Document Type:
-
Funding:
-
Volume:273
-
Collection(s):
-
Main Document Checksum:
-
Download URL:
-
File Type:
Supporting Files
-
jpeg 
gif 
jpeg 
gif 
jpeg 
gif 
jpeg 
gif 
jpeg 
xml 
gif 
pdf 
gif 
jpeg 
gif 
jpeg 
gif 
jpeg 
gif
