Why choose our test?

The GenomEra^® SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit is a new and improved version of Uniogen’s GenomEra^® SARS-CoV-2, Flu A/B + RSV Assay Kit. It is intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), influenza A and B, and respiratory syncytial virus (RSV) from individuals with symptoms of a respiratory viral infection—now with an even faster and safer workflow.

Key benefits of version 2.0

• Improved sensitivity and specificity
• Inactivation of viruses during sample collection
• Wider usability of different sample collection media
• Quicker workflow: shorter hands-on time and reduced assay time

SARS-CoV-2 is the cause of the COVID-19 pandemic that was designated a public health emergency by the World Health Organization (WHO) in March 2020.^1,2 While COVID-19 still poses a global health threat, other common seasonal respiratory viruses continue to circulate in the population. The RNA viruses SARS-CoV-2, influenza A, influenza B, and RSV all cause acute respiratory infections with similar clinical manifestations, ranging from an asymptomatic or mild illness in most individuals to a more severe and life-threatening disease.^3,4 Infection management and treatment strategies, however, differ from one pathogen to another.

Differentiation between SARS-CoV-2 and the other common respiratory viruses is thus crucial for ensuring correct and timely infection control and treatment measures. The WHO recommends the use of sensitive nucleic acid amplification assays, such as reverse transcriptase polymerase chain reaction (RT-PCR), for guiding the diagnosis of SARS-CoV-2, influenza, and RSV in symptomatic patients.^6-9

Key facts

• Simultaneous detection and differentiation of SARS-CoV-2, influenza A and B, and RSV from a single respiratory specimen
• Safety guaranteed with specimen collection directly in Copan eNAT inactivating medium
• Automated and rapid RT-PCR testing—results for four samples in just 50 minutes

Assay principle

The GenomEra SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit is a rapid and easy-to-use multiplex RT-PCR test for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A and B, and RSV nucleic acids from a single respiratory specimen on the GenomEra^® CDX System. The assay utilizes real-time RT-PCR and hydrolysis probes to detect and amplify the unique sequence regions of SARS-CoV-2 RNA-dependent RNA polymerase (RdRP), influenza A matrix (M), influenza B hemagglutinin (HA), and RSV nucleocapsid (N) protein-coding genes from upper respiratory swab specimens collected in Copan eSwab, Universal Transport Medium (UTM), or phosphate buffered saline (PBS).

Sample preparation in the GenomEra SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit is simple with minimal hands-on time—only three minutes for one sample and less than five minutes for four samples. The samples can be collected directly in a Copan eNAT inactivating medium for sample lysis. Pre-loaded and sealed GenomEra Test Chips contain all the reagents needed for RT-PCR, and the results are automatically reported by the GenomEra Software in just 50 minutes.

• The GenomEra SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit is intended to aid the diagnosis of SARS-CoV-2, influenza A/B, and RSV infections in humans when used in conjunction with clinical evaluation, laboratory findings, and epidemiological information. Positive results indicate the presence of viral target RNA in the sample, while negative results do not preclude SARS-CoV-2, influenza A, influenza B and/or RSV infection and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Clinical performance

The clinical performance of the GenomEra SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit was evaluated at four institutions across Europe during February-April 2022 (Table 1). Study specimens consisted of fresh and frozen respiratory swab specimens collected in eSwab, UTM, PBS, or similar transport media from patients with signs and symptoms of a respiratory infection. The reference assays used were different in-house or commercial RT-PCR assays developed for SARS-CoV-2, influenza, and RSV detection.

Table 1. The GenomEra SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit shows excellent specificity and sensitivity in clinical respiratory specimens. PPA, positive percent agreement; NPA, negative percent agreement (NPA).

Analyte	Sample size (n)	PPA, %	NPA, %
SARS-CoV-2	749	98.4	100
Influenza A	749	98.3	100
Influenza B	749	100	100
RSV	749	94.4	100

Ordering information

To place an order, please contact your local distributor.

Product name	Product code
GenomEra SARS-CoV-2, Flu A/B + RSV 2.0
20 tests	CDX-160-01-20
100 tests	CDX-160-01-100
GenomEra CDX System	CDX-10-020

The GenomEra SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit has received the European CE marking for In Vitro Diagnostic (IVD) medical devices according to the requirements of EU Directive 98/79/EC (IVDD) and is available in European markets. In other markets, please contact your local distributor for availability. The product is manufactured by Uniogen, Finland.

References

1. Wolfel R, Corman VM, Guggemos W, et al. Virological assessment of hospitalized patients with COVID-2019. Nature 2020. PMID: 32235945.
2. World Health Organization. WHO Director General’s opening remarks at the media briefing on COVID-19 – 11 March, 2020.
3. Ding Q, Lu P, Fan Y, Xia Y, Liu M. The clinical characteristics of pneumonia patients coinfected with 2019 novel coronavirus and influenza virus in Wuhan, China. J Med Virol 2020. PMID: 32196707.
4. Zhang N, Wang L, Deng X, et al. Recent advances in the detection of respiratory virus infection in humans. J Med Virol 2020;92(4):408−417.
5. Lian J., Jin X., Hao S., Cai H., Zhang S., Zheng L. Analysis of epidemiological and clinical features in older patients with corona virus disease 2019 (COVID-19) out of Wuhan. Clin Infect Dis 2020 Jul 28;71(15):740−747.
6. Diagnostic testing for SARS-CoV-2. World Health Organization (WHO). Interim guidance 11 September 2020.
7. WHO information for molecular diagnosis of influenza virus – update. 6th revision on January 2020.
8. WHO Global Influenza Surveillance Network. Manual for the laboratory diagnosis and virological surveillance of influenza. ISBN 9789241548090. .
9. Centers for Disease Control and Prevention (CDC). Respiratory Syncytial Virus Infection (RSV). For Healthcare Professionals.