Flu A/B + RSV

Influenza (Flu) A and B together with respiratory syncytial virus (RSV) are among the main causes of respiratory infections during the winter months. It is estimated that these viruses infect 5-10 % of the world’s population

annually. Children and the elderly are particularly at risk and their infections can be severe. As an optimal diagnostic tool to detect influenza and RSV reliably and quickly GenomEra® Flu A/B + RSV can play a major role in the prevention of epidemics, with their associated deaths and costs to society.

GenomEra is a simple-to-use platform without RNA-extraction to detect and differentiate influenza A, influenza B, RSV A and RSV B in a multiplexed RT-PCR assay. RT-PCR is the most reliable method for detecting influenza and RSV and it is nowadays regarded as the golden standard. Reliable and fast results mean reduced costs through improved patient management and isolation practices.

The GenomEra Flu A/B + RSV assay is validated for nasal, nasal + throat or nasopharyngeal swab specimens collected into liquid transport media, or nasopharyngeal aspirate specimens from patients with signs and symptoms of respiratory infection. Assay reports influenza A, influenza B, RSV A and RSV B results separately.

Clinical performance

The performance characteristics of the assay were evaluated at five institutions across Europe during 2018/2019 influenza season. Over 1200 individual samples were included in evaluations and used reference methods were CE IVD approved nucleic acid amplifications tests.

Overall accuracy: 99.4%

Analyte PPA
(sensitivity)

NPA
(specificity)

Accuracy
Influenza A 97.1% 99.8% 98.8%
Influenza B 100% 100% 100%
RSV 98.0% 99.8% 99.6%

Assay procedure

1. Vortex the original sample for
5 seconds. Pipette 50 μl of the specimen into the bottom of the GenomEra® Resp SPC tube
2. Close the sample tube and heat the sample for 5 minutes at 90 °C. 3. Empty the contents of the 1 ml Buffer Ampoule into the sample tube. 4. Vortex the sample briefly, pipette 35 μl of the sample to the Test Chip and start the assay.

GenomEra Flu A/B + RSV Brochure